Page last updated: 2024-12-10

montelukast

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Description

montelukast: a leukotriene D4 receptor antagonist [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID5281040
CHEMBL ID787
CHEBI ID50730
CHEBI ID94710
SCHEMBL ID4486
SCHEMBL ID4487
MeSH IDM0247416

Synonyms (78)

Synonym
BIDD:GT0394
bdbm50052024
AB01275454-01
{1-[({(1r)-1-{3-[(e)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl}-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl}sulfanyl)methyl]cyclopropyl}acetic acid
{1-[({(1r)-1-{3-[(e)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl}-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl}sulfanyl)methyl]cyclopropyl}acetic acid
CHEBI:50730 ,
158966-92-8
montelukast
C07482
DB00471
(r-(e))-1-(((1-(3-(2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetic acid
1-[[[(1 r)-1-[3-[(1e)-2-(7-chloro-2-quinolinyl)ethenyl] phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]sulfanyl]methyl]cyclopropaneacetic acid
cyclopropaneacetic acid, 1-((((1r)-1-(3-((1e)-2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)-
cyclopropaneacetic acid, 1-(((1-(3-(2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)-, (r-(e))-
1-((((1r)-1-(3-((1e)-2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetic acid
montelukast [inn:ban]
HMS2089D07
CHEMBL787 ,
brondilat
montelukast (inn)
brondilat (tn)
D08229
NCGC00188977-01
2-[1-[[(1r)-1-[3-[(e)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanylmethyl]cyclopropyl]acetic acid
aerokast
hsdb 7582
unii-mhm278sd3e
mhm278sd3e ,
2-[1-[[(1r)-1-[3-[(e)-2-(7-chloro-2-quinolyl)vinyl]phenyl]-3-[2-(1-hydroxy-1-methyl-ethyl)phenyl]propyl]sulfanylmethyl]cyclopropyl]acetic acid
cis-montelukast
2-[1-({[(1r)-1-{3-[(e)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl}-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanyl}methyl)cyclopropyl]acetic acid
gtpl3340
BRD-K99673372-001-01-9
AKOS025310659
montelukast [inn]
montelukast [hsdb]
montelukast [who-dd]
(1-((((1r)-1-(3-((e)-2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropyl)acetic acid
montelukast [vandf]
cyclopropaneacetic acid, 1-((((1r)-1-(3-((e)-2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)-
montelukast [mi]
CCG-221186
SCHEMBL4486
SCHEMBL4487
UCHDWCPVSPXUMX-TZIWLTJVSA-N
(r,e)-2-(1-(((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propyl)thio)methyl)cyclopropyl)acetic acid ,
DTXSID9023334 ,
sr-01000763441
SR-01000763441-5
SR-01000763441-3
CHEBI:94710
r-(e)-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid
HY-13315A
CS-0002595
cyclopropaneacetic acid, 1-[[[(1r)-1-[3-[(1e)-2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]-
HMS3715N13
142522-28-9
Q417767
mk0476 (free acid)
1124196-02-6
cyclopropaneacetic acid,1-[[[(1r)-1-[3-[(1e)-2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]-
HMS3886L03
BS-49158
(r,e)-2-(1-(((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propyl)thio)methyl)cyclopropyl)aceticacid
(r)-2-(1-(((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propyl)thio)methyl)cyclopropyl)acetic acid
S5783
mfcd05662278
montelukast racemate
montelukast- bio-x
BM164608
2-[1-({[(1r)-1-{3-[2-(7-chloroquinolin-2-yl)ethenyl]phenyl}-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanyl}methyl)cyclopropyl]acetic acid
EN300-20599903
2-[1-({[(1r)-1-{3-[(1e)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl}-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanyl}methyl)cyclopropyl]acetic acid
EN300-1644598
(1-((((1r)-1-(3-((e)-2-(7-chloroquinolin-2-yl)ethenyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propyl)sulfanyl)methyl)cyclopropyl)acetic acid
montelukastum
r03dc03
dtxcid403334

Research Excerpts

Overview

Montelukast is an antagonist of cysteinyl leukotriene receptor 1 (CysLTR1) that protects against inflammation and oxidative stress. It is widely used to treat chronic asthma and allergic rhinitis.

ExcerptReferenceRelevance
"Montelukast is a cysteinyl leukotriene receptor 1 (CysLTR1) antagonist widely used to suppress the inflammatory response in asthma and allergic rhinitis. "( Montelukast attenuates interleukin IL-1β-induced oxidative stress and apoptosis in chondrocytes by inhibiting CYSLTR1 (Cysteinyl Leukotriene Receptor 1) and activating KLF2 (Kruppel Like Factor 2).
Li, Z; Ma, Y; Wang, J, 2021
)
3.51
"Montelukast is an antagonist of the LT-B4 receptor."( Efficacy, tolerability, and safety of montelukast versus finasteride for the treatment of moderate acne in women: A prospective, randomized, single-blinded, active-controlled trial.
Goldust, M; Gupta, A; Mohammadnezhad, F; Rokni, GR; Saeedi, M; Sandhu, S; Shadi, S; Sharma, A, 2021
)
1.61
"Montelukast is a medicine indicated for use in asthma. "( Montelukast and Nightmares: Further Characterisation Using Data from VigiBase.
Attalla, M; Kaminsky, E; Taavola, H; Watson, S; Yue, QY, 2022
)
3.61
"Montelukast (MTK) is an antagonist of the cysteinyl leukotrienes receptor 1 widely used to manage asthma symptoms among adults and children. "( The mechanisms underlying montelukast's neuropsychiatric effects - new insights from a combined metabolic and multiomics approach.
Justino, GC; Marques, CF; Marques, MM, 2022
)
2.46
"Montelukast is a leukotriene inhibitor that is widely used to treat chronic asthma and allergic rhinitis. "( Montelukast as a potential treatment for COVID-19.
McCarthy, MW, 2023
)
3.8
"Montelukast is an antagonist of cysteinyl leukotriene receptor 1 (CysLTR1) that protects against inflammation and oxidative stress. "( Montelukast prevents mice against carbon tetrachloride- and methionine-choline deficient diet-induced liver fibrosis: Reducing hepatic stellate cell activation and inflammation.
Cao, F; Pu, S; Ren, C; Wang, Y; Wu, Y; Yang, S; Zhang, J; Zhou, H, 2023
)
3.8
"Montelukast is a highly selective and specific cysteinyl leukotriene receptor antagonist used in the treatment of asthma. "( Efficacy and safety of montelukast adjuvant therapy in adults with cough variant asthma: A systematic review and meta-analysis.
Lu, T; Song, Z; Wu, Y; Xu, Q; Yang, K; Zhang, L; Zhang, Z; Zhu, P, 2023
)
2.66
"Montelukast (MK) is a selective cysteinyl leukotriene receptor (Cys LT1) antagonist."( Montelukast influence on kidney in experimental induced diabetes mellitus.
Gales, C; Nechifor, M; Rusu-Zota, G; Stoica, B, 2023
)
3.07
"Montelukast sodium is an anti-asthmatic agent and leukotriene receptor antagonist used in the treatment of respiratory disorders."( A Review of Different Analytical Techniques for Fexofenadine Hydrochloride and Montelukast Sodium in Different Matrices.
Kumar, V; Nalini, CN, 2021
)
1.57
"Montelukast is a leukotriene receptor antagonist that is mainly used in the management of asthma."( Montelukast ameliorates Concanavalin A-induced autoimmune hepatitis in mice via inhibiting TNF-α/JNK signaling pathway.
Abdelrahman, RS; El-Kashef, DH, 2020
)
2.72
"Montelukast is a cysteinyl leukotriene receptor antagonist licensed to treat asthma and allergic rhinitis."( The association between obesity and poor outcome after COVID-19 indicates a potential therapeutic role for montelukast.
Almerie, MQ; Kerrigan, DD, 2020
)
1.49
"Montelukast sodium is an effective and well-tolerated anti-asthmatic drug. "( lncRNA PCGEM1 strengthens anti-inflammatory and lung protective effects of montelukast sodium in children with cough-variant asthma.
Guo, W; Meng, L; Xie, Y; Xu, Z, 2020
)
2.23
"Montelukast is a leukotriene receptor antagonist that is known to prevent allergic rhinitis and asthma. "( Montelukast alleviates inflammation in experimental autoimmune encephalomyelitis by altering Th17 differentiation in a mouse model.
Guo, XY; Han, B; Li, X; Rasouli, J; Rostami, A; Wang, LB; Wu, WC; Xiao, Y; Ye, SM; Ye, ZQ; Zhang, Y; Zhang, YY; Zhu, L, 2021
)
3.51
"Montelukast is an oral, once a day, easy to give therapy but there is no definite evidence to support its use in a recent meta-analysis."( Role of montelukast in multitrigger wheezers attending chest clinic in Punjab, India.
Arora, K; Bhargava, S; Bhat, D; Dhooria, GS; Gill, KS; Kahlon, GK; Pooni, PA, 2021
)
1.78
"Montelukast (MK) is a safe asthma controller drug, which is considered as a potential antiviral drug for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)."( Montelukast and Coronavirus Disease 2019: A Scoping Review.
Qorbani, M; Salekmoghadam, S; Sharafian, S; Sharifinejad, N; Tavakol, M, 2021
)
2.79
"Montelukast is an effective control treatment for preschool children who had asthma symptoms more than once a month but less than once a week."( Early control treatment with montelukast in preschool children with asthma: A randomized controlled trial.
Fujisawa, T; Fukuda, N; Habukawa, C; Ikeda, M; Katsunuma, T; Kitamura, T; Nagao, M, 2018
)
2.21
"Montelukast is a leukotriene receptor antagonist used in asthma and rhinitis treatment. "( Montelukast use-a 19-year nationwide drug utilisation study.
Christiansen, A; Damkier, P; Davidsen, JR; Hallas, J; Henriksen, DP; Laursen, CB; Pottegård, A, 2017
)
3.34
"Montelukast sodium is a leukotriene-receptor antagonist approved as a controller medication for chronic asthma and allergic rhinitis in children and adults. "( Adverse events are rare after single-dose montelukast exposures in children.
Arnold, DH; Bowman, N; Hartert, TV; Reiss, TF; Seger, DL, 2018
)
2.19
"Montelukast is a selective cysteinyl leukot-riene receptor 1 (cysLT1R) antagonist, which has been used for the treatment of bronchial asthma in clinics."( Antagonism of cysteinyl leukot-riene receptor 1 (cysLT1R) by montelukast regulates differentiation of MC3T3-E1 cells under overloaded mechanical environment.
Chen, S; Chu, J; Feng, B; Guo, W; Huang, C; Wei, J; Yang, S, 2018
)
1.44
"Montelukast is a selective cysteinyl leukotrienes receptor 1 (cysLT1R) antagonist used clinically for the treatment of asthma, as it reduces eosinophilic inflammation in airways."( The cysteinyl leukotriene receptor 1 (CysLT1R) antagonist montelukast suppresses matrix metalloproteinase-13 expression induced by lipopolysaccharide.
Chen, S; Chu, J; Feng, B; Guo, W; Huang, C; Wei, J; Yang, S, 2018
)
1.45
"Montelukast is a selective leukotriene D-4 receptor antagonist, which specifically and reversibly inhibits cysteinyl leukotriene-1 receptor. "( The protective effect of Montelukast against skeletal muscle ischemia reperfusion injury: An experimental rat model.
Altun, G; Bilgiç, Mİ; Çakıcı, H; Gideroğlu, K; Saka, G, 2018
)
2.23
"Montelukast is a cysteinyl leukotriene receptor 1 (CysLTR1) antagonist clinically used for the treatment of asthma."( Montelukast inhibits RANKL‑induced osteoclast formation and bone loss via CysLTR1 and P2Y12.
Kang, JH; Lee, DS; Lim, H; Yim, M, 2018
)
2.64
"Montelukast is an anti-asthmatic medication, and has recently showed its inhibitory effects on the proliferation of cancers. "( Montelukast enhances cytocidal effects of carfilzomib in multiple myeloma by inhibiting mTOR pathway.
Tong, J; Wu, C; Wu, Y; Xu, W; Yan, H; Yu, Q; Yu, W, 2019
)
3.4
"Montelukast is a selective and orally active leukotriene D"( Effects of montelukast on human nasal mucosa.
Cheng, LH; Chu, YH; Lee, JC; Lin, YY; Wang, HW; Wu, PC, 2019
)
2.35
"Montelukast is a selective reversible cysteinyl-leukotriene type 1 receptor antagonist used in clinical practice for its anti-inflammatory effects."( Colonic anastomosis can be protected from ischemia reperfusion injury with intra-peritoneal Montelukast treatment.
Akbaba, S; Bostancı, T; Cimen, S; Ersoy, PE; Sayin, T; Yildirim, Z, 2020
)
1.5
"Montelukast is a selective cys-LT 1 receptor antagonist that can suppress atherosclerotic diseases."( Montelukast, a Cysteinyl Leukotriene Receptor 1 Antagonist, Induces M2 Macrophage Polarization and Inhibits Murine Aortic Aneurysm Formation.
Kawai, Y; Komori, K; Narita, Y; Usui, A; Yamawaki-Ogata, A, 2019
)
2.68
"Montelukast is a leukotrien receptor antagonist used for asthma treatment. "( Bioequivalence study of montelukast tablets in healthy Pakistani volunteers.
Abbas, M; Amin, S; Ashraf, M; Khan, AM; Riffat, S; Waheed, N, 2013
)
2.14
"Montelukast (MK) is a potent cysteinyl-leukotriene receptor antagonist that causes dose-related improvements in chronic asthma. "( Protective effect of high-dose montelukast on salbutamol-induced homologous desensitisation in airway smooth muscle.
Breschi, MC; Calderone, V; Daniele, S; Fogli, S; Martelli, A; Martini, C; Stefanelli, F; Testai, L; Trincavelli, ML, 2013
)
2.12
"Montelukast is an anti-asthmatic drug, a selective reversible cysteinyl leukotriene D4 receptor antagonist."( Histopathologic evaluation of anti-ulcerogenic effect of montelukast in indomethacin-induced experimental ulcer model.
Cadırcı, E; Ozbakış-Dengiz, G; Yurdakan, G, 2013
)
1.36
"Montelukast which is a leukotriene receptor type I inhibitor has variable efficacy in children with AR and the guidelines recommend its use in children with seasonal AR aged six years and above."( Effectiveness of montelukast in pediatric patients with allergic rhinitis.
Altintas, D; Cingi, C; Oghan, F; Rondon, C; Yilmaz, O, 2013
)
1.45
"Montelukast is an orally administered leukotriene receptor antagonist commonly used in managing childhood atopic illnesses and theoretically safe for use in patients with renal failure."( Montelukast: a novel therapeutic option in eosinophilic peritonitis.
Forbes, TA; Lunn, AJ, 2014
)
2.57
"Montelukast (MON) is a cysteinyl leukotriene receptor antagonist."( Renoprotective effects of montelukast, a cysteinyl leukotriene receptor antagonist, against methotrexate-induced kidney damage in rats.
Abdel-Raheem, IT; Khedr, NF, 2014
)
1.42
"Montelukast is a conventional medication used to treat allergic rhinitis and asthma."( Effects of thymoquinone and montelukast on sinonasal ciliary beat frequency.
Chen, B; Cingi, C; Cohen, NA; Palmer, JN; Unlu, H; Uz, U,
)
1.15
"Montelukast is an antiinflammatory drug with an antioxidant property. "( Montelukast inhibits pentylenetetrazol-induced seizures in rats.
Aksoy, D; Cevik, B; Erbas, O; Solmaz, V, 2015
)
3.3
"Montelukast (MT) is a leukotriene D4 antagonist. "( Investigation of the bioequivalence of montelukast chewable tablets after a single oral administration using a validated LC-MS/MS method.
Abualhasan, MN; Bustami, R; Ghazal, N; Mousa, A; Watson, DG; Zaid, AN, 2015
)
2.13
"Montelukast sodium is a leukotriene antagonist of growing interest as an alternative therapy for asthma across different age groups due to its bronchoprotective, anti-inflammatory and anti-allergic properties. "( Montelukast medicines of today and tomorrow: from molecular pharmaceutics to technological formulations.
Almeida Paz, FA; Barbosa, JS; Braga, SS, 2016
)
3.32
"Montelukast (MK) is a selective cysLT1 receptor antagonist, with anti-inflammatory and anti-proliferative properties, which has been used for treatment of various diseases."( Electrosprayed Montelukast/poly (lactic-co-glycolic acid) particle based coating: A new therapeutic approach towards the prevention of in-stent restenosis.
Mhaisalkar, PS; Prabhakaran, MP; Ramakrishna, S; Varshosaz, J; Zamani, M, 2016
)
1.51
"Montelukast (MK) is a selective cysLT1 receptor antagonist, with anti-inflammatory and anti-proliferative properties. "( Electrosprayed Montelukast/poly (lactic-co-glycolic acid) particle based coating: A new therapeutic approach towards the prevention of in-stent restenosis.
Mhaisalkar, PS; Prabhakaran, MP; Ramakrishna, S; Varshosaz, J; Zamani, M, 2016
)
2.23
"Montelukast is an effective treatment for asthma and allergic rhinitis (AR), and an ODT formulation became available in Japan in 2015."( Early patient experiences with montelukast orally disintegrating tablets in Japan: a cross-sectional survey of treatment satisfaction in patients with asthma and/or allergic rhinitis.
Petigara, T; Rasouliyan, L; Tobe, K; Tunceli, K; Whalley, D, 2017
)
1.46
"Montelukast is a licensed drug approved by the Food and Drug Administration (FDA) and clinically used for the treatment of asthma by reducing the eosinophilic inflammation in the airway."( Montelukast inhibits oxidized low-density lipoproteins (ox-LDL) induced vascular endothelial attachment: An implication for the treatment of atherosclerosis.
Di, X; Tang, X, 2017
)
2.62
"Montelukast is a potent leukotriene-receptor antagonist administered once daily that provides clinical benefit in the treatment of asthma and allergic rhinitis in children and adults. "( Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions.
Bisgaard, H; Boza, ML; Knorr, B; Newcomb, K; Noonan, G; Reiss, TF; Skoner, D; Tozzi, CA, 2009
)
2.09
"Montelukast is an effective and well-tolerated alternative to ICS treatment in patients with mild asthma who are uncontrolled or unsatisfied with low-dose ICS therapy."( Montelukast as an alternative to low-dose inhaled corticosteroids in the management of mild asthma (the SIMPLE trial): an open-label effectiveness trial.
Kaplan, A; Koch, C; McIvor, RA; Sampalis, JS,
)
3.02
"Montelukast (Singulair) is a selective leukotriene receptor antagonist (LTRA) indicated for the maintenance treatment of asthma. "( Montelukast use during pregnancy: a multicentre, prospective, comparative study of infant outcomes.
Avgil, M; Berkovich, M; De Santis, M; Diav-Citrin, O; Einarson, A; Kalra, S; Koren, G; Lavigne, SV; Sarkar, M; Smorlesi, C; Ying, A, 2009
)
3.24
"Montelukast is a drug that improves the disease-specific quality of life in patients being treated for persistent allergic rhinitis better than placebo."( Effects of montelukast on quality of life in patients with persistent allergic rhinitis.
Cingi, C; Ozlugedik, S, 2010
)
2.19
"Montelukast is a valid alternative to ICS especially in poorly compliant preschool children, or in subjects who show adverse effects related to long-term steroid therapy."( Update on leukotriene receptor antagonists in preschool children wheezing disorders.
De Stefano, S; Di Giorgio, A; Maglione, M; Manna, A; Montella, S; Santamaria, F, 2012
)
1.1
"Montelukast (MK) is a leukotriene receptor (CysLT1) antagonist that has been shown to prevent exacerbation of asthma."( Montelukast inhibits leukotriene stimulation of human dendritic cells in vitro.
Adamko, DJ; Ilarraza, R; Wu, Y, 2012
)
2.54
"Montelukast is a cysteinyl leukotriene receptor antagonist that exerts an anti-inflammatory and antioxidant influence."( Cysteinyl leukotriene receptor antagonist montelukast ameliorates acute lung injury following haemorrhagic shock in rats.
Al-Amran, FG; Hadi, NR; Hashim, AM, 2013
)
1.38
"Montelukast (MKST) is a leukotriene receptor antagonist that has been concomitantly used with inhaled corticosteroids (ICS) for its steroid-sparing effect in the long-term management of asthma. "( Simultaneous determination of montelukast as sparing therapy with some inhaled corticosteroids in plasma of asthmatic patients.
Ahmed, S; Atia, NN, 2013
)
2.12
"Montelukast is a leukotriene receptor antagonist that is effective in the treatment of allergic rhinitis and asthma. "( A rare adverse effect of montelukast treatment: ecchymosis.
Aypak, C; Görpelioğlu, S; Solmaz, N; Türedi, Ö; Yıkılkan, H, 2013
)
2.14
"Montelukast is a specific cysteinyl-leukotriene receptor1 antagonist without known effects on the pulmonary vessels, which in theory should be advantageous with respect to gas exchange."( Effects of montelukast on physical performance and exercise economy in adult asthmatics with exercise-induced bronchoconstriction.
Bjermer, L; Sandsund, M; Steinshamn, S; Sue-Chu, M, 2002
)
1.43
"Montelukast (Singulair) is an antiasthmatic agent that has the chemical structure of a quinoline. "( [Pharmacological profile and clinical effects of montelukast sodium (Singulair chewable tablet), an antiasthmatic agent].
Nishikibe, M; Suzuki, J, 2002
)
2.01
"Montelukast is a potent and selective antagonist of the cysteinyl leukotriene receptor used for the treatment of asthma."( A semi-automated 96-well protein precipitation method for the determination of montelukast in human plasma using high performance liquid chromatography/fluorescence detection.
Fisher, AL; Kitchen, CJ; Musson, DG; Wang, AQ; Yang, AY, 2003
)
1.27
"Montelukast is a leukotriene receptor antagonist recently approved for the treatment of seasonal allergic rhinitis (SAR)."( Fluticasone propionate aqueous nasal spray provided significantly greater improvement in daytime and nighttime nasal symptoms of seasonal allergic rhinitis compared with montelukast.
Arastu, R; Baidoo, CA; Faris, MA; Howland, WC; Klein, KC; Philpot, EE; Ratner, PH; Rickard, KA, 2003
)
1.23
"Montelukast is an inhibitor of CysLT and also has been shown to decrease eosinophil counts in peripheral blood and sputum of patients with asthma."( Montelukast inhibits interleukin-5 mRNA expression and cysteinyl leukotriene production in ragweed and mite-stimulated peripheral blood mononuclear cells from patients with asthma.
Frieri, M; Huang, CY; Therattil, J; Wang, SF; Wang, YC,
)
2.3
"Montelukast is a cysteinyl leukotriene receptor antagonist which is used as a preventive treatment for persistent asthma in patients > or =2 years of age. "( Spotlight on montelukast in asthma in children 2 to 14 years of age.
Muijsers, RB; Noble, S, 2002
)
2.13
"Montelukast is an effective and well-tolerated preventative treatment for asthma and allergic rhinitis in adults and children."( A review of montelukast in the treatment of asthma and allergic rhinitis.
Nayak, A, 2004
)
1.42
"Montelukast is a cysteinyl leukotriene receptor antagonist approved for the treatment of asthma for those ages 1 year old to adult. "( Pharmacokinetics of montelukast in asthmatic patients 6 to 24 months old.
Deutsch, P; Hartford, A; Kearns, GL; Knorr, B; Migoya, E; Tozzi, CA; van Adelsberg, J; Zhao, J, 2004
)
2.09
"Montelukast is a potent leukotriene receptor antagonist effective for treating asthma symptoms in adult and pediatric patients. "( Montelukast in asthmatic patients 6 years-14 years old with an FEV1 > 75%.
Becker, A; Knorr, B; Reiss, T; Swern, A; Tozzi, CA; Yu, Q, 2004
)
3.21
"Montelukast is an effective, well-tolerated treatment for asthma in routine practice. "( The national montelukast survey.
Barnes, N; Price, D; Tate, H; Thomas, M, 2005
)
2.14
"Montelukast is a cysteinyl leukotriene antagonist, which also reduces sputum and blood eosinophils."( Failure of montelukast to reduce sputum eosinophilia in high-dose corticosteroid-dependent asthma.
Duong, M; Efthimiadis, A; Hargreave, FE; Jayaram, L; Kamada, D; Pizzichini, E; Pizzichini, MM, 2005
)
1.44
"Montelukast is a cys-LT antagonist that significantly improves asthma control in corticosteroid-treated asthmatic patients."( Effect of montelukast on exhaled leukotrienes and quality of life in asthmatic patients.
Barnes, PJ; Biernacka, HM; Biernacki, WA; Kharitonov, SA, 2005
)
1.45
"Montelukast is a widely used controller agent in childhood asthma. "( Effect of montelukast on peripheral airflow obstruction in children with asthma.
Covar, RA; Gelfand, EW; Gleason, M; Jain, N; Shimamoto, R; Spahn, JD; Szefler, SJ, 2006
)
2.18
"Montelukast is a leukotriene receptor antagonist (LTRA) currently licensed for the treatment of asthma."( Montelukast in the treatment of HIV associated immune reconstitution disease.
Breen, RA; Hardwick, C; Lipman, M; Monteiro, EF; Morris, E; White, D, 2006
)
2.5
"Montelukast is an antagonist of cys-leukotriene receptors used mainly in the treatment of asthma- and seasonal-allergic rhinitis. "( A double-blind, placebo-controlled trial of montelukast in adult atopic eczema.
Barclay, G; Berth-Jones, J; Friedmann, PS; Hotchkiss, K; Ogboli, M; Palmer, R; Tan, E, 2007
)
2.04
"Montelukast is a viable treatment option for women with vulvar vestibulitis. "( Improvement in vulvar vestibulitis with montelukast.
Fisher, L; Kamdar, N; MacNeill, C, 2007
)
2.05
"Montelukast is a potent cysteinyl leukotriene-1 receptor antagonist possessing some anti-inflammatory effects although the molecular mechanism of these anti-inflammatory effects is unknown. "( Montelukast inhibits tumour necrosis factor-alpha-mediated interleukin-8 expression through inhibition of nuclear factor-kappaB p65-associated histone acetyltransferase activity.
Adcock, IM; Jazrawi, E; Moodley, T; Rovati, GE; Tahan, F, 2008
)
3.23
"Montelukast (MLK) is a cysteinyl leukotriene receptor-1 (cysLT(1)R) antagonist with inhibitory effects on eosinophils, key proinflammatory cells in asthma. "( Montelukast inhibition of resting and GM-CSF-stimulated eosinophil adhesion to VCAM-1 under flow conditions appears independent of cysLT(1)R antagonism.
Kashanin, D; O'Dowd, F; Robinson, AJ; Walsh, GM; Williams, V, 2008
)
3.23
"Montelukast is a relatively large anionic inhibitor that exhibits a tripartite structure and complements the size and shape of the active-site cavity."( Determinants of cytochrome P450 2C8 substrate binding: structures of complexes with montelukast, troglitazone, felodipine, and 9-cis-retinoic acid.
Dansette, PM; Johnson, EF; Sansen, S; Schoch, GA; Stout, CD; Yano, JK, 2008
)
1.29
"Montelukast is a selective antagonist of the leukotriene D4 (LTD4) receptor. "( Montelukast.
Faulds, D; Markham, A, 1998
)
3.19
"Montelukast is a cysteinyl leukotriene1 (CysLT1) receptor antagonist which improves asthma control; the aim of this study was to investigate its effect on induced sputum eosinophils."( Montelukast reduces airway eosinophilic inflammation in asthma: a randomized, controlled trial.
Boulet, LP; Efthimiadis, AE; Hargreave, FE; Hendeles, L; Leff, JA; Pizzichini, E; Reiss, TF; Wei, LX; Zhang, J, 1999
)
2.47
"Montelukast is a cysteinyl leukotriene receptor antagonist used to treat persistent asthma in patients aged > or = 6 years. "( Montelukast: a review of its therapeutic potential in persistent asthma.
Jarvis, B; Markham, A, 2000
)
3.19
"Montelukast is a selective leukotriene receptor antagonist that has been shown to be effective in the treatment of chronic asthma. "( Montelukast adult (10-mg film-coated tablet) and pediatric (5-mg chewable tablet) dose selections.
Holland, S; Knorr, B; Nguyen, HH; Reiss, TF; Rogers, JD, 2000
)
3.19
"Montelukast is a leukotriene receptor antagonist administered orally once daily for treatment of chronic asthma in adults and children. "( Clinical safety and tolerability of montelukast, a leukotriene receptor antagonist, in controlled clinical trials in patients aged > or = 6 years.
Knorr, B; Michele, TM; Noonan, G; Reiss, TF; Shapiro, G; Shingo, S; Storms, W; Zhang, J, 2001
)
2.03
"Montelukast is a cysteinyl leukotrienes antagonist."( Use of montelukast in the treatment of early childhood wheezing from clinical experience with three cases.
Chan, HK; Chau, KW; Law, AK; Ng, DK, 2000
)
1.48
"Montelukast is a complementary to inhaled corticosteroids in controlling asthma."( [Pharma-clinics. Medication of the month. Montelukast (Singulair)].
Louis, R, 2001
)
1.3
"Montelukast is a specific antagonist of leukotrienes' receptors and constitutes a therapeutic option in controlling asthma."( [Experience with montelukast, a leukotriene receptor antagonist, in pediatric patients with asthma].
Jiménez Ferral, R; Vega López, M,
)
1.91
"Montelukast is an orally administered cysteinyl receptor antagonist, approved for the treatment of asthma. "( Montelukast and improvement of eczema: observations from a prescription event monitoring study in England.
Biswas, P; Shakir, SA; Wilton, LV, 2001
)
3.2
"Montelukast is a cysteinyl leukotriene receptor antagonist which is used as a preventive treatment for persistent asthma in patients > or =2 years of age. "( Montelukast: a review of its therapeutic potential in asthma in children 2 to 14 years of age.
Muijsers, RB; Noble, S, 2002
)
3.2
"Montelukast is a leukotriene antagonist approved for the treatment of childhood asthma in children age 2 years and older. "( The efficacy of montelukast in the treatment of cat allergen-induced asthma in children.
Eggleston, PA; Kesavan, J; Nowak-Wegrzyn, A; Phipatanakul, W; Schuberth, K; Van Natta, M; Wood, RA, 2002
)
2.1

Effects

Montelukast has an intermediate behavior, inasmuch as its interaction with (3)H-LTC(4) sites can be revealed only in kinetic studies. It has a potential to attenuate the detrimental effects of ischemia reperfusion injury on intestinal anastomosis.

Montelukast has been the subject of small studies of SARS-CoV-2 and will be included in a large, randomized, double-blind, placebo-controlled study of outpatients with COVID-19 sponsored by the United States National Institutes of Health.

ExcerptReferenceRelevance
"Montelukast has an intermediate behavior, inasmuch as its interaction with (3)H-LTC(4) sites can be revealed only in kinetic studies, while zafirlukast is totally unable to inhibit (3)H-LTC(4) binding."( Pharmacological differences among CysLT(1) receptor antagonists with respect to LTC(4) and LTD(4) in human lung parenchyma.
Capra, V; Nicosia, S; Panigalli, T; Ravasi, S; Rovati, GE, 2002
)
1.04
"Montelukast has an inhibitory effect on the inflammatory microenvironment of RA by decreasing the secretion of IL-6, IL-8, MMP-3 and MMP-13 in FLSs induced by IL-1β."( Montelukast inhibits inflammatory response in rheumatoid arthritis fibroblast-like synoviocytes.
Dong, H; Li, X; Liu, B; Liu, F; Ma, F; Pang, L; Wang, L; Xu, L, 2018
)
2.64
"Montelukast has a potential to attenuate the detrimental effects of ischemia reperfusion injury on intestinal anastomosis."( Colonic anastomosis can be protected from ischemia reperfusion injury with intra-peritoneal Montelukast treatment.
Akbaba, S; Bostancı, T; Cimen, S; Ersoy, PE; Sayin, T; Yildirim, Z, 2020
)
2.22
"Montelukast has a reliable clinical curative efficacy for bronchiolitis in infants, possibly by decreasing serum leukotriene D4 and urinary leukotriene E4 levels."( [Clinical efficacy of montelukast for the treatment of bronchiolitis in infants].
Li, J; Pan, JH, 2015
)
2.17
"Montelukast has a significant influence in improving patients' nasal symptoms quality of live but is not as effective as SAHs, and may have a slight advantage over SAHs in relieving nighttime symptoms significantly. "( The efficacy and safety of H1-antihistamine versus Montelukast for allergic rhinitis: A systematic review and meta-analysis.
Wei, C, 2016
)
2.13
"Montelukast has a protective effect on ischemic injury in neurons."( [Effect of montelukast on morphological changes in neurons after ischemic injury].
Fang, SH; Huang, XQ; Lu, YB; Wang, XX; Wei, EQ; Yu, SY; Zhang, WP; Zhang, XY; Zhao, R, 2012
)
2.21
"Montelukast has a high affinity for the CysLT1 receptor and a potency that is not influenced by human serum protein."( [Pharmacological profile and clinical effects of montelukast sodium (Singulair chewable tablet), an antiasthmatic agent].
Nishikibe, M; Suzuki, J, 2002
)
1.29
"Montelukast has a protective effect against both lower and upper airway responses during exposure to high levels of cat allergen."( Protective effect of montelukast on lower and upper respiratory tract responses to short-term cat allergen exposure.
Conover-Walker, MK; Corren, J; Dass, SB; Kim, EH; Malice, MP; Massaad, R; Perry, TT; Philip, G; Reiss, TF; Wood, RA, 2004
)
2.09
"Montelukast has a rapid onset of action and may be effective if used intermittently."( Short-course montelukast for intermittent asthma in children: a randomized controlled trial.
Fitzgerald, D; Glasgow, N; Henry, R; Lee, AJ; Mellis, C; Price, D; Robertson, CF; Sant, M; Turner, J, 2007
)
1.43
"Montelukast has an intermediate behavior, inasmuch as its interaction with (3)H-LTC(4) sites can be revealed only in kinetic studies, while zafirlukast is totally unable to inhibit (3)H-LTC(4) binding."( Pharmacological differences among CysLT(1) receptor antagonists with respect to LTC(4) and LTD(4) in human lung parenchyma.
Capra, V; Nicosia, S; Panigalli, T; Ravasi, S; Rovati, GE, 2002
)
1.04
"Montelukast has also been noted to have anti-inflammatory properties, suggesting it may have a role in the treatment of coronavirus disease 2019 (COVID-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which has been noted to induce misfiring of the immune system in some patients. "( Montelukast as a potential treatment for COVID-19.
McCarthy, MW, 2023
)
3.8
"Montelukast has been the subject of small studies of SARS-CoV-2 and will be included in a large, randomized, double-blind, placebo-controlled study of outpatients with COVID-19 sponsored by the United States National Institutes of Health known as Accelerating COVID-19 Therapeutic Interventions and Vaccines-6. "( Montelukast as a potential treatment for COVID-19.
McCarthy, MW, 2023
)
3.8
"Montelukast has short-term beneficial treatment effects for OSA in otherwise healthy, non-obese, surgically untreated children (moderate certainty for primary outcome and moderate and high certainty, respectively, for two secondary outcomes) by significantly reducing the number of apnoeas, hypopnoeas, and respiratory arousals during sleep."( Anti-inflammatory medications for obstructive sleep apnoea in children.
Hoffmann, DU; Kuhle, S; Mitra, S; Urschitz, MS, 2020
)
1.28
"Montelukast has shown anti-inflammatory effects, reduced cytokine production, improvement in post-infection cough production and other lung complications."( Possible Therapeutic Potential of Cysteinyl Leukotriene Receptor Antagonist Montelukast in Treatment of SARS-CoV-2-Induced COVID-19.
Dey, M; Singh, RK, 2021
)
1.57
"Montelukast has had questionable efficacy in patients with atopic dermatitis, whereas small pilots using zileuton did have some clinically significant improvement."( Emerging therapies for atopic dermatitis: The prostaglandin/leukotriene pathway.
Mosser-Goldfarb, JL; Yanes, DA, 2018
)
1.2
"Montelukast has an inhibitory effect on the inflammatory microenvironment of RA by decreasing the secretion of IL-6, IL-8, MMP-3 and MMP-13 in FLSs induced by IL-1β."( Montelukast inhibits inflammatory response in rheumatoid arthritis fibroblast-like synoviocytes.
Dong, H; Li, X; Liu, B; Liu, F; Ma, F; Pang, L; Wang, L; Xu, L, 2018
)
2.64
"Montelukast has a potential to attenuate the detrimental effects of ischemia reperfusion injury on intestinal anastomosis."( Colonic anastomosis can be protected from ischemia reperfusion injury with intra-peritoneal Montelukast treatment.
Akbaba, S; Bostancı, T; Cimen, S; Ersoy, PE; Sayin, T; Yildirim, Z, 2020
)
2.22
"Montelukast (MNK) has prominent anti-inflammatory and antioxidant activities. "( Montelukast modifies simvastatin-induced myopathy and hepatotoxicity.
Ahmed, EA; Ali, MF; Hareedy, MS, 2019
)
3.4
"Montelukast has been recommended as a selective in vitro and in vivo probe of cytochrome P450 (P450) CYP2C8 activity, but its selectivity toward this enzyme remains unclear. "( In Vitro Metabolism of Montelukast by Cytochrome P450s and UDP-Glucuronosyltransferases.
Cardoso, Jde O; Desta, Z; Lu, JB; Oliveira, RV, 2015
)
2.17
"Montelukast has a reliable clinical curative efficacy for bronchiolitis in infants, possibly by decreasing serum leukotriene D4 and urinary leukotriene E4 levels."( [Clinical efficacy of montelukast for the treatment of bronchiolitis in infants].
Li, J; Pan, JH, 2015
)
2.17
"Montelukast has a significant influence in improving patients' nasal symptoms quality of live but is not as effective as SAHs, and may have a slight advantage over SAHs in relieving nighttime symptoms significantly. "( The efficacy and safety of H1-antihistamine versus Montelukast for allergic rhinitis: A systematic review and meta-analysis.
Wei, C, 2016
)
2.13
"Montelukast has minimal risk of adverse reactions compared with steroid therapy and may offer clinical relief in a small subset of children with eosinophilic esophagitis."( Observations on use of montelukast in pediatric eosinophilic esophagitis: insights for the future.
Al-Zubeidi, D; Guerin, L; Mitros, F; Rahhal, R; Stumphy, J, 2011
)
1.4
"Montelukast has been well studied through rigorous clinical trials. "( Montelukast for the treatment of asthma in the adult population.
Amlani, S; McIvor, RA; Nadarajah, T, 2011
)
3.25
"Montelukast has been proven to assure a protective effect against exercise-induced bronchoconstriction."( Time-effect of montelukast on protection against exercise-induced bronchoconstriction.
Boner, AL; Chinellato, I; Peroni, DG; Pescollderungg, L; Piacentini, GL; Sandri, M, 2011
)
2.16
"Montelukast has ameliorated I/R induced vasculitic neuropathic pain, these effects may be due to inhibition of lipid peroxidation, reduction of oxidative stress, release of inflammatory mediators and neuroprotective actions. "( Ameliorative potential of montelukast on ischemia-reperfusion injury induced vasculitic neuropathic pain in rat.
Muthuraman, A; Ramesh, M; Sood, S, 2012
)
2.12
"Montelukast has a protective effect on ischemic injury in neurons."( [Effect of montelukast on morphological changes in neurons after ischemic injury].
Fang, SH; Huang, XQ; Lu, YB; Wang, XX; Wei, EQ; Yu, SY; Zhang, WP; Zhang, XY; Zhao, R, 2012
)
2.21
"Montelukast has a high affinity for the CysLT1 receptor and a potency that is not influenced by human serum protein."( [Pharmacological profile and clinical effects of montelukast sodium (Singulair chewable tablet), an antiasthmatic agent].
Nishikibe, M; Suzuki, J, 2002
)
1.29
"Montelukast has been found to be of significant help in the symptomatic control of these patients while avoiding long term corticosteroids use."( Eosinophilic oesophagitis: a novel treatment using Montelukast.
Armstrong, GR; Attwood, SE; Bronder, CS; Lewis, CJ; Morris, CD; Whittam, J, 2003
)
1.29
"Oral montelukast has shown efficacy as a preventive treatment for asthma during clinical trials in children aged 2 to 14 years. "( Spotlight on montelukast in asthma in children 2 to 14 years of age.
Muijsers, RB; Noble, S, 2002
)
1.2
"Montelukast has a protective effect against both lower and upper airway responses during exposure to high levels of cat allergen."( Protective effect of montelukast on lower and upper respiratory tract responses to short-term cat allergen exposure.
Conover-Walker, MK; Corren, J; Dass, SB; Kim, EH; Malice, MP; Massaad, R; Perry, TT; Philip, G; Reiss, TF; Wood, RA, 2004
)
2.09
"Montelukast has been shown to be effective in controlling the increase in exhaled NO in asthmatic children re-exposed to house dust mite (HDM). "( Effect of budesonide and montelukast in asthmatic children exposed to relevant allergens.
Baraldi, E; Bodini, A; Boner, AL; Loiacono, A; Miraglia Del Giudice, M; Peroni, D; Piacentini, G, 2005
)
2.07
"Montelukast has shown efficacy for seasonal allergic rhinitis (SAR); however, onset of action for SAR has not been presented. "( Onset of efficacy of montelukast in seasonal allergic rhinitis.
Dass, SB; Hampel, FC; Malice, MP; Philip, G; Reiss, TF; Swern, AS; Weinstein, SF,
)
1.89
"Montelukast has demonstrated consistent benefit in controlling symptoms of asthma and may be an alternative, orally administered, nonsteroidal agent for treating mild asthma."( Montelukast, compared with fluticasone, for control of asthma among 6- to 14-year-old patients with mild asthma: the MOSAIC study.
Garcia Garcia, ML; Gilles, L; Polos, P; Swern, A; Tozzi, CA; Wahn, U, 2005
)
2.49
"Montelukast has proven efficacy in the treatment of chronic asthma and seasonal allergic rhinitis, but it has not been evaluated in the subpopulation of asthmatic patients with seasonal asthma symptoms."( Efficacy of montelukast during the allergy season in patients with chronic asthma and seasonal aeroallergen sensitivity.
Bird, SR; Busse, WW; Casale, TB; Dykewicz, MS; Edelman, JM; Grant, E; Hustad, CM; Meltzer, EO; Zeldin, RK, 2006
)
2.16
"Montelukast has onset of action within one hour."( Montelukast in pediatric asthma management.
Kabra, SK; Lodha, R; Walia, M, 2006
)
2.5
"Montelukast has a rapid onset of action and may be effective if used intermittently."( Short-course montelukast for intermittent asthma in children: a randomized controlled trial.
Fitzgerald, D; Glasgow, N; Henry, R; Lee, AJ; Mellis, C; Price, D; Robertson, CF; Sant, M; Turner, J, 2007
)
1.43
"Montelukast has demonstrated consistent benefit in controlling symptoms of asthma and may be an alternative, orally administered, nonsteroidal agent for treating mild asthma."( Montelukast vs. inhaled low-dose budesonide as monotherapy in the treatment of mild persistent asthma: a randomized double blind controlled trial.
Kabra, SK; Kumar, V; Lodha, R; Pandey, RM; Ramesh, P, 2007
)
2.5
"Montelukast has not been reported to have major effects on sneezing and itching in the clinic but reduces nasal obstruction (lower nasal airway pressure or nasal patency)."( Differential responses to various classes of drugs in a model of allergic rhinitis in guinea pigs.
Al Suleimani, YM; Dong, Y; Walker, MJ, 2008
)
1.07
"Montelukast (5 mg/day) has also demonstrated efficacy in childhood asthma."( Montelukast.
Faulds, D; Markham, A, 1998
)
2.46
"Montelukast has been associated with Churg-Strauss syndrome in a very small number of adults."( Tolerability of montelukast.
Price, D, 2000
)
1.37
"Oral montelukast has shown efficacy as a preventive treatment for asthma during clinical trials in children aged 2 to 14 years. "( Montelukast: a review of its therapeutic potential in asthma in children 2 to 14 years of age.
Muijsers, RB; Noble, S, 2002
)
2.27

Actions

Montelukast, which plays an anti-inflammatory role, is used to treat patients with asthma. It may suppress eosinophil infiltrating into lungs of asthmatic mice. It does not inhibit the proliferation and emigration of CD(34)(+) cells.

ExcerptReferenceRelevance
"The montelukast group had a lower percentage of children with an ACT/C-ACT score ≤ 19 (P = 0.015)."( Treatment of pediatric mild persistent asthma with low-dose budesonide inhalation suspension vs. montelukast in China.
Chen, ZM; Hong, JG; Xiang, L; Zhao, DY, 2021
)
1.32
"Montelukast, which plays an anti-inflammatory role, is used to treat patients with asthma."( Montelukast treatment protects nigral dopaminergic neurons against microglial activation in the 6-hydroxydopamine mouse model of Parkinson's disease.
Jang, H; Kim, S; Kim, SR; Lee, JM; Oh, YS; Park, SM, 2017
)
2.62
"Montelukast may suppress eosinophil infiltrating into lungs of asthmatic mice, but it does not inhibit the proliferation and emigration of CD(34)(+) cells and does not show apparent synergistic effect with prednisone."( [The effects of anti-inflammatory and anti-asthmatic agents on CD34+ hematopoietic cells in bone marrow of asthmatic mice].
Deng, YL; Liu, CT; Mao, H; Wang, ZL; Yin, KS; Yu, YH, 2004
)
1.04
"Montelukast failed to cause vasoconstriction in LPS challenged rat lung, or to inhibit i- and eNOS activity as well as iNOS expression in aortic rings from the same species."( Montelukast exerts no acute direct effect on NO synthases.
Braun, C; Eichert, K; Eltze, M; Grebe, T; Hamacher, J; Lucas, R; Strub, A; Wendel, A, 2007
)
2.5

Treatment

Montelukast pretreatment provided highly significant protection against adenosine induced bronchoconstriction. Pre-treatment with montlukast attenuated chlorine-induced neutrophilia and AHR in mice. Treatment with montalukast compared to placebo may result in a reduction of pruritus, but the evidence is very uncertain.

ExcerptReferenceRelevance
"Montelukast treatment failed to improve FEV1% in both groups compared to the placebo."( The Montelukast Therapy in Asthmatic Children with and without Food Allergy: Does It Make Any Difference?
Arik Yilmaz, E; Custovic, A; Fontanella, S; Haider, S; Kalayci, O; Sackesen, C; Sahiner, UM; Soyer, O,
)
1.41
"Montelukast treatment resulted in modulation of beclin-1 expression, a marker for autophagy, and in a reduction in the human alpha-synulcein load in the transgenic mice."( The Leukotriene Receptor Antagonist Montelukast Reduces Alpha-Synuclein Load and Restores Memory in an Animal Model of Dementia with Lewy Bodies.
Aigner, L; Altendorfer, B; Attems, J; Chishty, M; Felder, T; Garnweidner-Raith, J; Holztrattner, M; Hutter-Paier, B; Johnson, M; Leister, I; Marschallinger, J; Masliah, E; Pillichshammer, N; Rockenstein, E; Strempfl, K; Unger, MS, 2020
)
1.55
"Montelukast treatment restored their expressions to normal values."( Mechanisms underlying the protective effect of leukotriene receptor antagonist montelukast against doxorubicin induced testicular injury in rats.
Mohamed, MZ; Zenhom, NM, 2020
)
1.51
"Montelukast treatment significantly reduced airway hyperresponsiveness (AHR) and airway remodeling."( Cysteinyl Leukotriene Synthesis via Phospholipase A2 Group IV Mediates Exercise-induced Bronchoconstriction and Airway Remodeling.
Arakawa, M; Hasegawa, T; Hayashi, M; Kikuchi, T; Kimura, Y; Koya, T; Saito, A; Takeuchi, H; Tsukioka, K; Ueno, H; Watanabe, S, 2020
)
1.28
"Montelukast treatment attenuated chlorine-induced macrophage influx, neutrophilia and eosinophilia in BAL fluid."( Montelukast reduces inhaled chlorine triggered airway hyperresponsiveness and airway inflammation in the mouse.
Allard, B; Ano, S; Hamamoto, Y; Martin, JG; McGovern, TK; O'Sullivan, M, 2017
)
2.62
"Montelukast treatment for 4 days protected against cell death with 90% more cell death in the vehicle group compared to the montelukast group 24 h after CIR."( The anti-asthmatic drug, montelukast, modifies the neurogenic potential in the young healthy and irradiated brain.
Blennow, K; Boström, M; Eriksson, Y; Kalm, M; Kuhn, G; Sandelius, Å; Zetterberg, H, 2018
)
1.51
"Montelukast treatment prevented IL-8 release and heterologous β2-adrenoceptor desensitization in human BSMC exposed to monocyte-derived MPs by blocking NF-κB nuclear translocation."( Montelukast prevents microparticle-induced inflammatory and functional alterations in human bronchial smooth muscle cells.
Amoruso, A; Bardelli, C; Breschi, MC; Brunelleschi, S; Celi, A; Fogli, S; Neri, T; Stefanelli, F, 2013
)
2.55
"Montelukast treatment for asthma symptoms reversibly suppresses nasal AEC release of pro-inflammatory mediators (i.e. "( Inhibitory effects of Montelukast on mediator release by nasal epithelial cells from asthmatic subjects with or without allergic rhinitis.
Devereux, GS; Miller, D; Scaife, A; Spiteri-Cornish, D; Turner, SW; Walsh, GM, 2013
)
2.15
"Montelukast treatment prevented tissue damage in ovaries, and this result was significant."( Montelukast prevents ischaemia/reperfusion-induced ovarian damage in rats.
Akdemir, A; Erbaş, O; Ergenoğlu, M; Oltulu, F; Ozgür Yeniel, A; Taskiran, D; Yavaşoğlu, A, 2014
)
2.57
"Montelukast may be a new treatment option to prevent and control the OHSS."( Comparison of montelukast and cabergoline for prevention of ovarian hyperstimulation syndrome: in an experimental rat model.
Akdogan, A; Akman, L; Aktug, H; Erbas, O; Goker, EN; Sahin, G; Taskiran, D; Tavmergen, E, 2015
)
1.5
"Montelukast treatment decreased the cumulative numbers of recurrent wheezing episodes and recurrent respiratory tract infections at 9 and 12 months."( Characteristics of respiratory syncytial virus-induced bronchiolitis co-infection with Mycoplasma pneumoniae and add-on therapy with montelukast.
Chen, XQ; Dong, L; Kong, X; Liao, PY; Wu, JM; Wu, SH; Yin, PL, 2016
)
1.36
"The montelukast treatment group showed significantly lower serum leukotriene B4 and urinary leukotriene E4 levels than the control group (P<0.05)."( [Clinical efficacy of montelukast for the treatment of bronchiolitis in infants].
Li, J; Pan, JH, 2015
)
1.21
"Montelukast-treated mDCs suppressed IFN-γ and IL-13 production by T cells."( Cysteinyl leukotriene receptor antagonist epigenetically modulates cytokine expression and maturation of human myeloid dendritic cells.
Hsieh, CC; Huang, MY; Huang, SK; Hung, CH; Kuo, CH; Kuo, HF; Lee, MS; Lin, YC; Yang, SN, 2016
)
1.16
"Montelukast treatment resulted in the functional ANS status re-arrangement, with sympathetic overdrive and parasympathetic withdrawal."( THE INFLUENCE OF MONTELUKAST ON THE ACTIVITY OF THE AUTONOMIC NERVOUS SYSTEM ESTIMATED BY HEART RATE VARIABILITY IN EXPERIMENTAL PARTIAL BLADDER OUTLET OBSTRUCTION IN RATS.
Baranowska, A; Dobrek, Ł; Skowron, B; Thor, PJ; Zurowski, D,
)
1.19
"Montelukast treatment decreased the number of both mature granulated and degranulated mast cells in rats subjected to WAS."( The leukotriene d4 receptor antagonist, montelukast, inhibits mast cell degranulation in the dermis induced by water avoidance stress.
Cetinel, S; Cikler, E; Ercan, F; Ersoy, Y, 2009
)
1.34
"Montelukast treatment reduced BBB permeability."( Cysteinyl-leukotriene receptor antagonist montelukast decreases blood-brain barrier permeability but does not prevent oedema formation in traumatic brain injury.
Berkman, Z; Biber, N; Dulger, FG; Gultomruk, M; Hakan, T; Solakoglu, S; Toklu, HZ, 2009
)
1.34
"Montelukast treatment reduces eosinophil degranulation and is associated with a decrease in recurrent wheezing episodes in post-RSV bronchiolitis."( A randomized intervention of montelukast for post-bronchiolitis: effect on eosinophil degranulation.
Callaway, Z; Choi, J; Fujisawa, T; Kim, CK; Kim, HB; Kim, JT; Koh, YY; Shin, BM, 2010
)
2.09
"Montelukast treatment also significantly reduced these levels to the levels seen after saline challenges in GATA-3-overexpressing mice."( Blockade of cysteinyl leukotriene-1 receptors suppresses airway remodelling in mice overexpressing GATA-3.
Haraguchi, N; Hizawa, N; Ishii, Y; Kawaguchi, M; Kikuchi, N; Kiwamoto, T; Masuko, H; Morishima, Y; Nomura, A; Sakamoto, T; Takahashi, S; Yoh, K, 2011
)
1.09
"Montelukast treatment normalized changes of LPO and MPO and stimulated an overproduction of endogenous SOD and GSH. "( Protective effects of montelukast on ischemia-reperfusion injury in rat ovaries subjected to torsion and detorsion: biochemical and histopathologic evaluation.
Coskun, AK; Halici, Z; Keles, ON; Kilic, C; Odabasoglu, F; Oral, A; Salman, AB; Surer, I; Unal, B, 2011
)
2.13
"Montelukast treatment also decreased mRNA levels of IL-6, IL-10, IL-13, and TGF-β1, all of which were elevated in fibrotic lungs."( Effects of montelukast, a cysteinyl-leukotriene type 1 receptor antagonist, on the pathogenesis of bleomycin-induced pulmonary fibrosis in mice.
Okunishi, H; Shimbori, C; Shiota, N, 2011
)
1.48
"Montelukast-treated rats showed reduction in collagen deposition by 29% and significant reduction in lung hydroxyproline content by 32%."( Effect of leukotriene receptor antagonists on lung fibrosis in rats.
Shaker, OG; Sourour, DA, 2011
)
1.09
"Montelukast treatment after CP injection exerted therapeutic effects against CP-induced acute kidney damage."( Beneficial effects of montelukast against cisplatin-induced acute renal damage in rats.
Beytur, A; Cetin, A; Dogan, Z; Ekinci, N; Köse, E; Sapmaz, HI; Sarihan, ME; Turkoz, Y; Vardi, N, 2012
)
2.14
"Montelukast treatment after amikacin injection could reduce the amikacin-induced kidney damage."( The effects of montelukast against amikacin-induced acute renal damage.
Beytur, A; Cinar, K; Dogan, Z; Ekinci, N; Ekincioglu, Z; Kose, E; Soysal, H; Turkoz, Y; Vardi, N, 2012
)
2.17
"Montelukast treatment (Group III) significantly reduced the total lung injury score, compared with the HS group (Group II) (P < 0.05). "( Cysteinyl leukotriene receptor antagonist montelukast ameliorates acute lung injury following haemorrhagic shock in rats.
Al-Amran, FG; Hadi, NR; Hashim, AM, 2013
)
2.1
"Montelukast and zileuton treatments prevented the T/D-induced augmentation in MDA levels."( Effects of montelukast and zileuton on testicular torsion/detorsion injury in rats.
Acikgoz, S; Baba, F; Banoglu, ZN; Dengiz, GO; Isikdemir, F; Kelek, S; Kurcer, Z; Sipahi, EY, 2014
)
1.51
"Montelukast treatment compared with placebo was associated with a lower mean maximum decrease of FEV(1) (mean +/- SEM: 17.3% +/- 2.4% and 35.1% +/- 2.6%, respectively), decrease of the area above the curve (267.8% +/- 42.7%/min and 868.0% +/- 103.8%/min, respectively), and shorter time for recovery (6.9 +/- 1.1 minutes and 30.9 +/- 4.0 minutes, respectively; P <.05)."( Exercise-induced bronchoconstriction in children: montelukast attenuates the immediate-phase and late-phase responses.
Melo, RE; Naspitz, CK; Solé, D, 2003
)
1.29
"Montelukast pretreatment significantly increased (P <.01) the PC(15) NKA value (708.8 microg/mL; +SE, 890.47 microg/mL; -SE, 564.15 microg/mL) in comparison with placebo (394.4 microg/mL; +SE, 491.88 microg/mL; -SE, 248.16 microg/mL) and produced a shift of the NKA concentration-response curve to the right in all the subjects studied."( Inhibitory effect of a leukotriene receptor antagonist (montelukast) on neurokinin A-induced bronchoconstriction.
Crimi, N; Mastruzzo, C; Pagano, C; Palermo, F; Pistorio, MP; Prosperini, G; Vancheri, C, 2003
)
1.29
"Montelukast treatment significantly decreased physician-rated hyperemia, secretion, and chemosis as well as patient-rated burning, tearing, photophobia, secretion, and redness."( Montelukast, a leukotriene receptor antagonist, in vernal keratoconjunctivitis associated with asthma.
Bonini, S; Bruscolini, A; Coassin, M; Lambiase, A; Rasi, G, 2003
)
2.48
"Montelukast treatment significantly increased the number of rescue-free days in symptomatic children with asthma."( Montelukast improves asthma control in asthmatic children maintained on inhaled corticosteroids.
Cronin, B; Downes, SJ; Eller, TJ; Greene, C; Irani, AM; Phipatanakul, W; Schneider, LC, 2003
)
3.2
"Montelukast treatment resulted in a significant improvement in exercise tolerance: median delta FEV1 20.0% (range 0-50) prior to treatment vs. "( The effect of montelukast on bronchial provocation tests and exhaled nitric oxide levels in asthmatic patients.
Avital, A; Bardach, E; Berkman, N; Breuer, R; Godfrey, S; Springer, C, 2003
)
2.12
"Montelukast treatment induced a significant decrease of IL4 and IL13 levels (p < 0.001, for both comparisons), and a significant increase of IFN gamma (p < 0.001)."( Nasal cytokine modulation by montelukast in allergic children: a pilot study.
Ciprandi, G; Frati, F; Marcucci, F; Milanese, M; Ricca, V; Sensi, L; Tosca, MA, 2003
)
2.05
"Montelukast treatment reversed a typical Th2 cytokine pattern (IL4 and IL13) toward a Th1 (IFN gamma) predominance in children with PAR and EIA. "( Nasal cytokine modulation by montelukast in allergic children: a pilot study.
Ciprandi, G; Frati, F; Marcucci, F; Milanese, M; Ricca, V; Sensi, L; Tosca, MA, 2003
)
2.05
"Montelukast treatment resulted in a significant decrease of eosinophils in the nasal mucosa, and in either bone marrow interleukin (IL)-5-, but not IL-3-, or granulocyte-macrophage colony-stimulating factor-responsive eosinophil/basophil colony-forming units, and IL-5-stimulated eosinophil maturation."( Effects of a cysteinyl leukotriene receptor antagonist on eosinophil recruitment in experimental allergic rhinitis.
Baatjes, AJ; Crawford, L; Cyr, MM; Denburg, E; Denburg, JA; Howie, K; Morikawa, H; Saito, H, 2004
)
1.04
"Montelukast treatment induced significant reductions in adenoid size and respiratory-related sleep disturbances, which were absent in 16 children with SDB who did not receive treatment. "( Leukotriene modifier therapy for mild sleep-disordered breathing in children.
Goldbart, AD; Goldman, JL; Gozal, D; Veling, MC, 2005
)
1.77
"Oral montelukast sodium treatment of these children with mild to moderate asthma effectively improved asthmatic symptoms and suppressed airway inflammation in 1 week, suggesting that this leukotriene antagonist combined with short-acting beta2 agonists may provide effective treatment option in mild to moderate childhood asthma. "( Effects of montelukast on symptoms and eNO in children with mild to moderate asthma.
Chen, CJ; Hung, CH; Lai, YS; Lee, MY; Yang, KD, 2005
)
1.23
"Montelukast treatment also improved global evaluations of allergic rhinitis by patients and Rhinoconjunctivitis Quality of Life Questionnaire scores: differences vs the placebo group were -0.15 (95% CI, -0.27 to -0.04; P < .01) and -0.15 (95% CI, -0.24 to -0.06; P < .001), respectively."( Randomized, double-blind, placebo-controlled study of montelukast for treating perennial allergic rhinitis.
Call, R; Dass, SB; Garrett, GC; Gilles, L; Horak, F; Knorr, BA; LaForce, C; Patel, P; Philip, G; Reiss, TF; Yang, W, 2005
)
1.3
"Montelukast treatment resulted in significantly less regional air-trapping on HRCT on the pre-methacholine images when compared with placebo, as well as improvement in total quality of life scores and symptom sub-scores."( Montelukast improves regional air-trapping due to small airways obstruction in asthma.
Elashoff, R; Goldin, JG; Kim, HJ; Kleerup, EC; Liu, W; Sayre, JW; Simmons, MD; Tashkin, DP; Truong, DA; Zeidler, MR, 2006
)
2.5
"Montelukast-treated patients had lower residual volume (P = .05), residual volume-total lung capacity ratio (P = .04), Raw (P = .02), Sgaw (P = .03), and serum ECP levels (P = .02) at 8 weeks compared with those treated with placebo. "( Effect of montelukast on peripheral airflow obstruction in children with asthma.
Covar, RA; Gelfand, EW; Gleason, M; Jain, N; Shimamoto, R; Spahn, JD; Szefler, SJ, 2006
)
2.18
"Montelukast treatment did not produce a significant effect on eNO levels compared with placebo (P = .96)."( Effect of montelukast on symptoms and exhaled nitric oxide levels in 7- to 14-year-old children with seasonal allergic rhinitis.
Bakirtas, A; Erbas, D; Harmanci, K; Razi, C; Turktas, I, 2006
)
1.46
"Montelukast treatment provided significant improvement in symptoms and peripheral eosinophil counts of school-age children with seasonal allergic rhinitis; however, it did not show a significant effect on eNO levels."( Effect of montelukast on symptoms and exhaled nitric oxide levels in 7- to 14-year-old children with seasonal allergic rhinitis.
Bakirtas, A; Erbas, D; Harmanci, K; Razi, C; Turktas, I, 2006
)
2.18
"Montelukast treatment reversed all these biochemical indices, as well as histopathological alterations induced by CRF."( Chronic renal failure-induced multiple-organ injury in rats is alleviated by the selective CysLT1 receptor antagonist montelukast.
Ekşioğlu-Demiralp, E; Ercan, F; Gedik, N; Sakarcan, A; Sehirli, O; Sener, E; Sener, G; Yeğen, BC, 2007
)
1.27
"Montelukast treatment in the I/R group decreased these parameters compared with I/R alone."( Montelukast reduces ischaemia/reperfusion-induced bladder dysfunction and oxidant damage in the rat.
Alican, I; Ercan, F; Sehirli, O; Sener, G; Toklu, H, 2007
)
2.5
"Montelukast is a viable treatment option for women with vulvar vestibulitis. "( Improvement in vulvar vestibulitis with montelukast.
Fisher, L; Kamdar, N; MacNeill, C, 2007
)
2.05
"Montelukast treatment resulted in a shorter time to recovery (18 vs 28 minutes for montelukast and placebo, respectively, P = .079)."( Montelukast once daily inhibits exercise-induced bronchoconstriction in 6- to 14-year-old children with asthma.
Dockhorn, RJ; Kemp, JP; Knorr, B; Nguyen, HH; Reiss, TF; Seidenberg, BC; Shapiro, GG, 1998
)
2.46
"Montelukast pretreatment was generally not effective in altering upper airway reactions and only partly effective in altering lower airway reactions."( Montelukast is only partially effective in inhibiting aspirin responses in aspirin-sensitive asthmatics.
Christiansen, SC; Mathison, DA; Simon, RA; Stevenson, DD, 2000
)
2.47
"Montelukast treatment resulted in significant improvement in urinary frequency and pain. "( The cysteinyl leukotriene D4 receptor antagonist montelukast for the treatment of interstitial cystitis.
Bouchelouche, K; Bouchelouche, P; Hald, T; Nordling, J, 2001
)
2.01
"The montelukast treatment group was more adherent with their regimen than the inhaled beclomethasone treatment group; almost twice as many children on montelukast compared with inhaled beclomethasone were highly compliant (82% versus 45%)."( Oral montelukast versus inhaled beclomethasone in 6- to 11-year-old children with asthma: results of an open-label extension study evaluating long-term safety, satisfaction, and adherence with therapy.
Dueñas-Meza, E; Kosa, L; Leff, JA; Maspero, JF; Pinacho Daza, C; Volovitz, B; Vrijens, F, 2001
)
1.31
"Montelukast pretreatment provided highly significant protection against adenosine induced bronchoconstriction, with geometric mean PC(20)AMP values of 52.6 mg/ml (95% CI 35.2 to 78.7) after placebo and 123.9 mg/ml (95% CI 83.0 to 185.0) after montelukast (p=0.006). "( Role of cysteinyl leukotrienes in adenosine 5'-monophosphate induced bronchoconstriction in asthma.
Arshad, H; Holgate, ST; Jeffs, JA; Jennison, S; Rorke, S; Sampson, AP, 2002
)
1.76
"Treatment with montelukast compared to placebo may result in a reduction of pruritus, but the evidence is very uncertain (two studies, 87 participants): SMD -1.40, 95% CI -1.87 to -0.92; certainty of evidence: very low."( Pharmacological interventions for pruritus in adult palliative care patients.
Becker, C; Becker, G; Boehlke, C; Buroh, S; Coune, B; Hercz, D; Joos, L; Meerpohl, JJ; Schwarzer, G, 2023
)
1.25
"Pre-treatment with montelukast attenuated chlorine-induced neutrophilia and AHR in mice. "( Montelukast reduces inhaled chlorine triggered airway hyperresponsiveness and airway inflammation in the mouse.
Allard, B; Ano, S; Hamamoto, Y; Martin, JG; McGovern, TK; O'Sullivan, M, 2017
)
2.23
"Treatment with montelukast and intranasal steroids or montelukast alone is potentially beneficial for short-term management of mild pediatric OSA."( Montelukast and Nasal Corticosteroids to Treat Pediatric Obstructive Sleep Apnea: A Systematic Review and Meta-analysis.
Ahmad, I; Camacho, M; Liming, BJ; Mack, D; Ryan, M, 2019
)
2.31
"Treatment with montelukast significantly attenuated the AHR and eosinophilic airway inflammation in OVA-sensitized and OVA-challenged mice."( Effect of a cysteinyl leukotriene receptor antagonist on experimental emphysema and asthma combined with emphysema.
Fuchimoto, Y; Ikeda, G; Kanehiro, A; Kataoka, M; Koga, H; Kurimoto, E; Miyahara, N; Taniguchi, A; Tanimoto, M; Tanimoto, Y; Waseda, K, 2014
)
0.74
"Pretreatment with montelukast reduced lipid peroxidation (p<0.005) and improved antioxidant status in rats (p<0.001)."( Montelukast prevents ischaemia/reperfusion-induced ovarian damage in rats.
Akdemir, A; Erbaş, O; Ergenoğlu, M; Oltulu, F; Ozgür Yeniel, A; Taskiran, D; Yavaşoğlu, A, 2014
)
2.17
"Treatment with Montelukast sodium was provided over the course of 12 weeks."( Clinical efficacy of montelukast sodium in treating infantile wheezing.
Guo, YS; Li, J; Ma, C; Zai, J; Zhang, J; Zou, YX, 2014
)
1.06
"Treatment with montelukast sodium directly targeted the cysteinyl leukotriene type 1 receptor, leading to increased chondrocyte proliferation at early time points."( Enhanced fracture repair by leukotriene antagonism is characterized by increased chondrocyte proliferation and early bone formation: a novel role of the cysteinyl LT-1 receptor.
Ayers, DC; Fanning, PJ; Gaur, T; Lian, JB; Mason-Savas, A; O'Connell, SL; Silva, J; Stein, GS; Wixted, JJ, 2009
)
0.69
"Treatment with montelukast after hospital admission for RSV bronchiolitis in children younger than 2 years of age did not reduce symptoms of cough and wheeze. "( Montelukast does not prevent reactive airway disease in young children hospitalized for RSV bronchiolitis.
De Bilderling, G; De Boeck, K; Govaere, E; Proesmans, M; Raes, M; Sauer, K, 2009
)
2.15
"Treatment with montelukast was generally well tolerated."( Add-on montelukast in inadequately controlled asthma patients in a 6-month open-label study: the MONtelukast In Chronic Asthma (MONICA) study.
Ljungblad, L; Mehta, A; Mitfessel, H; Virchow, JC, 2010
)
1.16
"Treatment with montelukast for 10 days resulted in an impressive reduction in the basal portal pressure and an attenuation of the KC-dependent increase in portal pressure."( Treatment with the leukotriene inhibitor montelukast for 10 days attenuates portal hypertension in rat liver cirrhosis.
Bilzer, M; Gerbes, AL; Göke, B; Hartmann, AC; Hennenberg, M; op den Winkel, M; Pfeiler, S; Steib, CJ, 2010
)
0.97
"Treatment with montelukast significantly attenuated the increased fibrotic area and hydroxyproline content in the fibrotic lungs of bleomycin-instilled mice."( Effects of montelukast, a cysteinyl-leukotriene type 1 receptor antagonist, on the pathogenesis of bleomycin-induced pulmonary fibrosis in mice.
Okunishi, H; Shimbori, C; Shiota, N, 2011
)
1.1
"Treatment with montelukast attenuated the maximal early asthmatic response compared with placebo (p < 0.001) and budesonide (p = 0.002)."( Effects of montelukast and budesonide on airway responses and airway inflammation in asthma.
Inman, MD; Leigh, R; O'Byrne, PM; Rerecich, T; Vethanayagam, D; Watson, RM; Yoshida, M, 2002
)
1.04
"Pretreatment with montelukast significantly protected against this reduction."( Montelukast prevents antigen-induced mucociliary dysfunction in sheep.
Abraham, WM; Sabater, JR; Wanner, A, 2002
)
2.08
"Treatment with montelukast also abolished late-phase responses."( Exercise-induced bronchoconstriction in children: montelukast attenuates the immediate-phase and late-phase responses.
Melo, RE; Naspitz, CK; Solé, D, 2003
)
0.91
"Pretreatment with montelukast mildly decreased NO production without producing a concomitant significant decrease in iNOS mRNA expression."( Effect of montelukast pretreatment on inducible nitric oxide synthase mRNA expression in the lungs of antigen-challenged allergic mice.
Chernichovski, T; Fireman, E; Iaina, A; Kivity, S; Sade, K; Schwartz, D; Schwartz, I; Wolman, Y, 2003
)
1.04
"Treatment with montelukast prevented the damage as well as the changes in biochemical parameters in all tissues studied."( Gastroprotective effect of leukotriene receptor blocker montelukast in alendronat-induced lesions of the rat gastric mucosa.
Ayanoğlu-Dülger, G; Cetinel, S; Cikler, E; Kapucu, C; Sener, G, 2005
)
0.91
"Treatment with montelukast may also be associated with deviation of the immune system towards the Th1-specific pathway."( Brief case series: montelukast, at doses recommended for asthma treatment, reduces disease severity and increases soluble CD14 in children with atopic dermatitis.
Fok, TF; Hon, KL; Leung, TF; Ma, KC; Wong, Y, 2005
)
1
"Treatment with montelukast and loratadine inhibited the release of cysteinyl leukotrienes and histamine into the airways, but did not inhibit the release of columnar epithelial cells into the airways."( Inflammatory basis of exercise-induced bronchoconstriction.
Aitken, ML; Hallstrand, TS; Henderson, WR; Moody, MW; Schwartz, LB; Wurfel, MM, 2005
)
0.67
"Pre-treatment with montelukast did not influence wheal size (p=0.099, 0.21, 0.066 for histamine, codeine and allergens, respectively), but significantly reduced flare (p=0.005; 0.003; 0.02 for histamine, codeine and allergens, respectively)."( The effect of montelukast (10mg daily) and loratadine (10mg daily) on wheal, flare and itching reactions in skin prick tests.
Górski, P; Kuna, P; Kupczyk, M; Kupryś, I, 2007
)
1.02
"Treatment with montelukast significantly reduced clinical scores and X-ray scores of collagen-induced arthritis, and decreased the number of mast cells in the inflamed paws of collagen-induced arthritic mice."( Pathophysiological role of mast cells in collagen-induced arthritis: study with a cysteinyl leukotriene receptor antagonist, montelukast.
Okunishi, H; Shimoura, K; Shiota, N, 2006
)
0.88
"Treatment with montelukast showed no significant difference by comparison with placebo but did show a significant within-group treatment-related decrease in airway wall myofibroblasts not seen in the placebo group. "( Montelukast treatment attenuates the increase in myofibroblasts following low-dose allergen challenge.
Boulet, LP; Chakir, J; Gauldie, J; Kelly, MM; Laviolette, M; O'Byrne, PM; Vethanayagam, D, 2006
)
2.13
"Treatment with montelukast or placebo was initiated by parents at the onset of each upper respiratory tract infection or asthma symptoms and continued for a minimum of 7 days or until symptoms had resolved for 48 hours."( Short-course montelukast for intermittent asthma in children: a randomized controlled trial.
Fitzgerald, D; Glasgow, N; Henry, R; Lee, AJ; Mellis, C; Price, D; Robertson, CF; Sant, M; Turner, J, 2007
)
1.05
"Treatment with montelukast was evaluated as add-on to the higher dose of BDP."( Differential anti-inflammatory effects of large and small particle size inhaled corticosteroids in asthma.
Hopkinson, P; Lipworth, BJ; McFarlane, L; Menzies, D; Nair, A, 2007
)
0.68
"Treatment with montelukast almost completely reversed the low contractile responses of rat urinary bladder to carbachol and prevented oxidative tissue damage following I/R."( Montelukast reduces ischaemia/reperfusion-induced bladder dysfunction and oxidant damage in the rat.
Alican, I; Ercan, F; Sehirli, O; Sener, G; Toklu, H, 2007
)
2.12
"Pretreatment with montelukast allowed only one patient to proceed through all challenge doses of ASA without any reactions. "( Montelukast is only partially effective in inhibiting aspirin responses in aspirin-sensitive asthmatics.
Christiansen, SC; Mathison, DA; Simon, RA; Stevenson, DD, 2000
)
2.08
"Treatment with montelukast effected a significant increase (p < 0.05) in MEF25 from 59.1 to 67.8% in base line lung function alone."( [Preventive monotherapy with montelukast versus DNCG in children with mild asthma. Results of and exploratory pilot study].
Liebke, C; Niggemann, B; Sommerfeld, C; Wahn, U, 2001
)
0.94

Toxicity

Recent studies suggest that the leukotriene receptor antagonist montelukast may have neuropsychiatric adverse effects. This study assessed the efficacy and safety of montelUKast sodium combined with fluticasone in the treatment of adult BA.

ExcerptReferenceRelevance
" Adverse effects were not significantly different for montelukast than for placebo, with the exception of allergic rhinitis which was more prevalent in the placebo group."( Leukotriene receptor antagonists: efficacy and safety in children with asthma.
Becker, A, 2000
)
0.56
" Summary statistics comparing incidences of adverse events among treatment groups were calculated."( Clinical safety and tolerability of montelukast, a leukotriene receptor antagonist, in controlled clinical trials in patients aged > or = 6 years.
Knorr, B; Michele, TM; Noonan, G; Reiss, TF; Shapiro, G; Shingo, S; Storms, W; Zhang, J, 2001
)
0.59
"The overall incidence of clinical and laboratory adverse events among montelukast-treated patients, both adult and paediatric, was similar to that among patients receiving placebo."( Clinical safety and tolerability of montelukast, a leukotriene receptor antagonist, in controlled clinical trials in patients aged > or = 6 years.
Knorr, B; Michele, TM; Noonan, G; Reiss, TF; Shapiro, G; Shingo, S; Storms, W; Zhang, J, 2001
)
0.82
" After reading this article, readers should have an understanding both of the general safety of anti-LTs and their specific adverse effects."( Safety of antileukotriene agents in asthma management.
Spector, SL, 2001
)
0.31
" Although most agents are safe and well tolerated when used properly, adverse effects may occur with use at higher dose levels."( Safety of antileukotriene agents in asthma management.
Spector, SL, 2001
)
0.31
"The results of clinical trials and real-world experience indicate that these agents are generally safe and well tolerated, with an incidence of adverse effects comparable with placebo."( Safety of antileukotriene agents in asthma management.
Spector, SL, 2001
)
0.31
" Montelukast represents a safe and effective asthma treatment regimen to which children with asthma are more likely to adhere."( Oral montelukast versus inhaled beclomethasone in 6- to 11-year-old children with asthma: results of an open-label extension study evaluating long-term safety, satisfaction, and adherence with therapy.
Dueñas-Meza, E; Kosa, L; Leff, JA; Maspero, JF; Pinacho Daza, C; Volovitz, B; Vrijens, F, 2001
)
1.73
"6%) adverse events were reported, all of which were of mild to moderate intensity."( A clinical trial of the efficacy and safety of montelukast as monotherapy in patients with chronic stable bronchial asthma.
Athavale, A; Avasthi, R; Kale, M; Singh, NP; Sireesha, K; Souza, GA; Taneja, A, 2004
)
0.58
" The primary variables were the frequency of clinical and laboratory adverse experiences."( Safety, tolerability, and exploratory efficacy of montelukast in 6- to 24-month-old patients with asthma.
Knorr, B; Moy, J; Reiss, TF; Tozzi, CA; van Adelsberg, J; Wei, LX, 2005
)
0.58
"The most common clinical adverse experiences were upper respiratory tract infection, asthma, fever, diarrhea, and vomiting occurring with similar frequencies between treatment groups."( Safety, tolerability, and exploratory efficacy of montelukast in 6- to 24-month-old patients with asthma.
Knorr, B; Moy, J; Reiss, TF; Tozzi, CA; van Adelsberg, J; Wei, LX, 2005
)
0.58
" Adverse events (69% vs 71%) and mean end point to baseline 12-hour urinary cortisol excretion ratios were similar."( Comparative efficacy and safety of low-dose fluticasone propionate and montelukast in children with persistent asthma.
Carranza Rosenzweig, JR; Crim, C; Decotiis, BA; Edwards, LD; Hanson, KM; Lincourt, WR; Ostrom, NK, 2005
)
0.56
" Adverse drug reactions occurred in 14 out of 6158 patients."( Efficacy and safety of montelukast in adults with asthma and allergic rhinitis.
Bachert, C; Virchow, JC, 2006
)
0.64
" The use of a combination of inhaled corticosteroids, long-acting beta-agonists, systemic corticosteroids, and leukotriene modifier drugs stabilized underlying airways in preparation for a reasonably safe and accurate oral aspirin challenge."( Effect of leukotriene modifier drugs on the safety of oral aspirin challenges.
Ludington, E; Mehra, P; Simon, RA; Stevenson, DD; White, A, 2006
)
0.33
"Use of LTRAs in pregnancy was not associated with a specific pattern of major structural anomalies in offspring or a large risk of other adverse perinatal outcomes."( Safety of leukotriene receptor antagonists in pregnancy.
Bakhireva, LN; Chambers, CD; Johnson, D; Jones, KL; Klonoff-Cohen, HS; Schatz, M; Slymen, DJ, 2007
)
0.34
" Descriptive analyses of the adverse drug reactions reported in children were performed."( Individual case safety reports in children in commonly used drug groups - signal detection.
Brunlöf, G; Tukukino, C; Wallerstedt, SM, 2008
)
0.35
" The largest number was found in the drug group R03DC, the leukotriene receptor antagonist montelukast; the majority of the children being <5 years old and experiencing psychiatric adverse drug reactions."( Individual case safety reports in children in commonly used drug groups - signal detection.
Brunlöf, G; Tukukino, C; Wallerstedt, SM, 2008
)
0.57
" A possible signal for montelukast and psychiatric adverse drug reactions was found, which should be further explored."( Individual case safety reports in children in commonly used drug groups - signal detection.
Brunlöf, G; Tukukino, C; Wallerstedt, SM, 2008
)
0.66
" Clinical and laboratory adverse experiences for patients treated with montelukast were generally mild and transient."( Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions.
Bisgaard, H; Boza, ML; Knorr, B; Newcomb, K; Noonan, G; Reiss, TF; Skoner, D; Tozzi, CA, 2009
)
0.88
" Subjects treated with L/M experienced a similar incidence of total adverse events versus placebo and a lower incidence of total adverse events (including dizziness, insomnia, jitteriness, nausea, and dry mouth) versus PSE."( Efficacy and safety of fixed-dose loratadine/montelukast in seasonal allergic rhinitis: effects on nasal congestion.
Anolik, R; Danzig, M; Prenner, B; Yao, R,
)
0.39
" Second-generation antihistamines have become increasingly popular because of their comparable efficacy and lower incidence of adverse effects relative to their first-generation counterparts, and the safety and efficacy of this drug class are established in the adult population."( Treatment of allergic rhinitis in infants and children: efficacy and safety of second-generation antihistamines and the leukotriene receptor antagonist montelukast.
Moeller, ML; Nahata, MC; Phan, H, 2009
)
0.55
" An understanding of structure-activity relationships (SARs) of chemicals can make a significant contribution to the identification of potential toxic effects early in the drug development process and aid in avoiding such problems."( Developing structure-activity relationships for the prediction of hepatotoxicity.
Fisk, L; Greene, N; Naven, RT; Note, RR; Patel, ML; Pelletier, DJ, 2010
)
0.36
" Due to the adverse effects of these treatments, new drugs like leukotriene receptor antagonists are being investigated for the treatment of allergic rhinitis."( Efficacy and safety of montelukast add-on therapy in allergic rhinitis.
Badyal, DK; Modgill, V; Verghese, A, 2010
)
0.67
" Adverse events (AEs) were defined as any unfavorable and unintended sign, symptom, or laboratory data, including onset of new illness and exacerbation of preexisting conditions."( Safety of fixed-dose loratadine/montelukast in subjects with allergic rhinitis.
Danzig, MR; Lu, S; Prenner, BM,
)
0.41
" A lesser but not significantly different adverse event rate was reported in the Zileuton ER group than the Montelukast group with the commonest events being headache and gastrointestinal effects in both the groups."( A randomized, comparative, multicentric clinical trial to assess the efficacy and safety of zileuton extended-release tablets with montelukast sodium tablets in patients suffering from chronic persistent asthma.
Bhargava, S; Khippal, N; Kshatriya, RR; Kubavat, AH; Mittal, R; Patel, T; Rijhwani, P; Shah, N; Tak, S,
)
0.55
" Secondary outcome measures included quality of life as measured by the Paediatric Asthma Quality of Life Questionnaire with Standardised Activities [PAQLQ(S)] and the Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ); time from randomisation to first exacerbation requiring treatment with a short course of oral corticosteroids; school attendance; hospital admissions; amount of rescue beta-2 agonist therapy prescribed; time from randomisation to treatment withdrawal (because of lack of efficacy or side effects); lung function at 48 weeks (as assessed by spirometry); cost-effectiveness; adverse events."( Management of Asthma in School age Children On Therapy (MASCOT): a randomised, double-blind, placebo-controlled, parallel study of efficacy and safety.
James, M; Lenney, W; McKay, AJ; Price, D; Tudur Smith, C; Williamson, PR, 2013
)
0.39
" Adverse events were similar between the groups except for nervous system disorders, which were more frequently reported on fluticasone plus montelukast."( Management of Asthma in School age Children On Therapy (MASCOT): a randomised, double-blind, placebo-controlled, parallel study of efficacy and safety.
James, M; Lenney, W; McKay, AJ; Price, D; Tudur Smith, C; Williamson, PR, 2013
)
0.59
" Available studies specifically addressing the role of montelukast in the elderly are scarce; however, leukotriene modifiers have been demonstrated to be safe in this age group, even though cases of acute hepatitis and occurrence of Churg-Strauss syndrome have been described in elderly patients; whether this is associated with age is to be confirmed."( Safety and efficacy of montelukast as adjunctive therapy for treatment of asthma in elderly patients.
Battaglia, S; Bellia, V; Benfante, A; Scichilone, N, 2013
)
0.95
" In conclusion, it was determined that TCDD exposure caused adverse effects on cytokine levels, histological alterations, and oxidative stress in rats."( Anti-inflammatory Montelukast prevents toxic effects of 2,3,7,8-tetrachlorodibenzo-p-dioxin: Oxidative stress, histological alterations in liver, and serum cytokine levels.
Bentli, R; Cetin, A; Ciftci, O; Otlu, A, 2016
)
0.77
" This case report indicates the possibility of adverse effects developing when the 2 drugs are used together."( Effect of concomitant use of montelukast and efavirenz on neuropsychiatric adverse events.
Ibarra-Barrueta, O; Mayo-Suarez, J; Mora-Atorrasagasti, O; Palacios-Zabalza, I, 2014
)
0.69
" Using an analogue approach, we tested if medication beliefs predict whether participants misattribute a headache as a side effect and subsequently intend to stop medication."( Beliefs about medication predict the misattribution of a common symptom as a medication side effect--Evidence from an analogue online study.
Chapman, SC; Heller, MK; Horne, R, 2015
)
0.42
" Finally, they rated whether the headache was a side effect (misattribution) and if they would stop taking Molair (behavioral intention)."( Beliefs about medication predict the misattribution of a common symptom as a medication side effect--Evidence from an analogue online study.
Chapman, SC; Heller, MK; Horne, R, 2015
)
0.42
" Clearly, longer acyl glucuronide half-lives were observed for safe drugs compared to drugs that can cause IDT."( Toxicity of Carboxylic Acid-Containing Drugs: The Role of Acyl Migration and CoA Conjugation Investigated.
Aatsinki, SM; Hokkanen, J; Lassila, T; Mattila, S; Tolonen, A; Turpeinen, M, 2015
)
0.42
"Many adverse drug reactions are caused by the cytochrome P450 (CYP)-dependent activation of drugs into reactive metabolites."( Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
Jones, LH; Nadanaciva, S; Rana, P; Will, Y, 2016
)
0.43
"To determine the toxic effect of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) on reproductive system and the beneficial effects of Montelukast (ML) with histological and biochemical analysis."( The beneficial effects of Montelukast against 2,3,7,8-tetrachlorodibenzo- p -dioxin toxicity in female reproductive system in rats.
Basak, N; Celik, E; Cetin, A; Ciftci, O; Melekoglu, R, 2016
)
0.94
"The toxic effects of 2,3,7,8-tetrachlorodibenzo-p-dioxin on female reproductive system were reversed with Montelukast treatment."( The beneficial effects of Montelukast against 2,3,7,8-tetrachlorodibenzo- p -dioxin toxicity in female reproductive system in rats.
Basak, N; Celik, E; Cetin, A; Ciftci, O; Melekoglu, R, 2016
)
0.95
" The incidence of adverse events showed no significant difference between the two groups."( [Therapeutic effect and safety of montelukast sodium combined with budesonide in children with cough variant asthma: a Meta analysis].
Li, DS; Liu, JJ; Wei, Y; Zhang, J; Zhao, HE, 2016
)
0.71
"Inhalation of montelukast sodium combined with budesonide has a significant effect in children with cough variant asthma and does not increase the incidence of adverse events."( [Therapeutic effect and safety of montelukast sodium combined with budesonide in children with cough variant asthma: a Meta analysis].
Li, DS; Liu, JJ; Wei, Y; Zhang, J; Zhao, HE, 2016
)
1.07
" We sought to characterize adverse events associated with single montelukast exposures in children ages 5-17 years and to determine whether adverse events were dose related for all-dose and for ultra-high-dose (≥50 mg) exposures."( Adverse events are rare after single-dose montelukast exposures in children.
Arnold, DH; Bowman, N; Hartert, TV; Reiss, TF; Seger, DL, 2018
)
0.98
" Characteristics of adverse events were examined using descriptive statistics and multivariable logistic models were used to examine whether associations of montelukast and adverse events were dose related."( Adverse events are rare after single-dose montelukast exposures in children.
Arnold, DH; Bowman, N; Hartert, TV; Reiss, TF; Seger, DL, 2018
)
0.94
" Abdominal pain was the most common adverse event (0."( Adverse events are rare after single-dose montelukast exposures in children.
Arnold, DH; Bowman, N; Hartert, TV; Reiss, TF; Seger, DL, 2018
)
0.75
"Single-dose exposures of montelukast up to 445 mg are rarely associated with any adverse events and are not associated with serious or life-threatening adverse events in children aged 5-17 years."( Adverse events are rare after single-dose montelukast exposures in children.
Arnold, DH; Bowman, N; Hartert, TV; Reiss, TF; Seger, DL, 2018
)
1.05
" Routine hematological and biochemical tests and treatment-emergent adverse events were monitored for safety."( Effectiveness and safety of levocetirizine 10 mg versus a combination of levocetirizine 5 mg and montelukast 10 mg in chronic urticaria resistant to levocetirizine 5 mg: A double-blind, randomized, controlled trial.
Das, NK; Ghosh, C; Pal, S; Sarkar, TK; Sil, A,
)
0.35
"The fixed-dose combination of montelukast and levocetirizine was effective and safe in treating perennial allergic rhinitis in patients with asthma compared with montelukast alone."( A Randomized, Multicenter, Double-blind, Phase III Study to Evaluate the Efficacy on Allergic Rhinitis and Safety of a Combination Therapy of Montelukast and Levocetirizine in Patients With Asthma and Allergic Rhinitis.
Chang, YS; Cho, YJ; Cho, YS; Choi, BW; Chung, JH; Jee, YK; Jo, EJ; Jung, J; Kim, HK; Kim, MK; Kim, SH; Lee, BJ; Lee, JM; Lee, SK; Lee, SY; Park, CS; Park, HS; Park, HW; Park, JW; Yoo, KH; Yoon, HJ, 2018
)
0.97
" Co-administration of MNK and SMV decreased their toxic potentials on the liver, skeletal muscles, and kidney."( Montelukast modifies simvastatin-induced myopathy and hepatotoxicity.
Ahmed, EA; Ali, MF; Hareedy, MS, 2019
)
1.96
"There have been conflicting results from observational studies regarding the risk of psychiatric adverse events (PAEs) with montelukast use."( Risk of Psychiatric Adverse Events Among Montelukast Users.
Bradley, M; Cocoros, NM; Dee, EC; Eworuke, E; Haug, N; Kim, I; Lyons, JG; Ma, Y; Mosholder, A; Pennap, D; Pestine, E; Petrone, AB; Sansing-Foster, V; Toh, S, 2021
)
1.09
" Clinical practice has shown that montelukast sodium combined with fluticasone in the treatment of adult BA can improve clinical efficacy and reduce adverse reactions."( Efficacy and safety of montelukast sodium combined with fluticasone in the treatment of adult bronchial asthma: A protocol for systematic review and meta-analysis.
Han, H; Liu, Q; Liu, X; Luo, H, 2020
)
1.15
"This study assessed the efficacy and safety of montelukast sodium combined with fluticasone in the treatment of adult BA through total effective rate, pulmonary function (FEV1, FVC, PEF, FEV1/FVC), and adverse reactions."( Efficacy and safety of montelukast sodium combined with fluticasone in the treatment of adult bronchial asthma: A protocol for systematic review and meta-analysis.
Han, H; Liu, Q; Liu, X; Luo, H, 2020
)
1.13
" Adverse reactions from trials were also recorded."( The efficacy and safety of montelukast in children with obstructive sleep apnea: a systematic review and meta-analysis.
Guo, Y; Ji, T; Li, X; Liu, Y; Lu, T; Ni, X; Qiu, Y; Tai, J; Wang, S; Xu, Z; Zhang, J; Zhao, J, 2021
)
0.92
" In terms of treatment safety, one study reported adverse reactions of OM such as headache, nausea and vomiting, while no adverse events were reported after OM treatment in another study."( The efficacy and safety of montelukast in children with obstructive sleep apnea: a systematic review and meta-analysis.
Guo, Y; Ji, T; Li, X; Liu, Y; Lu, T; Ni, X; Qiu, Y; Tai, J; Wang, S; Xu, Z; Zhang, J; Zhao, J, 2021
)
0.92
" Adverse effects of the drugs were noted."( Efficacy, tolerability, and safety of montelukast versus finasteride for the treatment of moderate acne in women: A prospective, randomized, single-blinded, active-controlled trial.
Goldust, M; Gupta, A; Mohammadnezhad, F; Rokni, GR; Saeedi, M; Sandhu, S; Shadi, S; Sharma, A, 2021
)
0.89
" Secondary outcomes included risk of hospitalization, pulmonary function, asthma control level, quality of life, and adverse events (AEs)."( Efficacy and safety of salmeterol/fluticasone compared with montelukast alone (or add-on therapy to fluticasone) in the treatment of bronchial asthma in children and adolescents: a systematic review and meta-analysis.
Hong, JG; Lu, J; Qin, Z; Zhou, XJ, 2021
)
0.86
"The aim of the study was to evaluate the treatment effects and adverse events of Monterizine® (a combination of montelukast and levocetirizine); a total of 2,254 patients with perennial allergic rhinitis and asthma were prospectively enrolled from 60 hospitals nationwide in Korea."( Multicenter Prospective Observational Study to Evaluate the Therapeutic Effect and Safety of a Combination of Montelukast and Levocetirizine for Allergic Rhinitis when Administered to Patients with Allergic Rhinitis and Asthma.
Cho, YJ; Choi, BW; Jung, JW; Kim, MH; Kwon, JW; Nam, YH; Park, CS; Park, HJ; Park, JS; Shin, YS; Sohn, KH, 2022
)
1.14
" There were no serious adverse drug reactions, but there were some minor reactions including nasopharyngitis (2."( Multicenter Prospective Observational Study to Evaluate the Therapeutic Effect and Safety of a Combination of Montelukast and Levocetirizine for Allergic Rhinitis when Administered to Patients with Allergic Rhinitis and Asthma.
Cho, YJ; Choi, BW; Jung, JW; Kim, MH; Kwon, JW; Nam, YH; Park, CS; Park, HJ; Park, JS; Shin, YS; Sohn, KH, 2022
)
0.93
"TNSS score and QoL were significantly improved by 3-6 months' treatment with Monterizine without significant adverse reactions."( Multicenter Prospective Observational Study to Evaluate the Therapeutic Effect and Safety of a Combination of Montelukast and Levocetirizine for Allergic Rhinitis when Administered to Patients with Allergic Rhinitis and Asthma.
Cho, YJ; Choi, BW; Jung, JW; Kim, MH; Kwon, JW; Nam, YH; Park, CS; Park, HJ; Park, JS; Shin, YS; Sohn, KH, 2022
)
0.93
"Recent observational studies suggest that the leukotriene receptor antagonist montelukast may have neuropsychiatric adverse effects; however, results are conflicting."( Psychiatric Adverse Effects of Montelukast-A Nationwide Cohort Study.
Bønnelykke, K; Eklöf, J; Jordan, A; Meteran, H; Sivapalan, P; Stæhr Jensen, JU; Toennesen, LL; Ulrik, CS, 2023
)
1.42
"To assess whether montelukast exposure in adults with asthma is associated with onset of neuropsychiatric adverse events using data from the Danish nationwide health registers."( Psychiatric Adverse Effects of Montelukast-A Nationwide Cohort Study.
Bønnelykke, K; Eklöf, J; Jordan, A; Meteran, H; Sivapalan, P; Stæhr Jensen, JU; Toennesen, LL; Ulrik, CS, 2023
)
1.53
" Clinicians should increase awareness of such adverse effects when prescribing montelukast."( Psychiatric Adverse Effects of Montelukast-A Nationwide Cohort Study.
Bønnelykke, K; Eklöf, J; Jordan, A; Meteran, H; Sivapalan, P; Stæhr Jensen, JU; Toennesen, LL; Ulrik, CS, 2023
)
1.42
"Mon + Flu is effective and safe for the treatment of CVA in children."( An efficacy and safety evaluation of montelukast + fluticasone propionate vs. fluticasone propionate in the treatment of cough variant asthma in children: a meta-analysis.
Li, S; Wei, Z, 2023
)
1.18

Pharmacokinetics

montelukast and levocetirizine when administered as separate tablets or as a fixed-dose combination were compared, and the parameters met the pharmacokinetic equities. A 5 mg chewable tablet dose was selected for use in clinical efficacy studies in 6- to 14-year-old children with asthma.

ExcerptReferenceRelevance
" The mean values of plasma clearance (CL), steady-state volume of distribution (Vss), plasma terminal half-life (t1/12), and mean residence time in the body (MRTi."( Pharmacokinetics, bioavailability, and safety of montelukast sodium (MK-0476) in healthy males and females.
Amin, R; Cheng, H; De Smet, M; Gertz, BJ; Leff, JA; Malbecq, W; Meisner, D; Noonan, N; Rogers, JD; Somers, G, 1996
)
0.55
" In elderly subjects, mean values of plasma clearance (Cl), steady-state volume of distribution (Vss), plasma terminal half-life (t1/2), and mean residence time in the body (MRTIV) following a 7 mg intravenous (5 min infusion) administration of montelukast sodium in the elderly were 30."( Pharmacokinetics and bioavailability of montelukast sodium (MK-0476) in healthy young and elderly volunteers.
Amin, RD; Cheng, H; Freeman, A; Haesen, R; Holland, SD; Larson, P; Merz, M; Rogers, JD; Seiberling, M; Zhao, JJ, 1997
)
0.75
" Montelukast decreased theophylline Cmax by 12% and 10%, AUC0-->infinity by 43% and 44%, and elimination half-time by 44% and 39% at 200 mg/d (oral and intravenous, respectively), and at 600 mg/d, montelukast decreased theophylline Cmax by 25%, AUC0-->infinity by 66%, and elimination half-time by 63%."( Effect of montelukast on single-dose theophylline pharmacokinetics.
Bachmann, K; Ebel, D; Huhn, RD; Hunt, TL; Jauregui, L; Larson, P; Malmstrom, K; Miller, K; Peszek, I; Reese, JH; Reiss, TF; Schwartz, J; Scott, M; Shingo, S; Sullivan, TJ, 1998
)
1.61
" However, slight but statistically significant decreases in time to peak concentration of both warfarin enantiomers and in elimination half-life of the less potent R-warfarin were observed in the presence of montelukast."( Effect of montelukast on the pharmacokinetics and pharmacodynamics of warfarin in healthy volunteers.
Arnout, J; De Lepeleire, I; De Schepper, PJ; Depré, M; Freeman, A; Gertz, B; Holland, S; Van Hecken, A; Verbesselt, R; Wong, PH; Wynants, K, 1999
)
0.89
" Based on this approach, which included dose normalization of data from several pediatric pharmacokinetic studies, a 5 mg chewable tablet dose of montelukast was selected for use in clinical efficacy studies in 6- to 14-year-old children with asthma."( Montelukast dose selection in 6- to 14-year-olds: comparison of single-dose pharmacokinetics in children and adults.
Amin, RD; Blake, K; Chervinsky, P; Freeman, A; Gertz, BJ; Haesen, R; Holland, S; Knorr, B; Larson, P; Michiels, N; Nguyen, HH; Noonan, G; Reiss, TF; Rogers, JD; Seidenberg, BC; Spielberg, S; van Nispen, CH; Xu, X; Zhao, J, 1999
)
1.95
" The pharmacokinetic parameters of digoxin (AUC0-->24' AUC0-->infinity' Cmax' tmax' t1/2) and cumulative urinary excretion over 120 hours were not affected by the multiple doses of montelukast."( Effect of multiple doses of montelukast, a CysLT1 receptor antagonist, on digoxin pharmacokinetics in healthy volunteers.
De Lepeleire, I; De Schepper, PJ; Depré, M; Freeman, A; Gertz, B; Holland, S; Shahane, A; Van Hecken, A; Verbesselt, R; Wynants, K, 1999
)
0.79
" The purpose of this open, one-period, multicenter population pharmacokinetic study was to identify a chewable tablet (CT) dose of montelukast for administration to children ages 2 to 5 years with asthma, yielding a single-dose pharmacokinetic profile (area under the plasma concentration-time curve [AUC]) comparable to that of the 10 mg film-coated tablet (FCT) dose in adults."( Montelukast dose selection in children ages 2 to 5 years: comparison of population pharmacokinetics between children and adults.
Boza, ML; Kearns, GL; Knorr, B; Larson, P; Nguyen, HH; Reiss, TF; Rogers, JD; Spielberg, S; Villaran, C; Zhang, J, 2001
)
1.96
"To determine if patients with cystic fibrosis (CF) have an altered pharmacokinetic profile of montelukast, we studied the single-dose pharmacokinetics in 12 patients with CF and 12 age- and gender-matched controls after they received a 10-mg oral dose."( Montelukast pharmacokinetics in cystic fibrosis.
Graff, GR; Smith, AL; Weber, A; Wessler-Starman, D, 2003
)
1.98
"05) in the measured pharmacokinetic parameters between the CF and control subjects."( Montelukast pharmacokinetics in cystic fibrosis.
Graff, GR; Smith, AL; Weber, A; Wessler-Starman, D, 2003
)
1.76
" The purpose of this study was to evaluate the pharmacokinetic comparability of a 4-mg dose of montelukast oral granules in patients > or = 6 to < 24 months old to the 10-mg approved dose in adults."( Pharmacokinetics of montelukast in asthmatic patients 6 to 24 months old.
Deutsch, P; Hartford, A; Kearns, GL; Knorr, B; Migoya, E; Tozzi, CA; van Adelsberg, J; Zhao, J, 2004
)
0.87
"The purpose was to develop a population pharmacokinetic model for montelukast after intravenous administration."( A population pharmacokinetic model for montelukast disposition in adults and children.
Knorr, B; Migoya, E; Ramakrishnan, R, 2005
)
0.83
"A linear three-compartment pharmacokinetic model was found to best describe the disposition of montelukast."( A population pharmacokinetic model for montelukast disposition in adults and children.
Knorr, B; Migoya, E; Ramakrishnan, R, 2005
)
0.82
" Also, the peak plasma concentration and elimination half-life of pioglitazone remained unaffected by montelukast and zafirlukast."( Montelukast and zafirlukast do not affect the pharmacokinetics of the CYP2C8 substrate pioglitazone.
Backman, JT; Jaakkola, T; Neuvonen, M; Neuvonen, PJ; Niemi, M, 2006
)
1.99
" The results highlight the importance of in vivo interaction studies and of the incorporation of relevant pharmacokinetic properties of drugs, including plasma protein binding data, to in vitro-in vivo interaction predictions."( Montelukast and zafirlukast do not affect the pharmacokinetics of the CYP2C8 substrate pioglitazone.
Backman, JT; Jaakkola, T; Neuvonen, M; Neuvonen, PJ; Niemi, M, 2006
)
1.78
" Pharmacokinetic parameters were determined using a population-based approach with a nonlinear mixed-effect, 1-compartment model with first-order absorption and elimination."( Pharmacokinetics and safety of montelukast in children aged 3 to 6 months.
Kearns, G; Knorr, B; Maganti, L; Migoya, E; Ramakrishnan, R; Tozzi, CA, 2006
)
0.62
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
" The protocol herein described was employed in a pharmacokinetic study of tablet formulation of montelukast in healthy Thai male volunteers."( A simple bioanalytical assay for determination of montelukast in human plasma: application to a pharmacokinetic study.
Kongthong, B; Saraphanchotiwitthaya, A; Sripalakit, P, 2008
)
0.82
" This novel method has been applied to a pharmacokinetic study of MTK in humans."( Quantification of montelukast, a selective cysteinyl leukotriene receptor (CysLT1) antagonist in human plasma by liquid chromatography-mass spectrometry: validation and its application to a human pharmacokinetic study.
Bharathi, DV; Hotha, KK; Jagadeesh, B; Mullangi, R; Naidu, A, 2009
)
0.69
"This nonrandomized, fixed-sequence, 3-period study investigated potential pharmacokinetic interactions between the leukotriene receptor antagonist montelukast, approved for the treatment of asthma, and roflumilast, an oral, once-daily phosphodiesterase 4 inhibitor in clinical development for asthma and chronic obstructive pulmonary disease."( The targeted oral, once-daily phosphodiesterase 4 inhibitor roflumilast and the leukotriene receptor antagonist montelukast do not exhibit significant pharmacokinetic interactions.
Böhmer, GM; Gleiter, CH; Hermann, R; Hünnemeyer, A; Lahu, G; Nassr, N; Templin, S; Wenger, M, 2009
)
0.76
"935G>A, the authors conducted a single-dose, pharmacokinetic study of montelukast co-ingested with citrus juice."( Effect of citrus juice and SLCO2B1 genotype on the pharmacokinetics of montelukast.
Lang, JE; Lima, JJ; Mougey, EB; Wen, X, 2011
)
0.84
" Saliva and plasma samples were collected for 3-5 half-life values of sitagliptin, cinacalcet, metformin, montelukast, tolterodine, hydrochlorothiazide (HCT), lornoxicam, azithromycin, diacerhein, rosuvastatin, cloxacillin, losartan and tamsulosin after oral dosing."( Saliva versus plasma pharmacokinetics: theory and application of a salivary excretion classification system.
Arafat, T; Idkaidek, N, 2012
)
0.59
" Its levels were measured up to 24 hours and a pharmacokinetic analysis was performed based on the SLCO2B1 polymorphisms."( Effects of polymorphisms of the SLCO2B1 transporter gene on the pharmacokinetics of montelukast in humans.
Joo, HJ; Kim, KA; Lee, HM; Park, IB; Park, JY, 2013
)
0.61
" The assay has been applied successfully in a pharmacokinetic study."( High-performance liquid chromatographic method for the determination of dasatinib in rabbit plasma using fluorescence detection and its application to a pharmacokinetic study.
Ezzeldin, E; Kassem, MG; Korashy, HM; Mostafa, GA, 2013
)
0.39
" This study showed that developed method is suitable for MO pharmacokinetic study."( Development of an LC-tandem mass spectrometry method for the separation of montelukast and its application to a pharmacokinetic study in humans.
AboTalib, NF; Ezzeldin, E; Tammam, MH, 2014
)
0.63
" Clinical DDIs of montelukast were evaluated using physiologically based pharmacokinetic modeling; and simulation of the interactions with gemfibrozil-CYP2C8 and OATP1B1/1B3 inhibitor, clarithromycin-CYP3A and OATP1B1/1B3 inhibitor, and itraconazole-CYP3A inhibitor, implicated OATPs-CYP2C8-CYP2C8 interplay as the primary determinant of montelukast pharmacokinetics."( Transporter-Mediated Hepatic Uptake Plays an Important Role in the Pharmacokinetics and Drug-Drug Interactions of Montelukast.
Bi, Y; El-Kattan, AF; Eng, H; Kalgutkar, AS; Kimoto, E; Lin, J; Rodrigues, AD; Scialis, R; Tremaine, LM; Varma, MV, 2017
)
1
"To identify the genetic basis of interindividual variability in montelukast exposure, we determined its pharmacokinetics and sequenced 379 pharmacokinetic genes in 191 healthy volunteers."( Comprehensive Pharmacogenomic Study Reveals an Important Role of UGT1A3 in Montelukast Pharmacokinetics.
Backman, JT; Hirvensalo, P; Kärjä, V; Männistö, VT; Neuvonen, M; Niemi, M; Paile-Hyvärinen, M; Pihlajamäki, J; Tapaninen, T; Tornio, A, 2018
)
0.95
"The accuracy of physiologically based pharmacokinetic (PBPK) model prediction in children, especially those younger than 2 years old, has not been systematically evaluated."( Predictive Performance of Physiologically Based Pharmacokinetic (PBPK) Modeling of Drugs Extensively Metabolized by Major Cytochrome P450s in Children.
Al-Huniti, N; Bui, KH; Cheung, SYA; Johnson, TN; Li, J; Xu, H; Zhou, D; Zhou, W, 2018
)
0.48
"  Amenamevir increased peak concentration and area under the concentration-time curve of montelukast by about 22% (ratio 121."( Amenamevir: Studies of Potential CYP2C8- and CYP2B6-Mediated Pharmacokinetic Interactions With Montelukast and Bupropion in Healthy Volunteers.
Adeloye, T; Dennison, J; Endo, T; Johnston, A; Puri, A; Warrington, S, 2018
)
0.92
" Although pharmacokinetic studies of montelukast have been reported in Caucasian adults and children, and showed large inter-individual variability on pharmacokinetics, none of these studies has been explored in Chinese children."( Developmental Pharmacogenetics of SLCO2B1 on Montelukast Pharmacokinetics in Chinese Children.
Hao, GX; Jacqz-Aigrain, E; Kan, M; Li, Q; Shi, HY; Su, LQ; Wang, K; Wang, XL; Wu, YE; Yang, XM; Yang, YL; Zhao, W; Zheng, Y; Zhou, J; Zhou, Y, 2019
)
1.05
" A previously published pharmacokinetic model was validated using the opportunistic pharmacokinetic samples, and individual patient's clearance was calculated using the validated model."( Developmental Pharmacogenetics of SLCO2B1 on Montelukast Pharmacokinetics in Chinese Children.
Hao, GX; Jacqz-Aigrain, E; Kan, M; Li, Q; Shi, HY; Su, LQ; Wang, K; Wang, XL; Wu, YE; Yang, XM; Yang, YL; Zhao, W; Zheng, Y; Zhou, J; Zhou, Y, 2019
)
0.77
" The objective of this study was to compare the pharmacokinetic profiles of a montelukast/levocetirizine fixed-dose combination chewable tablet with individual administration of montelukast and levocetirizine in healthy subjects."( Comparative pharmacokinetics of a montelukast/levocetirizine fixed-dose combination chewable tablet versus individual administration of montelukast and levocetirizine after a single oral administration in healthy Korean male subjects
.
Jung, J; Kim, MG; Kim, YI; Moon, SJ; Yu, KS, 2020
)
1.07
"A total of 22 subjects were included in pharmacokinetic analysis."( Comparative pharmacokinetics of a montelukast/levocetirizine fixed-dose combination chewable tablet versus individual administration of montelukast and levocetirizine after a single oral administration in healthy Korean male subjects
.
Jung, J; Kim, MG; Kim, YI; Moon, SJ; Yu, KS, 2020
)
0.84
"The pharmacokinetic parameters of montelukast and levocetirizine when administered as separate tablets or as a fixed-dose combination were compared, and the parameters met the pharmacokinetic equivalence criteria."( Comparative pharmacokinetics of a montelukast/levocetirizine fixed-dose combination chewable tablet versus individual administration of montelukast and levocetirizine after a single oral administration in healthy Korean male subjects
.
Jung, J; Kim, MG; Kim, YI; Moon, SJ; Yu, KS, 2020
)
1.12
"The aim of this study was to assess and compare the pharmacokinetic (PK) properties and bioequivalence of montelukast sodium chewable tablets prepared by two different manufacturers in healthy Chinese volunteers to obtain adequate PK evidence for the registration approval of the test formulation."( Pharmacokinetics and Bioequivalence Evaluation of Two Montelukast Sodium Chewable Tablets in Healthy Chinese Volunteers Under Fasted and Fed Conditions.
Li, W; Pei, Y; Wang, Y; Xia, Y, 2021
)
1.08

Compound-Compound Interactions

Budesonide combined with montelukast sodium in the treatment of bronchial asthma has the value of clinical application.

ExcerptReferenceRelevance
"Montelukast alone or in combination with loratadine is well tolerated and provides clinical and quality-of-life benefits for patients with seasonal allergic rhinitis."( Efficacy and tolerability of montelukast alone or in combination with loratadine in seasonal allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled trial performed in the fall.
Lu, S; Malice, MP; Nayak, AS; Philip, G; Reiss, TF, 2002
)
2.05
"Salmeterol (S) and montelukast (M) individually inhibit the obstructive consequences of thermal stimuli such as exercise and hyperventilation (HV), but there is no information on whether these drugs can interact positively."( Bronchoprotective effects of single doses of salmeterol combined with montelukast in thermally induced bronchospasm.
Coreno, A; El-Ekiaby, A; McFadden, ER; Skowronski, M; West, E, 2005
)
0.89
" We present an asthmatic patient who developed primary bacterial peritonitis while receiving a leukotriene modulator in combination with prednisolone therapy."( Leukotriene inhibitors in combination with steroids: potential role in the development of primary bacterial peritonitis.
Ammori, BJ; Farooq, A, 2005
)
0.33
"The % fall in FEV(1) from baseline and the area under the 30-min FEV(1) time curve and time to recover to 95% baseline FEV(1) were used to express protection from 40 mg sodium cromoglycate alone, and in combination with 10 mg montelukast, in subjects with asthma."( Sodium cromoglycate alone and in combination with montelukast on the airway response to mannitol in asthmatic subjects.
Anderson, SD; Brannan, JD; Caillaud, C; Perry, CP; Seale, JP, 2010
)
0.8
"Montelukast alone or in combination with antihistamines gave a gradual increase in nasal symptom improvement within 6 weeks of treatment in patients with persistent AR."( Use of montelukast alone or in combination with desloratadine or levocetirizine in patients with persistent allergic rhinitis.
Barylski, M; Ciebiada, M; Gorska-Ciebiada, M; Gorski, P; Kmiecik, T,
)
2.03
" We evaluated the effect of montelukast, a CysLT1R antagonist, on mouse models of asthma, porcine pancreatic elastase (PPE)-induced emphysema, and asthma combined with emphysema."( Effect of a cysteinyl leukotriene receptor antagonist on experimental emphysema and asthma combined with emphysema.
Fuchimoto, Y; Ikeda, G; Kanehiro, A; Kataoka, M; Koga, H; Kurimoto, E; Miyahara, N; Taniguchi, A; Tanimoto, M; Tanimoto, Y; Waseda, K, 2014
)
0.7
" This study assessed the effect of long-lasting treatment with montelukast alone or in combination with antihistamines on wheal and flare in skin pricks tests (SPT) in patients sensitized to perennial allergens."( Wheal and flare reactions in skin prick tests of patients treated with montelukast alone or in combination with antihistamines.
Barylski, M; Ciebiada, M; Ciebiada, MG, 2014
)
0.88
"Both levocetirizine and desloratadine in monotherapy, or in combination with montelukast, were effective in reducing wheal and flare in SPT."( Wheal and flare reactions in skin prick tests of patients treated with montelukast alone or in combination with antihistamines.
Barylski, M; Ciebiada, M; Ciebiada, MG, 2014
)
0.86
"Predicting Drug-Drug Interactions (DDIs) from in vitro data is made difficult by not knowing concentrations of substrate and inhibitor at the target site."( Case study 4. Predicting the drug interaction potential for inhibition of CYP2C8 by montelukast.
Korzekwa, K, 2014
)
0.63
" We hypothesized that this drug might provide benefit if combined with montelukast, a leukotriene receptor antagonist, in patients whose symptoms are uncontrolled by inhaled corticosteroids and long-acting β-agonists."( Roflumilast combined with montelukast versus montelukast alone as add-on treatment in patients with moderate-to-severe asthma.
Bateman, ED; Goehring, UM; Richard, F; Watz, H, 2016
)
0.97
" We evaluated the quantitative role of hepatic uptake transport in its pharmacokinetics and drug-drug interactions (DDIs)."( Transporter-Mediated Hepatic Uptake Plays an Important Role in the Pharmacokinetics and Drug-Drug Interactions of Montelukast.
Bi, Y; El-Kattan, AF; Eng, H; Kalgutkar, AS; Kimoto, E; Lin, J; Rodrigues, AD; Scialis, R; Tremaine, LM; Varma, MV, 2017
)
0.67
"To evaluate the therapeutic effect and safety of montelukast sodium combined with budesonide in children with cough variant asthma."( [Therapeutic effect and safety of montelukast sodium combined with budesonide in children with cough variant asthma: a Meta analysis].
Li, DS; Liu, JJ; Wei, Y; Zhang, J; Zhao, HE, 2016
)
0.97
"The databases CNKI, Wanfang Data, VIP, PubMed, EMbase, and BioMed Central were searched for randomized controlled trials (RCTs) of montelukast sodium combined with budesonide in the treatment of children with cough variant asthma."( [Therapeutic effect and safety of montelukast sodium combined with budesonide in children with cough variant asthma: a Meta analysis].
Li, DS; Liu, JJ; Wei, Y; Zhang, J; Zhao, HE, 2016
)
0.92
" The results of the Meta analysis showed that compared with the control group (inhalation of budesonide alone), the observation group (inhalation of montelukast sodium combined with budesonide) had significantly higher overall response rate and more improved pulmonary function parameters including forced expiratory volume in the first second, percentage of forced expiratory volume in the first second, and peak expiratory flow, as well as significantly lower recurrence rate (P<0."( [Therapeutic effect and safety of montelukast sodium combined with budesonide in children with cough variant asthma: a Meta analysis].
Li, DS; Liu, JJ; Wei, Y; Zhang, J; Zhao, HE, 2016
)
0.91
"Inhalation of montelukast sodium combined with budesonide has a significant effect in children with cough variant asthma and does not increase the incidence of adverse events."( [Therapeutic effect and safety of montelukast sodium combined with budesonide in children with cough variant asthma: a Meta analysis].
Li, DS; Liu, JJ; Wei, Y; Zhang, J; Zhao, HE, 2016
)
1.07
"This study was designed to investigate the clinical effect of montelukast sodium combined with inhaled corticosteroids in the treatment of children with obstructive sleep apnea syndrome (OSAS)."( Clinical effect of montelukast sodium combined with inhaled corticosteroids in the treatment of OSAS children.
Liang, J; Shu, Y; Yang, DZ; Yao, HB; Zhang, F, 2017
)
1.02
"To observe the effects of micro-invasive embedding combined with montelukast sodium and simple montelukast sodium for children cough variant asthma (CVA)."( [Micro-invasive embedding combined with montelukast sodium for children cough variant asthma:a randomized controlled trial].
Ding, D; Han, X; Li, H; Liu, B; Lu, B; Wang, L; Wang, X; Zhang, Y, 2017
)
0.96
"Micro-invasive embedding combined with montelukast sodium achieved de-finite effect for children CVA, which can improve the body's immune and microcirculation."( [Micro-invasive embedding combined with montelukast sodium for children cough variant asthma:a randomized controlled trial].
Ding, D; Han, X; Li, H; Liu, B; Lu, B; Wang, L; Wang, X; Zhang, Y, 2017
)
0.99
"The use of polypharmacy in the present day clinical therapy has made the identification of clinical drug-drug interaction risk an important aspect of drug development process."( In Vitro Drug-Drug Interaction Potential of Sulfoxide and/or Sulfone Metabolites of Albendazole, Triclabendazole , Aldicarb, Methiocarb, Montelukast and Ziprasidone.
Giri, P; Giri, S; Gupta, L; Joshi, V; Naidu, S; Patel, N; Srinivas, NR, 2018
)
0.68
"In vitro drug-drug interaction potential of test compounds was investigated in two stages; 1) assessment of CYP450 inhibition potential of test compounds using human liver microsomes (HLM); and 2) assessment of test compounds as substrate of Phase I enzymes; including CYP450, FMO, AO and MAO using HLM, recombinant human CYP enzymes (rhCYP), Human Liver Cytosol (HLC) and Human Liver Mitochondrial (HLMit)."( In Vitro Drug-Drug Interaction Potential of Sulfoxide and/or Sulfone Metabolites of Albendazole, Triclabendazole , Aldicarb, Methiocarb, Montelukast and Ziprasidone.
Giri, P; Giri, S; Gupta, L; Joshi, V; Naidu, S; Patel, N; Srinivas, NR, 2018
)
0.68
", perpetrator and/or victim drug) to overcome any imminent risk of potential clinical drug-drug interaction when sulfoxide/sulfone metabolite(s) generating drugs are coadministered in therapy."( In Vitro Drug-Drug Interaction Potential of Sulfoxide and/or Sulfone Metabolites of Albendazole, Triclabendazole , Aldicarb, Methiocarb, Montelukast and Ziprasidone.
Giri, P; Giri, S; Gupta, L; Joshi, V; Naidu, S; Patel, N; Srinivas, NR, 2018
)
0.68
"To examine the clinical typing and individualized treatment approach for allergic rhinitis and to determine the optimal treatment method for this disease using various drug combination therapies."( Individualized treatment for allergic rhinitis based on key nasal clinical manifestations combined with histamine and leukotriene D4 levels.
Chen, F; Li, G; Shen, C; Wang, H; Wen, Z; Zhang, X,
)
0.13
"Clinical symptom evaluation combined with experimental detection of histamine and leukotriene levels can be an objective and accurate method to clinically classify the allergic rhinitis types."( Individualized treatment for allergic rhinitis based on key nasal clinical manifestations combined with histamine and leukotriene D4 levels.
Chen, F; Li, G; Shen, C; Wang, H; Wen, Z; Zhang, X,
)
0.13
"To study the effect of the leukotriene receptor agonist montelukast combined with methylprednisolone on inflammatory response and peripheral blood lymphocyte subset content in children with mycoplasma pneumonia."( Effect of montelukast combined with methylprednisolone for the treatment of mycoplasma pneumonia.
Ding, X; Ji, W; Liang, Y; Wu, H; Zhao, D, 2019
)
1.16
"Montelukast combined with methylprednisolone for the treatment of mycoplasma pneumonia can inhibit inflammatory responses and regulate levels of Th1/Th2 and Th17/Treg cells."( Effect of montelukast combined with methylprednisolone for the treatment of mycoplasma pneumonia.
Ding, X; Ji, W; Liang, Y; Wu, H; Zhao, D, 2019
)
2.36
"The aim of this study was to explore the clinical effect of montelukast sodium chewable tablets combined with inhaled budesonide in the treatment of pediatric asthma and its influence on inflammatory factors."( Efficacy of montelukast sodium chewable tablets combined with inhaled budesonide in treating pediatric asthma and its effect on inflammatory factors.
Wang, H; Zhang, Y, 2019
)
1.14
"To evaluate the efficacy of Chinese medicine acupoint application (CMAA) combined with Western medicine for perennial allergic rhinitis (PAR) in children."( Efficacy of Chinese Medicine Acupoint Application Combined with Montelukast on Children with Perennial Allergic Rhinitis: A Randomized Controlled Trial.
Ding, LF; Li, YJ; Ma, BY; Qin, LP; Rui, XQ; Zong, M, 2020
)
0.8
" Clinical practice has shown that montelukast sodium combined with fluticasone in the treatment of adult BA can improve clinical efficacy and reduce adverse reactions."( Efficacy and safety of montelukast sodium combined with fluticasone in the treatment of adult bronchial asthma: A protocol for systematic review and meta-analysis.
Han, H; Liu, Q; Liu, X; Luo, H, 2020
)
1.15
"The Chinese databases (CNKI, VIP, Wanfang, Chinese Biomedical Database) and English databases (PubMed, the Cochrane Library, Embase, Web of Science) were searched by computer, for the randomized controlled clinical studies of montelukast sodium combined with fluticasone in the treatment of adult BA from establishment of database to October 2020."( Efficacy and safety of montelukast sodium combined with fluticasone in the treatment of adult bronchial asthma: A protocol for systematic review and meta-analysis.
Han, H; Liu, Q; Liu, X; Luo, H, 2020
)
1.05
"This study assessed the efficacy and safety of montelukast sodium combined with fluticasone in the treatment of adult BA through total effective rate, pulmonary function (FEV1, FVC, PEF, FEV1/FVC), and adverse reactions."( Efficacy and safety of montelukast sodium combined with fluticasone in the treatment of adult bronchial asthma: A protocol for systematic review and meta-analysis.
Han, H; Liu, Q; Liu, X; Luo, H, 2020
)
1.13
"This study will provide reliable evidence-based evidence for the clinical application of montelukast sodium combined with fluticasone in the treatment of adult BA."( Efficacy and safety of montelukast sodium combined with fluticasone in the treatment of adult bronchial asthma: A protocol for systematic review and meta-analysis.
Han, H; Liu, Q; Liu, X; Luo, H, 2020
)
1.09
" This study is designed to explore the therapeutic potential of metformin and montelukast, in combination with Lactobacillus, for modulation of intestinal flora and suppression of oxidative stress in testicular and liver damage in diabetic male rats."( The therapeutic role of lactobacillus and montelukast in combination with metformin in diabetes mellitus complications through modulation of gut microbiota and suppression of oxidative stress.
El-Baz, AM; El-Sokkary, MMA; Hassan, HM; Khodir, AE; Shata, A, 2021
)
1.11
"Predicting drug-drug interactions (DDIs) from in vitro data is made difficult by not knowing concentrations of substrate and inhibitor at the target site."( Case Study 5: Predicting the Drug Interaction Potential for Inhibition of CYP2C8 by Montelukast.
Korzekwa, K, 2021
)
0.85
"Our study aims to explore the impact of non-invasive ventilation (NIV) alone or combined with montelukast on clinical efficiency and pulmonary function (PF) in treating patients with bronchial asthma complicated by obstructive sleep apnea hypopnea syndrome (OSAHS)."( The Impact of Non-Invasive Ventilation Combined with Montelukast on Clinical Efficiency and Pulmonary Function in Patients with Bronchial Asthma Complicated by Obstructive Sleep Apnea Hypopnea Syndrome.
Feng, XK; Lin, JL; Pei, J; Sun, HY; Zhang, DM, 2022
)
1.19
"To observe the clinical efficacy of self-made Lifei Dingchuan decoction combined with western medicine in the treatment of cough variant asthma (phlegm-heat accumulation in the lung syndrome)."( Study on the Effect of Self-Made Lifei Dingchuan Decoction Combined with Western Medicine on Cough Variant Asthma.
Huang, Z; Jian, X; Li, J; Li, K; Liang, B, 2022
)
0.72
" The purpose of this study is to further investigate the clinical effects of budesonide combined with montelukast sodium in treating bronchial asthma."( Effect of budesonide combined with montelukast sodium on pulmonary function parameters and immunoglobulin levels in children with bronchial asthma.
Chen, F; Chu, F; Liang, L, 2023
)
1.4
" The control group was treated with aerosol inhalation of budesonide combined with placebo, while the study group was treated with budesonide combined with montelukast sodium."( Effect of budesonide combined with montelukast sodium on pulmonary function parameters and immunoglobulin levels in children with bronchial asthma.
Chen, F; Chu, F; Liang, L, 2023
)
1.38
"Budesonide combined with montelukast sodium in the treatment of bronchial asthma has the value of clinical application and promotion."( Effect of budesonide combined with montelukast sodium on pulmonary function parameters and immunoglobulin levels in children with bronchial asthma.
Chen, F; Chu, F; Liang, L, 2023
)
1.49
"This meta-analysis aimed to compare the efficacy of montelukast (MKST) combined with budesonide (BUD) and BUD alone in the treatment of pulmonary inflammation and pulmonary function in children with cough variant asthma (CVA)."( Effect of Montelukast Combined with Budesonide on Inflammatory Response and Pulmonary Function in Children with Cough Variant Asthma: A Meta-analysis.
Lin, H; Wang, L; Wu, M; Wu, Q, 2023
)
1.56

Bioavailability

The dose of montelukast per kg bodyweight was approximately the same as that for human beings, but the C(max) in the horses was 28 times lower. Based on these results it could be concluded that a major part of the radioactivity was excreted via bile.

ExcerptReferenceRelevance
") montelukast sodium (Singulair, MK-0476), and the oral bioavailability of montelukast sodium in healthy males and healthy females were studied."( Pharmacokinetics, bioavailability, and safety of montelukast sodium (MK-0476) in healthy males and females.
Amin, R; Cheng, H; De Smet, M; Gertz, BJ; Leff, JA; Malbecq, W; Meisner, D; Noonan, N; Rogers, JD; Somers, G, 1996
)
1.27
" Following oral administration of a 10-mg tablet of montelukast sodium, the AUC, maximum plasma concentration (Cmax), time when Cmax occurred (Tmax), apparent t1/12, mean absorption time (MAT), and bioavailability (F) of montelukast sodium averaged 2441 ng."( Pharmacokinetics, bioavailability, and safety of montelukast sodium (MK-0476) in healthy males and females.
Amin, R; Cheng, H; De Smet, M; Gertz, BJ; Leff, JA; Malbecq, W; Meisner, D; Noonan, N; Rogers, JD; Somers, G, 1996
)
0.8
" Based on these results and the reported modestly high oral bioavailability of montelukast, it could be concluded that a major part of the radioactivity was excreted via bile."( Metabolic profiles of montelukast sodium (Singulair), a potent cysteinyl leukotriene1 receptor antagonist, in human plasma and bile.
Amin, RD; Arison, BH; Baillie, TA; Balani, SK; Chiba, M; Doss, GA; Dufresne, C; Freeman, A; Gertz, BJ; Holland, SD; Isenberg, JI; Koss, MA; Lasseter, KC; Lin, JH; Miller, RR; Pratha, V; Rogers, JD; Schwartz, JI; Xu, X, 1997
)
0.84
"A study was conducted to (i) characterize the multiple-dose pharmacokinetics of oral montelukast sodium (MK-0476), 10 mg d-1 in healthy young subjects (N = 12), (ii) evaluate the pharmacokinetics of montelukast in healthy elderly subjects (N = 12), and (iii) compare the pharmacokinetics and oral bioavailability of montelukast between elderly and young subjects."( Pharmacokinetics and bioavailability of montelukast sodium (MK-0476) in healthy young and elderly volunteers.
Amin, RD; Cheng, H; Freeman, A; Haesen, R; Holland, SD; Larson, P; Merz, M; Rogers, JD; Seiberling, M; Zhao, JJ, 1997
)
0.79
" The dose of montelukast per kg bodyweight was approximately the same as that for human beings, but the C(max) in the horses was 28 times lower and the t(max) was reached in one-fifth of the time, suggesting that its oral bioavailability may be lower."( Efficacy of montelukast in the treatment of chronic obstructive pulmonary disease in five horses.
Kolm, G; Riedelberger, K; Schmid, R; Van den Hoven, R; Zappe, H, 2003
)
1.07
" Human oral bioavailability is an important pharmacokinetic property, which is directly related to the amount of drug available in the systemic circulation to exert pharmacological and therapeutic effects."( Hologram QSAR model for the prediction of human oral bioavailability.
Andricopulo, AD; Moda, TL; Montanari, CA, 2007
)
0.34
" Age and sex have no apparent effect on the drug's metabolism and elimination, and food does not affect its bioavailability or absorption."( Desloratadine for chronic idiopathic urticaria: a review of clinical efficacy.
DuBuske, L, 2007
)
0.34
" The in vitro results of the dynamic dissolution test were able to predict the clinical data from a bioavailability study best."( Dynamic dissolution testing to establish in vitro/in vivo correlations for montelukast sodium, a poorly soluble drug.
DiMaso, M; Löbenberg, R; Okumu, A, 2008
)
0.58
"Oral bioavailability (F) is a product of fraction absorbed (Fa), fraction escaping gut-wall elimination (Fg), and fraction escaping hepatic elimination (Fh)."( Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
Chang, G; El-Kattan, A; Miller, HR; Obach, RS; Rotter, C; Steyn, SJ; Troutman, MD; Varma, MV, 2010
)
0.36
" The aim of this study was to compare the pharmacokinetics and relative bioavailability of a test and reference formulation of montelukast 5-mg chewable tablets in healthy Korean male volunteers to meet KFDA regulatory criteria for marketing of the new generic formulation."( Relative bioavailability of two 5-mg montelukast sodium chewable tablets: a single dose, randomized, open-label, 2-period crossover comparison in healthy korean adult male volunteers.
Kim, CK; Kim, HT; Lee, SD; Park, Y; Song, YK, 2012
)
0.86
"To compare the bioavailability of Amisped® (5 mg montelukast chewable tablets) manufactured by Sanofi-Aventis and 5 mg chewable tablet montelukast (Singulair®) developed by Merck."( [Bioequivalence study of montelukast 5 mg chewable tablets].
Medina, AP; Muñoz, E; Navas, MP; Olaya, FJ; Tilano, AM, 2012
)
0.94
"The absorption rate of montelukast was not altered when administered with desloratadine."( Does desloratadine alter the serum levels of montelukast when administered in a fixed-dose combination?
Cakli, H; Cingi, C; Erdogmus, N; Ertugay, CK; Gurbuz, MK; Ince, I; Karasulu, E; Kaya, E; Toros, SZ, 2013
)
0.96
" In vivo single dose oral pharmacokinetic study demonstrated 143-fold improvement in bioavailability as compared to montelukast-aqueous solution."( Montelukast-loaded nanostructured lipid carriers: part I oral bioavailability improvement.
Patil-Gadhe, A; Pokharkar, V, 2014
)
2.05
" A common ground to these reports is the pursue of an enhanced montelukast performance, by increasing its bioavailability and physico-chemical stability."( Montelukast medicines of today and tomorrow: from molecular pharmaceutics to technological formulations.
Almeida Paz, FA; Barbosa, JS; Braga, SS, 2016
)
2.12
" We similarly measured the oral and inhalational bioavailability by monitoring the pharmacokinetics and disposition of the drug in live animals."( Aerosolizable modified-release particles of montelukast improve retention and availability of the drug in the lungs.
Ahsan, F; Patel, B; Rashid, J, 2017
)
0.72
" The available marketed formulations of montelukast present challenges such as poor bioavailability and reduced uptake, reflecting the lack of effectiveness of its desired action in the CNS."( Targeted Delivery of Montelukast for the Treatment of Alzheimer's Disease.
Datusalia, AK; Gaun, S; Manik, M; Singh, G; Singh, RK; Yadav, N, 2022
)
1.31

Dosage Studied

Montelukast attenuated LTD4-induced bronchoconstriction and, at a dosage of 10 mg, significantly reduced early and late airway response to allergen (dust mite extract) relative to placebo. This montelukasts sodium-loaded oral suspension could be a prospective dosage form for the treatment of asthma.

ExcerptRelevanceReference
" dosage range."( Pharmacokinetics, bioavailability, and safety of montelukast sodium (MK-0476) in healthy males and females.
Amin, R; Cheng, H; De Smet, M; Gertz, BJ; Leff, JA; Malbecq, W; Meisner, D; Noonan, N; Rogers, JD; Somers, G, 1996
)
0.55
" In conclusion, montelukast caused dose-related protection against exercise-induced bronchoconstriction at the end of a once-daily dosing interval."( Dose-related protection of exercise bronchoconstriction by montelukast, a cysteinyl leukotriene-receptor antagonist, at the end of a once-daily dosing interval.
Bronsky, EA; Guerreiro, D; Kemp, JP; Reiss, TF; Zhang, J, 1997
)
0.89
" There is no need to modify dosage as a function of age."( Pharmacokinetics and bioavailability of montelukast sodium (MK-0476) in healthy young and elderly volunteers.
Amin, RD; Cheng, H; Freeman, A; Haesen, R; Holland, SD; Larson, P; Merz, M; Rogers, JD; Seiberling, M; Zhao, JJ, 1997
)
0.56
" Exercise challenges were performed at base line; 20 to 24 hours after dosing at weeks 4, 8, and 12; and at the end of the washout period."( Montelukast, a leukotriene-receptor antagonist, for the treatment of mild asthma and exercise-induced bronchoconstriction.
Bronsky, EA; Busse, WW; Dockhorn, R; Hendeles, L; Kemp, J; Kundu, S; Leff, JA; Pearlman, D; Reiss, TF; Seidenberg, BC; Zhang, J, 1998
)
1.74
" In patients with asthma, montelukast 5 to 250 mg/day attenuated LTD4-induced bronchoconstriction and, at a dosage of 10 mg, significantly reduced early and late airway response to allergen (dust mite extract) relative to placebo."( Montelukast.
Faulds, D; Markham, A, 1998
)
2.04
"Montelukast attenuates EIB at the end of the dosing interval in 6- to 14-year-old children with asthma."( Montelukast once daily inhibits exercise-induced bronchoconstriction in 6- to 14-year-old children with asthma.
Dockhorn, RJ; Kemp, JP; Knorr, B; Nguyen, HH; Reiss, TF; Seidenberg, BC; Shapiro, GG, 1998
)
3.19
" However, using the present dosing and sample size, this protection was not accompanied with changes in sputum eosinophil percentage or activity, which may require more prolonged pretreatment with cysLT1 receptor antagonists."( The effect of montelukast (MK-0476), a cysteinyl leukotriene receptor antagonist, on allergen-induced airway responses and sputum cell counts in asthma.
De Smet, M; Diamant, Z; Grootendorst, DC; Leff, JA; Peszek, I; Seidenberg, BC; Sterk, PJ; Timmers, MC; Veselic-Charvat, M; Zwinderman, AH, 1999
)
0.66
" These results show that montelukast at the clinical dosage did not change theophylline pharmacokinetics in a clinically important manner, but at 20- to 60-fold higher dosages, montelukast significantly reduced the theophylline pharmacokinetics parameters; an apparent dosage dependence is suggested."( Effect of montelukast on single-dose theophylline pharmacokinetics.
Bachmann, K; Ebel, D; Huhn, RD; Hunt, TL; Jauregui, L; Larson, P; Malmstrom, K; Miller, K; Peszek, I; Reese, JH; Reiss, TF; Schwartz, J; Scott, M; Shingo, S; Sullivan, TJ, 1998
)
1.01
" This study was designed to evaluate whether montelukast at clinically used dosage levels would interfere with the anticoagulant effect of warfarin."( Effect of montelukast on the pharmacokinetics and pharmacodynamics of warfarin in healthy volunteers.
Arnout, J; De Lepeleire, I; De Schepper, PJ; Depré, M; Freeman, A; Gertz, B; Holland, S; Van Hecken, A; Verbesselt, R; Wong, PH; Wynants, K, 1999
)
0.97
" Exercise challenge was repeated at day 3, week 4, and week 8 after randomization near the end of the dosing interval for both drugs."( Montelukast versus salmeterol in patients with asthma and exercise-induced bronchoconstriction. Montelukast/Salmeterol Exercise Study Group.
Chuchalin, AG; Gunawardena, KA; Helbling, A; Jasan, J; Langley, SJ; Laurenzi, M; Lee, TH; Leff, JA; Menten, J; O'Neill, SJ; Suskovic, S; van Noord, JA; Villaran, C, 1999
)
1.75
" Long-term administration of montelukast provided consistent inhibition of exercise-induced bronchoconstriction at the end of the 8-week dosing interval without tolerance."( Oral montelukast compared with inhaled salmeterol to prevent exercise-induced bronchoconstriction. A randomized, double-blind trial. Exercise Study Group.
Bronsky, EA; DeLucca, PT; Edelman, JM; Ghannam, AF; Gormley, GJ; Grossman, J; Kemp, JP; Pearlman, DS; Turpin, JA, 2000
)
1.11
"Montelukast, a new leukotriene modifier, has several benefits in the treatment of asthma in adults and children including improved relief of asthma symptoms, rapid onset, a safety profile comparable with placebo, and oral, once-daily dosing means excellent adherence."( Use of oral montelukast in the treatment of asthma.
Angner, R; Knorr, B; Lu, S; Noonan, GP; Reiss, TF; Williams, B, 2001
)
2.13
" The drug has to be taken by the oral route at the dosage of 10 mg/day in adults and 5 mg/day in children under 15 years."( [Pharma-clinics. Medication of the month. Montelukast (Singulair)].
Louis, R, 2001
)
0.57
" The present study, performed using single-dose treatments, demonstrated that maximal protective effect by montelukast was obtained 12 h after dosing and that montelukast plus loratadine did not result in significant additive bronchoprotective effects on exercise-induced bronchoconstriction."( The combination of single-dose montelukast and loratadine on exercise-induced bronchospasm in children.
Boner, AL; De Gasperi, W; Loiacono, A; Micciolo, R; Peroni, DG; Piacentini, GL; Pietrobelli, A; Sabbion, A, 2002
)
0.81
" In mild asthmatics, the timing of administration of single dosage before exercise should be strictly considered in order to obtain the drug protective effects."( Time efficacy of a single dose of montelukast on exercise-induced asthma in children.
Aralla, R; Bodini, A; Boner, AL; Loiacono, A; Peroni, DG; Piacentini, GL; Ress, M, 2002
)
0.59
"We conclude that the dose of montelukast and the dosing interval does not need to be modified if the goal is to mimic the serum concentration used to treat asthma."( Montelukast pharmacokinetics in cystic fibrosis.
Graff, GR; Smith, AL; Weber, A; Wessler-Starman, D, 2003
)
2.05
"Whether chronic dosing with montelukast confers benefit in patients with moderate to severe asthma remains to be fully established."( A proof of concept study to evaluate putative benefits of montelukast in moderate persistent asthmatics.
Cowan, LM; Currie, GP; Dempsey, OJ; Fowler, SJ; Lee, DK; Lipworth, BJ, 2003
)
0.86
"The anti-inflammatory effects of repeated dosing with mediator antagonists as add-on therapy to that with inhaled corticosteroids (ICSs) in patients with asthma remain to be fully established."( Repeated dosing effects of mediator antagonists in inhaled corticosteroid-treated atopic asthmatic patients.
Haggart, K; Jackson, CM; Lee, DK; Lipworth, BJ, 2004
)
0.32
"We elected to evaluate the effects of repeated dosing with fexofenadine (FEX) and montelukast (ML) at clinically recommended doses in ICS-treated asthmatic patients using adenosine monophosphate (AMP) bronchial challenge as the primary outcome."( Repeated dosing effects of mediator antagonists in inhaled corticosteroid-treated atopic asthmatic patients.
Haggart, K; Jackson, CM; Lee, DK; Lipworth, BJ, 2004
)
0.55
"Repeated dosing with FEX and ML as add-on therapy improved AMP PC(20) and other surrogate inflammatory markers along with asthma diary outcomes in ICS-treated atopic asthmatic patients."( Repeated dosing effects of mediator antagonists in inhaled corticosteroid-treated atopic asthmatic patients.
Haggart, K; Jackson, CM; Lee, DK; Lipworth, BJ, 2004
)
0.32
" Although leukotriene CysLT1-receptor antagonists improve lower airway outcomes in AIA, their effects and dose-response in the upper airway is less well documented."( Montelukast protects against nasal lysine-aspirin challenge in patients with aspirin-induced asthma.
Haggart, K; Lee, DK; Lipworth, BJ; Robb, FM, 2004
)
1.77
" However, there is no information to determine if this effectiveness could vary depending on dosage time."( Montelukast administered in the morning or evening to prevent exercise-induced bronchoconstriction in children.
Garcia-Marcos, L; Garcia-Rubia, S; Pajaron-Fernandez, M; Sanchez-Solis, M, 2006
)
1.78
" Fewer patients required postexercise beta-agonist rescue at 2 hours after dosing with montelukast (P = ."( Onset and duration of protection against exercise-induced bronchoconstriction by a single oral dose of montelukast.
Busse, W; Dass, SB; Hendeles, L; Loeys, T; Pearlman, DS; Philip, G; Reiss, TF; Tilles, SA; van Adelsberg, J, 2006
)
0.77
"To investigate the effect of multiple dosing with montelukast, a selective leukotriene-receptor antagonist, on the pharmacokinetics of rosiglitazone, a CYP2C8 substrate, in humans."( Effect of multiple doses of montelukast on the pharmacokinetics of rosiglitazone, a CYP2C8 substrate, in humans.
Kim, KA; Kim, KR; Park, JY; Park, PW, 2007
)
0.89
" Further considerations for measuring long-term outcomes and dose-response relationships might be required to provide further evidence on the cost effectiveness of combination therapy with ICS plus LABA."( Single-inhaler combination therapy for asthma: a review of cost effectiveness.
Akazawa, M; Stempel, DA, 2006
)
0.33
"Response to salmeterol does not vary between ADRB2 genotypes after chronic dosing with an inhaled corticosteroid."( Salmeterol response is not affected by beta2-adrenergic receptor genotype in subjects with persistent asthma.
Anderson, WH; Baitinger, LA; Bleecker, ER; Dorinsky, PM; Edwards, LD; Klotsman, M; Yancey, SW, 2006
)
0.33
"To examine the effect of dosing frequency and mode of delivery of therapy on adherence and clinical outcomes."( Adherence with montelukast or fluticasone in a long-term clinical trial: results from the mild asthma montelukast versus inhaled corticosteroid trial.
Bilderback, A; Edelman, JM; Hustad, CM; Rand, C; Schiller, K; Zeiger, RS, 2007
)
0.69
" In the DB, a dose-response relationship was observed with fluticasone and asthma rescue-free days (P = ."( Adherence with montelukast or fluticasone in a long-term clinical trial: results from the mild asthma montelukast versus inhaled corticosteroid trial.
Bilderback, A; Edelman, JM; Hustad, CM; Rand, C; Schiller, K; Zeiger, RS, 2007
)
0.69
" The major degradation product in the latter solvent was Monte S-oxide and it was also detected as a major degradation product in Monte tablet dosage form during the incubation at 40 degrees C/75% RH for 6 months."( Effect of light and heat on the stability of montelukast in solution and in its solid state.
Al Omari, MM; Badwan, AA; Hasan, EI; Khader, TZ; Zoubi, RM, 2007
)
0.6
" Other important prescribing considerations are that, unlike all first-generation and some second-generation antihistamines, desloratadine is nonsedating at its clinically approved dosage and does not impair psychomotor function."( Desloratadine for chronic idiopathic urticaria: a review of clinical efficacy.
DuBuske, L, 2007
)
0.34
"Performances on VigTrack and MAT from 1 to 6 hours after dosing were not significantly different between L/M and placebo groups; in contrast, diphenhydramine resulted in significant impairment of tracking for up to 5 hours (P< or =0."( Effects of loratadine/montelukast on vigilance and alertness task performance in a simulated cabin environment.
Simons, M; Valk, PJ, 2009
)
0.67
" This pathophysiological feature is characterized by the absence of a dose-response plateau to methacholine (Mtc)."( Effect of montelukast on excessive airway narrowing response to methacholine in adult asthmatic patients not on controller therapy.
Diamant, Z; Ulrik, CS,
)
0.53
" Patients evaluated nasal congestion and other symptoms of AR and measured peak nasal inspiratory flow before dosing and at 20-minute intervals during the subsequent 8 hours of pollen exposure."( Efficacy of loratadine-montelukast on nasal congestion in patients with seasonal allergic rhinitis in an environmental exposure unit.
Briscoe, MP; Danzig, M; Day, JH; Ratz, JD; Yao, R, 2009
)
0.66
" Alternative dosage forms such as liquids or oral disintegrating tablets are available for most agents, allowing ease of administration to most young children and infants; however, limited data are available regarding use in infants for most agents, except desloratadine, cetirizine and montelukast."( Treatment of allergic rhinitis in infants and children: efficacy and safety of second-generation antihistamines and the leukotriene receptor antagonist montelukast.
Moeller, ML; Nahata, MC; Phan, H, 2009
)
0.73
"Two simple, rapid, accurate and precise methods have been developed for simultaneous estimation of Montelukast sodium and Bambuterol hydrochloride from tablet dosage form."( Simultaneous estimation of Montelukast sodium and Bambuterol hydrochloride in tablets by spectrophotometry.
Kothapalli, LP; Nanda, RK; Pangarkar, VB; Pawar, AA; Thomas, AB,
)
0.64
" The antiinflammatory dose-response curve of loratadine was shifted to the left when studied in combination with montelukast (0."( Concomitant activity of histamine and cysteinyl leukotrienes on porcine nasal mucosal vessels and nasal inflammation in the rat.
Hunter, JC; Jia, Y; Jimenez, J; Lieber, G; McLeod, RL, 2010
)
0.57
" Montelukast was delivered as a witnessed dose through dry powder inhaler at doses of 25, 250, or 1000 μg, and doses of 50, 100, and 500 μg could be used if needed based on a prespecified dose-response algorithm."( A phase I randomized, placebo-controlled, dose-exploration study of single-dose inhaled montelukast in patients with chronic asthma.
Korenblat, PE; Pedinoff, A; Philip, G; Reiss, TF; Smugar, SS; Tymofyeyev, Y; Vandormael, K, 2010
)
1.49
"05 L), whereas montelukast 100 μg provided significant bronchodilation relative to placebo within 2 hours of dosing (0."( A phase I randomized, placebo-controlled, dose-exploration study of single-dose inhaled montelukast in patients with chronic asthma.
Korenblat, PE; Pedinoff, A; Philip, G; Reiss, TF; Smugar, SS; Tymofyeyev, Y; Vandormael, K, 2010
)
0.94
" The method demonstrated robustness and showed to be viable for the sodium montelukast determination in pharmaceutical dosage form."( Stability indicating method for sodium montelukast in pharmaceutical preparations by micellar electrokinetic capillary chromatography.
Jablonski, A; Malesuik, MD; Roman, J; Steppe, M, 2010
)
0.86
" We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts."( FDA-approved drug labeling for the study of drug-induced liver injury.
Chen, M; Fang, H; Liu, Z; Shi, Q; Tong, W; Vijay, V, 2011
)
0.37
" This developed method show to be viable for the determination of sodium montelukast in pharmaceutical dosage form and satisfactory in the determination of the kinetics of degradation."( Stability indicating LC method to determination of sodium montelukast in pharmaceutical dosage form and its photodegradation kinetics.
Breier, AR; Roman, J; Steppe, M, 2011
)
0.85
"To verify exactly when montelukast begins protection in asthmatic children by evaluating different time intervals between dosing and challenge."( Time-effect of montelukast on protection against exercise-induced bronchoconstriction.
Boner, AL; Chinellato, I; Peroni, DG; Pescollderungg, L; Piacentini, GL; Sandri, M, 2011
)
1.03
" A subsample of 259 families had controller medication use monitored objectively for approximately 1 month by MDILog (fluticasone propionate), TrackCap (montelukast), or dosage counter (fluticasone/salmeterol combination)."( Complementary and alternative medicine use and adherence to asthma medications among Latino and non-Latino white families.
Adams, SK; Canino, G; Fedele, DA; Fritz, GK; Jandasek, B; Koinis-Mitchell, D; Kopel, SJ; McQuaid, EL; Mitchell, J; Seifer, R,
)
0.33
"Dissolution testing is a performance test for many dosage forms including tablets and capsules."( Simulation of in vitro dissolution behavior using DDDPlus™.
Almukainzi, M; Löbenberg, R; Okumu, A; Wei, H, 2015
)
0.42
" A clear dose-response relationship was not observed."( Exploring the possible association between montelukast and neuropsychiatric events among children with asthma: a matched nested case-control study.
Ali, MM; Cleves, MA; Martin, BC; O'Brien, CE, 2015
)
0.68
" Differential scanning calorimetry (DSC), Fourier transform-Infrared (FT-IR), X-ray powder diffraction (XRPD) and scanning electron microscope (SEM) techniques were used to characterize Cop-CM, in addition to characterization of its powder and ODT dosage form."( Co-processed chitin-mannitol as a new excipient for Oro-dispersible tablets.
Al Omari, MM; Badwan, AA; Chowdhry, BZ; Daraghmeh, N; Leharne, SA, 2015
)
0.42
" Thus, this montelukast sodium-loaded oral suspension, with bioequivalence to the commercial granules and excellent stability, could be a prospective dosage form for the treatment of asthma."( Novel montelukast sodium-loaded stable oral suspension bioequivalent to the commercial granules in rats.
Cho, KH; Choi, HG; Jin, SG; Kim, DS; Kim, DW; Kim, JO; Kim, KS; Kim, YH; Kim, YI; Kwon, TK; Li, DX; Park, JH; Woo, JS; Yong, CS; Yousaf, AM, 2016
)
1.29
" Currently, montelukast is commercialized only in oral solid dosage forms, which are the favorite of adult patients but may pose challenges in administration to children of young age or patients suffering from dysphagia."( Montelukast medicines of today and tomorrow: from molecular pharmaceutics to technological formulations.
Almeida Paz, FA; Barbosa, JS; Braga, SS, 2016
)
2.26
" Finally, the CD-MEKC system was successfully applied to the determination of related substances in MK bulk drug and its quantification in two pediatric pharmaceutical dosage forms."( Development of an enantioselective capillary electrophoretic method for the simultaneous determination of montelukast enantiomeric and diastereoisomeric forms and its main degradation product.
Flor, S; Huala Juan, M; Lucangioli, S; Tripodi, V, 2016
)
0.65
"Montelukast ODT may be an acceptable dosage formulation for adults with mild-to-moderate asthma and/or AR in Japan."( Early patient experiences with montelukast orally disintegrating tablets in Japan: a cross-sectional survey of treatment satisfaction in patients with asthma and/or allergic rhinitis.
Petigara, T; Rasouliyan, L; Tobe, K; Tunceli, K; Whalley, D, 2017
)
2.18
" The EAACI/GA[2]LEN/EDF/WAO guidelines advocate an increased antihistamine dosage up to four times the standard, before adding leukotriene receptor antagonists."( Effectiveness and safety of levocetirizine 10 mg versus a combination of levocetirizine 5 mg and montelukast 10 mg in chronic urticaria resistant to levocetirizine 5 mg: A double-blind, randomized, controlled trial.
Das, NK; Ghosh, C; Pal, S; Sarkar, TK; Sil, A,
)
0.35
"A total of 310 patients were randomised and dosed in the study."( Efficacy and safety of lebrikizumab in adult patients with mild-to-moderate asthma not receiving inhaled corticosteroids.
Anzures-Cabrera, J; Governale, L; Holweg, CTJ; Kerwin, E; Korenblat, P; Leshchenko, I; Martin, C; Matthews, JG; Olsson, J; Putnam, WS; Yen, K, 2018
)
0.48
" Dosage and speed of infusion of Daratumumab have to be strictly controlled."( [Infusion of Daratumumab in Combination Therapies - Practical Information for The Outpatient Area].
Engelhardt, M; Munder, M; Salwender, H; Scheid, C, 2018
)
0.48
" Montelukast dosing was 10 mg for adults (age 14 years and above) and 5 mg for children (age 6 years to 14 years)."( Leukotriene receptor antagonists for eczema.
Ferguson, L; Futamura, M; Kojima, R; Mori, R; Roberts, A; Sasaki, H; Vakirlis, E, 2018
)
1.39
" In cases of failure, treatment was switched to omalizumab at doses of < 300 mg/month with incremental dosage increases as necessary (monthly dose range, 150-600 mg/month)."( Real-life experience in the treatment of solar urticaria: retrospective cohort study.
Enk, CD; Hodak, E; Lapidoth, M; Levi, A; Mazor, S; Snast, I; Uvaidov, V, 2019
)
0.51
" This article exemplifies the reported analytical methods like electrometric methods, ultraviolet spectroscopy, mass spectroscopy, thin layer chromatography, high performance liquid chromatography, high performance thin layer chromatography and tandem spectroscopy for determination of fexofenadine HCl and montelukast sodium in dosage form and in biological matrices."( A Review of Different Analytical Techniques for Fexofenadine Hydrochloride and Montelukast Sodium in Different Matrices.
Kumar, V; Nalini, CN, 2021
)
1.02
" The dosing scenarios tested reflected in vivo paediatric administration practices: (i."( In Vivo Predictive Dissolution Testing of Montelukast Sodium Formulations Administered with Drinks and Soft Foods to Infants.
Flanagan, T; Fotaki, N; Mann, J; Martir, J, 2020
)
0.82
" According to a literature review, no UV-visible spectrophotometric method has been reported yet for simultaneous estimation of montelukast sodium and bilastine in their combined pharmaceutical dosage forms."( Risk Assessment-Based Enhanced Analytical Quality-by-Design Approach to Eco-Friendly and Economical Multicomponent Spectrophotometric Methods for Simultaneous Estimation of Montelukast Sodium and Bilastine.
Mishra, A; Prajapati, P; Surati, P; Tamboli, J, 2021
)
1.02
"The developed and validated methods were applied for assay of combined pharmaceutical dosage forms of montelukast sodium and bilastine and results were found to be in good agreement with their label claims."( Risk Assessment-Based Enhanced Analytical Quality-by-Design Approach to Eco-Friendly and Economical Multicomponent Spectrophotometric Methods for Simultaneous Estimation of Montelukast Sodium and Bilastine.
Mishra, A; Prajapati, P; Surati, P; Tamboli, J, 2021
)
1.03
" An assay of combined tablet dosage forms of montelukast sodium and bilastine was then carried out using the developed methods."( Risk Assessment-Based Enhanced Analytical Quality-by-Design Approach to Eco-Friendly and Economical Multicomponent Spectrophotometric Methods for Simultaneous Estimation of Montelukast Sodium and Bilastine.
Mishra, A; Prajapati, P; Surati, P; Tamboli, J, 2021
)
1.07
" MON, or combination of MFC, with no limitation of dosage or duration."( Efficacy and safety of salmeterol/fluticasone compared with montelukast alone (or add-on therapy to fluticasone) in the treatment of bronchial asthma in children and adolescents: a systematic review and meta-analysis.
Hong, JG; Lu, J; Qin, Z; Zhou, XJ, 2021
)
0.86
" Effects of CysLTR1 inhibition on basal autophagic activity were analyzed at inactive/low and high lysosomal degradation activity with the antagonists zafirlukast (ZTK) and montelukast (MTK) at a dosage of 100 nM for 3 hours."( Chronobiological activity of cysteinyl leukotriene receptor 1 during basal and induced autophagy in the ARPE-19 retinal pigment epithelial cell line.
Aigner, L; Brunner, SM; Koller, A; Ladek, AM; Preishuber-Pflügl, J; Reitsamer, H; Runge, C; Trost, A, 2021
)
0.81
"When dosed at sleep time, the prepared cross-linked beads may deliver montelukast sodium required to relieve early morning symptoms in asthmatic patients."( Cross-linked Alginate Beads of Montelukast Sodium Coated with Eudragit for Chronotherapy: Statistical Optimization,
Dave, V; Kumar, N; Ranjan, OP, 2022
)
1.24
"An extended release dosage form based on encapsulating the challenging drug busulfan within microspheres of the biodegradable, biocompatible and biosynthesized poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV) polyester was achieved."( Biosynthesized poly(3-hydroxybutyrate-co-3-hydroxyvalerate) as biocompatible microcapsules with extended release for busulfan and montelukast.
Aboulsoud, M; Alamry, KA; Alenazi, E; Alsafadi, D; Hussein, MA; Ibrahim, MI; Safi, E, 2022
)
0.93
" For potent and effective dosing in elderly patients, a parenteral prolonged delivery system is favored, with improved medication adherence with reduced dosage frequency."( Design of Montelukast Nanocrystalline Suspension for Parenteral Prolonged Delivery.
Choi, JH; Choi, YS; Choi, YW; Ho, MJ; Joung, MY; Kang, MJ; Kim, MS; Lee, S; Park, HJ; Park, JS; Seo, JH; Song, WH, 2022
)
1.12
" At present, we analyzed the dose-response effects of a selective cysteinyl leukotriene receptor type-1 antagonist during bone repair after tooth extraction and on non-injured skeleton."( Dose-response effect of Montelukast on post-extraction dental socket repair and skeletal phenotype of mice.
Bacelar, ACZ; Barreto, AJM; Biguetti, CC; Chaves-Neto, AH; da Silva, RBP; Duarte, MAH; Ervolino, E; Fakhouri, WD; Matsumoto, MA; Ribeiro, KHC; Roseno, ACB, 2023
)
1.22
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (3)

RoleDescription
leukotriene antagonistA drug designed to prevent leukotriene synthesis or activity by blocking binding at the receptor level.
anti-asthmatic drugA drug used to treat asthma.
anti-arrhythmia drugA drug used for the treatment or prevention of cardiac arrhythmias. Anti-arrhythmia drugs may affect the polarisation-repolarisation phase of the action potential, its excitability or refractoriness, or impulse conduction or membrane responsiveness within cardiac fibres.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (3)

ClassDescription
quinolinesA class of aromatic heterocyclic compounds each of which contains a benzene ring ortho fused to carbons 2 and 3 of a pyridine ring.
monocarboxylic acidAn oxoacid containing a single carboxy group.
aliphatic sulfide
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (26)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Epidermal growth factor receptorHomo sapiens (human)IC50 (µMol)3.19700.00000.536910.0000AID625184
Tyrosine-protein kinase FynHomo sapiens (human)IC50 (µMol)4.70200.00021.67898.6800AID625185
Beta-2 adrenergic receptorHomo sapiens (human)IC50 (µMol)3.48800.00020.93267.2000AID625205
Beta-2 adrenergic receptorHomo sapiens (human)Ki2.39800.00000.66359.5499AID625205
Aldo-keto reductase family 1 member B1Rattus norvegicus (Norway rat)IC50 (µMol)2.68900.00041.877310.0000AID625207
Aldo-keto reductase family 1 member B1Rattus norvegicus (Norway rat)Ki2.66700.00322.28879.3160AID625207
Alpha-2A adrenergic receptorHomo sapiens (human)IC50 (µMol)3.91900.00001.44217.3470AID625201
Alpha-2A adrenergic receptorHomo sapiens (human)Ki1.47000.00010.807410.0000AID625201
Adenosine receptor A3Homo sapiens (human)IC50 (µMol)0.43400.00001.89408.5470AID625196
Adenosine receptor A3Homo sapiens (human)Ki0.24500.00000.930610.0000AID625196
Cytochrome P450 2C8Homo sapiens (human)IC50 (µMol)0.70000.00081.88487.9000AID1813642; AID1911194
Muscarinic acetylcholine receptor M1Homo sapiens (human)IC50 (µMol)8.04500.00001.403910.0000AID625151
Muscarinic acetylcholine receptor M1Homo sapiens (human)Ki1.93800.00000.59729.1201AID625151
Beta-3 adrenergic receptorHomo sapiens (human)IC50 (µMol)4.30000.00233.24158.0600AID625206
Beta-3 adrenergic receptorHomo sapiens (human)Ki3.20000.00302.30986.0450AID625206
Alpha-1B adrenergic receptorRattus norvegicus (Norway rat)IC50 (µMol)0.43400.00021.874210.0000AID625196
Alpha-1B adrenergic receptorRattus norvegicus (Norway rat)Ki0.24500.00010.949010.0000AID625196
Alpha-2C adrenergic receptorHomo sapiens (human)IC50 (µMol)5.27900.00001.47257.8980AID625203
Alpha-2C adrenergic receptorHomo sapiens (human)Ki0.76700.00030.483410.0000AID625203
Muscarinic acetylcholine receptor M3Homo sapiens (human)IC50 (µMol)6.62600.00011.01049.9280AID625153
Muscarinic acetylcholine receptor M3Homo sapiens (human)Ki1.40400.00000.54057.7600AID625153
Substance-K receptorHomo sapiens (human)IC50 (µMol)3.82200.00013.12109.5530AID625227
Substance-K receptorHomo sapiens (human)Ki1.27400.00011.92429.7930AID625227
Sodium-dependent noradrenaline transporter Homo sapiens (human)IC50 (µMol)2.68900.00081.541620.0000AID625207
Sodium-dependent noradrenaline transporter Homo sapiens (human)Ki2.66700.00031.465610.0000AID625207
Thromboxane-A synthase Homo sapiens (human)IC50 (µMol)1.52500.00091.230410.0000AID625229
D(3) dopamine receptorHomo sapiens (human)IC50 (µMol)7.74700.00011.01788.7960AID625254
D(3) dopamine receptorHomo sapiens (human)Ki2.63100.00000.602010.0000AID625254
Delta-type opioid receptorHomo sapiens (human)IC50 (µMol)4.79500.00020.75218.0140AID625161
Delta-type opioid receptorHomo sapiens (human)Ki1.69000.00000.59789.9300AID625161
5-hydroxytryptamine receptor 2BHomo sapiens (human)IC50 (µMol)6.25600.00011.18738.9125AID625217
5-hydroxytryptamine receptor 2BHomo sapiens (human)Ki3.98100.00030.769310.0000AID625217
Alpha-1A adrenergic receptorRattus norvegicus (Norway rat)IC50 (µMol)0.43400.00001.819410.0000AID625196
Alpha-1A adrenergic receptorRattus norvegicus (Norway rat)Ki0.24500.00000.965010.0000AID625196
Sodium-dependent dopamine transporter Homo sapiens (human)IC50 (µMol)2.60100.00071.841946.0000AID625256
Sodium-dependent dopamine transporter Homo sapiens (human)Ki2.06700.00021.11158.0280AID625256
Uracil nucleotide/cysteinyl leukotriene receptorHomo sapiens (human)Ki6.54001.21003.03506.5400AID1137667
Mitogen-activated protein kinase 14Homo sapiens (human)IC50 (µMol)0.85600.00010.72667.8000AID625182
Leukotriene C4 synthaseHomo sapiens (human)IC50 (µMol)5.00003.00004.00005.0000AID1579865
Cysteinyl leukotriene receptor 1Cavia porcellus (domestic guinea pig)Ki0.00050.00010.23581.5000AID55069
Cysteinyl leukotriene receptor 2Homo sapiens (human)IC50 (µMol)10.00000.00102.405210.0000AID1236111
Cysteinyl leukotriene receptor 1Homo sapiens (human)IC50 (µMol)0.00150.00030.948710.0000AID102799; AID1236112; AID55235; AID625145
Cysteinyl leukotriene receptor 1Homo sapiens (human)Ki0.00110.00021.56248.8720AID625145
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Cysteinyl leukotriene receptor 1Homo sapiens (human)EC50 (µMol)0.07200.00090.05500.1040AID497575
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (436)

Processvia Protein(s)Taxonomy
cell surface receptor signaling pathwayEpidermal growth factor receptorHomo sapiens (human)
epidermal growth factor receptor signaling pathwayEpidermal growth factor receptorHomo sapiens (human)
positive regulation of cell population proliferationEpidermal growth factor receptorHomo sapiens (human)
MAPK cascadeEpidermal growth factor receptorHomo sapiens (human)
ossificationEpidermal growth factor receptorHomo sapiens (human)
embryonic placenta developmentEpidermal growth factor receptorHomo sapiens (human)
positive regulation of protein phosphorylationEpidermal growth factor receptorHomo sapiens (human)
hair follicle developmentEpidermal growth factor receptorHomo sapiens (human)
translationEpidermal growth factor receptorHomo sapiens (human)
signal transductionEpidermal growth factor receptorHomo sapiens (human)
epidermal growth factor receptor signaling pathwayEpidermal growth factor receptorHomo sapiens (human)
activation of phospholipase C activityEpidermal growth factor receptorHomo sapiens (human)
salivary gland morphogenesisEpidermal growth factor receptorHomo sapiens (human)
midgut developmentEpidermal growth factor receptorHomo sapiens (human)
learning or memoryEpidermal growth factor receptorHomo sapiens (human)
circadian rhythmEpidermal growth factor receptorHomo sapiens (human)
positive regulation of cell population proliferationEpidermal growth factor receptorHomo sapiens (human)
diterpenoid metabolic processEpidermal growth factor receptorHomo sapiens (human)
peptidyl-tyrosine phosphorylationEpidermal growth factor receptorHomo sapiens (human)
cerebral cortex cell migrationEpidermal growth factor receptorHomo sapiens (human)
positive regulation of cell growthEpidermal growth factor receptorHomo sapiens (human)
lung developmentEpidermal growth factor receptorHomo sapiens (human)
positive regulation of cell migrationEpidermal growth factor receptorHomo sapiens (human)
positive regulation of superoxide anion generationEpidermal growth factor receptorHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylationEpidermal growth factor receptorHomo sapiens (human)
response to cobalaminEpidermal growth factor receptorHomo sapiens (human)
response to hydroxyisoflavoneEpidermal growth factor receptorHomo sapiens (human)
cellular response to reactive oxygen speciesEpidermal growth factor receptorHomo sapiens (human)
peptidyl-tyrosine autophosphorylationEpidermal growth factor receptorHomo sapiens (human)
ERBB2-EGFR signaling pathwayEpidermal growth factor receptorHomo sapiens (human)
negative regulation of epidermal growth factor receptor signaling pathwayEpidermal growth factor receptorHomo sapiens (human)
negative regulation of protein catabolic processEpidermal growth factor receptorHomo sapiens (human)
vasodilationEpidermal growth factor receptorHomo sapiens (human)
positive regulation of phosphorylationEpidermal growth factor receptorHomo sapiens (human)
ovulation cycleEpidermal growth factor receptorHomo sapiens (human)
hydrogen peroxide metabolic processEpidermal growth factor receptorHomo sapiens (human)
negative regulation of apoptotic processEpidermal growth factor receptorHomo sapiens (human)
positive regulation of MAP kinase activityEpidermal growth factor receptorHomo sapiens (human)
tongue developmentEpidermal growth factor receptorHomo sapiens (human)
positive regulation of cyclin-dependent protein serine/threonine kinase activityEpidermal growth factor receptorHomo sapiens (human)
positive regulation of DNA repairEpidermal growth factor receptorHomo sapiens (human)
positive regulation of DNA replicationEpidermal growth factor receptorHomo sapiens (human)
positive regulation of bone resorptionEpidermal growth factor receptorHomo sapiens (human)
positive regulation of DNA-templated transcriptionEpidermal growth factor receptorHomo sapiens (human)
positive regulation of vasoconstrictionEpidermal growth factor receptorHomo sapiens (human)
negative regulation of mitotic cell cycleEpidermal growth factor receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIEpidermal growth factor receptorHomo sapiens (human)
regulation of JNK cascadeEpidermal growth factor receptorHomo sapiens (human)
symbiont entry into host cellEpidermal growth factor receptorHomo sapiens (human)
protein autophosphorylationEpidermal growth factor receptorHomo sapiens (human)
astrocyte activationEpidermal growth factor receptorHomo sapiens (human)
positive regulation of fibroblast proliferationEpidermal growth factor receptorHomo sapiens (human)
digestive tract morphogenesisEpidermal growth factor receptorHomo sapiens (human)
positive regulation of smooth muscle cell proliferationEpidermal growth factor receptorHomo sapiens (human)
neuron projection morphogenesisEpidermal growth factor receptorHomo sapiens (human)
epithelial cell proliferationEpidermal growth factor receptorHomo sapiens (human)
positive regulation of epithelial cell proliferationEpidermal growth factor receptorHomo sapiens (human)
regulation of peptidyl-tyrosine phosphorylationEpidermal growth factor receptorHomo sapiens (human)
protein insertion into membraneEpidermal growth factor receptorHomo sapiens (human)
response to calcium ionEpidermal growth factor receptorHomo sapiens (human)
regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionEpidermal growth factor receptorHomo sapiens (human)
positive regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionEpidermal growth factor receptorHomo sapiens (human)
positive regulation of synaptic transmission, glutamatergicEpidermal growth factor receptorHomo sapiens (human)
positive regulation of glial cell proliferationEpidermal growth factor receptorHomo sapiens (human)
morphogenesis of an epithelial foldEpidermal growth factor receptorHomo sapiens (human)
eyelid development in camera-type eyeEpidermal growth factor receptorHomo sapiens (human)
response to UV-AEpidermal growth factor receptorHomo sapiens (human)
positive regulation of mucus secretionEpidermal growth factor receptorHomo sapiens (human)
regulation of ERK1 and ERK2 cascadeEpidermal growth factor receptorHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeEpidermal growth factor receptorHomo sapiens (human)
cellular response to amino acid stimulusEpidermal growth factor receptorHomo sapiens (human)
cellular response to mechanical stimulusEpidermal growth factor receptorHomo sapiens (human)
cellular response to cadmium ionEpidermal growth factor receptorHomo sapiens (human)
cellular response to epidermal growth factor stimulusEpidermal growth factor receptorHomo sapiens (human)
cellular response to estradiol stimulusEpidermal growth factor receptorHomo sapiens (human)
cellular response to xenobiotic stimulusEpidermal growth factor receptorHomo sapiens (human)
cellular response to dexamethasone stimulusEpidermal growth factor receptorHomo sapiens (human)
positive regulation of canonical Wnt signaling pathwayEpidermal growth factor receptorHomo sapiens (human)
liver regenerationEpidermal growth factor receptorHomo sapiens (human)
cell-cell adhesionEpidermal growth factor receptorHomo sapiens (human)
positive regulation of protein kinase C activityEpidermal growth factor receptorHomo sapiens (human)
positive regulation of G1/S transition of mitotic cell cycleEpidermal growth factor receptorHomo sapiens (human)
positive regulation of non-canonical NF-kappaB signal transductionEpidermal growth factor receptorHomo sapiens (human)
positive regulation of prolactin secretionEpidermal growth factor receptorHomo sapiens (human)
positive regulation of miRNA transcriptionEpidermal growth factor receptorHomo sapiens (human)
positive regulation of protein localization to plasma membraneEpidermal growth factor receptorHomo sapiens (human)
negative regulation of cardiocyte differentiationEpidermal growth factor receptorHomo sapiens (human)
neurogenesisEpidermal growth factor receptorHomo sapiens (human)
multicellular organism developmentEpidermal growth factor receptorHomo sapiens (human)
positive regulation of kinase activityEpidermal growth factor receptorHomo sapiens (human)
cell surface receptor protein tyrosine kinase signaling pathwayEpidermal growth factor receptorHomo sapiens (human)
response to singlet oxygenTyrosine-protein kinase FynHomo sapiens (human)
neuron migrationTyrosine-protein kinase FynHomo sapiens (human)
stimulatory C-type lectin receptor signaling pathwayTyrosine-protein kinase FynHomo sapiens (human)
adaptive immune responseTyrosine-protein kinase FynHomo sapiens (human)
negative regulation of inflammatory response to antigenic stimulusTyrosine-protein kinase FynHomo sapiens (human)
heart processTyrosine-protein kinase FynHomo sapiens (human)
protein phosphorylationTyrosine-protein kinase FynHomo sapiens (human)
calcium ion transportTyrosine-protein kinase FynHomo sapiens (human)
G protein-coupled glutamate receptor signaling pathwayTyrosine-protein kinase FynHomo sapiens (human)
axon guidanceTyrosine-protein kinase FynHomo sapiens (human)
learningTyrosine-protein kinase FynHomo sapiens (human)
feeding behaviorTyrosine-protein kinase FynHomo sapiens (human)
regulation of cell shapeTyrosine-protein kinase FynHomo sapiens (human)
gene expressionTyrosine-protein kinase FynHomo sapiens (human)
negative regulation of gene expressionTyrosine-protein kinase FynHomo sapiens (human)
negative regulation of hydrogen peroxide biosynthetic processTyrosine-protein kinase FynHomo sapiens (human)
positive regulation of neuron projection developmentTyrosine-protein kinase FynHomo sapiens (human)
protein ubiquitinationTyrosine-protein kinase FynHomo sapiens (human)
peptidyl-tyrosine phosphorylationTyrosine-protein kinase FynHomo sapiens (human)
protein catabolic processTyrosine-protein kinase FynHomo sapiens (human)
forebrain developmentTyrosine-protein kinase FynHomo sapiens (human)
T cell costimulationTyrosine-protein kinase FynHomo sapiens (human)
negative regulation of protein ubiquitinationTyrosine-protein kinase FynHomo sapiens (human)
intracellular signal transductionTyrosine-protein kinase FynHomo sapiens (human)
cellular response to platelet-derived growth factor stimulusTyrosine-protein kinase FynHomo sapiens (human)
Fc-gamma receptor signaling pathway involved in phagocytosisTyrosine-protein kinase FynHomo sapiens (human)
negative regulation of protein catabolic processTyrosine-protein kinase FynHomo sapiens (human)
positive regulation of tyrosine phosphorylation of STAT proteinTyrosine-protein kinase FynHomo sapiens (human)
response to ethanolTyrosine-protein kinase FynHomo sapiens (human)
vascular endothelial growth factor receptor signaling pathwayTyrosine-protein kinase FynHomo sapiens (human)
ephrin receptor signaling pathwayTyrosine-protein kinase FynHomo sapiens (human)
dendrite morphogenesisTyrosine-protein kinase FynHomo sapiens (human)
regulation of peptidyl-tyrosine phosphorylationTyrosine-protein kinase FynHomo sapiens (human)
activated T cell proliferationTyrosine-protein kinase FynHomo sapiens (human)
modulation of chemical synaptic transmissionTyrosine-protein kinase FynHomo sapiens (human)
T cell receptor signaling pathwayTyrosine-protein kinase FynHomo sapiens (human)
leukocyte migrationTyrosine-protein kinase FynHomo sapiens (human)
detection of mechanical stimulus involved in sensory perception of painTyrosine-protein kinase FynHomo sapiens (human)
cellular response to hydrogen peroxideTyrosine-protein kinase FynHomo sapiens (human)
cellular response to transforming growth factor beta stimulusTyrosine-protein kinase FynHomo sapiens (human)
positive regulation of protein targeting to membraneTyrosine-protein kinase FynHomo sapiens (human)
dendritic spine maintenanceTyrosine-protein kinase FynHomo sapiens (human)
positive regulation of protein localization to nucleusTyrosine-protein kinase FynHomo sapiens (human)
regulation of glutamate receptor signaling pathwayTyrosine-protein kinase FynHomo sapiens (human)
negative regulation of oxidative stress-induced intrinsic apoptotic signaling pathwayTyrosine-protein kinase FynHomo sapiens (human)
negative regulation of dendritic spine maintenanceTyrosine-protein kinase FynHomo sapiens (human)
response to amyloid-betaTyrosine-protein kinase FynHomo sapiens (human)
cellular response to amyloid-betaTyrosine-protein kinase FynHomo sapiens (human)
cellular response to L-glutamateTyrosine-protein kinase FynHomo sapiens (human)
cellular response to glycineTyrosine-protein kinase FynHomo sapiens (human)
positive regulation of protein localization to membraneTyrosine-protein kinase FynHomo sapiens (human)
regulation of calcium ion import across plasma membraneTyrosine-protein kinase FynHomo sapiens (human)
positive regulation of cysteine-type endopeptidase activityTyrosine-protein kinase FynHomo sapiens (human)
innate immune responseTyrosine-protein kinase FynHomo sapiens (human)
cell differentiationTyrosine-protein kinase FynHomo sapiens (human)
cell surface receptor protein tyrosine kinase signaling pathwayTyrosine-protein kinase FynHomo sapiens (human)
diet induced thermogenesisBeta-2 adrenergic receptorHomo sapiens (human)
regulation of sodium ion transportBeta-2 adrenergic receptorHomo sapiens (human)
transcription by RNA polymerase IIBeta-2 adrenergic receptorHomo sapiens (human)
receptor-mediated endocytosisBeta-2 adrenergic receptorHomo sapiens (human)
smooth muscle contractionBeta-2 adrenergic receptorHomo sapiens (human)
cell surface receptor signaling pathwayBeta-2 adrenergic receptorHomo sapiens (human)
activation of transmembrane receptor protein tyrosine kinase activityBeta-2 adrenergic receptorHomo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayBeta-2 adrenergic receptorHomo sapiens (human)
endosome to lysosome transportBeta-2 adrenergic receptorHomo sapiens (human)
response to coldBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of protein kinase A signalingBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of bone mineralizationBeta-2 adrenergic receptorHomo sapiens (human)
heat generationBeta-2 adrenergic receptorHomo sapiens (human)
negative regulation of multicellular organism growthBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeBeta-2 adrenergic receptorHomo sapiens (human)
bone resorptionBeta-2 adrenergic receptorHomo sapiens (human)
negative regulation of G protein-coupled receptor signaling pathwayBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIBeta-2 adrenergic receptorHomo sapiens (human)
negative regulation of smooth muscle contractionBeta-2 adrenergic receptorHomo sapiens (human)
brown fat cell differentiationBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of mini excitatory postsynaptic potentialBeta-2 adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayBeta-2 adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of protein serine/threonine kinase activityBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of cold-induced thermogenesisBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of autophagosome maturationBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of lipophagyBeta-2 adrenergic receptorHomo sapiens (human)
cellular response to amyloid-betaBeta-2 adrenergic receptorHomo sapiens (human)
response to psychosocial stressBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of cAMP-dependent protein kinase activityBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of AMPA receptor activityBeta-2 adrenergic receptorHomo sapiens (human)
norepinephrine-epinephrine-mediated vasodilation involved in regulation of systemic arterial blood pressureBeta-2 adrenergic receptorHomo sapiens (human)
positive regulation of cytokine productionAlpha-2A adrenergic receptorHomo sapiens (human)
DNA replicationAlpha-2A adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
Ras protein signal transductionAlpha-2A adrenergic receptorHomo sapiens (human)
Rho protein signal transductionAlpha-2A adrenergic receptorHomo sapiens (human)
female pregnancyAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of cell population proliferationAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of norepinephrine secretionAlpha-2A adrenergic receptorHomo sapiens (human)
regulation of vasoconstrictionAlpha-2A adrenergic receptorHomo sapiens (human)
actin cytoskeleton organizationAlpha-2A adrenergic receptorHomo sapiens (human)
platelet activationAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of cell migrationAlpha-2A adrenergic receptorHomo sapiens (human)
activation of protein kinase activityAlpha-2A adrenergic receptorHomo sapiens (human)
activation of protein kinase B activityAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of epinephrine secretionAlpha-2A adrenergic receptorHomo sapiens (human)
cellular response to hormone stimulusAlpha-2A adrenergic receptorHomo sapiens (human)
receptor transactivationAlpha-2A adrenergic receptorHomo sapiens (human)
vasodilationAlpha-2A adrenergic receptorHomo sapiens (human)
glucose homeostasisAlpha-2A adrenergic receptorHomo sapiens (human)
fear responseAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of potassium ion transportAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of MAP kinase activityAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of epidermal growth factor receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of calcium ion-dependent exocytosisAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretionAlpha-2A adrenergic receptorHomo sapiens (human)
intestinal absorptionAlpha-2A adrenergic receptorHomo sapiens (human)
thermoceptionAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of lipid catabolic processAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of membrane protein ectodomain proteolysisAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of calcium ion transportAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretion involved in cellular response to glucose stimulusAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of uterine smooth muscle contractionAlpha-2A adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
adenylate cyclase-inhibiting adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
phospholipase C-activating adrenergic receptor signaling pathwayAlpha-2A adrenergic receptorHomo sapiens (human)
positive regulation of wound healingAlpha-2A adrenergic receptorHomo sapiens (human)
presynaptic modulation of chemical synaptic transmissionAlpha-2A adrenergic receptorHomo sapiens (human)
negative regulation of calcium ion transmembrane transporter activityAlpha-2A adrenergic receptorHomo sapiens (human)
inflammatory responseAdenosine receptor A3Homo sapiens (human)
signal transductionAdenosine receptor A3Homo sapiens (human)
activation of adenylate cyclase activityAdenosine receptor A3Homo sapiens (human)
regulation of heart contractionAdenosine receptor A3Homo sapiens (human)
negative regulation of cell population proliferationAdenosine receptor A3Homo sapiens (human)
response to woundingAdenosine receptor A3Homo sapiens (human)
regulation of norepinephrine secretionAdenosine receptor A3Homo sapiens (human)
negative regulation of cell migrationAdenosine receptor A3Homo sapiens (human)
negative regulation of NF-kappaB transcription factor activityAdenosine receptor A3Homo sapiens (human)
presynaptic modulation of chemical synaptic transmissionAdenosine receptor A3Homo sapiens (human)
G protein-coupled adenosine receptor signaling pathwayAdenosine receptor A3Homo sapiens (human)
lipid hydroxylationCytochrome P450 2C8Homo sapiens (human)
organic acid metabolic processCytochrome P450 2C8Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2C8Homo sapiens (human)
steroid metabolic processCytochrome P450 2C8Homo sapiens (human)
estrogen metabolic processCytochrome P450 2C8Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2C8Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2C8Homo sapiens (human)
retinol metabolic processCytochrome P450 2C8Homo sapiens (human)
retinoic acid metabolic processCytochrome P450 2C8Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 2C8Homo sapiens (human)
icosanoid biosynthetic processCytochrome P450 2C8Homo sapiens (human)
oxidative demethylationCytochrome P450 2C8Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 2C8Homo sapiens (human)
positive regulation of monoatomic ion transportMuscarinic acetylcholine receptor M1Homo sapiens (human)
signal transductionMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
protein kinase C-activating G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
phospholipase C-activating G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
neuromuscular synaptic transmissionMuscarinic acetylcholine receptor M1Homo sapiens (human)
nervous system developmentMuscarinic acetylcholine receptor M1Homo sapiens (human)
regulation of locomotionMuscarinic acetylcholine receptor M1Homo sapiens (human)
saliva secretionMuscarinic acetylcholine receptor M1Homo sapiens (human)
cognitionMuscarinic acetylcholine receptor M1Homo sapiens (human)
regulation of postsynaptic membrane potentialMuscarinic acetylcholine receptor M1Homo sapiens (human)
regulation of glial cell proliferationMuscarinic acetylcholine receptor M1Homo sapiens (human)
positive regulation of intracellular protein transportMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
postsynaptic modulation of chemical synaptic transmissionMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M1Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M1Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M1Homo sapiens (human)
receptor-mediated endocytosisBeta-3 adrenergic receptorHomo sapiens (human)
negative regulation of G protein-coupled receptor signaling pathwayBeta-3 adrenergic receptorHomo sapiens (human)
diet induced thermogenesisBeta-3 adrenergic receptorHomo sapiens (human)
carbohydrate metabolic processBeta-3 adrenergic receptorHomo sapiens (human)
generation of precursor metabolites and energyBeta-3 adrenergic receptorHomo sapiens (human)
energy reserve metabolic processBeta-3 adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerBeta-3 adrenergic receptorHomo sapiens (human)
adenylate cyclase-modulating G protein-coupled receptor signaling pathwayBeta-3 adrenergic receptorHomo sapiens (human)
response to coldBeta-3 adrenergic receptorHomo sapiens (human)
heat generationBeta-3 adrenergic receptorHomo sapiens (human)
negative regulation of multicellular organism growthBeta-3 adrenergic receptorHomo sapiens (human)
eating behaviorBeta-3 adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeBeta-3 adrenergic receptorHomo sapiens (human)
brown fat cell differentiationBeta-3 adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayBeta-3 adrenergic receptorHomo sapiens (human)
positive regulation of cold-induced thermogenesisBeta-3 adrenergic receptorHomo sapiens (human)
norepinephrine-epinephrine-mediated vasodilation involved in regulation of systemic arterial blood pressureBeta-3 adrenergic receptorHomo sapiens (human)
regulation of smooth muscle contractionAlpha-2C adrenergic receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
cell-cell signalingAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of norepinephrine secretionAlpha-2C adrenergic receptorHomo sapiens (human)
regulation of vasoconstrictionAlpha-2C adrenergic receptorHomo sapiens (human)
platelet activationAlpha-2C adrenergic receptorHomo sapiens (human)
activation of protein kinase B activityAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of epinephrine secretionAlpha-2C adrenergic receptorHomo sapiens (human)
receptor transactivationAlpha-2C adrenergic receptorHomo sapiens (human)
positive regulation of MAPK cascadeAlpha-2C adrenergic receptorHomo sapiens (human)
positive regulation of neuron differentiationAlpha-2C adrenergic receptorHomo sapiens (human)
adrenergic receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayAlpha-2C adrenergic receptorHomo sapiens (human)
negative regulation of insulin secretionAlpha-2C adrenergic receptorHomo sapiens (human)
calcium-mediated signalingMuscarinic acetylcholine receptor M3Homo sapiens (human)
regulation of monoatomic ion transmembrane transporter activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
smooth muscle contractionMuscarinic acetylcholine receptor M3Homo sapiens (human)
signal transductionMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
phospholipase C-activating G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
synaptic transmission, cholinergicMuscarinic acetylcholine receptor M3Homo sapiens (human)
nervous system developmentMuscarinic acetylcholine receptor M3Homo sapiens (human)
positive regulation of insulin secretionMuscarinic acetylcholine receptor M3Homo sapiens (human)
protein modification processMuscarinic acetylcholine receptor M3Homo sapiens (human)
positive regulation of smooth muscle contractionMuscarinic acetylcholine receptor M3Homo sapiens (human)
saliva secretionMuscarinic acetylcholine receptor M3Homo sapiens (human)
acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled serotonin receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
ion channel modulating, G protein-coupled receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
ligand-gated ion channel signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
regulation of smooth muscle contractionMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMuscarinic acetylcholine receptor M3Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMuscarinic acetylcholine receptor M3Homo sapiens (human)
chemical synaptic transmissionMuscarinic acetylcholine receptor M3Homo sapiens (human)
muscle contractionSubstance-K receptorHomo sapiens (human)
tachykinin receptor signaling pathwaySubstance-K receptorHomo sapiens (human)
positive regulation of acetylcholine secretion, neurotransmissionSubstance-K receptorHomo sapiens (human)
intestine smooth muscle contractionSubstance-K receptorHomo sapiens (human)
negative regulation of luteinizing hormone secretionSubstance-K receptorHomo sapiens (human)
operant conditioningSubstance-K receptorHomo sapiens (human)
positive regulation of vascular permeabilitySubstance-K receptorHomo sapiens (human)
positive regulation of monoatomic ion transportSubstance-K receptorHomo sapiens (human)
positive regulation of smooth muscle contractionSubstance-K receptorHomo sapiens (human)
response to electrical stimulusSubstance-K receptorHomo sapiens (human)
prolactin secretionSubstance-K receptorHomo sapiens (human)
positive regulation of uterine smooth muscle contractionSubstance-K receptorHomo sapiens (human)
positive regulation of flagellated sperm motilitySubstance-K receptorHomo sapiens (human)
monoamine transportSodium-dependent noradrenaline transporter Homo sapiens (human)
neurotransmitter transportSodium-dependent noradrenaline transporter Homo sapiens (human)
chemical synaptic transmissionSodium-dependent noradrenaline transporter Homo sapiens (human)
response to xenobiotic stimulusSodium-dependent noradrenaline transporter Homo sapiens (human)
response to painSodium-dependent noradrenaline transporter Homo sapiens (human)
norepinephrine uptakeSodium-dependent noradrenaline transporter Homo sapiens (human)
neuron cellular homeostasisSodium-dependent noradrenaline transporter Homo sapiens (human)
amino acid transportSodium-dependent noradrenaline transporter Homo sapiens (human)
norepinephrine transportSodium-dependent noradrenaline transporter Homo sapiens (human)
dopamine uptake involved in synaptic transmissionSodium-dependent noradrenaline transporter Homo sapiens (human)
sodium ion transmembrane transportSodium-dependent noradrenaline transporter Homo sapiens (human)
prostaglandin biosynthetic processThromboxane-A synthase Homo sapiens (human)
icosanoid metabolic processThromboxane-A synthase Homo sapiens (human)
cyclooxygenase pathwayThromboxane-A synthase Homo sapiens (human)
intracellular chloride ion homeostasisThromboxane-A synthase Homo sapiens (human)
response to ethanolThromboxane-A synthase Homo sapiens (human)
positive regulation of vasoconstrictionThromboxane-A synthase Homo sapiens (human)
response to fatty acidThromboxane-A synthase Homo sapiens (human)
response to ethanolD(3) dopamine receptorHomo sapiens (human)
synaptic transmission, dopaminergicD(3) dopamine receptorHomo sapiens (human)
G protein-coupled receptor internalizationD(3) dopamine receptorHomo sapiens (human)
intracellular calcium ion homeostasisD(3) dopamine receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
adenylate cyclase-inhibiting dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
learning or memoryD(3) dopamine receptorHomo sapiens (human)
learningD(3) dopamine receptorHomo sapiens (human)
locomotory behaviorD(3) dopamine receptorHomo sapiens (human)
visual learningD(3) dopamine receptorHomo sapiens (human)
response to xenobiotic stimulusD(3) dopamine receptorHomo sapiens (human)
regulation of dopamine secretionD(3) dopamine receptorHomo sapiens (human)
positive regulation of cytokinesisD(3) dopamine receptorHomo sapiens (human)
circadian regulation of gene expressionD(3) dopamine receptorHomo sapiens (human)
response to histamineD(3) dopamine receptorHomo sapiens (human)
social behaviorD(3) dopamine receptorHomo sapiens (human)
response to cocaineD(3) dopamine receptorHomo sapiens (human)
dopamine metabolic processD(3) dopamine receptorHomo sapiens (human)
response to morphineD(3) dopamine receptorHomo sapiens (human)
negative regulation of blood pressureD(3) dopamine receptorHomo sapiens (human)
positive regulation of mitotic nuclear divisionD(3) dopamine receptorHomo sapiens (human)
acid secretionD(3) dopamine receptorHomo sapiens (human)
behavioral response to cocaineD(3) dopamine receptorHomo sapiens (human)
negative regulation of oligodendrocyte differentiationD(3) dopamine receptorHomo sapiens (human)
arachidonic acid secretionD(3) dopamine receptorHomo sapiens (human)
negative regulation of protein secretionD(3) dopamine receptorHomo sapiens (human)
musculoskeletal movement, spinal reflex actionD(3) dopamine receptorHomo sapiens (human)
regulation of dopamine uptake involved in synaptic transmissionD(3) dopamine receptorHomo sapiens (human)
negative regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionD(3) dopamine receptorHomo sapiens (human)
prepulse inhibitionD(3) dopamine receptorHomo sapiens (human)
positive regulation of dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
negative regulation of adenylate cyclase activityD(3) dopamine receptorHomo sapiens (human)
adenylate cyclase-activating adrenergic receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
negative regulation of voltage-gated calcium channel activityD(3) dopamine receptorHomo sapiens (human)
regulation of potassium ion transportD(3) dopamine receptorHomo sapiens (human)
phospholipase C-activating dopamine receptor signaling pathwayD(3) dopamine receptorHomo sapiens (human)
positive regulation of MAPK cascadeD(3) dopamine receptorHomo sapiens (human)
negative regulation of cytosolic calcium ion concentrationD(3) dopamine receptorHomo sapiens (human)
negative regulation of synaptic transmission, glutamatergicD(3) dopamine receptorHomo sapiens (human)
immune responseDelta-type opioid receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerDelta-type opioid receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
adult locomotory behaviorDelta-type opioid receptorHomo sapiens (human)
negative regulation of gene expressionDelta-type opioid receptorHomo sapiens (human)
negative regulation of protein-containing complex assemblyDelta-type opioid receptorHomo sapiens (human)
positive regulation of CREB transcription factor activityDelta-type opioid receptorHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylationDelta-type opioid receptorHomo sapiens (human)
response to nicotineDelta-type opioid receptorHomo sapiens (human)
G protein-coupled opioid receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
eating behaviorDelta-type opioid receptorHomo sapiens (human)
regulation of mitochondrial membrane potentialDelta-type opioid receptorHomo sapiens (human)
regulation of calcium ion transportDelta-type opioid receptorHomo sapiens (human)
cellular response to growth factor stimulusDelta-type opioid receptorHomo sapiens (human)
cellular response to hypoxiaDelta-type opioid receptorHomo sapiens (human)
cellular response to toxic substanceDelta-type opioid receptorHomo sapiens (human)
neuropeptide signaling pathwayDelta-type opioid receptorHomo sapiens (human)
neural crest cell migration5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of cytokine production5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of endothelial cell proliferation5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled receptor internalization5-hydroxytryptamine receptor 2BHomo sapiens (human)
heart morphogenesis5-hydroxytryptamine receptor 2BHomo sapiens (human)
cardiac muscle hypertrophy5-hydroxytryptamine receptor 2BHomo sapiens (human)
intracellular calcium ion homeostasis5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
activation of phospholipase C activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
protein kinase C-activating G protein-coupled receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
phospholipase C-activating serotonin receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of cell population proliferation5-hydroxytryptamine receptor 2BHomo sapiens (human)
response to xenobiotic stimulus5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of phosphatidylinositol biosynthetic process5-hydroxytryptamine receptor 2BHomo sapiens (human)
neural crest cell differentiation5-hydroxytryptamine receptor 2BHomo sapiens (human)
intestine smooth muscle contraction5-hydroxytryptamine receptor 2BHomo sapiens (human)
phosphorylation5-hydroxytryptamine receptor 2BHomo sapiens (human)
calcium-mediated signaling5-hydroxytryptamine receptor 2BHomo sapiens (human)
cGMP-mediated signaling5-hydroxytryptamine receptor 2BHomo sapiens (human)
vasoconstriction5-hydroxytryptamine receptor 2BHomo sapiens (human)
negative regulation of apoptotic process5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of canonical NF-kappaB signal transduction5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of MAP kinase activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
phosphatidylinositol 3-kinase/protein kinase B signal transduction5-hydroxytryptamine receptor 2BHomo sapiens (human)
embryonic morphogenesis5-hydroxytryptamine receptor 2BHomo sapiens (human)
regulation of behavior5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of nitric-oxide synthase activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
release of sequestered calcium ion into cytosol5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of cell division5-hydroxytryptamine receptor 2BHomo sapiens (human)
ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2BHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascade5-hydroxytryptamine receptor 2BHomo sapiens (human)
protein kinase C signaling5-hydroxytryptamine receptor 2BHomo sapiens (human)
cellular response to temperature stimulus5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled serotonin receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger5-hydroxytryptamine receptor 2BHomo sapiens (human)
serotonin receptor signaling pathway5-hydroxytryptamine receptor 2BHomo sapiens (human)
chemical synaptic transmission5-hydroxytryptamine receptor 2BHomo sapiens (human)
monoamine transportSodium-dependent dopamine transporter Homo sapiens (human)
neurotransmitter transportSodium-dependent dopamine transporter Homo sapiens (human)
lactationSodium-dependent dopamine transporter Homo sapiens (human)
sensory perception of smellSodium-dependent dopamine transporter Homo sapiens (human)
locomotory behaviorSodium-dependent dopamine transporter Homo sapiens (human)
response to xenobiotic stimulusSodium-dependent dopamine transporter Homo sapiens (human)
response to iron ionSodium-dependent dopamine transporter Homo sapiens (human)
dopamine transportSodium-dependent dopamine transporter Homo sapiens (human)
adenohypophysis developmentSodium-dependent dopamine transporter Homo sapiens (human)
response to nicotineSodium-dependent dopamine transporter Homo sapiens (human)
positive regulation of multicellular organism growthSodium-dependent dopamine transporter Homo sapiens (human)
regulation of dopamine metabolic processSodium-dependent dopamine transporter Homo sapiens (human)
response to cocaineSodium-dependent dopamine transporter Homo sapiens (human)
dopamine biosynthetic processSodium-dependent dopamine transporter Homo sapiens (human)
dopamine catabolic processSodium-dependent dopamine transporter Homo sapiens (human)
response to ethanolSodium-dependent dopamine transporter Homo sapiens (human)
cognitionSodium-dependent dopamine transporter Homo sapiens (human)
dopamine uptake involved in synaptic transmissionSodium-dependent dopamine transporter Homo sapiens (human)
response to cAMPSodium-dependent dopamine transporter Homo sapiens (human)
norepinephrine uptakeSodium-dependent dopamine transporter Homo sapiens (human)
prepulse inhibitionSodium-dependent dopamine transporter Homo sapiens (human)
dopamine uptakeSodium-dependent dopamine transporter Homo sapiens (human)
hyaloid vascular plexus regressionSodium-dependent dopamine transporter Homo sapiens (human)
amino acid transportSodium-dependent dopamine transporter Homo sapiens (human)
norepinephrine transportSodium-dependent dopamine transporter Homo sapiens (human)
sodium ion transmembrane transportSodium-dependent dopamine transporter Homo sapiens (human)
negative regulation of inflammatory response to antigenic stimulusUracil nucleotide/cysteinyl leukotriene receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayUracil nucleotide/cysteinyl leukotriene receptorHomo sapiens (human)
oligodendrocyte differentiationUracil nucleotide/cysteinyl leukotriene receptorHomo sapiens (human)
chemokine-mediated signaling pathwayUracil nucleotide/cysteinyl leukotriene receptorHomo sapiens (human)
positive regulation of Rho protein signal transductionUracil nucleotide/cysteinyl leukotriene receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayUracil nucleotide/cysteinyl leukotriene receptorHomo sapiens (human)
positive regulation of blood vessel endothelial cell migrationMitogen-activated protein kinase 14Homo sapiens (human)
cellular response to lipopolysaccharideMitogen-activated protein kinase 14Homo sapiens (human)
DNA damage checkpoint signalingMitogen-activated protein kinase 14Homo sapiens (human)
cell morphogenesisMitogen-activated protein kinase 14Homo sapiens (human)
cartilage condensationMitogen-activated protein kinase 14Homo sapiens (human)
angiogenesisMitogen-activated protein kinase 14Homo sapiens (human)
osteoblast differentiationMitogen-activated protein kinase 14Homo sapiens (human)
placenta developmentMitogen-activated protein kinase 14Homo sapiens (human)
response to dietary excessMitogen-activated protein kinase 14Homo sapiens (human)
chondrocyte differentiationMitogen-activated protein kinase 14Homo sapiens (human)
negative regulation of inflammatory response to antigenic stimulusMitogen-activated protein kinase 14Homo sapiens (human)
glucose metabolic processMitogen-activated protein kinase 14Homo sapiens (human)
regulation of transcription by RNA polymerase IIMitogen-activated protein kinase 14Homo sapiens (human)
transcription by RNA polymerase IIMitogen-activated protein kinase 14Homo sapiens (human)
apoptotic processMitogen-activated protein kinase 14Homo sapiens (human)
chemotaxisMitogen-activated protein kinase 14Homo sapiens (human)
signal transductionMitogen-activated protein kinase 14Homo sapiens (human)
cell surface receptor signaling pathwayMitogen-activated protein kinase 14Homo sapiens (human)
cell surface receptor protein serine/threonine kinase signaling pathwayMitogen-activated protein kinase 14Homo sapiens (human)
skeletal muscle tissue developmentMitogen-activated protein kinase 14Homo sapiens (human)
positive regulation of gene expressionMitogen-activated protein kinase 14Homo sapiens (human)
positive regulation of myotube differentiationMitogen-activated protein kinase 14Homo sapiens (human)
peptidyl-serine phosphorylationMitogen-activated protein kinase 14Homo sapiens (human)
fatty acid oxidationMitogen-activated protein kinase 14Homo sapiens (human)
platelet activationMitogen-activated protein kinase 14Homo sapiens (human)
regulation of ossificationMitogen-activated protein kinase 14Homo sapiens (human)
osteoclast differentiationMitogen-activated protein kinase 14Homo sapiens (human)
stress-activated protein kinase signaling cascadeMitogen-activated protein kinase 14Homo sapiens (human)
positive regulation of cyclase activityMitogen-activated protein kinase 14Homo sapiens (human)
lipopolysaccharide-mediated signaling pathwayMitogen-activated protein kinase 14Homo sapiens (human)
response to muramyl dipeptideMitogen-activated protein kinase 14Homo sapiens (human)
positive regulation of interleukin-12 productionMitogen-activated protein kinase 14Homo sapiens (human)
response to insulinMitogen-activated protein kinase 14Homo sapiens (human)
negative regulation of hippo signalingMitogen-activated protein kinase 14Homo sapiens (human)
intracellular signal transductionMitogen-activated protein kinase 14Homo sapiens (human)
cellular response to vascular endothelial growth factor stimulusMitogen-activated protein kinase 14Homo sapiens (human)
response to muscle stretchMitogen-activated protein kinase 14Homo sapiens (human)
p38MAPK cascadeMitogen-activated protein kinase 14Homo sapiens (human)
positive regulation of protein import into nucleusMitogen-activated protein kinase 14Homo sapiens (human)
signal transduction in response to DNA damageMitogen-activated protein kinase 14Homo sapiens (human)
positive regulation of erythrocyte differentiationMitogen-activated protein kinase 14Homo sapiens (human)
positive regulation of myoblast differentiationMitogen-activated protein kinase 14Homo sapiens (human)
positive regulation of transcription by RNA polymerase IIMitogen-activated protein kinase 14Homo sapiens (human)
glucose importMitogen-activated protein kinase 14Homo sapiens (human)
positive regulation of glucose importMitogen-activated protein kinase 14Homo sapiens (human)
vascular endothelial growth factor receptor signaling pathwayMitogen-activated protein kinase 14Homo sapiens (human)
stem cell differentiationMitogen-activated protein kinase 14Homo sapiens (human)
striated muscle cell differentiationMitogen-activated protein kinase 14Homo sapiens (human)
positive regulation of muscle cell differentiationMitogen-activated protein kinase 14Homo sapiens (human)
stress-activated MAPK cascadeMitogen-activated protein kinase 14Homo sapiens (human)
positive regulation of cardiac muscle cell proliferationMitogen-activated protein kinase 14Homo sapiens (human)
bone developmentMitogen-activated protein kinase 14Homo sapiens (human)
3'-UTR-mediated mRNA stabilizationMitogen-activated protein kinase 14Homo sapiens (human)
cellular response to lipoteichoic acidMitogen-activated protein kinase 14Homo sapiens (human)
cellular response to tumor necrosis factorMitogen-activated protein kinase 14Homo sapiens (human)
cellular response to ionizing radiationMitogen-activated protein kinase 14Homo sapiens (human)
cellular response to UV-BMitogen-activated protein kinase 14Homo sapiens (human)
negative regulation of canonical Wnt signaling pathwayMitogen-activated protein kinase 14Homo sapiens (human)
positive regulation of brown fat cell differentiationMitogen-activated protein kinase 14Homo sapiens (human)
cellular senescenceMitogen-activated protein kinase 14Homo sapiens (human)
stress-induced premature senescenceMitogen-activated protein kinase 14Homo sapiens (human)
cellular response to virusMitogen-activated protein kinase 14Homo sapiens (human)
regulation of synaptic membrane adhesionMitogen-activated protein kinase 14Homo sapiens (human)
regulation of cytokine production involved in inflammatory responseMitogen-activated protein kinase 14Homo sapiens (human)
positive regulation of myoblast fusionMitogen-activated protein kinase 14Homo sapiens (human)
positive regulation of reactive oxygen species metabolic processMitogen-activated protein kinase 14Homo sapiens (human)
leukotriene metabolic processLeukotriene C4 synthaseHomo sapiens (human)
leukotriene metabolic processLeukotriene C4 synthaseHomo sapiens (human)
long-chain fatty acid biosynthetic processLeukotriene C4 synthaseHomo sapiens (human)
cellular oxidant detoxificationLeukotriene C4 synthaseHomo sapiens (human)
leukotriene biosynthetic processLeukotriene C4 synthaseHomo sapiens (human)
immune responseCysteinyl leukotriene receptor 2Homo sapiens (human)
leukotriene signaling pathwayCysteinyl leukotriene receptor 2Homo sapiens (human)
neuropeptide signaling pathwayCysteinyl leukotriene receptor 2Homo sapiens (human)
inflammatory response to antigenic stimulusCysteinyl leukotriene receptor 1Homo sapiens (human)
calcium ion transportCysteinyl leukotriene receptor 1Homo sapiens (human)
chemotaxisCysteinyl leukotriene receptor 1Homo sapiens (human)
defense responseCysteinyl leukotriene receptor 1Homo sapiens (human)
cell surface receptor signaling pathwayCysteinyl leukotriene receptor 1Homo sapiens (human)
positive regulation of cytosolic calcium ion concentrationCysteinyl leukotriene receptor 1Homo sapiens (human)
respiratory gaseous exchange by respiratory systemCysteinyl leukotriene receptor 1Homo sapiens (human)
positive regulation of angiogenesisCysteinyl leukotriene receptor 1Homo sapiens (human)
positive regulation of vasoconstrictionCysteinyl leukotriene receptor 1Homo sapiens (human)
establishment of localization in cellCysteinyl leukotriene receptor 1Homo sapiens (human)
positive regulation of glial cell proliferationCysteinyl leukotriene receptor 1Homo sapiens (human)
leukotriene signaling pathwayCysteinyl leukotriene receptor 1Homo sapiens (human)
cellular response to hypoxiaCysteinyl leukotriene receptor 1Homo sapiens (human)
neuropeptide signaling pathwayCysteinyl leukotriene receptor 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (116)

Processvia Protein(s)Taxonomy
epidermal growth factor receptor activityEpidermal growth factor receptorHomo sapiens (human)
virus receptor activityEpidermal growth factor receptorHomo sapiens (human)
chromatin bindingEpidermal growth factor receptorHomo sapiens (human)
double-stranded DNA bindingEpidermal growth factor receptorHomo sapiens (human)
MAP kinase kinase kinase activityEpidermal growth factor receptorHomo sapiens (human)
protein tyrosine kinase activityEpidermal growth factor receptorHomo sapiens (human)
transmembrane receptor protein tyrosine kinase activityEpidermal growth factor receptorHomo sapiens (human)
transmembrane signaling receptor activityEpidermal growth factor receptorHomo sapiens (human)
epidermal growth factor receptor activityEpidermal growth factor receptorHomo sapiens (human)
integrin bindingEpidermal growth factor receptorHomo sapiens (human)
protein bindingEpidermal growth factor receptorHomo sapiens (human)
calmodulin bindingEpidermal growth factor receptorHomo sapiens (human)
ATP bindingEpidermal growth factor receptorHomo sapiens (human)
enzyme bindingEpidermal growth factor receptorHomo sapiens (human)
kinase bindingEpidermal growth factor receptorHomo sapiens (human)
protein kinase bindingEpidermal growth factor receptorHomo sapiens (human)
protein phosphatase bindingEpidermal growth factor receptorHomo sapiens (human)
protein tyrosine kinase activator activityEpidermal growth factor receptorHomo sapiens (human)
transmembrane receptor protein tyrosine kinase activator activityEpidermal growth factor receptorHomo sapiens (human)
ubiquitin protein ligase bindingEpidermal growth factor receptorHomo sapiens (human)
identical protein bindingEpidermal growth factor receptorHomo sapiens (human)
cadherin bindingEpidermal growth factor receptorHomo sapiens (human)
actin filament bindingEpidermal growth factor receptorHomo sapiens (human)
ATPase bindingEpidermal growth factor receptorHomo sapiens (human)
epidermal growth factor bindingEpidermal growth factor receptorHomo sapiens (human)
protein tyrosine kinase activityTyrosine-protein kinase FynHomo sapiens (human)
non-membrane spanning protein tyrosine kinase activityTyrosine-protein kinase FynHomo sapiens (human)
protein bindingTyrosine-protein kinase FynHomo sapiens (human)
ATP bindingTyrosine-protein kinase FynHomo sapiens (human)
phospholipase activator activityTyrosine-protein kinase FynHomo sapiens (human)
enzyme bindingTyrosine-protein kinase FynHomo sapiens (human)
type 5 metabotropic glutamate receptor bindingTyrosine-protein kinase FynHomo sapiens (human)
identical protein bindingTyrosine-protein kinase FynHomo sapiens (human)
alpha-tubulin bindingTyrosine-protein kinase FynHomo sapiens (human)
phospholipase bindingTyrosine-protein kinase FynHomo sapiens (human)
transmembrane transporter bindingTyrosine-protein kinase FynHomo sapiens (human)
metal ion bindingTyrosine-protein kinase FynHomo sapiens (human)
ephrin receptor bindingTyrosine-protein kinase FynHomo sapiens (human)
tau protein bindingTyrosine-protein kinase FynHomo sapiens (human)
tau-protein kinase activityTyrosine-protein kinase FynHomo sapiens (human)
growth factor receptor bindingTyrosine-protein kinase FynHomo sapiens (human)
scaffold protein bindingTyrosine-protein kinase FynHomo sapiens (human)
disordered domain specific bindingTyrosine-protein kinase FynHomo sapiens (human)
signaling receptor bindingTyrosine-protein kinase FynHomo sapiens (human)
amyloid-beta bindingBeta-2 adrenergic receptorHomo sapiens (human)
beta2-adrenergic receptor activityBeta-2 adrenergic receptorHomo sapiens (human)
protein bindingBeta-2 adrenergic receptorHomo sapiens (human)
adenylate cyclase bindingBeta-2 adrenergic receptorHomo sapiens (human)
potassium channel regulator activityBeta-2 adrenergic receptorHomo sapiens (human)
identical protein bindingBeta-2 adrenergic receptorHomo sapiens (human)
protein homodimerization activityBeta-2 adrenergic receptorHomo sapiens (human)
protein-containing complex bindingBeta-2 adrenergic receptorHomo sapiens (human)
norepinephrine bindingBeta-2 adrenergic receptorHomo sapiens (human)
alpha2-adrenergic receptor activityAlpha-2A adrenergic receptorHomo sapiens (human)
protein bindingAlpha-2A adrenergic receptorHomo sapiens (human)
protein kinase bindingAlpha-2A adrenergic receptorHomo sapiens (human)
alpha-1B adrenergic receptor bindingAlpha-2A adrenergic receptorHomo sapiens (human)
alpha-2C adrenergic receptor bindingAlpha-2A adrenergic receptorHomo sapiens (human)
thioesterase bindingAlpha-2A adrenergic receptorHomo sapiens (human)
heterotrimeric G-protein bindingAlpha-2A adrenergic receptorHomo sapiens (human)
protein homodimerization activityAlpha-2A adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-2A adrenergic receptorHomo sapiens (human)
epinephrine bindingAlpha-2A adrenergic receptorHomo sapiens (human)
norepinephrine bindingAlpha-2A adrenergic receptorHomo sapiens (human)
guanyl-nucleotide exchange factor activityAlpha-2A adrenergic receptorHomo sapiens (human)
G protein-coupled adenosine receptor activityAdenosine receptor A3Homo sapiens (human)
monooxygenase activityCytochrome P450 2C8Homo sapiens (human)
iron ion bindingCytochrome P450 2C8Homo sapiens (human)
protein bindingCytochrome P450 2C8Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2C8Homo sapiens (human)
retinoic acid 4-hydroxylase activityCytochrome P450 2C8Homo sapiens (human)
caffeine oxidase activityCytochrome P450 2C8Homo sapiens (human)
aromatase activityCytochrome P450 2C8Homo sapiens (human)
estrogen 16-alpha-hydroxylase activityCytochrome P450 2C8Homo sapiens (human)
heme bindingCytochrome P450 2C8Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2C8Homo sapiens (human)
phosphatidylinositol phospholipase C activityMuscarinic acetylcholine receptor M1Homo sapiens (human)
protein bindingMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M1Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M1Homo sapiens (human)
norepinephrine bindingBeta-3 adrenergic receptorHomo sapiens (human)
beta-adrenergic receptor activityBeta-3 adrenergic receptorHomo sapiens (human)
protein bindingBeta-3 adrenergic receptorHomo sapiens (human)
beta3-adrenergic receptor activityBeta-3 adrenergic receptorHomo sapiens (human)
beta-3 adrenergic receptor bindingBeta-3 adrenergic receptorHomo sapiens (human)
protein homodimerization activityBeta-3 adrenergic receptorHomo sapiens (human)
epinephrine bindingBeta-3 adrenergic receptorHomo sapiens (human)
alpha2-adrenergic receptor activityAlpha-2C adrenergic receptorHomo sapiens (human)
protein bindingAlpha-2C adrenergic receptorHomo sapiens (human)
alpha-2A adrenergic receptor bindingAlpha-2C adrenergic receptorHomo sapiens (human)
protein homodimerization activityAlpha-2C adrenergic receptorHomo sapiens (human)
protein heterodimerization activityAlpha-2C adrenergic receptorHomo sapiens (human)
epinephrine bindingAlpha-2C adrenergic receptorHomo sapiens (human)
guanyl-nucleotide exchange factor activityAlpha-2C adrenergic receptorHomo sapiens (human)
phosphatidylinositol phospholipase C activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
protein bindingMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled acetylcholine receptor activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
signaling receptor activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
acetylcholine bindingMuscarinic acetylcholine receptor M3Homo sapiens (human)
G protein-coupled serotonin receptor activityMuscarinic acetylcholine receptor M3Homo sapiens (human)
tachykinin receptor activitySubstance-K receptorHomo sapiens (human)
protein bindingSubstance-K receptorHomo sapiens (human)
substance K receptor activitySubstance-K receptorHomo sapiens (human)
actin bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
neurotransmitter transmembrane transporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
neurotransmitter:sodium symporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
dopamine:sodium symporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
norepinephrine:sodium symporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
protein bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
monoamine transmembrane transporter activitySodium-dependent noradrenaline transporter Homo sapiens (human)
alpha-tubulin bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
metal ion bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
beta-tubulin bindingSodium-dependent noradrenaline transporter Homo sapiens (human)
monooxygenase activityThromboxane-A synthase Homo sapiens (human)
thromboxane-A synthase activityThromboxane-A synthase Homo sapiens (human)
iron ion bindingThromboxane-A synthase Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygenThromboxane-A synthase Homo sapiens (human)
heme bindingThromboxane-A synthase Homo sapiens (human)
12-hydroxyheptadecatrienoic acid synthase activityThromboxane-A synthase Homo sapiens (human)
hydroperoxy icosatetraenoate dehydratase activityThromboxane-A synthase Homo sapiens (human)
dopamine neurotransmitter receptor activity, coupled via Gi/GoD(3) dopamine receptorHomo sapiens (human)
protein bindingD(3) dopamine receptorHomo sapiens (human)
G protein-coupled receptor activityD(3) dopamine receptorHomo sapiens (human)
G protein-coupled opioid receptor activityDelta-type opioid receptorHomo sapiens (human)
protein bindingDelta-type opioid receptorHomo sapiens (human)
receptor serine/threonine kinase bindingDelta-type opioid receptorHomo sapiens (human)
G protein-coupled enkephalin receptor activityDelta-type opioid receptorHomo sapiens (human)
neuropeptide bindingDelta-type opioid receptorHomo sapiens (human)
Gq/11-coupled serotonin receptor activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
G-protein alpha-subunit binding5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled serotonin receptor activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
GTPase activator activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
protein binding5-hydroxytryptamine receptor 2BHomo sapiens (human)
serotonin binding5-hydroxytryptamine receptor 2BHomo sapiens (human)
neurotransmitter receptor activity5-hydroxytryptamine receptor 2BHomo sapiens (human)
protease bindingSodium-dependent dopamine transporter Homo sapiens (human)
signaling receptor bindingSodium-dependent dopamine transporter Homo sapiens (human)
neurotransmitter transmembrane transporter activitySodium-dependent dopamine transporter Homo sapiens (human)
dopamine:sodium symporter activitySodium-dependent dopamine transporter Homo sapiens (human)
protein bindingSodium-dependent dopamine transporter Homo sapiens (human)
monoamine transmembrane transporter activitySodium-dependent dopamine transporter Homo sapiens (human)
dopamine bindingSodium-dependent dopamine transporter Homo sapiens (human)
amine bindingSodium-dependent dopamine transporter Homo sapiens (human)
protein-containing complex bindingSodium-dependent dopamine transporter Homo sapiens (human)
metal ion bindingSodium-dependent dopamine transporter Homo sapiens (human)
protein phosphatase 2A bindingSodium-dependent dopamine transporter Homo sapiens (human)
heterocyclic compound bindingSodium-dependent dopamine transporter Homo sapiens (human)
norepinephrine:sodium symporter activitySodium-dependent dopamine transporter Homo sapiens (human)
chemokine receptor activityUracil nucleotide/cysteinyl leukotriene receptorHomo sapiens (human)
receptor serine/threonine kinase bindingUracil nucleotide/cysteinyl leukotriene receptorHomo sapiens (human)
G protein-coupled receptor activityUracil nucleotide/cysteinyl leukotriene receptorHomo sapiens (human)
protein serine/threonine kinase activityMitogen-activated protein kinase 14Homo sapiens (human)
MAP kinase activityMitogen-activated protein kinase 14Homo sapiens (human)
MAP kinase kinase activityMitogen-activated protein kinase 14Homo sapiens (human)
protein bindingMitogen-activated protein kinase 14Homo sapiens (human)
ATP bindingMitogen-activated protein kinase 14Homo sapiens (human)
enzyme bindingMitogen-activated protein kinase 14Homo sapiens (human)
protein phosphatase bindingMitogen-activated protein kinase 14Homo sapiens (human)
mitogen-activated protein kinase p38 bindingMitogen-activated protein kinase 14Homo sapiens (human)
NFAT protein bindingMitogen-activated protein kinase 14Homo sapiens (human)
protein serine kinase activityMitogen-activated protein kinase 14Homo sapiens (human)
leukotriene-C4 synthase activityLeukotriene C4 synthaseHomo sapiens (human)
protein bindingLeukotriene C4 synthaseHomo sapiens (human)
enzyme activator activityLeukotriene C4 synthaseHomo sapiens (human)
lipid bindingLeukotriene C4 synthaseHomo sapiens (human)
identical protein bindingLeukotriene C4 synthaseHomo sapiens (human)
glutathione peroxidase activityLeukotriene C4 synthaseHomo sapiens (human)
glutathione transferase activityLeukotriene C4 synthaseHomo sapiens (human)
leukotriene receptor activityCysteinyl leukotriene receptor 2Homo sapiens (human)
protein bindingCysteinyl leukotriene receptor 2Homo sapiens (human)
cysteinyl leukotriene receptor activityCysteinyl leukotriene receptor 2Homo sapiens (human)
G protein-coupled peptide receptor activityCysteinyl leukotriene receptor 2Homo sapiens (human)
leukotriene receptor activityCysteinyl leukotriene receptor 1Homo sapiens (human)
cysteinyl leukotriene receptor activityCysteinyl leukotriene receptor 1Homo sapiens (human)
G protein-coupled peptide receptor activityCysteinyl leukotriene receptor 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (73)

Processvia Protein(s)Taxonomy
endosomeEpidermal growth factor receptorHomo sapiens (human)
plasma membraneEpidermal growth factor receptorHomo sapiens (human)
ruffle membraneEpidermal growth factor receptorHomo sapiens (human)
Golgi membraneEpidermal growth factor receptorHomo sapiens (human)
extracellular spaceEpidermal growth factor receptorHomo sapiens (human)
nucleusEpidermal growth factor receptorHomo sapiens (human)
cytoplasmEpidermal growth factor receptorHomo sapiens (human)
endosomeEpidermal growth factor receptorHomo sapiens (human)
endoplasmic reticulum membraneEpidermal growth factor receptorHomo sapiens (human)
plasma membraneEpidermal growth factor receptorHomo sapiens (human)
focal adhesionEpidermal growth factor receptorHomo sapiens (human)
cell surfaceEpidermal growth factor receptorHomo sapiens (human)
endosome membraneEpidermal growth factor receptorHomo sapiens (human)
membraneEpidermal growth factor receptorHomo sapiens (human)
basolateral plasma membraneEpidermal growth factor receptorHomo sapiens (human)
apical plasma membraneEpidermal growth factor receptorHomo sapiens (human)
cell junctionEpidermal growth factor receptorHomo sapiens (human)
clathrin-coated endocytic vesicle membraneEpidermal growth factor receptorHomo sapiens (human)
early endosome membraneEpidermal growth factor receptorHomo sapiens (human)
nuclear membraneEpidermal growth factor receptorHomo sapiens (human)
membrane raftEpidermal growth factor receptorHomo sapiens (human)
perinuclear region of cytoplasmEpidermal growth factor receptorHomo sapiens (human)
multivesicular body, internal vesicle lumenEpidermal growth factor receptorHomo sapiens (human)
intracellular vesicleEpidermal growth factor receptorHomo sapiens (human)
protein-containing complexEpidermal growth factor receptorHomo sapiens (human)
receptor complexEpidermal growth factor receptorHomo sapiens (human)
Shc-EGFR complexEpidermal growth factor receptorHomo sapiens (human)
basal plasma membraneEpidermal growth factor receptorHomo sapiens (human)
membrane raftTyrosine-protein kinase FynHomo sapiens (human)
dendriteTyrosine-protein kinase FynHomo sapiens (human)
nucleusTyrosine-protein kinase FynHomo sapiens (human)
mitochondrionTyrosine-protein kinase FynHomo sapiens (human)
endosomeTyrosine-protein kinase FynHomo sapiens (human)
cytosolTyrosine-protein kinase FynHomo sapiens (human)
actin filamentTyrosine-protein kinase FynHomo sapiens (human)
plasma membraneTyrosine-protein kinase FynHomo sapiens (human)
postsynaptic densityTyrosine-protein kinase FynHomo sapiens (human)
dendriteTyrosine-protein kinase FynHomo sapiens (human)
perikaryonTyrosine-protein kinase FynHomo sapiens (human)
cell bodyTyrosine-protein kinase FynHomo sapiens (human)
membrane raftTyrosine-protein kinase FynHomo sapiens (human)
perinuclear region of cytoplasmTyrosine-protein kinase FynHomo sapiens (human)
perinuclear endoplasmic reticulumTyrosine-protein kinase FynHomo sapiens (human)
glial cell projectionTyrosine-protein kinase FynHomo sapiens (human)
Schaffer collateral - CA1 synapseTyrosine-protein kinase FynHomo sapiens (human)
plasma membraneTyrosine-protein kinase FynHomo sapiens (human)
nucleusBeta-2 adrenergic receptorHomo sapiens (human)
lysosomeBeta-2 adrenergic receptorHomo sapiens (human)
endosomeBeta-2 adrenergic receptorHomo sapiens (human)
early endosomeBeta-2 adrenergic receptorHomo sapiens (human)
Golgi apparatusBeta-2 adrenergic receptorHomo sapiens (human)
plasma membraneBeta-2 adrenergic receptorHomo sapiens (human)
endosome membraneBeta-2 adrenergic receptorHomo sapiens (human)
membraneBeta-2 adrenergic receptorHomo sapiens (human)
apical plasma membraneBeta-2 adrenergic receptorHomo sapiens (human)
clathrin-coated endocytic vesicle membraneBeta-2 adrenergic receptorHomo sapiens (human)
neuronal dense core vesicleBeta-2 adrenergic receptorHomo sapiens (human)
receptor complexBeta-2 adrenergic receptorHomo sapiens (human)
plasma membraneBeta-2 adrenergic receptorHomo sapiens (human)
cytoplasmAlpha-2A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2A adrenergic receptorHomo sapiens (human)
basolateral plasma membraneAlpha-2A adrenergic receptorHomo sapiens (human)
neuronal cell bodyAlpha-2A adrenergic receptorHomo sapiens (human)
axon terminusAlpha-2A adrenergic receptorHomo sapiens (human)
presynaptic active zone membraneAlpha-2A adrenergic receptorHomo sapiens (human)
dopaminergic synapseAlpha-2A adrenergic receptorHomo sapiens (human)
postsynaptic density membraneAlpha-2A adrenergic receptorHomo sapiens (human)
glutamatergic synapseAlpha-2A adrenergic receptorHomo sapiens (human)
GABA-ergic synapseAlpha-2A adrenergic receptorHomo sapiens (human)
receptor complexAlpha-2A adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2A adrenergic receptorHomo sapiens (human)
plasma membraneAdenosine receptor A3Homo sapiens (human)
presynaptic membraneAdenosine receptor A3Homo sapiens (human)
Schaffer collateral - CA1 synapseAdenosine receptor A3Homo sapiens (human)
dendriteAdenosine receptor A3Homo sapiens (human)
plasma membraneAdenosine receptor A3Homo sapiens (human)
synapseAdenosine receptor A3Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2C8Homo sapiens (human)
plasma membraneCytochrome P450 2C8Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C8Homo sapiens (human)
cytoplasmCytochrome P450 2C8Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C8Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
presynaptic membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
axon terminusMuscarinic acetylcholine receptor M1Homo sapiens (human)
Schaffer collateral - CA1 synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
postsynaptic density membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
glutamatergic synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
cholinergic synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M1Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M1Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M1Homo sapiens (human)
plasma membraneBeta-3 adrenergic receptorHomo sapiens (human)
receptor complexBeta-3 adrenergic receptorHomo sapiens (human)
plasma membraneBeta-3 adrenergic receptorHomo sapiens (human)
cytoplasmAlpha-2C adrenergic receptorHomo sapiens (human)
endosomeAlpha-2C adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2C adrenergic receptorHomo sapiens (human)
plasma membraneAlpha-2C adrenergic receptorHomo sapiens (human)
endoplasmic reticulum membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
basal plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
basolateral plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
postsynaptic membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
synapseMuscarinic acetylcholine receptor M3Homo sapiens (human)
plasma membraneMuscarinic acetylcholine receptor M3Homo sapiens (human)
dendriteMuscarinic acetylcholine receptor M3Homo sapiens (human)
plasma membraneSubstance-K receptorHomo sapiens (human)
sperm flagellumSubstance-K receptorHomo sapiens (human)
sperm headSubstance-K receptorHomo sapiens (human)
sperm midpieceSubstance-K receptorHomo sapiens (human)
sperm midpieceSubstance-K receptorHomo sapiens (human)
plasma membraneSubstance-K receptorHomo sapiens (human)
plasma membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
cell surfaceSodium-dependent noradrenaline transporter Homo sapiens (human)
membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
neuronal cell body membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
presynaptic membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
plasma membraneSodium-dependent noradrenaline transporter Homo sapiens (human)
axonSodium-dependent noradrenaline transporter Homo sapiens (human)
endoplasmic reticulumThromboxane-A synthase Homo sapiens (human)
endoplasmic reticulum membraneThromboxane-A synthase Homo sapiens (human)
cytosolThromboxane-A synthase Homo sapiens (human)
plasma membraneD(3) dopamine receptorHomo sapiens (human)
synapseD(3) dopamine receptorHomo sapiens (human)
plasma membraneD(3) dopamine receptorHomo sapiens (human)
plasma membraneDelta-type opioid receptorHomo sapiens (human)
synaptic vesicle membraneDelta-type opioid receptorHomo sapiens (human)
dendrite membraneDelta-type opioid receptorHomo sapiens (human)
presynaptic membraneDelta-type opioid receptorHomo sapiens (human)
axon terminusDelta-type opioid receptorHomo sapiens (human)
spine apparatusDelta-type opioid receptorHomo sapiens (human)
postsynaptic density membraneDelta-type opioid receptorHomo sapiens (human)
neuronal dense core vesicleDelta-type opioid receptorHomo sapiens (human)
plasma membraneDelta-type opioid receptorHomo sapiens (human)
neuron projectionDelta-type opioid receptorHomo sapiens (human)
nucleoplasm5-hydroxytryptamine receptor 2BHomo sapiens (human)
cytoplasm5-hydroxytryptamine receptor 2BHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2BHomo sapiens (human)
synapse5-hydroxytryptamine receptor 2BHomo sapiens (human)
G protein-coupled serotonin receptor complex5-hydroxytryptamine receptor 2BHomo sapiens (human)
dendrite5-hydroxytryptamine receptor 2BHomo sapiens (human)
plasma membrane5-hydroxytryptamine receptor 2BHomo sapiens (human)
cytoplasmSodium-dependent dopamine transporter Homo sapiens (human)
plasma membraneSodium-dependent dopamine transporter Homo sapiens (human)
cell surfaceSodium-dependent dopamine transporter Homo sapiens (human)
membraneSodium-dependent dopamine transporter Homo sapiens (human)
axonSodium-dependent dopamine transporter Homo sapiens (human)
neuron projectionSodium-dependent dopamine transporter Homo sapiens (human)
neuronal cell bodySodium-dependent dopamine transporter Homo sapiens (human)
axon terminusSodium-dependent dopamine transporter Homo sapiens (human)
membrane raftSodium-dependent dopamine transporter Homo sapiens (human)
postsynaptic membraneSodium-dependent dopamine transporter Homo sapiens (human)
dopaminergic synapseSodium-dependent dopamine transporter Homo sapiens (human)
flotillin complexSodium-dependent dopamine transporter Homo sapiens (human)
axonSodium-dependent dopamine transporter Homo sapiens (human)
presynaptic membraneSodium-dependent dopamine transporter Homo sapiens (human)
plasma membraneSodium-dependent dopamine transporter Homo sapiens (human)
neuronal cell body membraneSodium-dependent dopamine transporter Homo sapiens (human)
plasma membraneUracil nucleotide/cysteinyl leukotriene receptorHomo sapiens (human)
plasma membraneUracil nucleotide/cysteinyl leukotriene receptorHomo sapiens (human)
cytosolMitogen-activated protein kinase 14Homo sapiens (human)
spindle poleMitogen-activated protein kinase 14Homo sapiens (human)
extracellular regionMitogen-activated protein kinase 14Homo sapiens (human)
nucleusMitogen-activated protein kinase 14Homo sapiens (human)
nucleoplasmMitogen-activated protein kinase 14Homo sapiens (human)
cytoplasmMitogen-activated protein kinase 14Homo sapiens (human)
mitochondrionMitogen-activated protein kinase 14Homo sapiens (human)
cytosolMitogen-activated protein kinase 14Homo sapiens (human)
nuclear speckMitogen-activated protein kinase 14Homo sapiens (human)
secretory granule lumenMitogen-activated protein kinase 14Homo sapiens (human)
glutamatergic synapseMitogen-activated protein kinase 14Homo sapiens (human)
ficolin-1-rich granule lumenMitogen-activated protein kinase 14Homo sapiens (human)
nucleusMitogen-activated protein kinase 14Homo sapiens (human)
cytoplasmMitogen-activated protein kinase 14Homo sapiens (human)
nuclear envelopeLeukotriene C4 synthaseHomo sapiens (human)
nuclear outer membraneLeukotriene C4 synthaseHomo sapiens (human)
endoplasmic reticulumLeukotriene C4 synthaseHomo sapiens (human)
endoplasmic reticulum membraneLeukotriene C4 synthaseHomo sapiens (human)
membraneLeukotriene C4 synthaseHomo sapiens (human)
nuclear membraneLeukotriene C4 synthaseHomo sapiens (human)
intracellular membrane-bounded organelleLeukotriene C4 synthaseHomo sapiens (human)
nuclear envelopeLeukotriene C4 synthaseHomo sapiens (human)
endoplasmic reticulumLeukotriene C4 synthaseHomo sapiens (human)
cellular_componentCysteinyl leukotriene receptor 2Homo sapiens (human)
plasma membraneCysteinyl leukotriene receptor 2Homo sapiens (human)
plasma membraneCysteinyl leukotriene receptor 2Homo sapiens (human)
plasma membraneCysteinyl leukotriene receptor 1Homo sapiens (human)
membraneCysteinyl leukotriene receptor 1Homo sapiens (human)
plasma membraneCysteinyl leukotriene receptor 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (112)

Assay IDTitleYearJournalArticle
AID1698006Ratio of drug level in cynomolgus monkey blood to plasma administered through iv dosing by LC-MS/MS analysis
AID444054Oral bioavailability in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID1579859Inhibition of LTC4S in healthy human whole blood assessed as inhibition of calcium ionophore A23187 stimulated cysteinyl leukotrienes production preincuabted for 30 mins followed by calcium ionophore stimulation and measured after 10 mins by LC-MS analysi2019Journal of medicinal chemistry, 09-12, Volume: 62, Issue:17
Discovery of the Oral Leukotriene C4 Synthase Inhibitor (1
AID678717Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-benzyloxyquinoline as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID55076In vitro binding affinity towards Cysteinyl leukotriene D4 receptor by using [3H]LTD4 binding assay in guinea pig lung membranes2000Journal of medicinal chemistry, Feb-10, Volume: 43, Issue:3
Derivation of pharmacophore and CoMFA models for leukotriene D(4) receptor antagonists of the quinolinyl(bridged)aryl series.
AID1579860Inhibition of LTC4S in asthmatic human whole blood assessed as inhibition of calcium ionophore A23187 stimulated cysteinyl leukotrienes production preincuabted for 30 mins followed by calcium ionophore stimulation and measured after 10 mins by LC-MS analy2019Journal of medicinal chemistry, 09-12, Volume: 62, Issue:17
Discovery of the Oral Leukotriene C4 Synthase Inhibitor (1
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID444058Volume of distribution at steady state in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID588209Literature-mined public compounds from Greene et al multi-species hepatotoxicity modelling dataset2010Chemical research in toxicology, Jul-19, Volume: 23, Issue:7
Developing structure-activity relationships for the prediction of hepatotoxicity.
AID444051Total clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1698010Hepatic clearance in human administered through iv dosing
AID89083Fold shift in LTD4 dose response curve 25 hr following 40 mg oral dose1996Journal of medicinal chemistry, Jul-05, Volume: 39, Issue:14
Modulators of leukotriene biosynthesis and receptor activation.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID102664In vitro inhibition of [3H]-LTD4 binding to LTD4 receptor of guinea pig lung membrane without human serum albumin (HSA).1998Bioorganic & medicinal chemistry letters, Mar-03, Volume: 8, Issue:5
A series of non-quinoline cysLT1 receptor antagonists: SAR study on pyridyl analogs of Singulair.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID55069Binding affinity towards Cysteinyl leukotriene D4 receptor (cysLT1) was measured by the displacement of [3H]LTD4 radioligand1998Journal of medicinal chemistry, Apr-23, Volume: 41, Issue:9
Development of a three-dimensional CysLT1 (LTD4) antagonist model with an incorporated amino acid residue from the receptor.
AID428143Bioavailability in rat2009Bioorganic & medicinal chemistry letters, Aug-01, Volume: 19, Issue:15
Synthesis and structure-activity relationships of gamma-carboline derivatives as potent and selective cysLT(1) antagonists.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID678714Inhibition of human CYP2C19 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 3-butyryl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID55235Compound were tested for inhibitory activity against Cysteinyl leukotriene D4 receptor1996Journal of medicinal chemistry, Jul-05, Volume: 39, Issue:14
Modulators of leukotriene biosynthesis and receptor activation.
AID1236107Antiasthmatic activity in human bronchi assessed as inhibition of antigen-induced bronchoconstriction at 10 nmol/L preincubated for 30 mins with addition of cyclooxygenase inhibitor indomethacin at 10 mins and antihistamine drug pyrilamine at 5 mins prior2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Discovery of Gemilukast (ONO-6950), a Dual CysLT1 and CysLT2 Antagonist As a Therapeutic Agent for Asthma.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1236111Antagonist activity at human CysLT2 expressed in HEK293T cells assessed as inhibition of LTC4-induced effect preincubated for 30 mins prior to LTC4 addition by Aequorin luminescence assay2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Discovery of Gemilukast (ONO-6950), a Dual CysLT1 and CysLT2 Antagonist As a Therapeutic Agent for Asthma.
AID444050Fraction unbound in human plasma2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1698016Dissociation constant, basic pKa of compound measured up to 18 mins by capillary electrophoresis
AID678713Inhibition of human CYP2C9 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-methoxy-4-trifluoromethylcoumarin-3-acetic acid as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1698000Apparent permeability in dog MDCKII-LE cells at pH 7.4
AID1579865Inhibition of recombinant human N-terminal His6-tagged LTC4S expressed in in Pichia pastoris X33 assessed as inhibition of EXC4 formation using EXA4 as substrate preincubated for 10 mins followed by substrate addition and measured after 1 min by EIA2019Journal of medicinal chemistry, 09-12, Volume: 62, Issue:17
Discovery of the Oral Leukotriene C4 Synthase Inhibitor (1
AID588210Human drug-induced liver injury (DILI) modelling dataset from Ekins et al2010Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 38, Issue:12
A predictive ligand-based Bayesian model for human drug-induced liver injury.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID1636484Drug activation in human Hep3B cells assessed as human CYP2C9-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 49.7 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of N2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID497575Antagonist activity at CysLT1 receptor in human dU937 cells assessed as inhibition of LTD4-induced increase of calcium level treated 30 mins before LTD4 challenge2010Bioorganic & medicinal chemistry, Aug-01, Volume: 18, Issue:15
Pharmacophore identification, synthesis, and biological evaluation of carboxylated chalcone derivatives as CysLT1 antagonists.
AID1698011Fraction unbound in human plasma
AID444057Fraction escaping hepatic elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID373867Hepatic clearance in human hepatocytes in absence of fetal calf serum2009European journal of medicinal chemistry, Apr, Volume: 44, Issue:4
First-principle, structure-based prediction of hepatic metabolic clearance values in human.
AID497576Antagonist activity at CysLT1 receptor in human dU937 cells assessed as inhibition of LTD4-induced increase of calcium level treated 30 mins before LTD4 challenge relative to control2010Bioorganic & medicinal chemistry, Aug-01, Volume: 18, Issue:15
Pharmacophore identification, synthesis, and biological evaluation of carboxylated chalcone derivatives as CysLT1 antagonists.
AID1698004Fraction unbound in cynomolgus monkey plasma
AID1222793Dissociation constant, pKa of the compound2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Which metabolites circulate?
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID428080Inhibition of LTD4-induced airway microvascular permeability in po dosed Dunkin-Hartley guinea pig after 8 hrs using Evans blue staining2009Bioorganic & medicinal chemistry letters, Aug-01, Volume: 19, Issue:15
Synthesis and structure-activity relationships of gamma-carboline derivatives as potent and selective cysLT(1) antagonists.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1636370Drug activation in human Hep3B cells assessed as human CYP3A4-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 29.6 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of N2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID678722Covalent binding affinity to human liver microsomes assessed per mg of protein at 10 uM after 60 mins presence of NADPH2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1698009Hepatic clearance in cynomolgus monkey at < 1 mg/kg, iv administered as cassette dosing
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID428079Inhibition of LTD4-induced airway microvascular permeability in po dosed Dunkin-Hartley guinea pig after 4 hrs using Evans blue staining2009Bioorganic & medicinal chemistry letters, Aug-01, Volume: 19, Issue:15
Synthesis and structure-activity relationships of gamma-carboline derivatives as potent and selective cysLT(1) antagonists.
AID1472629Inhibition of CYP2C8 in human liver microsomes using paclitaxel as substrate upto 10 uM after 20 mins in presence of NADPH by LC-MS/MS analysis2018Journal of medicinal chemistry, 01-11, Volume: 61, Issue:1
Novel Terminal Bipheny-Based Diapophytoene Desaturases (CrtN) Inhibitors as Anti-MRSA/VISR/LRSA Agents with Reduced hERG Activity.
AID102799In vitro inhibition of [3H]-LTD4 binding to LTD4 receptor of DMSO differentiated human U937 cell membranes1998Bioorganic & medicinal chemistry letters, Mar-03, Volume: 8, Issue:5
A series of non-quinoline cysLT1 receptor antagonists: SAR study on pyridyl analogs of Singulair.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1236104Antiasthmatic activity in guinea pig assessed as inhibition of LTC4-induced bronchoconstriction at 0.1 mg/kg, po measured over 30 mins2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Discovery of Gemilukast (ONO-6950), a Dual CysLT1 and CysLT2 Antagonist As a Therapeutic Agent for Asthma.
AID1137667Displacement of [3H]PSB-12150 from human GPR17 expressed in CHO-K1 cell membranes after 60 mins by heterologous competition binding assay2014ACS medicinal chemistry letters, Apr-10, Volume: 5, Issue:4
Development of [(3)H]2-Carboxy-4,6-dichloro-1H-indole-3-propionic Acid ([(3)H]PSB-12150): A Useful Tool for Studying GPR17.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1318758Induction of peroxisomal enzyme activity in mouse assessed as increase in fatty acyl Co-A oxidase activity at 400 mg/kg, po for 4 days2016Journal of medicinal chemistry, 10-13, Volume: 59, Issue:19
The "Cyclopropyl Fragment" is a Versatile Player that Frequently Appears in Preclinical/Clinical Drug Molecules.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID444053Renal clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID678716Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using diethoxyfluorescein as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1318757Displacement of [3H]LTD4 from LTD4 receptor in guinea pig lung membrane2016Journal of medicinal chemistry, 10-13, Volume: 59, Issue:19
The "Cyclopropyl Fragment" is a Versatile Player that Frequently Appears in Preclinical/Clinical Drug Molecules.
AID428078Inhibition of LTD4-induced airway microvascular permeability in po dosed Dunkin-Hartley guinea pig after 1 hr using Evans blue staining2009Bioorganic & medicinal chemistry letters, Aug-01, Volume: 19, Issue:15
Synthesis and structure-activity relationships of gamma-carboline derivatives as potent and selective cysLT(1) antagonists.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID678715Inhibition of human CYP2D6 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 4-methylaminoethyl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID678712Inhibition of human CYP1A2 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using ethoxyresorufin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID444055Fraction absorbed in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1636426Drug activation in human Hep3B cells assessed as human CYP2D6-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 79.2 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of N2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID1698007Ratio of drug level in human blood to plasma administered through iv dosing by LC-MS/MS analysis
AID444056Fraction escaping gut-wall elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID444052Hepatic clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID102663In vitro inhibition of [3H]LTD4 binding to LTD4 receptor of guinea pig lung membrane with human serum albumin (HSA).1998Bioorganic & medicinal chemistry letters, Mar-03, Volume: 8, Issue:5
A series of non-quinoline cysLT1 receptor antagonists: SAR study on pyridyl analogs of Singulair.
AID311524Oral bioavailability in human2007Bioorganic & medicinal chemistry, Dec-15, Volume: 15, Issue:24
Hologram QSAR model for the prediction of human oral bioavailability.
AID625277FDA Liver Toxicity Knowledge Base Benchmark Dataset (LTKB-BD) drugs of less concern for DILI2011Drug discovery today, Aug, Volume: 16, Issue:15-16
FDA-approved drug labeling for the study of drug-induced liver injury.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID1813642Inhibition of CYP2C8 in human liver microsome using paclitaxel as substrate2021Journal of medicinal chemistry, 12-09, Volume: 64, Issue:23
Synthesis, Characterization, and Preclinical Evaluation of a Small-Molecule Prostate-Specific Membrane Antigen-Targeted Monomethyl Auristatin E Conjugate.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1124818Activation of FXR (unknown origin) at 10 uM2014Bioorganic & medicinal chemistry, Apr-01, Volume: 22, Issue:7
Some non-conventional biomolecular targets for diamidines. A short survey.
AID1854971Antimicrobial activity against Mycobacterium tuberculosis H37Rv incubated for 24 hrs and measured by MTT assay2022Bioorganic & medicinal chemistry, 10-01, Volume: 71Drug screening approach against mycobacterial fatty acyl-AMP ligase FAAL32 renews the interest of the salicylanilide pharmacophore in the fight against tuberculosis.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID79495Compound was tested for LTD4 induced guinea pig trachea contraction1996Journal of medicinal chemistry, Jul-05, Volume: 39, Issue:14
Modulators of leukotriene biosynthesis and receptor activation.
AID1698001Lipophilicity, log D of the compound at pH 7.4 by by shake flask method
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1236112Antagonist activity at human CysLT12015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
Discovery of Gemilukast (ONO-6950), a Dual CysLT1 and CysLT2 Antagonist As a Therapeutic Agent for Asthma.
AID1911194Inhibition of CYP2C8 in human liver microsomes using paclitaxel as substrate incubated for 5 to 45 mins in presence of NADPH by LC/MS analysis
AID1346031Human CysLT1 receptor (Leukotriene receptors)1999Nature, Jun-24, Volume: 399, Issue:6738
Characterization of the human cysteinyl leukotriene CysLT1 receptor.
AID1346031Human CysLT1 receptor (Leukotriene receptors)2002Biochemical pharmacology, Apr-15, Volume: 63, Issue:8
Pharmacological differences among CysLT(1) receptor antagonists with respect to LTC(4) and LTD(4) in human lung parenchyma.
AID1346857Mouse GPR17 (Class A Orphans)2008PloS one, , Volume: 3, Issue:10
The recently identified P2Y-like receptor GPR17 is a sensor of brain damage and a new target for brain repair.
AID1346031Human CysLT1 receptor (Leukotriene receptors)1999Molecular pharmacology, Sep, Volume: 56, Issue:3
Identification, molecular cloning, expression, and characterization of a cysteinyl leukotriene receptor.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,806)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's86 (4.76)18.2507
2000's861 (47.67)29.6817
2010's631 (34.94)24.3611
2020's228 (12.62)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 132.06

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index132.06 (24.57)
Research Supply Index7.85 (2.92)
Research Growth Index5.15 (4.65)
Search Engine Demand Index249.87 (26.88)
Search Engine Supply Index2.01 (0.95)

This Compound (132.06)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials598 (30.43%)5.53%
Reviews213 (10.84%)6.00%
Case Studies161 (8.19%)4.05%
Observational19 (0.97%)0.25%
Other974 (49.57%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (314)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated With Amivantamab, an EGFR-MET Bispecific Antibody, Among Post-osimertinib Treated EGFRm NSCLC; SKIPPirr, a Phase 2 Study [NCT05663866]Phase 2126 participants (Anticipated)Interventional2023-05-18Recruiting
Effects of Montelukast Therapy on Alzheimer's Disease (EMERALD) [NCT03991988]Phase 232 participants (Actual)Interventional2019-09-25Completed
Randomized Double-blind Placebo-controlled Study of add-on Montelukast to Inhaled Budesonide in the Treatment of Nonasthmatic Eosinophilic Bronchitis [NCT01121016]Phase 463 participants (Anticipated)Interventional2010-06-30Not yet recruiting
A Multicenter, Randomized, Double-blind, Placebo-Controlled Parallel Group 8-week Study to Evaluate the Efficacy and Safety of Chewable Montelukast When Initiated at the Start of the School Year in Pediatric Patients With Chronic Asthma [NCT00461032]Phase 31,162 participants (Actual)Interventional2006-06-30Completed
Montelukast, on Pediatric Bronchial Asthma in Multicenter Comparative Double-Blind Clinical Study (Phase IV) With Ketotifen Fumarate [NCT00446056]Phase 4188 participants (Actual)Interventional2003-09-25Completed
A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled, 2-Arm, 2X2 Crossover Study Comparing the Effects of Montelukast, Inhaled Budesonide, and Placebo on Lower Leg Growth in Children (Prepubertal, Tanner Stage I) With Mild Asthma [NCT00092092]Phase 471 participants (Actual)Interventional2002-10-31Completed
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 2-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast on Exercise-Induced Bronchospasm [NCT00090142]Phase 362 participants (Actual)Interventional2004-05-31Completed
Parent-determined Oral Montelukast Therapy for Preschool Wheeze With Stratification for Arachidonate-5-Lipoxygenase (ALOX5) Promoter Genotype [NCT01142505]Phase 31,358 participants (Actual)Interventional2010-11-30Completed
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing the Effect on Linear Growth of Montelukast With Placebo and Inhaled Beclomethasone in Pediatric Patients (Prepubertal, Tanner Stage I) With Mild Asthma [NCT00395408]Phase 4360 participants (Actual)Interventional2000-06-30Completed
A Multicenter, Double-Blind, Placebo Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral Montelukast Versus Placebo in Persistent Asthma Which is Also Active During Allergy Seasons in Pediatric Patients With Seasonal Aeroa [NCT00289874]Phase 3421 participants (Actual)Interventional2006-03-31Completed
A Double-Blind, Randomized Multicenter, 3-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast Compared With Placebo and Salmeterol on Exercise-Induced Bronchoconstriction [NCT00245570]Phase 347 participants (Actual)Interventional2005-12-31Completed
MK0476 Phase II/III Placebo Controlled Double Blind Study [NCT00229970]Phase 3225 participants (Actual)Interventional2005-09-30Completed
A 12 Week Multicenter, Open-label, Observational Study to Evaluate the Effectiveness of Montelukast Sodium (Singulair®), 4 or 5 mg/Day in Pediatric Subjects With Uncontrolled Asthma [NCT00832455]Phase 4445 participants (Actual)Interventional2006-06-30Completed
Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing in Infants 3 to 12 Months of Age in Bandar Abbas Children' Hospital [NCT01370187]146 participants (Actual)Interventional2010-07-31Completed
Study HZA114971, A Multicentre Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effects of a One-Year Regimen of Orally Inhaled Fluticasone Furoate 50 mcg Once Daily on Growth Velocity in Prepubertal, Paediatric Subjects [NCT02889809]Phase 4477 participants (Actual)Interventional2016-10-20Completed
A Multi-Center, Double-blind, Randomized, Parallel-Group Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Spring 2001 Study [NCT00972738]Phase 31,214 participants (Actual)Interventional2001-04-30Completed
MK-476 IV Formulation Phase III Open Label Exploratory Comparative Study - Acute Exacerbations of Asthma - [NCT00442338]Phase 391 participants (Actual)Interventional2007-03-31Completed
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Two-Period, Parallel-group Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients. [NCT00140946]Phase 4546 participants (Actual)Interventional1998-03-31Completed
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis [NCT00092118]Phase 31,992 participants (Actual)Interventional2003-10-31Completed
Phase 4 Study of Single Dose of Oral Montelukast When Adding to Standard Treatment in Acute Moderate to Severe Wheezing in Preschool Children. [NCT01304901]Phase 480 participants (Actual)Interventional2010-04-30Completed
Comparison of Daily Mometasone Furoate Nasal Spray Alone Versus a Combination With Montelukast for Treatment of Chronic Rhinosinusitis With Asthma After Functional Endoscopic Sinus Surgery: a 9-month Randomized, Open-label, Controlled Study [NCT02110654]Phase 450 participants (Actual)Interventional2014-06-30Completed
Comparative Study of the Effect of Two Doses of Mometasone Furoate Dry Powder Inhaler 200 mcg and 400 mcg QD PM, Fluticasone Propionate 250 mcg BID, and Montelukast 10 mg QD PM, on Bone Mineral Density in Adults With Asthma [NCT00394355]Phase 4566 participants (Actual)Interventional2006-09-30Completed
Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma [NCT00666679]Phase 2134 participants (Actual)Interventional2008-05-31Completed
Evaluating the Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients. [NCT05959889]50 participants (Anticipated)Interventional2023-03-01Recruiting
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis [NCT00974571]Phase 31,365 participants (Actual)Interventional2001-11-30Completed
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Fall Study [NCT00960141]Phase 3829 participants (Actual)Interventional2000-08-31Completed
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Aged 6 to 24 Months With Asthma [NCT00943683]256 participants (Actual)Interventional2000-08-31Completed
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, 2-Period, Parallel-Group Study to Assess the Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients [NCT00911547]Phase 3642 participants (Actual)Interventional1995-03-31Completed
A Randomized Controlled Study of Montelukast Plus Low Dose Inhaled Budesonide Versus Medium Dose Inhaled Budesonide on Asthma Control in Elderly Patients [NCT01147510]Phase 4140 participants (Actual)Interventional2010-07-31Completed
A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children [NCT00189462]Phase 499 participants (Actual)Interventional2004-03-31Completed
The Effect of Montelukast on Anti-inflammatory Treatment and Asthma Exacerbation Prevention in Children Sensitive to Dust Mites. [NCT01266772]Phase 3160 participants (Anticipated)Interventional2011-01-31Recruiting
A Multicenter, Double-Blind, Randomized, Crossover Design Study to Evaluate the Effect of Montelukast Vs. Salmeterol on the Inhibition of Exercise-Induced Bronchoconstriction in Asthmatic Patients Aged 6-14 Years [NCT00127166]Phase 3154 participants (Actual)Interventional2005-12-31Completed
A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Pediatric Patients (Ages 6 to 14 Years) With Acute Asthma [NCT00117338]Phase 3276 participants (Actual)Interventional2005-07-31Completed
The Effects on Airway Reactivity of the Use of Preoperative Montelukast Sodium [NCT02494466]Phase 430 participants (Actual)Interventional2014-05-31Completed
Effect of BMS-986020 on the Pharmacokinetics of Montelukast, Flurbiprofen, and Digoxin as Probe Substrates for CYP2C8, CYP2C9, and P-gp [NCT02227173]Phase 120 participants (Actual)Interventional2014-09-30Completed
The Effect of Montelukast on Asthma Control in Overweight/Obese Atopic Asthmatics [NCT01329939]26 participants (Actual)Interventional2011-04-30Completed
A Randomized, Placebo-controlled, Dose-ranging, Multi-centre Trial of QAW039 (1-450 mg p.o.), to Investigate the Effect on FEV1 and ACQ in Patients With Moderate-to-severe, Persistent, Allergic Asthma, Inadequately Controlled With ICS Therapy. [NCT01437735]Phase 21,043 participants (Actual)Interventional2011-08-31Completed
Randomised, Double-blind, Triple Dummy, Partial Cross-over (Each Active Treatment With Placebo) Study Using an Environmental Challenge Chamber (ECC) to Assess the Safety and Efficacy of 2 Weeks of Oral BI 671800 ED 50, 200 or 400 mg Bid, Compared to Monte [NCT01007721]Phase 2146 participants (Actual)Interventional2009-10-31Completed
Feasibility of a Personalised Medicine Clinic for Children With Asthma Aged 5-11 Years [NCT03269318]Phase 42 participants (Actual)Interventional2017-07-01Terminated(stopped due to Change to Primary Endpoint resulted in development of new protocol)
A Multicenter, Double-Blind, Randomized, Parallel-Group Chronic Asthma Study Comparing Montelukast With Placebo in 2- to 5-Year-Old Patients [NCT00968201]Phase 3689 participants (Actual)Interventional1997-12-31Completed
A Multicenter, Open-Label, Controlled, Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma [NCT00943397]Phase 3190 participants (Actual)Interventional2001-04-30Completed
A Multicenter, Double-Blind, Randomized Study Investigating the Clinical Effect of Montelukast on Allergic Rhinitis in Patients With Seasonal Allergic Rhinitis and Chronic Asthma [NCT00092885]Phase 3831 participants (Actual)Interventional2003-03-31Completed
A Multicenter, Double-Blind, Randomized, Crossover Study Investigating the Clinical Effect of Montelukast in Patients With Concomitant Asthma and Allergic Rhinitis Upon Controlled Exposure to Cat Allergen [NCT00092105]Phase 358 participants (Actual)Interventional2002-04-01Completed
A Randomized, 2-Period, Multicenter, Dble-Blind, Parallel-Group Study Comparing Effects of 2 Doses of MK0476 and Placebo in the Tx of Respiratory Symptoms Associated w/ Respiratory Syncytial Virus-Induced Bronchiolitis in Children 3 to 24 Mths [NCT00076973]Phase 31,125 participants (Actual)Interventional2003-08-31Completed
Effects of Concomitant Administration of BMS-986195 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates for Cytochrome P450 1A2, 2C8, 2C9, 2C19, 3A4, Organic Anion Transporter Polypeptide 1B1 and P-glycoprotein in Healthy Participants [NCT03131973]Phase 126 participants (Actual)Interventional2017-05-13Completed
Targeting Leukotrienes in Kidney Disease: A Pilot Study [NCT05362474]Phase 320 participants (Anticipated)Interventional2022-07-01Recruiting
A Two-Part, Randomized, Placebo-Controlled, Crossover Trial to Evaluate the Differential Effects of Inhaled Nedocromil, Oral Montelukast, and Inhaled Mometasone on Markers of the Early Airway Response to Allergen in Asthmatics [NCT01061333]Phase 116 participants (Actual)Interventional2010-06-30Completed
Randomised, Double Blind, Double Dummy, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 6 Weeks of Oral BI 671800 ED Twice Daily (b.i.d.), Montelukast Once Daily (q.d.) or Placebo in Symptomatic Asthmatic Patients on Low Dose [NCT01103349]Phase 2243 participants (Actual)Interventional2010-04-20Completed
An Open Label, Observational Study to Assess The Efficacy, Safety and Tolerability of Added Singulair in Persistent Asthma Patients With or Without Allergic Rhinitis and Long Acting B-Agonist [NCT00445107]Phase 3198 participants (Actual)Interventional2005-11-01Completed
An Open-Label Study to Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy [NCT00398151]Phase 358 participants (Actual)Interventional2005-08-01Completed
MK0476 Phase III Double-Blind Comparative Study - Allergic Rhinitis [NCT00127647]Phase 31,375 participants (Actual)Interventional2004-11-30Completed
The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial [NCT04080947]Phase 1/Phase 256 participants (Actual)Interventional2019-08-01Completed
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN ADULT PATIENTS WITH MILD TO MODERATE ASTHMA [NCT02104674]Phase 3313 participants (Actual)Interventional2014-06-30Completed
Pilot Study Testing a New Strategy for Management of Spontaneous Preterm Birth. [NCT02108886]Phase 2100 participants (Anticipated)Interventional2011-12-31Active, not recruiting
The Impact of Particulate Matters Air Pollution on Accelerated Atherosclerosis: A Montelukast Interventional Study for Atherosclerosis Prevention in Modernizing China [NCT04762472]Phase 4200 participants (Anticipated)Interventional2023-09-30Not yet recruiting
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety of Combination Montelukast/Loratadine (MK-0476A) in Mexican Patients With Allergic Rhinitis [NCT01673620]Phase 369 participants (Actual)Interventional2012-07-04Completed
Fractional Concentration of Exhaled NO(FENO) to Direct Montelukast Treatment of Sub-acute Cough:A Prospective, Open Label, Randomized and Placebo-Controlled Trial [NCT02303600]200 participants (Anticipated)Interventional2014-08-31Recruiting
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Age 2 Through 14 Years With Seasonal Allergic Rhinitis [NCT00968149]Phase 3413 participants (Actual)Interventional2001-03-31Completed
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Montelukast in Patients With Seasonal Allergic Rhinitis Over a 4-Week Treatment Period-Fall 2001 [NCT00963469]Phase 31,079 participants (Actual)Interventional2001-08-31Completed
An Open-Label, Multicenter, Phase 1b Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Regimens for the Treatment of Subjects With Multiple Myeloma [NCT01998971]Phase 1242 participants (Actual)Interventional2014-02-18Active, not recruiting
A Randomized, 3-Period, Multiple-Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Plasma Concentration Profile of Montelukast Administered Once Daily as Oral Granules in Children Aged 3 to 6 Months [NCT00394069]Phase 214 participants (Actual)Interventional2003-07-31Completed
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children [NCT00140881]Phase 4220 participants (Actual)Interventional2000-06-01Completed
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 2-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast on Exercise-Induced Bronchospasm [NCT00092131]Phase 351 participants (Actual)Interventional2003-06-30Completed
Impact of Blocked Cysteinyl Leukotriene Pathway on Endothelial Function in Patients With Obstructive Sleep Apnea Syndrome: Multicenter Randomized Placebo Controlled Crossover Trial [NCT03545997]Phase 31 participants (Actual)Interventional2019-11-29Terminated(stopped due to lack of recruitment)
"A 12 Week Multicenter, Open-Label, Randomized, Observational Study Comparing Singulair® 10 Mg As Controller Monotherapy In Adults With Mild Asthma To Low Dose Inhaled Corticosteroid Treatment" [NCT00545324]Phase 4399 participants (Actual)Interventional2002-09-30Completed
Mk0476 Phase II Dose Finding Study -Allergic Rhinitis- [NCT00446186]Phase 2945 participants (Actual)Interventional2004-02-29Completed
A Randomized, 3-Period, Multiple-Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Plasma Concentration Profile of Montelukast Administered Once Daily as Oral Granules in Children Aged 1 to 3 Months [NCT00394160]Phase 212 participants (Actual)Interventional2004-12-31Completed
A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral MK0476 Vs Placebo During the Allergy Season in Patients With Seasonal Aeroallergen Sensitivity and Chronic Asthma Which is Also Activ [NCT00092144]Phase 3500 participants (Anticipated)Interventional2004-02-26Completed
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3 [NCT01224964]1 participants (Actual)Interventional2011-01-31Terminated(stopped due to A lot of patients recruited in our center were already on montelukast treatment. It was not possible to recruit sufficient patients for the study.)
Genotype Stratified Pharmacokinetic Study of Montelukast [NCT01086527]Phase 12 participants (Actual)Interventional2010-03-31Completed
A Randomized, Double Blind, Placebo Controlled Trial With Montelukast to Treat Bronchiolitis Obliterans Syndrome After Lung Transplantation [NCT01211509]Phase 430 participants (Actual)Interventional2010-10-31Completed
Clinical Study Evaluating the Effect of Histamine 1 Receptor Antagonist and Leukotreine Receptor Antagonist on Patients With Rheumatoid Arithritis [NCT03770923]Phase 375 participants (Anticipated)Interventional2018-10-01Recruiting
Single-Dose Open-label Randomized Crossover, in Two Periods and in Two Sequences, Single-Center Comparative Bioequivalence Study of Montelukast, 5 mg Chewable Tablets (Pharmtechnology LLC, Republic of Belarus), and Singulair®, 5 mg Chewable Tablets (Merck [NCT03898193]Phase 134 participants (Actual)Interventional2019-03-23Completed
A Phase 1, Single-center, Open-label, Sequential Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants [NCT05852769]Phase 118 participants (Actual)Interventional2023-05-31Completed
A Randomized Phase IIa, Multi-center, Double-blind, Placebo-controlled Study to Assess the Safety, Feasibility, Tolerability, and Efficacy of a New Buccal Film of Montelukast in Patients With Mild to Moderate Alzheimer's Disease [NCT03402503]Phase 254 participants (Anticipated)Interventional2018-11-26Active, not recruiting
A Randomized Trial of Comparing a Combination of Montelukast and Budesonide With Budesonide in Allergic Rhinitis [NCT04077892]Early Phase 146 participants (Actual)Interventional2016-06-01Completed
A Multicenter, Randomized, Double Blind, Crossover Study Comparing the Effect of MK0524 With Placebo and Concomitant Administration of MK0524 Plus Montelukast in Adult Patients With Chronic Asthma [NCT00783601]Phase 2130 participants (Actual)Interventional2004-10-31Completed
Effects of Oral Montelukast on Airway Inflammation in Children With Mild Asthma [NCT00675285]Phase 326 participants (Actual)Interventional2005-09-30Completed
Efficacy of Oral Leukotriene in Long Term Therapy of Mild and Moderate Obstructive Sleep Apnea Syndrome (OSAS) in Children [NCT00912171]Phase 445 participants (Actual)Interventional2009-01-31Completed
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Seasonal Allergic Rhinitis--Spring Study [NCT00979901]Phase 31,577 participants (Actual)Interventional2000-03-31Completed
A Six-week Evaluator-Blind, Randomized, Active-Controlled Evaluation of the Effects of Three Doses of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI), Montelukast, and Beclomethasone Dipropionate (BDP HFA) on the HPA Axis in Asthm [NCT01615874]Phase 20 participants (Actual)Interventional2013-01-31Withdrawn
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Combination Montelukast/Loratadine in Patients With Seasonal Allergic Rhinitis-Fall Study [NCT00963599]Phase 3907 participants (Actual)Interventional1999-09-30Completed
A Randomized, Double-Blind (3rd Party Open), Double-Dummy, Placebo- And Active Controlled, 3-Way Crossover Study To Determine The Effects Of Oral PF-03893787 On Allergen-Induced Airway Responses In Mild Asthmatic Subjects. [NCT00856687]Phase 112 participants (Anticipated)Interventional2009-04-30Completed
Effects of Montelukast on Airway Foxp3+ and CTLA4+CD25highCD4+ T Cells in Asthmatics [NCT01951898]Phase 2/Phase 315 participants (Anticipated)Interventional2012-06-30Recruiting
Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants [NCT04474327]Phase 140 participants (Actual)Interventional2020-07-24Completed
ATATURK UNİVERSITY [NCT05094596]Phase 4180 participants (Anticipated)Interventional2021-10-22Not yet recruiting
Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Montelukast From Asmakast 10mg Tabs (Sandoz, Egypt) & Singulair® 10mg Tabs (Merck & Co, Egypt) to Healthy Adult Volunteers [NCT02480049]Phase 126 participants (Actual)Interventional2014-08-31Completed
Double-blind Randomized Clinical Trial, Placebo-controlled to Assess the Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID-19: E-SPERANZA COVID-19 PROJECT [NCT04695704]Phase 3284 participants (Anticipated)Interventional2021-08-01Recruiting
Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations [NCT03277170]Phase 2320 participants (Anticipated)Interventional2025-09-01Not yet recruiting
A Phase II Study, Evaluating the Efficacy of Montelukast in Reducing the Incidence and Severity of Monoclonal Antibodies Associated Infusion Reactions [NCT04198623]Phase 280 participants (Anticipated)Interventional2020-03-20Recruiting
An 8 Week Study to Evaluate the Effectiveness of Adding Montelukast to Inhaled Corticosteroid (ICS) to the ICS/Long-Acting Beta 2-Agonist Therapy in Adult Subjects With Asthma and Allergic Rhinitis [NCT00545844]Phase 4313 participants (Actual)Interventional2007-04-01Completed
Montelukast Effects on Pulmonary Function in Children With Wheezing Aged Less Than 2 Years [NCT00775697]Phase 440 participants (Anticipated)Interventional2009-09-30Enrolling by invitation
"Korean Study of Real-World Montelukast Use in Mild Asthmatic Children With Concomitant Allergic Rhinitis" [NCT00442559]Phase 4191 participants (Actual)Interventional2005-01-31Completed
Impact Of Montelukast On Allergic Rhinitis And Its Inflammatory Makers [NCT05381207]Early Phase 160 participants (Anticipated)Interventional2022-10-31Not yet recruiting
Study of the Decongestant Effect of the Combination of Loratadine and Montelukast Compared With Placebo in SAR Subjects Exposed to Pollen in an Environmental Exposure Unit [NCT00423995]Phase 3379 participants (Actual)Interventional2006-11-01Completed
An Evaluation of the Effectiveness of Pulmicort Respules (Budesonide Inhalation Suspension) Versus SINGULAIR (Montelukast Sodium) in Children 2-8 Years Old With Asthma Requiring Controller Therapy. [NCT00641472]Phase 4380 participants (Anticipated)Interventional2002-10-31Completed
An Open-label Balanced, Randomised, Single Dose, Two-way Crossover Study to Determine the Bioequivalence of GW483100 10 mg Tablets (Containing Montelukast Sodium Equivalent to 10 mg of Montelukast) Relative to Reference Montelukast Sodium 10 mg Tablets (C [NCT02658422]Phase 132 participants (Actual)Interventional2015-08-18Completed
Effects of Concomitant Administration of BMS-986142 on the Single-dose Pharmacokinetics of Probe Substrates for CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-gp in Healthy Subjects [NCT02762123]Phase 128 participants (Actual)Interventional2016-05-31Completed
Investigation to Identify Predictors of Response to a Treatment With Montelukast [NCT00721240]Phase 450 participants (Anticipated)Interventional2006-02-28Completed
Assessment of the Effect of Oral Montelukast as Additional Treatment in the Management of Patients With Acute Severe Asthma. [NCT01011452]Phase 487 participants (Actual)Interventional2001-05-31Completed
The Effect of Montelukast Therapy on mRNA Profile of Matrix Metalloproteinases and Their Inhibitors in the Sputum of Patients With Asthma [NCT00947453]Phase 215 participants (Actual)Interventional2009-07-31Completed
A National, Multi-Center, Open-Label, Three-Arm, Phase II Study to Investigate the Effect of Montelukast Between Emergency Room Visits and Hospitalizations in COVID-19 Pneumonia in Comparison With Standard Treatment [NCT04718285]Phase 2380 participants (Anticipated)Interventional2021-05-15Recruiting
Effect of Montelukast on Experimentally-Induced RV16 Infection in Volunteers With Mild Asthma [NCT00359073]25 participants (Actual)Interventional2006-10-31Completed
The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis [NCT00119015]Phase 4102 participants (Actual)Interventional2005-07-31Terminated(stopped due to Difficulty in recruitment)
Effect of Montelukast on the Airway Remodeling in Asthma Patients: Physiological-radiological Correlation [NCT00699062]Phase 440 participants (Actual)Interventional2010-01-31Completed
Assessment of Montelukast Efficacy in the Treatment of Refractive Uremic Pruritus [NCT02559388]73 participants (Actual)Interventional2015-04-30Completed
Effect of Add-on Montelukast to Inhaled Corticosteroids in Excessive Airway Narrowing in Adults With Asthma [NCT00913328]Phase 431 participants (Actual)Interventional2002-08-31Completed
Early Intervention With Leukotriene Receptor Antagonists in Patients With Grass Pollinosis: Effects on Clinical Symptoms and Allergic Inflammation [NCT05040828]Phase 459 participants (Actual)Interventional2020-07-01Completed
Istanbul Gaziosmanpasa Taksim Research and Training Hospital, [NCT02565212]Phase 430 participants (Actual)Interventional2014-05-31Completed
A Randomised, Double Blind, Placebo-Controlled, Multi-Centre, Parallel Group Study to Evaluate the Efficacy and Safety of ADC3680 Administered Once Daily as an Add-On Therapy to Inhaled Corticosteroids and When Co-Administered With Montelukast in Subjects [NCT01730027]Phase 2248 participants (Actual)Interventional2013-04-30Completed
Montelukast as Adjunct Treatment in Children With Atopic Dermatitis [NCT02534467]Phase 460 participants (Actual)Interventional2015-07-09Completed
The Effect of Montelukast Versus Co Enzyme Q10 on the Clinical Outcome of Patients With Sepsis [NCT05293132]Phase 2/Phase 390 participants (Actual)Interventional2022-02-01Completed
Randomised, Open-label, Parallel-group Study of Therapeutic Effect of Leukotriene Modulator Montelukast Alone or Combined With Inhaled Corticosteroid on Cough Variant Asthma [NCT01404013]Phase 499 participants (Anticipated)Interventional2012-02-29Recruiting
A 12 Week, Multi-center,Randomized, Double Blinded, Parallel Group, Placebo-controlled, 4-arm, Dose Finding Trial to Assess the Efficacy and Safety of SOTB07 in Persistent Asthma [NCT00936624]Phase 2245 participants (Actual)Interventional2009-07-31Completed
A Double Blind, Randomized, Crossover Study to Compare the Effectiveness of Montelukast on Atopic Dermatitis in Koreans [NCT00903357]54 participants (Actual)Interventional2009-08-31Completed
Efficacy and Safety of Combination Loratadine/Montelukast QD vs Pseudoephedrine and Placebo in the Treatment of Subjects With Seasonal Allergic Rhinitis [NCT00319995]Phase 31,095 participants (Actual)Interventional2006-03-01Completed
A Randomized, Open Labeled Comparative Study to Assess the Efficacy and Safety of Controller Medications as Add on to Inhaled Steroid and Long Acting β2 Agonist in Treatment of Moderate to Severe Persistent Bronchial Asthma [NCT01055041]50 participants (Actual)Interventional2008-12-31Completed
The Effect of Montelukast Therapy on Respiratory Symptoms, Lung Function and Airway Responsiveness in Wheezy Very Young Children [NCT00934713]Phase 4112 participants (Actual)Interventional2004-09-30Completed
Multi-Institutional Prospective Phase II Study of Montelukast for the Treatment of Bronchiolitis Obliterans Following Allogeneic or Autologous Stem Cell Transplantation in Children and Adults [NCT00656058]Phase 225 participants (Actual)Interventional2008-06-17Completed
Prospective, Randomized, Double-blind, Study to Evaluate the Eosinophils Activation Parameters and Phagocyte Function in Patients With Persistent Asthma Treated With Montelukast [NCT00770900]Phase 483 participants (Actual)Interventional2008-09-30Completed
A Double-Blind, Placebo-Controlled, Multicenter, Crossover Study to Evaluate the Effects of a Single Oral Dose of Montelukast, Compared With Placebo, on Exercise-Induced Bronchoconstriction (EIB) in Pediatric Patients Aged 4 to 14 Years [NCT00534976]Phase 4364 participants (Actual)Interventional2008-02-29Completed
Comparison of Efficacy, Safety and Cost Effectiveness of Montelukast and Levocetirizine Versus Montelukast and Fexofenadine in Patients of Allergic Rhinitis: a Randomized, Double-blind Clinical Trial [NCT02551536]Phase 470 participants (Actual)Interventional2014-04-30Completed
A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Bronchodilatory Effect of MK0476 in Patients With Chronic Asthma [NCT00739297]Phase 168 participants (Actual)Interventional2008-07-31Completed
A Randomized, Open-label, Three-period, Three-sequence, Crossover, Single-dose Bioequivalence Study of Montelukast Sodium Oral Thin Films in Healthy Chinese Volunteers Under Fasted Condition [NCT05528198]30 participants (Actual)Interventional2018-12-28Completed
A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD Versus Montelukast 10mg QD in Adolescent and Adult Subjects With Asth [NCT00296491]Phase 4725 participants (Actual)Interventional2005-09-30Completed
An Open Label, Randomized, Two-Period, Two-Treatment, Crossover, Single-Dose Bioequivalence Study of Montelukast Sodium Chewable Tablets 5mg [Test Formulation, Torrent Pharmaceutical Limited., India] Versus Singulair® (Montelukast Sodium) Chewable Tablets [NCT01931514]Phase 10 participants InterventionalCompleted
Usefulness of Exhaled Breath Condensate and FENO for Evaluation of Markers of Airway Inflammation in Children With Asthma [NCT00961155]Phase 2200 participants (Anticipated)Interventional2009-08-31Recruiting
Effect of Montelukast on Metalloproteinase (MMP)-9, MMP-12, Tissue Inhibitor Metalloproteinase-1 (TIMP-1), Procollagen Type I C-terminal Peptide (PICP) and TGF-beta1 Levels in Sputum From Mild Intermittent Asthmatic Children: a Pilot Study [NCT00875082]Phase 430 participants (Actual)Interventional2010-02-28Completed
The Evaluation of Singulair for the Treatment of Non-Allergic Rhinitis Eosinophil Syndrome (NARES) [NCT00406094]Phase 46 participants (Anticipated)Interventional2006-11-30Recruiting
Childhood Asthma Research and Education (CARE) Network Trial - Best Add-On Therapy Giving Effective Response (BADGER) [NCT00395304]Phase 3182 participants (Actual)Interventional2007-03-31Completed
Clinical Evaluation of Montelukast on Cognitive and Mood Dysfunction and Neuroinflammation in Veterans With Gulf War Illness (GWI) [NCT05992311]Phase 180 participants (Anticipated)Interventional2024-02-01Not yet recruiting
Role of the Arachidonate 5-Lipoxygenase Pathway in Coronary Heart Disease [NCT00379808]22 participants (Actual)Interventional2006-07-31Completed
The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial [NCT00156819]Phase 4500 participants (Actual)Interventional2003-06-30Completed
A Multicenter, Randomized, Double-Blind, Parallel-Group 6-Month Study to Evaluate the Efficacy and Safety of Oral Montelukast Sodium, Fluticasone Propionate and Placebo in Patients With Chronic Asthma Who Smoke Cigarettes [NCT00284856]Phase 31,640 participants (Actual)Interventional2006-05-31Completed
Double-blind, Three Parallel Randomized Groups, Therapeutic Confirmatory Clinical Trial to Compare the Efficacy of Oral Levocetirizine 5 mg and Montelukast 10 mg to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Ragweed Sensitive Subj [NCT00295022]Phase 4418 participants (Actual)Interventional2006-07-29Completed
An Open Label, Randomized, Two-Period, Two-Treatment, Crossover, Single-Dose Bioequivalence Study of Montelukast Sodium Chewable Tablets 5mg [Test Formulation, Torrent Pharmaceutical Limited., India] Versus Singulair® (Montelukast Sodium) Chewable Tablets [NCT01931501]Phase 10 participants InterventionalCompleted
Randomized Placebo-controlled Trial of Montelukast in Modulating Exacerbations of Asthma in Children, September 2005 [NCT00196547]Phase 4200 participants Interventional2005-09-30Completed
Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Study With Single Dosage of Two Oral Preparations Containing Montelukast 10 mg (Product of GlaxoSmithKline México, S.A. de C.V. vs. Singulair, Merck Sharp & Dohme de México, S.A. de [NCT01943942]Phase 132 participants (Actual)Interventional2010-05-16Completed
Montelukast as a Controller of Atopic Syndrome [NCT00559546]Phase 461 participants (Actual)Interventional2007-03-31Completed
Establishing the Collaborative Care Model of Traditional Chinse Medicine and Western Medicine for Allergic Rhinitis With Obstructive Sleep Apnea From Prevention to Treatment. [NCT04621513]60 participants (Anticipated)Interventional2020-07-29Recruiting
Montelukast for Children With Chronic Otitis Media With Effusion (COME): A Double-blind, Placebo-controlled Study [NCT01967498]52 participants (Anticipated)Interventional2013-11-30Not yet recruiting
The Effect Of SRP With Adjunctive Systemic Therapy Of Leukotriene Receptor Antagonist-Montelukast On The Serum C Reactive Protein Levels & Clinical Parameters In Chronic Periodontitis Patients - A Randomized Controlled Trial [NCT02014532]Phase 460 participants (Actual)Interventional2012-03-31Completed
Phase 2, Open-Label Randomized Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone vs Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma [NCT04268498]Phase 2306 participants (Anticipated)Interventional2020-02-11Recruiting
A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Compare the Safety and the Pharmacokinetic Characteristics of MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium) Tablet 10mg in Healthy Male Korean Subjects [NCT02029313]Phase 140 participants (Anticipated)Interventional2013-11-30Completed
A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Five-Treatment, Four 6-Week Period Cross-Over, Multi-Center Study to Evaluate the Effect of Adding GSK2190915 100mg, GSK2190915 300mg, Montelukast 10mg or Placebo Tablets Once Daily or Salmeter [NCT01156792]Phase 2162 participants (Actual)Interventional2010-09-30Completed
Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis [NCT04613180]Phase 4100 participants (Anticipated)Interventional2018-01-03Active, not recruiting
Effect Of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children Between 5-15 Years of Age - A Randomized, Double Blind, Placebo Controlled Trial [NCT00565955]Phase 3116 participants (Actual)Interventional2007-03-31Completed
A Randomised Double-Blind, Double-Dummy, Placebo-Controlled, Stratified, Parallel-Group, Multicentre, Dose Ranging Study to Evaluate the Efficacy and Safety of GSK2190915 Tablets Administered Once Daily, Fluticasone Propionate Inhalation Powder 100mcg Twi [NCT01147744]Phase 2700 participants (Actual)Interventional2010-06-28Completed
Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults [NCT01089647]Phase 334 participants (Actual)Interventional2010-09-30Completed
Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial [NCT01640535]Phase 3283 participants (Actual)Interventional2012-06-30Completed
A Randomized Double Blind Controlled Trial on the Effect of Treatment in Children With Obstructive Sleep Apnea Syndrome. [NCT00599534]Phase 20 participants (Actual)Interventional2007-12-31Withdrawn(stopped due to Principal Investigator has transferred to another Institution)
The Effects of Montelukast on Sputum Cells and Inflammatory Markers in Smokers With Asthma [NCT00712335]Phase 4105 participants (Actual)Interventional2007-02-28Completed
Dose Escalation Clinical Trial of High-dose Oral Montelukast to Inform Future RCT in Children With Acute Asthma Exacerbations [NCT05819541]Phase 290 participants (Anticipated)Interventional2023-11-01Recruiting
Airborne Ultrafine and Fine Particulate Matter: A Cause for Endothelial Dysfunction in Man? [NCT00814281]24 participants (Anticipated)Interventional2007-05-31Completed
A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in C [NCT00337675]Phase 31,771 participants (Actual)Interventional2006-10-31Completed
Time-Effect of Montelukast on Protection Against Exercise-Induced Bronchoconstriction [NCT00935415]Phase 469 participants (Actual)Interventional2007-01-31Completed
[NCT00536705]112 participants (Actual)Observational2009-01-31Completed
A Proof-of-concept Study to Evaluate the Benefit From add-on Therapy With Montelukast Versus Salmeterol in Children With Asthma Carrying the Arg/Arg-16 beta2-receptor Genotype [NCT00655616]64 participants (Actual)Interventional2007-08-31Completed
Asthma in the Elderly: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study of the Effect of Montelukast [NCT02635334]Phase 426 participants (Actual)Interventional2015-11-30Completed
A Study to Investigate Safety and Tolerability of Higher Infusion Rate to shORten the duraTion of FabrazymE Infusion [NCT06019728]Phase 418 participants (Anticipated)Interventional2023-11-10Recruiting
Prescribing Asthma Controller Medication According to Gene Status to Improve Quality of Life in Young People With Asthma [NCT02758873]241 participants (Actual)Interventional2016-02-29Completed
A Randomized, Double Blind, Placebo Controlled Trial of Daily Montelukast for the Treatment of Viral Bronchiolitis [NCT00863317]141 participants (Actual)Interventional2008-12-31Completed
Comparative Effects of Fish Oil Supplementation and a Leukotriene Receptor Antagonist on EIB and Airway Inflammation in Asthma [NCT00676468]Phase 120 participants (Actual)Interventional2008-09-30Completed
A Double Blind Randomised Placebo Controlled Trial of Montelukast in the Treatment of Acute Persistent Cough in Young People and Adults in Primary Care [NCT01279668]Phase 4276 participants (Actual)Interventional2011-05-31Active, not recruiting
A Randomised Controlled Open-Label Phase IV Mono Centre Study to Compare the Response Profiles of Montelukast Versus Fluticasone in Children With Pre-School Asthma [NCT00543686]Phase 2100 participants (Anticipated)Interventional2007-08-31Completed
Randomised, Double-blind, Double-dummy, Parallel-group, Comparative Study of Salmeterol/FP 50/100mcg bd Inhalation Powder Via Diskus With Oral Montelukast (5mg QD) Chewable Tablets in Children 6-14 Years [NCT00328718]Phase 3526 participants Interventional2005-10-31Completed
Could Leukotriene D4 Bronchial Provocation Test be a Clear Indicator for Predicting Therapeutic Outcomes of Leukotriene Receptor Antagonist A Pilot Study [NCT01414868]32 participants (Actual)Interventional2010-03-31Completed
Randomized, Double-blind, Placebo/Active-controlled, Multi-center Clinical Trial to Investigate the Safety/Tolerability and Efficacy of YHD001 Following 8 Weeks Oral Administration of YHD001 in Patients With Partially Controlled Asthma [NCT01424124]Phase 256 participants (Actual)Interventional2011-11-30Completed
Effects of GSK3640254 on the Single-Dose Pharmacokinetics of Probe Substrates (Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin) in Healthy Subjects [NCT04425902]Phase 120 participants (Actual)Interventional2020-12-16Completed
Does Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot Study [NCT01432080]Phase 212 participants (Actual)Interventional2011-09-30Terminated(stopped due to Not meeting recruitment targets)
Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus: A Randomized, Controlled Trial [NCT04075110]Early Phase 1100 participants (Actual)Interventional2019-07-01Completed
Fractional Concentration of Exhaled NO(FeNO) to Direct The Treatment of Sub-acute Cough:A Prospective, Open Label, Randomized and Placebo-Controlled Trial [NCT02655562]Phase 4200 participants (Anticipated)Interventional2016-04-30Suspended(stopped due to There are difficulties in recruiting patients)
Can Montelukast Shorten Corticosteroid Therapy In Children With Mild To Moderate Acute Asthma? [NCT00213252]Phase 2130 participants (Actual)Interventional2005-09-30Completed
Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Study With Single Dosage of Two Oral Preparations of Chewable Tablets of Montelukast 5 mg (Product of GlaxoSmithKline México, S.A. de C.V. vs. Singulair™, Merck Sharp & Dohme de Méxi [NCT01863654]Phase 132 participants (Actual)Interventional2010-05-16Completed
Bioequivalence Study of Montelukast Sodium Oral Thin Film and Chewable Tablet in Fed Healthy Volunteers [NCT05531994]30 participants (Actual)Interventional2018-11-27Completed
Effect of Pineapple Juice on the Pharmacokinetics of Celecoxib and Montelukast in Humans [NCT04374981]Phase 224 participants (Actual)Interventional2019-07-01Completed
A Four Year Observational Study Comparing Two Treatment Regimens: Inhaled Glucocorticosteroid + Salmeterol and Inhaled Glucocorticosteroid + Montelukast. [NCT01488773]132 participants (Actual)Observational1995-04-30Completed
Change of Airway Hyperresponsiveness to Mannitol and Methacholine During Intensified Anti-inflammatory Treatment in Patients With Asthma. [NCT01725360]Phase 417 participants (Actual)Interventional2007-01-31Completed
Open Label, Randomized, 6-sequence Crossover Study to Evaluate the Drug-drug Interaction Between Montelukast Sodium and Levocetirizine Dihydrochloride in Health Male Volunteers [NCT01491503]Phase 130 participants (Anticipated)Interventional2011-11-30Completed
[NCT00491790]Phase 2/Phase 352 participants (Anticipated)Interventional2006-12-31Recruiting
Pharmacokinetics of Montelukast in Very Low Birthweight (VLBW) Preterm Infants [NCT00492102]Phase 19 participants (Actual)Interventional2007-03-31Completed
A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Three-Treatment, Three 6-Week Period Cross-Over, Multi-Center Study to Evaluate the Effect of Adding GSK2190915 300mg as Compared to Adding Montelukast 10mg or Placebo Tablets QD to Fluticasone [NCT01248975]Phase 2145 participants (Actual)Interventional2010-12-31Completed
Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma - Randomized, Controlled Trial. [NCT00487773]Phase 496 participants (Actual)Interventional2007-09-30Completed
A Randomized Placebo-Controlled Trial of Montelukast in Maintenance Therapy of Asymptomatic Eosinophilic Esophagitis [NCT00511316]Phase 141 participants (Actual)Interventional2007-08-31Completed
A Double-Blind Placebo Controlled Randomized Trial of Montelukast in Acute Respiratory Syncytial Virus Bronchiolitis [NCT00524693]51 participants (Actual)Interventional2006-01-31Completed
Clinical Characteristics and Treatment of Chest Tightness Variant Asthma [NCT04322422]300 participants (Anticipated)Interventional2020-06-01Recruiting
Phase 3 Study of Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children [NCT00551382]Phase 3500 participants (Anticipated)Interventional2007-11-30Recruiting
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fed Conditions. [NCT01691469]Phase 131 participants (Actual)Interventional2011-01-31Completed
Short- and Long Term Growth in Children With Asthma Treated With Budesonide or Montelukast [NCT00380484]Phase 452 participants (Actual)Interventional2006-09-30Completed
Single Centre Allergen Challenge Study of GW274150 in Mild Asthmatic Subjects [NCT00273013]Phase 128 participants (Actual)Interventional2004-11-15Completed
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 10 mg Tablets Under Fasted Conditions [NCT01659931]Early Phase 134 participants (Actual)Interventional2008-02-29Completed
A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD Versus Montelukast 10mg QD in Adolescent and Adult Subjects With Asth [NCT00296530]Phase 4600 participants (Actual)Interventional2005-09-30Completed
ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications [NCT04885530]Phase 315,000 participants (Anticipated)Interventional2021-06-08Active, not recruiting
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone [NCT05457855]75,678 participants (Actual)Observational2022-02-01Active, not recruiting
Optimization of the Anti-Inflammatory Treatment of Asthma Patients Through Exhaled NO Measurements for Increased Asthma-Related Quality of Life in Primary Health Care (NOAK) [NCT00421018]187 participants (Actual)Interventional2006-11-30Completed
The Effect of Leukotriene Receptor Blockade on Endothelial Function in Acute Coronary Syndrome Patients [NCT00351364]Phase 440 participants (Actual)Interventional2006-07-31Terminated(stopped due to Diffic;ulty recruiting)
Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes [NCT00375232]0 participants (Actual)Interventional2006-10-31Withdrawn
A Randomised Double Blind, Placebo Controlled 4-way Cross Over Study Comparing Montelukast, Inhaled Budesonide and Their Combination on Exercise-induced Bronchoconstriction [NCT00462592]Phase 318 participants (Actual)Interventional2007-03-31Completed
Predicting the Bronchoprotective Response to a Leukotriene Modifier by Genetic Polymorphism [NCT00116324]Phase 3150 participants Interventional2003-04-30Completed
A Randomized, Double-Blind, Placebo- and Active-Controlled Crossover Study to Evaluate the Efficacy of JNJ 40929837 for the Treatment of Asthma Using a Bronchial Allergen Challenge Model [NCT01241422]Phase 222 participants (Actual)Interventional2010-11-30Completed
Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation Measured by Exhaled Nitric Oxide Concentration in Children With Seasonal Allergic Rhinitis [NCT00488176]Phase 4116 participants (Anticipated)Interventional2007-04-30Recruiting
A Randomized, Double-Blind Trial of the Effect of Different Anti-Asthmatic Treatments on Lung Function and on Exercise-Induced Bronchoconstriction in Children With Asthma [NCT00490243]Phase 4150 participants (Actual)Interventional2003-07-31Completed
Pharmacokinetics and Pharmacodynamics of Montelukast in Children, Ages 6 Through 18 Years Old, With Status Asthmaticus Unresponsive to Conventional Treatment [NCT00494572]Phase 2/Phase 352 participants (Anticipated)Interventional2006-12-31Recruiting
The Effect of Glucocorticosteroid and Vitamin D3 Administration and Montelukast Treatment on Early Clinical and Immunological Effect of Allergen-Specific Immunotherapy in Asthmatic Children, Double-Blind, Placebo-Controlled Study [NCT00504946]Phase 385 participants (Actual)Interventional2005-09-30Completed
A Pilot Study of Montelukast Sodium (Singulair) in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease [NCT00162864]Phase 3200 participants Interventional1999-12-31Completed
Phase 2, Single-Arm Study of Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma [NCT05896228]Phase 230 participants (Anticipated)Interventional2024-03-01Recruiting
Phase 4- The Role of Montelukast on Perennial Rhinitis and Associated Sleep Disturbance and Daytime Somnolence [NCT00590772]Phase 431 participants (Actual)Interventional2003-05-31Completed
A Randomized Double Blind Controlled Trial on the Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome [NCT01027806]Phase 464 participants (Actual)Interventional2010-07-31Terminated(stopped due to Poor accrual)
Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes [NCT05498116]Phase 450 participants (Anticipated)Interventional2023-01-26Recruiting
Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population [NCT01328964]9,906 participants (Actual)Observational2009-06-30Completed
Does Montelukast Decrease Post Adenotonsillectomy Pain in Children? A Randomized Controlled Trial [NCT02793375]Phase 3117 participants (Actual)Interventional2018-08-02Active, not recruiting
Airway Responses to Montelukast and Desloratadine. [NCT00424580]12 participants Interventional2007-01-31Completed
Prospective Single-centre, Double Blind Randomised Trial of Montelukast in Patients With Chronic Cough and Bronchial Hyperreactivity [NCT00453765]Phase 489 participants (Actual)Interventional2007-12-31Completed
Childhood Asthma Research and Education (CARE) Network Trial - Montelukast or Azithromycin for Reduction of Inhaled Corticosteroids in Childhood Asthma (MARS) [NCT00471809]Phase 4210 participants Interventional2006-03-31Terminated(stopped due to The CARE Network DSMB recommended to the NHLBI that the MARS trial be terminated, based on a futility analysis with 55 randomized children.)
Management of Asthma in School-age Children on Therapy [NCT01526161]Phase 4229 participants (Actual)Interventional2009-04-30Completed
A Double-blind, Placebo-controlled, Three-way Crossover Study to Compare the Safety and Efficacy of 8 Days of Therapy With ONO-6950 Versus Placebo and Montelukast (Singulair®) on Asthmatic Responses and Airway Hypersensitivity Following Allergen Challenge [NCT01551147]Phase 225 participants (Actual)Interventional2012-06-30Completed
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Crossover Study of MK-1029 in Adult Subjects With Persistent Asthma Who Remain Uncontrolled While Being Maintained on Montelukast [NCT01624974]Phase 2107 participants (Actual)Interventional2012-08-09Completed
A Multicenter, Open-Label, Randomized, Parallel Groups Study to Assess the Long-Term Safety Performance of Fexofenadine Compared to Montelukast in Subjects With Asthma [NCT00045955]Phase 31,200 participants (Anticipated)Interventional2002-02-28Completed
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 10 mg Tablets Under Fed Conditions [NCT01659918]Early Phase 135 participants (Actual)Interventional2008-02-29Completed
Trial of Asthma Patient Education (TAPE) [NCT00148408]Phase 4600 participants Interventional2003-12-31Completed
Montelukast in the Treatment of Duodenal Eosinophilia in Children With Dyspepsia: Effect on Eosinophil Density and Activation in Relation to Pharmacokinetics [NCT00148603]24 participants (Anticipated)Interventional2005-09-30Completed
Montelukast as an Alternative or Supplementary Treatment in ENL Reaction in Leprosy [NCT00406861]60 participants Interventional2006-12-31Not yet recruiting
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fed Conditions. [NCT01671722]Phase 143 participants (Actual)Interventional2010-02-28Completed
A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Study to Determine the Efficacy of Montelukast in the Treatment of Exacerbations in Asthmatic Patients Aged 2-to-5 Years [NCT00700661]Phase 3500 participants (Actual)Interventional2001-01-31Completed
The Assessment of Cysteinyl Leukotriene Receptor Antagonist Role in Inhibition of Atherosclerosis, Proliferation and Its Influence on Endothelial Function in Patients Undergoing Endovascular Treatment Due to Peripheral Arterial Disease. [NCT04277702]Phase 3200 participants (Anticipated)Interventional2020-05-31Not yet recruiting
A Single-centre, Open-label, Randomised, Crossover, Drug-drug Interaction Study in Healthy Men to Investigate the Effect of a Single Dose of ASP2151 on the Pharmacokinetics of Montelukast [NCT02321748]Phase 124 participants (Actual)Interventional2014-12-31Completed
Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis [NCT04561687]66 participants (Anticipated)Interventional2020-01-16Recruiting
Clinical Study Evaluating the Efficacy and Safety of Montelukast in the Treatment of Non-Alcoholic Steatohepatitis (NASH) [NCT04537780]Phase 444 participants (Actual)Interventional2019-08-20Completed
A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 µg, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - a 26-Week, Randomised, Open-Label, Parallel-Group, Mul [NCT00252863]Phase 31,600 participants Interventional2004-12-31Completed
Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing [NCT00299910]Phase 450 participants (Anticipated)Interventional2005-03-31Recruiting
"Pretreatment With Albuterol vs. Montelukast in Exercise Induced Bronchospasm in Children." [NCT00273689]Phase 413 participants (Actual)Interventional2005-12-31Completed
Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS) [NCT00319488]238 participants (Actual)Interventional2004-02-29Completed
A Single-center, Randomized, Double-blind, Two-cycle, Two-way Crossover Phase Ib Study to Evaluate the Efficacy and Safety of TQC3564 Tablets in the Treatment of Persistent Allergic Rhinitis [NCT05607446]Phase 124 participants (Anticipated)Interventional2022-09-14Recruiting
Bilastine and Montelukast in Patients With Seasonal Allergic Rhinoconjunctivitis and Asthma: Efficacy of Concomitant Administration - the SKY Study [NCT02761252]Phase 4454 participants (Actual)Interventional2016-04-13Completed
A Randomized Double-blind and Placebo-controlled Study to the Influence of Ramatroban/Montelukast Versus Montelukast/Placebo on the Early Allergic Reaction in Patients With Mild to Moderate Atopic Asthma (House Dust Mite) [NCT00311051]Phase 2/Phase 30 participants (Actual)Interventional2005-04-30Withdrawn
A Double-blind, Randomized, Cross-over Design Study to Compare the Lung Function Measure of Montelukast Versus Placebo in Children With Mild Persistent Asthma [NCT01581710]32 participants (Actual)Interventional2012-05-31Completed
Phase 4 Study of Effects of Montelukast Treatment on Allergic Inflammation in Children With and Without Food Allergy, Single Centered, Randomised, Double Blind, Placebo Controlled Parallel Group Cross-over Study [NCT01618929]Phase 4113 participants (Actual)Interventional2013-03-31Completed
A Study Comparing Measures of Ventilatory Heterogeneity (VH) in Asthma Patients [NCT01621386]Phase 134 participants (Actual)Interventional2013-01-31Completed
Open-label, Randomized, Single Dose Crossover Study to Evaluate the Pharmacokinetics and Safety of Singulair (10 mg) and Xyzal (5 mg) in Free Combination and Fixed-dose Combination as HCP1102 in Healthy Male Volunteers [NCT01651481]Phase 128 participants (Actual)Interventional2012-07-31Completed
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 5 mg Chewable Tablets Under Fed Conditions [NCT01659892]Early Phase 136 participants (Actual)Interventional2008-08-31Completed
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 5 mg Chewable Tablets Under Fasted Conditions [NCT01659905]Early Phase 135 participants (Actual)Interventional2008-08-31Completed
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fasting Conditions. [NCT01691456]Phase 145 participants (Actual)Interventional2011-01-31Completed
Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone [NCT01702701]Phase 30 participants (Actual)Interventional2012-01-31Withdrawn
The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia [NCT01717625]Phase 272 participants (Actual)Interventional2011-11-30Completed
The Effects of Alvokast (Montelukast) in Patients With Chronic Cough [NCT01754220]Phase 414 participants (Actual)Interventional2012-03-31Completed
A Prospective Analysis of the Use of Oral Montelukast in Children With Status Asthmaticus [NCT01770899]100 participants (Anticipated)Interventional2013-01-31Recruiting
A Randomized, Double-blind, Placebo-controlled Three-period Incomplete Cross Over Study to Compare the Efficacy of QAW039 Alone and in Combination With Montelukast in Patients With Allergic Rhinitis Using an Environmental Exposure Chamber [NCT01804400]Phase 2188 participants (Actual)Interventional2012-10-31Completed
A Study of the Effects of the Selective CysLT1 Antagonist Montelukast on Bronchoconstriction and Airway Inflammation Induced by Inhalation of Leukotriene E4 in Subjects With Asthma [NCT01841164]14 participants (Anticipated)Interventional2012-05-31Recruiting
A Multicenter, Double- Blind, Placebo- Controlled Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera® (Dimethyl Fumarate) Delayed Release Capsules [NCT02410278]Phase 4102 participants (Actual)Interventional2015-03-12Completed
Fluticasone Propionate, Azithromycin, and Montelukast Sodium in Treating Patients With Bronchiolitis Obliterans Who Previously Underwent Stem Cell Transplant [NCT01307462]Phase 236 participants (Actual)Interventional2011-06-30Completed
Study of Montelukast In ChiLdrEn With Sickle Cell Disease (SMILES) [NCT04351698]Phase 2/Phase 3200 participants (Anticipated)Interventional2023-10-16Recruiting
Montelukast for Postinfectious Cough in Adults [NCT02352545]Phase 2200 participants (Anticipated)Interventional2014-08-31Recruiting
A Randomized, Double-Blind, Placebo-Controlled, Cross-over Study to Evaluate the Effect of the Leukotriene Antagonist (Singulair©) Plus Moderate Dose Beclomethasone Compared to High Dose Beclomethasone in Obese Subjects With Moderate Persistent Asthma [NCT01016847]Phase 438 participants (Actual)Interventional2010-01-31Terminated(stopped due to Unable to enroll enough study subjects. Study has been terminated)
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fasting Conditions. [NCT01674504]Phase 163 participants (Actual)Interventional2010-01-31Completed
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fasting Conditions. [NCT01671709]Phase 141 participants (Actual)Interventional2010-02-28Completed
A Double-blind, Placebo-controlled, Four-way Crossover Study to Compare the Safety and Efficacy of ONO-6950 20 mg and 200 mg QD Versus Placebo and Montelukast (Singulair) in Asthmatic Patients Who Experience Exercise-induced Bronchoconstriction [NCT01536041]Phase 259 participants (Actual)Interventional2012-03-31Completed
A 3 Period, Double-Blind, Randomized Crossover Study to Evaluate the Effects of a Single Dose of Montelukast Compared With Placebo on Exercise-Induced Bronchoconstriction as Assessed by Hyperpolarized Gas Magnetic Resonance Imaging. [NCT00664937]Phase 124 participants (Actual)Interventional2007-05-31Completed
An Open Label, Randomised, 2-Period, 2-Treatment, 2-Sequence, Crossover, Single-Dose Bioequivalence Study of Montelukast Sodium 10mg Tablet (Test, Torrent Pharmaceuticals Ltd., India) Versus Singulair® (Montelukast Sodium) 10 mg Tablet (Reference, Merck & [NCT01928069]Phase 10 participants InterventionalCompleted
A Pilot Study to Evaluate the Potential of Montelukast to Prevent the Development of Nasal Symptomatology During Natural Viral Upper Respiratory Infections [NCT00189475]Phase 484 participants (Actual)Interventional2003-10-31Completed
Effects of Montelukast on Early Life Wheezing [NCT00115297]Phase 2/Phase 362 participants (Actual)Interventional2004-09-30Completed
Effect of Montelukast in Preventing Dengue With Warning Signs in Dengue Patients: a Multicenter Randomized, Double-blind, Placebo Controlled, Superiority Trial [NCT04673422]Phase 2/Phase 3358 participants (Actual)Interventional2021-01-15Completed
Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age [NCT04957927]Phase 460 participants (Anticipated)Interventional2020-12-12Recruiting
Randomized Controlled Trial of Oral Montelukast Added to Standard Therapy for Acute Asthma Exacerbations in Children Age 6 to 14 Years [NCT00353184]27 participants (Actual)Interventional2001-09-30Terminated(stopped due to Results of the interim analysis suggested no significant diff between study groups.)
Using Montelukast to Treat the Patients Infected With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) [NCT04714515]150 participants (Actual)Observational2020-02-20Completed
Medical vs Surgical Treatment Decision in Pediatric Obstructive Sleep Apnea Using Sleep Questionnaire [NCT05651750]Phase 490 participants (Anticipated)Interventional2022-11-15Recruiting
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of Once-daily Inhaled Fluticasone Furoate Inhalation Powder for Six Weeks on the Hypothalamic-pituitary-adrenocortical Axis of Children Aged 5-11 Years With Asthma [NCT02483975]Phase 3111 participants (Actual)Interventional2015-10-09Completed
Influence of Autoinhibition/Autoinduction and CYP2B6 Genetic Variations on CYP2B6 Activity and Drug Interactions in Healthy Volunteers [NCT02401256]Phase 470 participants (Actual)Interventional2013-07-31Completed
Individualized Therapy For Asthma in Toddlers [NCT01606306]Phase 3300 participants (Actual)Interventional2013-02-28Completed
Value of Montelukast as a Potential Treatment of Post COVID-19 Persistent Cough: A Randomized Controlled Pilot Study [NCT05447039]64 participants (Actual)Interventional2020-09-01Completed
An Open-Label, Phase 2 Study to Evaluate the Activity of Belumosudil in Subjects With New Onset and Incipient Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Cell Transplantation [NCT05922761]Phase 245 participants (Anticipated)Interventional2023-12-31Not yet recruiting
A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab (SAR650984) in Patients Awaiting Kidney Transplantation [NCT04294459]Phase 1/Phase 223 participants (Actual)Interventional2020-06-18Terminated(stopped due to Terminated due to non-safety reasons)
Early Detection and Management of Bronchiolitis Obliterans Syndrome Following Pediatric Hematopoietic Stem Cell Transplantation [NCT03072849]40 participants (Anticipated)Observational2015-04-30Recruiting
A Phase-II, Randomized, Placebo-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Safety of MK-1029 in Adult Subjects With Persistent Asthma That is Uncontrolled While Receiving Montelukast. [NCT02720081]Phase 2142 participants (Actual)Interventional2016-05-11Completed
[NCT02505113]150 participants (Anticipated)Observational2010-10-31Recruiting
Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease [NCT04815187]Phase 440 participants (Anticipated)Interventional2021-03-31Recruiting
Role of Montelukast in Preventing Relapse in Childhood Idiopathic Nephrotic Syndrome [NCT04818723]106 participants (Actual)Interventional2019-02-01Completed
Repurposing Montelukast for the Attenuation and Prophylaxis of Severe COVID-19 Symptoms: The COvid-19 Symptom MOntelukast (COSMO) Trial [NCT04389411]Phase 2/Phase 3250 participants (Anticipated)Interventional2022-11-01Not yet recruiting
A Randomized, Open Label, Cross-Over Study Comparing Effectiveness for the Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics [NCT00157937]Phase 431 participants (Actual)Interventional2003-02-28Completed
ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications [NCT05894577]Phase 31,403 participants (Actual)Interventional2023-01-27Active, not recruiting
A Phase 2, Randomized, Double-Blind, 4-week Crossover Trial to Investigate the Effect of a Once-Daily Combination of 500 µg Roflumilast Plus 10 mg Montelukast vs 10 mg Montelukast Alone on Pulmonary Function, Asthma Symptoms, and Inflammatory Markers in S [NCT01765192]Phase 264 participants (Actual)Interventional2013-02-28Completed
An Open Label, Randomised, 2-Period, 2-Treatment, 2-Sequence, Crossover, Single-Dose Bioequivalence Study of Montelukast Sodium 10 mg Tablet (Test, Torrent Pharmaceuticals Ltd., India) Versus Singulair® (Montelukast Sodium) 10 mg Tablet (Reference, Merck [NCT01928056]Phase 10 participants InterventionalCompleted
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Adaptive-Design, Dose-Ranging Study of MK-1029 in Adult Subjects With Persistent Asthma [NCT01656395]Phase 2576 participants (Actual)Interventional2012-08-23Terminated
Quality of Life in Asthma and Rhinitis Allergic With Singulair [NCT00380705]Phase 491 participants (Anticipated)Interventional2005-03-18Completed
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Montelukast (Singulair) in Participants Ages 1 - 8 Years Diagnosed With Atopic Dermatitis Induced by Food Allergens [NCT00557284]Phase 420 participants (Actual)Interventional2008-03-31Completed
MK0476 Phase III Long-term Study -Perennial Allergic Rhinitis- [NCT00771160]Phase 3120 participants (Actual)Interventional2004-09-30Completed
A Randomized Open-Label Comparative Study of Montelukast Versus Theophylline Added to Inhaled Corticosteroid in Pediatric Patients With Bronchial Asthma [NCT00756418]Phase 484 participants (Actual)Interventional2003-06-01Completed
An 8 Week Multicenter, Open-label, Observational Study to Evaluate the Effectiveness of Adding Montelukast Sodium 10 mg Per Day to Inhaled Corticosteroids in Adult Subjects With Uncontrolled Asthma [NCT00755794]Phase 3800 participants (Actual)Interventional2006-06-30Completed
A Double-Blind, Randomized, Double-Dummy, Multicenter Study to Evaluate and Compare Oral Montelukast and Inhaled Fluticasone in the Control of Asthma for 6- to 14-Year-Olds With Mild Persistent Asthma [NCT00489346]Phase 3994 participants (Actual)Interventional2001-10-31Completed
SAPS:Smoking Asthmatics Pilot Study: [NCT01696214]Phase 420 participants (Actual)Interventional2012-10-31Completed
Montelukast for Prevention & Treatment of Ovarian Hyperstimulation Syndrome in Freeze-all Cycles [NCT03794037]Phase 220 participants (Anticipated)Interventional2018-12-05Suspended(stopped due to no fund)
A Sequential, 3-Part, Double-Blind, Randomized, Placebo-Controlled, Single-Rising-Dose and Rising-Multiple-Dose Study in Healthy Subjects and Mild or Moderate Asthmatic Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled MK-0476 [NCT00636207]Phase 146 participants (Actual)Interventional2007-08-31Completed
Clinical Study to Investigate the Possible Efficacy and Safety of Montleukast in Parkinson Disease [NCT06113640]Phase 2/Phase 360 participants (Anticipated)Interventional2023-11-05Recruiting
Double Blind Study of Leukotriene Antagonism in the Nasal Recruitment of CD49d Expressing Neutrophils in Atopic Subjects [NCT03039101]25 participants (Actual)Interventional2017-09-06Completed
A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray Versus Montelukast in Adolescents/Adults With Asthma and Seasonal Allergic Rhin [NCT00385463]0 participants (Actual)Interventional2006-04-30Withdrawn
A Phase III, Open-Label Clinical Trial to Study the Safety and Pharmacokinetics of MK-0476 in Japanese Pediatric Subjects Aged 1 to 15 Years Old With Perennial Allergic Rhinitis [NCT01852812]Phase 387 participants (Actual)Interventional2013-06-07Completed
Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps. [NCT05143502]Phase 1/Phase 260 participants (Anticipated)Interventional2022-01-01Active, not recruiting
MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial) [NCT04572256]Early Phase 130 participants (Anticipated)Interventional2021-02-01Recruiting
Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Montelukast From Asmakast 5mg Chewable Tab.(Sandoz, Egypt) & Singulair 5mg Chewable Tab.(Merck) to Healthy Adult Volunteers Conditions. [NCT02479854]Phase 124 participants (Actual)Interventional2014-04-30Completed
The Utility of feNO in the Differential Diagnosis of Chronic Cough: The Response to Anti-inflammatory Therapy With Prednisolone and Montelukast [NCT02479074]Phase 449 participants (Actual)Interventional2016-01-31Completed
Clinical Study Evaluating the Efficacy and Safety of Adjunctive Use of Montelukast in Rheumatoid Arthritis Patients [NCT05447520]Phase 250 participants (Anticipated)Interventional2022-07-15Recruiting
Effects of BMS-986142 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates Montelukast (CYP2C8), Flurbiprofen (CYP2C9), Midazolam (CYP3A4), Digoxin (P-gp), and Pravastatin (OATP1B1) in Healthy Subjects [NCT02456844]Phase 124 participants (Actual)Interventional2015-05-31Completed
Role of Montelukast in Asthma and Allergic Rhinitis Patients [NCT03380975]Phase 4600 participants (Actual)Interventional2018-08-28Completed
An Open-label, Randomised, Single Dose, Three-Way Crossover, Six Sequence, Pilot Study to Determine the Relative Bioavailability of Montelukast Sodium 5mg From Two Candidate Chewable Tablet Formulations of GW483100 Relative to One 5mg Chewable Tablet of R [NCT02322671]Phase 118 participants (Actual)Interventional2015-02-23Completed
A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children [NCT01458418]4 participants (Actual)Interventional2011-12-31Terminated(stopped due to Inability to complete enrollment due to difficulty in finding subjects)
A Phase III Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Prospectively Evaluate Efficacy of Montelukast in Patients Aged 6 Months to 5 Years With Chronic Asthma [NCT00540839]Phase 30 participants (Actual)Interventional2007-11-30Withdrawn(stopped due to Based on input from regulatory agencies, it is not necessary to conduct this study. An ongoing study was sufficient for regulatory purposes.)
A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Patients With Acute Asthma [NCT00092989]Phase 3650 participants (Actual)Interventional2004-07-31Completed
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fed Conditions. [NCT01674517]Phase 135 participants (Actual)Interventional2010-02-28Completed
A Phase III, Double-Blind, Randomized, Placebo-Controlled Cross-over Clinical Trial to Study the Efficacy and Safety of MK-0476 in Japanese Pediatric Subjects With Seasonal Allergic Rhinitis [NCT01857063]Phase 3220 participants (Actual)Interventional2013-06-10Completed
Safety and Efficacy of Montelukast + Loratadine vs. Montelukast for the Control of Mild to Moderate Persistent Asthma in Children: Randomized Controlled Clinical Trial [NCT03372473]Phase 380 participants (Actual)Interventional2016-01-10Completed
A Randomized, Open Label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of HCP1102 in Comparison to HGP0813 and HGP1408 Administered in Healthy Male Volunteers [NCT03371849]Phase 124 participants (Actual)Interventional2017-07-19Completed
Phase 4 Study of Oral Montelukast Hospitalized Preschool Children [NCT03369119]Phase 4100 participants (Actual)Interventional2011-08-31Completed
TEAM (Trial on Efficacy and Quality of Life Among Asthmatic Patient With Montelukast) [NCT03096327]Phase 4180 participants (Actual)Interventional2017-05-01Completed
Population Pharmacokinetics of Montelukast in Infants and Children [NCT03238560]100 participants (Anticipated)Observational2016-10-01Recruiting
Phase 2 Study of Montelukast for the Treatment of Sickle Cell Anemia (Also Known as the Montelukast Trial in Sickle Cell Anemia) [NCT01960413]Phase 246 participants (Actual)Interventional2013-11-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00090142 (12) [back to overview]Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose
NCT00090142 (12) [back to overview]Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose
NCT00090142 (12) [back to overview]Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 12 Hours Postdose
NCT00090142 (12) [back to overview]Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose
NCT00090142 (12) [back to overview]Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose
NCT00090142 (12) [back to overview]Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB
NCT00090142 (12) [back to overview]Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Post-dose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)
NCT00090142 (12) [back to overview]Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB
NCT00090142 (12) [back to overview]Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose
NCT00090142 (12) [back to overview]Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose
NCT00090142 (12) [back to overview]Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose
NCT00090142 (12) [back to overview]Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose
NCT00092118 (3) [back to overview]Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period
NCT00092118 (3) [back to overview]Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis
NCT00092118 (3) [back to overview]Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period
NCT00092131 (12) [back to overview]Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)
NCT00092131 (12) [back to overview]Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose
NCT00092131 (12) [back to overview]Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose
NCT00092131 (12) [back to overview]Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose
NCT00092131 (12) [back to overview]Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 2 Hours Postdose
NCT00092131 (12) [back to overview]Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 12 Hours Postdose
NCT00092131 (12) [back to overview]Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)
NCT00092131 (12) [back to overview]Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose
NCT00092131 (12) [back to overview]Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose
NCT00092131 (12) [back to overview]Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose
NCT00092131 (12) [back to overview]Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose
NCT00092131 (12) [back to overview]Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)
NCT00115297 (3) [back to overview]Number of Wheezing-free Days of Infant (Observed by Primary Caregiver)
NCT00115297 (3) [back to overview]The Number of Participants Requiring Rescue Beta Agonist Use
NCT00115297 (3) [back to overview]Wheezing at Day 7
NCT00117338 (7) [back to overview]Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)
NCT00117338 (7) [back to overview]Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration
NCT00117338 (7) [back to overview]Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration
NCT00117338 (7) [back to overview]Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration
NCT00117338 (7) [back to overview]Change in FEV1 After 15 Minutes Following the End of Study Drug Administration
NCT00117338 (7) [back to overview]Change From Baseline in Modified Pulmonary Index [mPI] Score
NCT00117338 (7) [back to overview]Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration
NCT00119015 (5) [back to overview]Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period
NCT00119015 (5) [back to overview]Change From Baseline in Stuffy Nose Symptom Score Over 2 Week Randomized Treatment Period
NCT00119015 (5) [back to overview]Change From Baseline in Sneezing Symptom Score Over 2 Week Randomized Treatment Period
NCT00119015 (5) [back to overview]Change From Baseline in Runny Nose Symptom Score Over 2 Week Randomized Treatment Period
NCT00119015 (5) [back to overview]Change From Baseline in Other Symptom Score Over 2 Week Randomized Treatment Period
NCT00127166 (5) [back to overview]Maximum FEV1 % Predicted Following First Beta-agonist Use
NCT00127166 (5) [back to overview]Maximum Post-exercise Percent (%) Fall in FEV1
NCT00127166 (5) [back to overview]Time to Recovery to Within 5% of Baseline FEV1
NCT00127166 (5) [back to overview]Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))
NCT00127166 (5) [back to overview]Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use
NCT00156819 (1) [back to overview]Treatment Failure
NCT00189462 (1) [back to overview]Incidence of Acute Otitis Media
NCT00189475 (1) [back to overview]Nasal Secretion Weights
NCT00229970 (1) [back to overview]The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)
NCT00245570 (12) [back to overview]Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB
NCT00245570 (12) [back to overview]Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose
NCT00245570 (12) [back to overview]Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 24 Hours Postdose
NCT00245570 (12) [back to overview]Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 8.5 Hours Postdose
NCT00245570 (12) [back to overview]Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB
NCT00245570 (12) [back to overview]Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB)
NCT00245570 (12) [back to overview]Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose
NCT00245570 (12) [back to overview]Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose
NCT00245570 (12) [back to overview]Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose
NCT00245570 (12) [back to overview]Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose
NCT00245570 (12) [back to overview]Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose
NCT00245570 (12) [back to overview]Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose
NCT00284856 (3) [back to overview]Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period
NCT00284856 (3) [back to overview]Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period
NCT00284856 (3) [back to overview]Percentage of Asthma-control Days Over the 6-month Treatment Period
NCT00289874 (2) [back to overview]"Percent Change From Baseline in Mean Daily as Needed β-agonist Use Over the 3-week Treatment Period"
NCT00289874 (2) [back to overview]Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3
NCT00295022 (26) [back to overview]Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I
NCT00295022 (26) [back to overview]Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III)
NCT00295022 (26) [back to overview]Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II
NCT00295022 (26) [back to overview]Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III
NCT00295022 (26) [back to overview]Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III)
NCT00295022 (26) [back to overview]Change From Baseline in the TSC Score + Nasal Congestion Score Over Period I
NCT00295022 (26) [back to overview]Change From Baseline in the TSC Score + Nasal Congestion Score Over Period II
NCT00295022 (26) [back to overview]Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III
NCT00295022 (26) [back to overview]Global Satisfaction of the Subjects at the End of Period III
NCT00295022 (26) [back to overview]Onset of Action During Period I
NCT00295022 (26) [back to overview]Intensity of Action From Baseline in the MSC Score Over Period I
NCT00295022 (26) [back to overview]Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season
NCT00295022 (26) [back to overview]Time to First Feeling of Improvement During Period I
NCT00295022 (26) [back to overview]Change From Baseline in the Individual Symptom Scores Over Period I
NCT00295022 (26) [back to overview]Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I
NCT00295022 (26) [back to overview]Change From Baseline in the MSC Score Over Period II
NCT00295022 (26) [back to overview]Change From Baseline in the MSC Score Over Period III
NCT00295022 (26) [back to overview]Change From Baseline in the Individual Symptom Scores Over Period II
NCT00295022 (26) [back to overview]Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III)
NCT00295022 (26) [back to overview]Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III)
NCT00295022 (26) [back to overview]Variability of Action From Baseline in the MSC Score Over Period III
NCT00295022 (26) [back to overview]Variability of Action From Baseline in the MSC Score Over Period II
NCT00295022 (26) [back to overview]Variability of Action From Baseline in the MSC Score Over Period I
NCT00295022 (26) [back to overview]Intensity of Action From Baseline in the MSC Score Over Period III
NCT00295022 (26) [back to overview]Intensity of Action From Baseline in the MSC Score Over Period II
NCT00295022 (26) [back to overview]Change From Baseline in the Individual Symptom Scores Over Period III
NCT00296491 (10) [back to overview]Rhinitis: Mean Change From Baseline at 1-2 Weeks in Nightime Total Nasal Symptom Scores (N-TNSS)
NCT00296491 (10) [back to overview]Rhinitis: Mean Change From Baseline at 1-2 Weeks in Daytime Total Nasal Symptom Scores (D-TNNS).
NCT00296491 (10) [back to overview]Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population
NCT00296491 (10) [back to overview]Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population
NCT00296491 (10) [back to overview]Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Per Protocol Population
NCT00296491 (10) [back to overview]Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Intent-to-Treat Population
NCT00296491 (10) [back to overview]Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Per Protocol Population
NCT00296491 (10) [back to overview]Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol/Salbutamol-Free Days for Per Protocol Population
NCT00296491 (10) [back to overview]Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol-Salbutamol Free Days for Intent-to-Treat Population
NCT00296491 (10) [back to overview]Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Intent-to-Treat Population
NCT00337675 (3) [back to overview]Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes
NCT00337675 (3) [back to overview]Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode
NCT00337675 (3) [back to overview]Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period
NCT00359073 (3) [back to overview]Peak Viral Shedding
NCT00359073 (3) [back to overview]Sputum Eosinophil Count
NCT00359073 (3) [back to overview]Mean Asthma Symptom Score
NCT00379808 (6) [back to overview]Triglycerides
NCT00379808 (6) [back to overview]Interleukin 1 Receptor Antagonist (IL1ra)
NCT00379808 (6) [back to overview]High-sensitivity C-reactive Protein
NCT00379808 (6) [back to overview]High Density Lipoprotein (HDL)-Cholesterol
NCT00379808 (6) [back to overview]Epithelial Cell-derived Neutrophil-activating Peptide 78 (ENA-78)
NCT00379808 (6) [back to overview]Monocyte Chemotactic Protein-1 (MCP-1)
NCT00394355 (4) [back to overview]Summary of Change From Baseline to Endpoint in FEV1 (Forced Expiratory Volume in One Second).
NCT00394355 (4) [back to overview]Mean Percent Change in the Left Total Femur From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point
NCT00394355 (4) [back to overview]Mean Percent Change in the Femoral Neck BMD From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point
NCT00394355 (4) [back to overview]Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From the Averaged Baseline Value to the Endpoint of Treatment Time Point
NCT00395304 (14) [back to overview]Change From Baseline in the Post-bronchodilator FEV1 Percent Predicted
NCT00395304 (14) [back to overview]Change From Baseline in the Logarithm Base 2 of the Methacholine PC20
NCT00395304 (14) [back to overview]The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1.
NCT00395304 (14) [back to overview]Number of Participants With Asthma Exacerbations
NCT00395304 (14) [back to overview]Change From Baseline in the Pre-bronchodilator Forced Vital Capacity (FVC) % Predicted
NCT00395304 (14) [back to overview]Change From Baseline in the Natural Logarithm of Exhaled Nitric Oxide (eNO)
NCT00395304 (14) [back to overview]Change From Baseline in the Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) % Predicted
NCT00395304 (14) [back to overview]Change From Baseline in the Morning Peak Expiratory Flow Rate (PEFR) % Predicted
NCT00395304 (14) [back to overview]Change From Baseline in the Pre-bronchodilator FEV1/FVC Ratio
NCT00395304 (14) [back to overview]Change From Baseline in the Peak Expiratory Flow Rate (PEFR) Variability
NCT00395304 (14) [back to overview]Change From Baseline in the Impulse Oscillometry Resistance at 5 Hertz
NCT00395304 (14) [back to overview]Change From Baseline in the Evening Peak Expiratory Flow Rate (PEFR) % Predicted
NCT00395304 (14) [back to overview]Change From Baseline in the Asthma Control Test (ACT)
NCT00395304 (14) [back to overview]Change From Baseline in Asthma Quality of Life
NCT00442338 (1) [back to overview]Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration
NCT00442559 (2) [back to overview]Change From Baseline for Daytime Asthma Symptom Score
NCT00442559 (2) [back to overview]Change From Baseline for Daily Allergic Rhinitis Symptom Score
NCT00461032 (4) [back to overview]Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)
NCT00461032 (4) [back to overview]Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
NCT00461032 (4) [back to overview]Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
NCT00461032 (4) [back to overview]Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
NCT00534976 (8) [back to overview]Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 2 Hours Post-dose
NCT00534976 (8) [back to overview]Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 24 Hours Post-dose
NCT00534976 (8) [back to overview]Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose
NCT00534976 (8) [back to overview]Number of Participants Requiring Rescue Medication at 2 Hours Postdose
NCT00534976 (8) [back to overview]Number of Participants Requiring Rescue Medication at 24 Hours Postdose
NCT00534976 (8) [back to overview]Time to Recovery From Maximum Percent Fall in FEV1 at 2 Hours Post-dose
NCT00534976 (8) [back to overview]Time to Recovery From Maximum Percent Fall in FEV1 at 24 Hours Post-dose
NCT00534976 (8) [back to overview]Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose
NCT00545844 (6) [back to overview]The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score
NCT00545844 (6) [back to overview]Asthma Control
NCT00545844 (6) [back to overview]Patient Global Allergic Rhinitis Symptoms Assessment
NCT00545844 (6) [back to overview]Patient Global Satisfaction
NCT00545844 (6) [back to overview]Physician Global Satisfaction
NCT00545844 (6) [back to overview]Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ)
NCT00557284 (8) [back to overview]Mean Change in Pruritus
NCT00557284 (8) [back to overview]Mean Change in Serum IgE Levels
NCT00557284 (8) [back to overview]Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream
NCT00557284 (8) [back to overview]Mean Change in Serum and Urinary Inflammatory Marker Levels
NCT00557284 (8) [back to overview]Change in Percentage of Body Involvement
NCT00557284 (8) [back to overview]Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS
NCT00557284 (8) [back to overview]Mean Change in Investigator Global Assessment (IGA)
NCT00557284 (8) [back to overview]Mean Change in PADC (Caregivers Perception of Disease Control)
NCT00590772 (1) [back to overview]Change From Baseline in Fatigue and Daytime Sleepiness at 2 Weeks
NCT00636207 (12) [back to overview]Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose
NCT00636207 (12) [back to overview]Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose
NCT00636207 (12) [back to overview]Number of Participants Who Discontinued Study Drug Due to an Adverse Event
NCT00636207 (12) [back to overview]Number of Participants Who Experienced At Least One Adverse Event
NCT00636207 (12) [back to overview]Time to Cmax (Tmax) of Montelukast - Single Dose
NCT00636207 (12) [back to overview]AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses
NCT00636207 (12) [back to overview]AUC 0-24hr of Montelukast - Multiple Doses
NCT00636207 (12) [back to overview]Tmax of Montelukast - Multiple Doses
NCT00636207 (12) [back to overview]Cmax Accumulation Ratio of Montelukast - Multiple Doses
NCT00636207 (12) [back to overview]Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose
NCT00636207 (12) [back to overview]Cmax of Montelukast - Multiple Doses
NCT00636207 (12) [back to overview]t1/2 of Montelukast - Multiple Doses
NCT00656058 (6) [back to overview]Number of Participants With Stable or Improved Predicted Forced Expiratory Volume 1 (FEV-1) With Published Literature
NCT00656058 (6) [back to overview]Number of Participants With Improved, Stable or Declined Forced Expiratory Volume 1 (FEV-1) Slope at 6 Months
NCT00656058 (6) [back to overview]Number of Participants With Adverse Events
NCT00656058 (6) [back to overview]Number of Non-Infected Participants at Baseline With Cysteinyl Leukotriene Receptor Expression on Cluster of Differentiation (CD4) and CD8 T Cells, Granulocytes, and Eosinophils in Bronchoalveolar Lavage (BAL) Fluid
NCT00656058 (6) [back to overview]Forced Expiratory Volume 1 (FEV-1)/Vital Capacity (VC)
NCT00656058 (6) [back to overview]Percentage Overall 2-Year Survival
NCT00666679 (8) [back to overview]Change From Baseline in Daytime Asthma Symptom Score
NCT00666679 (8) [back to overview]Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)
NCT00666679 (8) [back to overview]Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) in Patients Who Met Lung Function Eligibility Criteria Specifically at the Randomization Visit.
NCT00666679 (8) [back to overview]Change From Baseline in Nighttime Asthma Symptom Score
NCT00666679 (8) [back to overview]Change From Baseline in Total Daily β-agonist Use
NCT00666679 (8) [back to overview]Change From Baseline in Total Peripheral Blood Eosinophils
NCT00666679 (8) [back to overview]Percentage of Days With Asthma Control
NCT00666679 (8) [back to overview]Percentage of Days With Asthma Exacerbations
NCT00712335 (7) [back to overview]Sputum RANTES Levels
NCT00712335 (7) [back to overview]Sputum Eosinophil Percentages
NCT00712335 (7) [back to overview]Sputum IL-8 Levels
NCT00712335 (7) [back to overview]Sputum Neutrophil Percentages
NCT00712335 (7) [back to overview]Sputum IFN-gamma/IL-5 Ratios
NCT00712335 (7) [back to overview]Sputum GM-CSF Levels
NCT00712335 (7) [back to overview]Sputum Eotaxin Levels
NCT00739297 (4) [back to overview]Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration
NCT00739297 (4) [back to overview]Change From Baseline in FEV1 Over 4 Hours
NCT00739297 (4) [back to overview]Change From Baseline in FEV1 at 8 Hours After Treatment With Montelukast
NCT00739297 (4) [back to overview]Change From Baseline in FEV1 at 24 Hours After Treatment With Montelukast
NCT00832455 (5) [back to overview]Physician Global Satisfaction
NCT00832455 (5) [back to overview]Patient Global Satisfaction
NCT00832455 (5) [back to overview]Asthma Control Questionnaire (ACQ)
NCT00832455 (5) [back to overview]Asthma Control Questionnaire (ACQ)
NCT00832455 (5) [back to overview]Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
NCT00863317 (1) [back to overview]Duration of Cough
NCT00903357 (3) [back to overview]Changes in SCORAD Index
NCT00903357 (3) [back to overview]Changes in Urinary EDN
NCT00903357 (3) [back to overview]Changes in Urinary LTE4
NCT00911547 (5) [back to overview]Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use
NCT00911547 (5) [back to overview]Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma
NCT00911547 (5) [back to overview]Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only
NCT00911547 (5) [back to overview]Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma
NCT00911547 (5) [back to overview]Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma
NCT00943397 (1) [back to overview]Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment
NCT00943683 (1) [back to overview]Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment
NCT00960141 (6) [back to overview]Patient's Global Evaluation of Allergic Rhinitis
NCT00960141 (6) [back to overview]Mean Change From Baseline in Daytime Eye Symptoms Score
NCT00960141 (6) [back to overview]Physician's Global Evaluation of Allergic Rhinitis
NCT00960141 (6) [back to overview]Mean Change From Baseline in Daytime Nasal Symptoms Score
NCT00960141 (6) [back to overview]Mean Change From Baseline in Nighttime Symptoms Score
NCT00960141 (6) [back to overview]Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score
NCT00963469 (7) [back to overview]Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment
NCT00963469 (7) [back to overview]Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period
NCT00963469 (7) [back to overview]Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment
NCT00963469 (7) [back to overview]Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period
NCT00963469 (7) [back to overview]Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period
NCT00963469 (7) [back to overview]Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period
NCT00963469 (7) [back to overview]Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period
NCT00963599 (12) [back to overview]Mean Change From Baseline in Nasal Congestion Upon Awakening
NCT00963599 (12) [back to overview]Mean Change From Baseline in Daytime Sneezing Score
NCT00963599 (12) [back to overview]Mean Change From Baseline in Daytime Rhinorrhea Score
NCT00963599 (12) [back to overview]Mean Change From Baseline in Daytime Nasal Symptoms Score
NCT00963599 (12) [back to overview]Mean Change From Baseline in Daytime Nasal Itching Score
NCT00963599 (12) [back to overview]Mean Change From Baseline in Daytime Nasal Congestion Score
NCT00963599 (12) [back to overview]Mean Change From Baseline in Daytime Eye Symptoms Score
NCT00963599 (12) [back to overview]Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)
NCT00963599 (12) [back to overview]Patient's Global Evaluation of Allergic Rhinitis
NCT00963599 (12) [back to overview]Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score
NCT00963599 (12) [back to overview]Mean Change From Baseline in Nighttime Symptoms Score
NCT00963599 (12) [back to overview]Physician's Global Evaluation of Allergic Rhinitis
NCT00968149 (8) [back to overview]Number of Patients Who Were Discontinued Due to LAEs
NCT00968149 (8) [back to overview]Number of Patients With Laboratory Adverse Experiences (LAEs)
NCT00968149 (8) [back to overview]Number of Patients With Drug-related LAEs
NCT00968149 (8) [back to overview]Number of Patients With Drug-related CAEs
NCT00968149 (8) [back to overview]Number of Patients With Clinical Adverse Experiences (CAEs)
NCT00968149 (8) [back to overview]Number of Patients Who Were Discontinued Due to CAEs
NCT00968149 (8) [back to overview]Number of Patients With Serious LAEs
NCT00968149 (8) [back to overview]Number of Patients With Serious CAEs
NCT00968201 (27) [back to overview]Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study
NCT00968201 (27) [back to overview]Number of Patients Who Were Discontinued Due to CAEs - Extension
NCT00968201 (27) [back to overview]Number of Patients Who Were Discontinued Due to CAEs - Base Study
NCT00968201 (27) [back to overview]Number of Patients Who Were Discontinued Due to LAEs - Extension
NCT00968201 (27) [back to overview]Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study
NCT00968201 (27) [back to overview]Number of Patients With Serious LAEs - Extension
NCT00968201 (27) [back to overview]Number of Patients Who Were Discontinued Due to Serious CAEs - Extension
NCT00968201 (27) [back to overview]Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension
NCT00968201 (27) [back to overview]Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study
NCT00968201 (27) [back to overview]Number of Patients Who Were Discontinued Due to Serious LAEs - Extension
NCT00968201 (27) [back to overview]Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension
NCT00968201 (27) [back to overview]Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension
NCT00968201 (27) [back to overview]Number of Patients With Drug-related CAEs Reported by Patients - Base Study
NCT00968201 (27) [back to overview]Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension
NCT00968201 (27) [back to overview]Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension
NCT00968201 (27) [back to overview]Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study
NCT00968201 (27) [back to overview]Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study
NCT00968201 (27) [back to overview]Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension
NCT00968201 (27) [back to overview]Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension
NCT00968201 (27) [back to overview]Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study
NCT00968201 (27) [back to overview]Number of Patients With Serious CAEs Reported by Patients - Extension
NCT00968201 (27) [back to overview]Number of Patients With Serious CAEs Reported by Patients - Base Study
NCT00968201 (27) [back to overview]Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension
NCT00968201 (27) [back to overview]Number of Patients Who Were Discontinued Due to LAEs - Base Study
NCT00968201 (27) [back to overview]Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension
NCT00968201 (27) [back to overview]Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study
NCT00968201 (27) [back to overview]Number of Patients With Drug-related CAEs Reported by Patients - Extension
NCT00972738 (6) [back to overview]Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period
NCT00972738 (6) [back to overview]Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period
NCT00972738 (6) [back to overview]Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period
NCT00972738 (6) [back to overview]Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period
NCT00972738 (6) [back to overview]Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period
NCT00972738 (6) [back to overview]Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period
NCT00974571 (5) [back to overview]Physician's Global Evaluation of Allergic Rhinitis
NCT00974571 (5) [back to overview]Patient's Global Evaluation of Allergic Rhinitis
NCT00974571 (5) [back to overview]Mean Change From Baseline in Nighttime Symptoms Score
NCT00974571 (5) [back to overview]Mean Change From Baseline in Composite Symptoms Score
NCT00974571 (5) [back to overview]Mean Change From Baseline in Daytime Nasal Symptoms Score
NCT00979901 (6) [back to overview]Patient's Global Evaluation of Allergic Rhinitis at Week 2
NCT00979901 (6) [back to overview]Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2
NCT00979901 (6) [back to overview]Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks
NCT00979901 (6) [back to overview]Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks
NCT00979901 (6) [back to overview]Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks
NCT00979901 (6) [back to overview]Physician's Global Evaluation of Allergic Rhinitis at Week 2
NCT01061333 (8) [back to overview]Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes
NCT01061333 (8) [back to overview]Change in Plasma 9P at 20 Minutes
NCT01061333 (8) [back to overview]Change in Forced Expiratory Volume in 1 Second (FEV1)
NCT01061333 (8) [back to overview]Allergen-induced Concentrations of Sputum LTE4
NCT01061333 (8) [back to overview]Allergen-induced Concentrations of Sputum LTD4
NCT01061333 (8) [back to overview]Allergen-induced Concentrations of Sputum LTC4
NCT01061333 (8) [back to overview]Allergen-induced Changes in Urinary Leukotriene (LT) E4
NCT01061333 (8) [back to overview]Allergen-induced Changes in Urinary 9P
NCT01089647 (1) [back to overview]Number of Participants With a Decrease in the Number of Apnea and/or Hypopnea Events to <5 Per Hour of Sleep
NCT01103349 (2) [back to overview]Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment
NCT01103349 (2) [back to overview]Asthma Control Questionnaire (ACQ) Mean Change in Score on a Scale From Baseline After Six Weeks of Treatment
NCT01147744 (12) [back to overview]Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period
NCT01147744 (12) [back to overview]Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period
NCT01147744 (12) [back to overview]Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period
NCT01147744 (12) [back to overview]Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period
NCT01147744 (12) [back to overview]Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period
NCT01147744 (12) [back to overview]Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period
NCT01147744 (12) [back to overview]Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1)
NCT01147744 (12) [back to overview]Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period
NCT01147744 (12) [back to overview]Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period
NCT01147744 (12) [back to overview]Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period
NCT01147744 (12) [back to overview]Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period
NCT01147744 (12) [back to overview]Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period
NCT01156792 (12) [back to overview]Percentage of Symptom-free Nights During the Last 3 Weeks of the 6 Week Treatment Period
NCT01156792 (12) [back to overview]Number of Participants Withdrawn Due to Lack of Efficacy During the Last 3 Weeks of the 6-week Treatment Period
NCT01156792 (12) [back to overview]Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period
NCT01156792 (12) [back to overview]Percentage of Nights Without Awakenings Due to Asthma During the Last 3 Weeks of the 6-week Treatment Period
NCT01156792 (12) [back to overview]Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period
NCT01156792 (12) [back to overview]Percentage of Rescue-free Days During the Last 3 Weeks of the 6-week Treatment Period
NCT01156792 (12) [back to overview]Percentage of Rescue-free Nights During the Last 3 Weeks of the 6-week Treatment Period
NCT01156792 (12) [back to overview]Percentage of Symptom-free Days During the Last 3 Weeks of the 6-week Treatment Period
NCT01156792 (12) [back to overview]Daily Rescue Short-acting beta2-agonist (SABA) Use Averaged Over the Last 3 Weeks of the 6-week Treatment Period
NCT01156792 (12) [back to overview]Daily Evening PEF Averaged Over the Last 3 Weeks of the 6-week Treatment Period
NCT01156792 (12) [back to overview]Daily Asthma Symptom Score Averaged Over the Last 3 Weeks of the 6-week Treatment Period
NCT01156792 (12) [back to overview]Daily (Average of Morning and Evening) PEF Averaged Over the Last 3 Weeks of the 6 -Week Treatment Period Between GSK2190915 and Montelukast Groups
NCT01307462 (9) [back to overview]Changes in Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)
NCT01307462 (9) [back to overview]Number of Subjects Who Experienced Grade 3-5 SAEs Attributable to FAM and Number of Subjects Who Stopped FAM as a Result
NCT01307462 (9) [back to overview]Number of Subjects Who Failed Treatment
NCT01307462 (9) [back to overview]Changes in Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)
NCT01307462 (9) [back to overview]Number of Subjects Were Able to Reduce Their Systemic Steroid Exposure by >=50%
NCT01307462 (9) [back to overview]Number of Subjects Who Experienced Statistically Significant Changes in FVC, TLC, RV, DLCO
NCT01307462 (9) [back to overview]Changes in Symptoms as Measured by Patient Self-report--Human Activities Profile (HAP)
NCT01307462 (9) [back to overview]Changes in Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale
NCT01307462 (9) [back to overview]Number of Subjects With Improvements in Other Chronic GVHD Characteristics
NCT01328964 (3) [back to overview]Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years
NCT01328964 (3) [back to overview]Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years
NCT01328964 (3) [back to overview]Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period
NCT01329939 (8) [back to overview]Serum Leptin Levels
NCT01329939 (8) [back to overview]Beclomethasone Equivalents
NCT01329939 (8) [back to overview]Urinary Leukotriene E4 (LTE4) Levels
NCT01329939 (8) [back to overview]Urinary Creatinine (Cr) Levels/Leukotriene E4 (LTE4) Ratio
NCT01329939 (8) [back to overview]Urinary Creatinine (Cr) Levels
NCT01329939 (8) [back to overview]Exhaled Nitric Oxide Measurement
NCT01329939 (8) [back to overview]Asthma Control Test (ACT) Scores
NCT01329939 (8) [back to overview]Spirometric Measures
NCT01458418 (1) [back to overview]Eosinophil Count
NCT01581710 (8) [back to overview]Baseline Lung Function of FEV1/FVC Before the Bronchodilator
NCT01581710 (8) [back to overview]Baseline Lung Function of FEV1 Before the Bronchodilator
NCT01581710 (8) [back to overview]Baseline Lung Function in MMEF
NCT01581710 (8) [back to overview]Relative Change (%) of FEV1 After the Bronchodilator
NCT01581710 (8) [back to overview]Baseline Lung Function of Xrs5 With IOS Before the Bronchodilator (Pre-Xrs 5)
NCT01581710 (8) [back to overview]Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5)
NCT01581710 (8) [back to overview]Baseline Lung Function of Xrs10 With IOS Before the Bronchodilator (Pre-Xrs10)
NCT01581710 (8) [back to overview]Baseline Lung Function of Rrs10 With IOS Before the Bronchodilator
NCT01606306 (1) [back to overview]Differential Response to the Three Therapies Based on Fixed Threshold Criteria for the Following Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations and Asthma Control Days.
NCT01624974 (9) [back to overview]Change From Baseline in Short-Acting Beta Agonist (SABA) Use at Week 4
NCT01624974 (9) [back to overview]Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 4
NCT01624974 (9) [back to overview]Adverse Events During Treatment and Follow-up
NCT01624974 (9) [back to overview]Change From Baseline in Daytime Symptom Score (DSS) at Week 4
NCT01624974 (9) [back to overview]Change From Baseline in Asthma Control Questionnaire (ACQ) Score at Week 4
NCT01624974 (9) [back to overview]Discontinuation of Treatment Due to An Adverse Event
NCT01624974 (9) [back to overview]Change From Baseline in Nocturnal Awakenings at Week 4
NCT01624974 (9) [back to overview]Change From Baseline in Morning (AM) Peak Expiratory Flow (PEF) at Week 4
NCT01624974 (9) [back to overview]Change From Baseline in Evening (PM) PEF at Week 4
NCT01656395 (13) [back to overview]Average Change From Baseline in Use of Short-Acting Beta-Agonists (SABAs)
NCT01656395 (13) [back to overview]Change From Baseline in Asthma Control Questionnaire (ACQ) Score
NCT01656395 (13) [back to overview]Percentage of Asthma Attack Days
NCT01656395 (13) [back to overview]Percentage of Asthma Exacerbation Days
NCT01656395 (13) [back to overview]Percentage of Participants Who Discontinue Study Due to AEs
NCT01656395 (13) [back to overview]Percentage of Participants Who Experience Adverse Events (AEs)
NCT01656395 (13) [back to overview]Percentage of Participants With a ≥0.5 Change From Baseline in ACQ Score
NCT01656395 (13) [back to overview]Percentage of Participants With a ≥0.5 Change From Baseline in AQLQ(S) Overall and Domain Scores
NCT01656395 (13) [back to overview]Average Change From Baseline in Daytime Symptom Score (DSS)
NCT01656395 (13) [back to overview]Change From Baseline in Asthma Quality of Life Questionnaire With Standardised Activities [AQLQ(S)] Overall and Domain Scores
NCT01656395 (13) [back to overview]Average Change From Baseline in Number of Nocturnal Awakenings
NCT01656395 (13) [back to overview]Average Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
NCT01656395 (13) [back to overview]Average Change From Baseline in Morning/Evening Peak Expiratory Flow (AM/PM PEF)
NCT01673620 (2) [back to overview]Number of Participants Discontinuing Study Treatment Due to AEs
NCT01673620 (2) [back to overview]Number of Participants Experiencing at Least One Adverse Event (AE)
NCT01696214 (3) [back to overview]Asthma Control Test
NCT01696214 (3) [back to overview]Percent (%) Perdicted FEV1 Changes
NCT01696214 (3) [back to overview]The Asthma Symptom Utility Index (ASUI)
NCT01765192 (7) [back to overview]Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Peak Expiratory Flow (PEF)
NCT01765192 (7) [back to overview]Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Vital Capacity (FVC)
NCT01765192 (7) [back to overview]Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
NCT01765192 (7) [back to overview]Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Expiratory Flow (FEF) 25-75%
NCT01765192 (7) [back to overview]Change From Baseline in Nighttime Asthma Symptoms
NCT01765192 (7) [back to overview]Change From Baseline in Morning Peak Expiratory Flow (PEF)
NCT01765192 (7) [back to overview]Change From Baseline in Daytime Asthma Symptoms
NCT01852812 (6) [back to overview]Apparent Elimination Half-life (t1/2) of Montelukast CT and Montelukast OG
NCT01852812 (6) [back to overview]Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG
NCT01852812 (6) [back to overview]Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG
NCT01852812 (6) [back to overview]Percentage of Participants Who Discontinue Study Drug Due to an AE
NCT01852812 (6) [back to overview]Percentage of Participants Who Experience at Least One Adverse Event (AE)
NCT01852812 (6) [back to overview]Time to Cmax (Tmax) of Montelukast CT and Montelukast OG
NCT01857063 (11) [back to overview]Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure
NCT01857063 (11) [back to overview]Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure
NCT01857063 (11) [back to overview]Change From Baseline in Sneezing Score Averaged During 3 Hours of Exposure
NCT01857063 (11) [back to overview]Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure
NCT01857063 (11) [back to overview]Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure
NCT01857063 (11) [back to overview]Percentage of Participants Who Experience at Least One Adverse Event
NCT01857063 (11) [back to overview]Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
NCT01857063 (11) [back to overview]Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
NCT01857063 (11) [back to overview]Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
NCT01857063 (11) [back to overview]Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
NCT01857063 (11) [back to overview]Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
NCT01960413 (1) [back to overview]Change in Soluble Vascular Cell Adhesion Molecule-1 (sVCAM)
NCT02321748 (17) [back to overview]Area Under the Curve (AUC) of Methyl Hydroxymontelukast
NCT02321748 (17) [back to overview]Area Under the Curve (AUC) of Montelukast
NCT02321748 (17) [back to overview]Half-Life (t1/2) of ASP2151
NCT02321748 (17) [back to overview]Half-Life (t1/2) of Methyl Hydroxymontelukast
NCT02321748 (17) [back to overview]Half-Life (t1/2) of Montelukast
NCT02321748 (17) [back to overview]Peak Plasma Concentration (Cmax) of ASP2151
NCT02321748 (17) [back to overview]Peak Plasma Concentration (Cmax) of Methyl Hydroxymontelukast
NCT02321748 (17) [back to overview]Peak Plasma Concentration (Cmax) of Montelukast
NCT02321748 (17) [back to overview]Time of Peak Concentration (Tmax) of ASP2151
NCT02321748 (17) [back to overview]Time of Peak Concentration (Tmax) of Methyl Hydroxymontelukast
NCT02321748 (17) [back to overview]Time of Peak Concentration (Tmax) of Montelukast
NCT02321748 (17) [back to overview]Number of Participants With Serious and Non-Serious Adverse Events
NCT02321748 (17) [back to overview]Apparent Volume of Distribution (Vd/f) of Montelukast
NCT02321748 (17) [back to overview]Apparent Total Body Clearance (CL/f) of ASP2151
NCT02321748 (17) [back to overview]Apparent Total Body Clearance (CL/f) of Montelukast
NCT02321748 (17) [back to overview]Apparent Volume of Distribution (Vd/f) of ASP2151
NCT02321748 (17) [back to overview]Area Under the Curve (AUC) of ASP2151
NCT02401256 (1) [back to overview]Efavirenz AUC0-inf (Single Dose) and AUC0-24(Multiple Dose)
NCT02410278 (10) [back to overview]Average Change From Baseline in GSRS Overall Score at Day 1 to Day 10
NCT02410278 (10) [back to overview]Percentage of Participants Who Discontinued DMF Therapy Due to GI-Related Adverse Events (AEs) From Day 0 to Week 10
NCT02410278 (10) [back to overview]Average Change From Baseline in GSRS Overall Score at Day 1 to Weeks 1 to 8
NCT02410278 (10) [back to overview]Percentage of Participants Who Experienced AEs Related to Flushing
NCT02410278 (10) [back to overview]Percentage of Participants Who Required GI Symptomatic Therapy During the Study
NCT02410278 (10) [back to overview]Percentage of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the GSRS From Day 0 to Day 10
NCT02410278 (10) [back to overview]Time to First Worsening From Baseline in GSRS Overall Score at Day 1 to Day 10
NCT02410278 (10) [back to overview]Time to Recovery to Baseline GSRS Score From Last Occurrence of Worst GSRS Score at Day 1 to Week 8
NCT02410278 (10) [back to overview]Average Change From Baseline in GSRS Overall Score at Day 0 to 72 Hours From the Initiation of Randomized Study Treatment
NCT02410278 (10) [back to overview]Average Change From Baseline in GSRS Overall Score at Day 1 to Week 10
NCT02483975 (5) [back to overview]Change From Baseline (Expressed as a Ratio) in 0-24 Hour Weighted Mean Serum Cortisol at the End of the Six Week Treatment Period (Day 42) in SC Population
NCT02483975 (5) [back to overview]Change From Baseline (Expressed as a Ratio) in 0-24 Hour Weighted Mean Serum Cortisol at the End of the Six Week Treatment Period (D 42) in Intention-to-treat (ITT) Population
NCT02483975 (5) [back to overview]Change From Baseline (Expressed as a Ratio) in 24-hour 6-beta Hydroxycortisol Excretion at the End of the Six Week Treatment Period (Day 42).
NCT02483975 (5) [back to overview]Change From Baseline (Expressed as a Ratio) in 24-hour Urinary Cortisol Excretion at the End of the Six Week Treatment Period (Day 42)
NCT02483975 (5) [back to overview]Change From Baseline (Expressed as a Ratio) in Area Under the Curve (AUC) 0-24 Hour Serum Cortisol at the End of the Six Week Treatment Period (Day 42).
NCT02720081 (26) [back to overview]Change From Baseline in Eosinophil (Percent [%]) at Week 6
NCT02720081 (26) [back to overview]Change From Baseline in Hematocrit (%) at Week 6
NCT02720081 (26) [back to overview]Change From Baseline in Diastolic Blood Pressure at Week 6
NCT02720081 (26) [back to overview]Change From Baseline in Diastolic Blood Pressure at Week 4
NCT02720081 (26) [back to overview]Change From Baseline in Diastolic Blood Pressure at Week 2
NCT02720081 (26) [back to overview]Change From Baseline in Heart Rate at Week 4
NCT02720081 (26) [back to overview]Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6
NCT02720081 (26) [back to overview]Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1)
NCT02720081 (26) [back to overview]Average Change From Baseline in Pre-dose FEV1 at Week 4 and Week 6
NCT02720081 (26) [back to overview]Change From Baseline in Alanine Aminotransferase (ALT) at Week 6
NCT02720081 (26) [back to overview]Percentage of Participants Who Experienced an Adverse Event (AE)
NCT02720081 (26) [back to overview]Change From Baseline in Neutrophil (%) at Week 6
NCT02720081 (26) [back to overview]Change From Baseline in Heart Rate at Week 6
NCT02720081 (26) [back to overview]Percentage of Participants Who Discontinued Study Drug Due to an AE
NCT02720081 (26) [back to overview]Change From Baseline in Heart Rate at Week 2
NCT02720081 (26) [back to overview]Change From Baseline in Bilirubin at Week 6
NCT02720081 (26) [back to overview]Change From Baseline in Aspartate Aminotransferase (AST) at Week 6
NCT02720081 (26) [back to overview]Change From Baseline in Alkaline Phosphatase (ALP) at Week 6
NCT02720081 (26) [back to overview]Change From Baseline in Platelet Count at Week 6
NCT02720081 (26) [back to overview]Change From Baseline in Respiratory Rate at Week 2
NCT02720081 (26) [back to overview]Change From Baseline in Respiratory Rate at Week 4
NCT02720081 (26) [back to overview]Change From Baseline in Respiratory Rate at Week 6
NCT02720081 (26) [back to overview]Change From Baseline in Systolic Blood Pressure at Week 2
NCT02720081 (26) [back to overview]Change From Baseline in Systolic Blood Pressure at Week 4
NCT02720081 (26) [back to overview]Change From Baseline in Systolic Blood Pressure at Week 6
NCT02720081 (26) [back to overview]Change From Baseline in White Blood Cell Count at Week 6
NCT02761252 (6) [back to overview]Change From Baseline With Montelukast+Bilastine Compared With Bilastine Monotherapy in SARC Symptoms
NCT02761252 (6) [back to overview]Change From Baseline With Montelukast+Bilastine Compared With Montelukast and Bilastine Monotherapies in Asthma Control
NCT02761252 (6) [back to overview]Change From Baseline With Montelukast+Bilastine Compared With Montelukast and Bilastine Monotherapies in SARC Symptoms (DNSS)
NCT02761252 (6) [back to overview]Usage of Relief Medication for Asthma
NCT02761252 (6) [back to overview]Usage of Relief Medication for SARC
NCT02761252 (6) [back to overview]Change From Baseline With Montelukast + Bilastine Compared With Montelukast and Bilastine Monotherapies in SARC Symptoms (DNNSS)
NCT02889809 (7) [back to overview]Number of Participants With On-treatment Asthma Exacerbations Over Double-blind Treatment Period
NCT02889809 (7) [back to overview]Growth Velocity Over the First 12 Weeks of Double-blind Treatment Period
NCT02889809 (7) [back to overview]Percentage of Participants Below the Third Percentile of Growth Velocity During Double-blind Treatment Period
NCT02889809 (7) [back to overview]Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT02889809 (7) [back to overview]Percentage of Participants With Change in Growth Velocity Quartiles From Baseline to Endpoint
NCT02889809 (7) [back to overview]Change in Height Standard Deviation Scores (SDS) From Baseline to Endpoint
NCT02889809 (7) [back to overview]Growth Velocity (Centimeter Per Year) Over the Double-blind Treatment Period, as Determined by Stadiometry
NCT04294459 (23) [back to overview]Number of Participants With Anti-Human Leukocyte Antigen (HLA)-Antibody Reduction
NCT04294459 (23) [back to overview]Number of Participants With Hematological Abnormalities
NCT04294459 (23) [back to overview]Number of Participants With Liver Function Abnormalities
NCT04294459 (23) [back to overview]Number of Participants With Renal Function Abnormalities
NCT04294459 (23) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)
NCT04294459 (23) [back to overview]PK Parameters: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 168 Hours Over the Dosing Interval (AUC0-168 Hours) After First Infusion of Isatuximab
NCT04294459 (23) [back to overview]Pharmacokinetics (PK) Parameters: Concentration Observed at the End of First Intravenous Infusion (Ceoi) of Isatuximab
NCT04294459 (23) [back to overview]Percentage of Participants With Response
NCT04294459 (23) [back to overview]Number of Participants With Graft Survival at 6 Months Post-Transplant
NCT04294459 (23) [back to overview]Number of Participants Achieving Target cPRA
NCT04294459 (23) [back to overview]Number of Kidney Transplant Offers
NCT04294459 (23) [back to overview]Duration of Response (DOR)
NCT04294459 (23) [back to overview]Duration for Achieving Target cPRA
NCT04294459 (23) [back to overview]Number of Participants With Anti-drug Antibodies (ADA) Against Isatuximab
NCT04294459 (23) [back to overview]PK Parameters: Last Concentration Observed Above the Lower Limit of Quantification (Clast) After the First Infusion of Isatuximab
NCT04294459 (23) [back to overview]PK Parameters: Maximum Concentration Observed (Cmax) After the First Infusion of Isatuximab
NCT04294459 (23) [back to overview]PK Parameters: Time of Clast (Tlast) After First Infusion of Isatuximab
NCT04294459 (23) [back to overview]PK Parameters: Time Taken to Reach Cmax (Tmax) After the First Infusion of Isatuximab
NCT04294459 (23) [back to overview]PK Parameters: Trough Plasma Concentrations (Ctrough) of Isatuximab
NCT04294459 (23) [back to overview]Time to First Transplant Offer
NCT04294459 (23) [back to overview]Time to Transplant
NCT04294459 (23) [back to overview]Number of Participants With Abnormal Electrolytes Parameters
NCT04294459 (23) [back to overview]Number of Participants With Abnormal Metabolism Parameters
NCT04425902 (171) [back to overview]Treatment C: Change From Baseline in Erythrocytes Mean Corpuscular Volume
NCT04425902 (171) [back to overview]Treatment C: Change From Baseline in Glucose, Carbon Dioxide, Cholesterol, Triglycerides, Anion Gap, Calcium, Chloride, Phosphate, Potassium, Sodium, Urea
NCT04425902 (171) [back to overview]Treatment C: Change From Baseline in Hematocrit
NCT04425902 (171) [back to overview]Treatment C: Change From Baseline in Hemoglobin
NCT04425902 (171) [back to overview]Treatment C: Change From Baseline in Oral Temperature
NCT04425902 (171) [back to overview]Treatment C: Change From Baseline in Platelet Count, Leukocyte Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
NCT04425902 (171) [back to overview]Treatment C: Change From Baseline in Pulse Rate
NCT04425902 (171) [back to overview]Treatment C: Change From Baseline in Respiratory Rate
NCT04425902 (171) [back to overview]Treatment C: Change From Baseline in SBP and DBP
NCT04425902 (171) [back to overview]Treatment C: Change From Baseline in Urate, Creatinine, Bilirubin, Direct Bilirubin
NCT04425902 (171) [back to overview]AUC(0-t) for 5-hydroxyomeprazole
NCT04425902 (171) [back to overview]AUC(0-t) for 36-hydroxymontelukast
NCT04425902 (171) [back to overview]AUC(0-t) for 1-hydroxymidazolam
NCT04425902 (171) [back to overview]AUC(0-infinity) for Pravastatin
NCT04425902 (171) [back to overview]AUC(0-infinity) for Omeprazole
NCT04425902 (171) [back to overview]AUC(0-infinity) for Montelukast
NCT04425902 (171) [back to overview]AUC(0-infinity) for Midazolam
NCT04425902 (171) [back to overview]AUC(0-infinity) for Metoprolol
NCT04425902 (171) [back to overview]AUC(0-infinity) for Flurbiprofen
NCT04425902 (171) [back to overview]AUC(0-infinity) for Digoxin
NCT04425902 (171) [back to overview]AUC(0-infinity) for Alpha-hydroxymetoprolol
NCT04425902 (171) [back to overview]AUC(0-infinity) for 5-hydroxyomeprazole
NCT04425902 (171) [back to overview]AUC(0-infinity) for 36-hydroxymontelukast
NCT04425902 (171) [back to overview]AUC(0-t) for Digoxin
NCT04425902 (171) [back to overview]AUC(0-t) for Flurbiprofen
NCT04425902 (171) [back to overview]AUC(0-t) for Metoprolol
NCT04425902 (171) [back to overview]AUC(0-infinity) for 1-hydroxymidazolam
NCT04425902 (171) [back to overview]AUC(0-t) for Midazolam
NCT04425902 (171) [back to overview]AUC(0-t) for Montelukast
NCT04425902 (171) [back to overview]AUC(0-t) for Omeprazole
NCT04425902 (171) [back to overview]AUC(0-t) for Pravastatin
NCT04425902 (171) [back to overview]Cmax for 1-hydroxymidazolam
NCT04425902 (171) [back to overview]Cmax for 36-hydroxymontelukast
NCT04425902 (171) [back to overview]Cmax for 5-hydroxyomeprazole
NCT04425902 (171) [back to overview]Cmax for Alpha-hydroxymetoprolol
NCT04425902 (171) [back to overview]Cmax for Digoxin
NCT04425902 (171) [back to overview]Cmax for Flurbiprofen
NCT04425902 (171) [back to overview]Cmax for Metoprolol
NCT04425902 (171) [back to overview]Cmax for Midazolam
NCT04425902 (171) [back to overview]AUC From Time Zero Extrapolated to Infinity (AUC[0-infinity]) for Caffeine
NCT04425902 (171) [back to overview]Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Time t (AUC[0-t]) for Caffeine
NCT04425902 (171) [back to overview]Apparent Terminal Phase Half-life (t1/2) for Caffeine
NCT04425902 (171) [back to overview]Cmax for Omeprazole
NCT04425902 (171) [back to overview]Cmax for Pravastatin
NCT04425902 (171) [back to overview]Maximum Observed Plasma Concentration (Cmax) for Caffeine
NCT04425902 (171) [back to overview]Ratio of AUC(0-infinity) of 1-hydroxymidazolam to Midazolam
NCT04425902 (171) [back to overview]Treatment B: Change From Baseline in Urate, Creatinine, Bilirubin, Direct Bilirubin
NCT04425902 (171) [back to overview]Ratio of AUC(0-infinity) of 5-hydroxyomeprazole to Omeprazole
NCT04425902 (171) [back to overview]Ratio of AUC(0-infinity) of Alpha-hydroxymetoprolol to Metoprolol
NCT04425902 (171) [back to overview]Ratio of Cmax of 1-hydroxymidazolam to Midazolam
NCT04425902 (171) [back to overview]Ratio of Cmax of 36-hydroxymontelukast to Montelukast
NCT04425902 (171) [back to overview]Ratio of Cmax of 5-hydroxyomeprazole to Omeprazole
NCT04425902 (171) [back to overview]Ratio of Cmax of Alpha-hydroxymetoprolol to Metoprolol
NCT04425902 (171) [back to overview]Treatment A: Change From Baseline in Albumin, Globulin, Protein
NCT04425902 (171) [back to overview]Treatment A: Change From Baseline in Amylase, Lipase
NCT04425902 (171) [back to overview]Treatment A: Change From Baseline in Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
NCT04425902 (171) [back to overview]Treatment A: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF
NCT04425902 (171) [back to overview]Treatment A: Change From Baseline in Glucose, Carbon Dioxide, Cholesterol, Triglycerides, Anion Gap, Calcium, Chloride, Phosphate, Potassium, Sodium, Urea
NCT04425902 (171) [back to overview]Treatment A: Change From Baseline in Platelet Count, Leukocyte Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
NCT04425902 (171) [back to overview]t1/2 for 1-hydroxymidazolam
NCT04425902 (171) [back to overview]Treatment A: Change From Baseline in SBP and DBP
NCT04425902 (171) [back to overview]Treatment A: Change From Baseline in Urate, Creatinine, Bilirubin, Direct Bilirubin
NCT04425902 (171) [back to overview]Treatment B: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval
NCT04425902 (171) [back to overview]Treatment B: Absolute Values of Albumin, Globulin, Protein
NCT04425902 (171) [back to overview]Treatment B: Absolute Values of Amylase, Lipase
NCT04425902 (171) [back to overview]Treatment B: Absolute Values of Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
NCT04425902 (171) [back to overview]Treatment B: Absolute Values of Erythrocytes
NCT04425902 (171) [back to overview]Treatment B: Absolute Values of Erythrocytes Mean Corpuscular Hemoglobin
NCT04425902 (171) [back to overview]Treatment B: Absolute Values of Erythrocytes Mean Corpuscular Volume
NCT04425902 (171) [back to overview]Treatment B: Absolute Values of Glucose, Carbon Dioxide, Cholesterol, Triglycerides, Anion Gap, Calcium, Chloride, Phosphate, Potassium, Sodium, Urea
NCT04425902 (171) [back to overview]Treatment B: Absolute Values of Hematocrit
NCT04425902 (171) [back to overview]Treatment B: Absolute Values of Hemoglobin
NCT04425902 (171) [back to overview]Treatment B: Absolute Values of Oral Temperature
NCT04425902 (171) [back to overview]Treatment B: Absolute Values of Platelet Count, Leukocyte Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
NCT04425902 (171) [back to overview]Treatment B: Absolute Values of Pulse Rate
NCT04425902 (171) [back to overview]Treatment B: Absolute Values of Respiratory Rate
NCT04425902 (171) [back to overview]Treatment B: Absolute Values of SBP and DBP
NCT04425902 (171) [back to overview]Ratio of AUC(0-infinity) of 36-hydroxymontelukast to Montelukast
NCT04425902 (171) [back to overview]Treatment B: Absolute Values of Urate, Creatinine, Bilirubin, Direct Bilirubin
NCT04425902 (171) [back to overview]Treatment B: Change From Baseline in Albumin, Globulin, Protein
NCT04425902 (171) [back to overview]Treatment B: Change From Baseline in Amylase, Lipase
NCT04425902 (171) [back to overview]Treatment B: Change From Baseline in Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
NCT04425902 (171) [back to overview]Treatment B: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF
NCT04425902 (171) [back to overview]Treatment B: Change From Baseline in Glucose, Carbon Dioxide, Cholesterol, Triglycerides, Anion Gap, Calcium, Chloride, Phosphate, Potassium, Sodium, Urea
NCT04425902 (171) [back to overview]Treatment B: Change From Baseline in Platelet Count, Leukocyte Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
NCT04425902 (171) [back to overview]Treatment B: Change From Baseline in SBP and DBP
NCT04425902 (171) [back to overview]AUC(0-t) for Alpha-hydroxymetoprolol
NCT04425902 (171) [back to overview]Treatment C: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval
NCT04425902 (171) [back to overview]Treatment C: Absolute Values of Albumin, Globulin, Protein
NCT04425902 (171) [back to overview]Treatment C: Absolute Values of Amylase, Lipase
NCT04425902 (171) [back to overview]Treatment C: Absolute Values of Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
NCT04425902 (171) [back to overview]Treatment C: Absolute Values of Erythrocytes
NCT04425902 (171) [back to overview]Treatment C: Absolute Values of Erythrocytes Mean Corpuscular Hemoglobin
NCT04425902 (171) [back to overview]Treatment C: Absolute Values of Erythrocytes Mean Corpuscular Volume
NCT04425902 (171) [back to overview]Treatment C: Absolute Values of Glucose, Carbon Dioxide, Cholesterol, Triglycerides, Anion Gap, Calcium, Chloride, Phosphate, Potassium, Sodium, Urea
NCT04425902 (171) [back to overview]Treatment C: Absolute Values of Hematocrit
NCT04425902 (171) [back to overview]Treatment C: Absolute Values of Hemoglobin
NCT04425902 (171) [back to overview]Treatment C: Absolute Values of Oral Temperature
NCT04425902 (171) [back to overview]Treatment C: Absolute Values of Platelet Count, Leukocyte Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
NCT04425902 (171) [back to overview]Treatment C: Absolute Values of Pulse Rate
NCT04425902 (171) [back to overview]Treatment C: Absolute Values of Respiratory Rate
NCT04425902 (171) [back to overview]Treatment C: Absolute Values of SBP and DBP
NCT04425902 (171) [back to overview]Treatment C: Absolute Values of Urate, Creatinine, Bilirubin, Direct Bilirubin
NCT04425902 (171) [back to overview]Treatment C: Change From Baseline in Albumin, Globulin, Protein
NCT04425902 (171) [back to overview]Treatment C: Change From Baseline in Amylase, Lipase
NCT04425902 (171) [back to overview]Treatment C: Change From Baseline in Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
NCT04425902 (171) [back to overview]Treatment C: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF
NCT04425902 (171) [back to overview]Treatment C: Change From Baseline in Erythrocytes
NCT04425902 (171) [back to overview]Treatment C: Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
NCT04425902 (171) [back to overview]t1/2 for 36-hydroxymontelukast
NCT04425902 (171) [back to overview]t1/2 for 5-hydroxyomeprazole
NCT04425902 (171) [back to overview]t1/2 for Alpha-hydroxymetoprolol
NCT04425902 (171) [back to overview]t1/2 for Digoxin
NCT04425902 (171) [back to overview]t1/2 for Flurbiprofen
NCT04425902 (171) [back to overview]t1/2 for Metoprolol
NCT04425902 (171) [back to overview]t1/2 for Midazolam
NCT04425902 (171) [back to overview]t1/2 for Montelukast
NCT04425902 (171) [back to overview]t1/2 for Omeprazole
NCT04425902 (171) [back to overview]t1/2 for Pravastatin
NCT04425902 (171) [back to overview]Time to Cmax (Tmax) for Caffeine
NCT04425902 (171) [back to overview]Tmax for 1-hydroxymidazolam
NCT04425902 (171) [back to overview]Tmax for 36-hydroxymontelukast
NCT04425902 (171) [back to overview]Tmax for 5-hydroxyomeprazole
NCT04425902 (171) [back to overview]Tmax for Alpha-hydroxymetoprolol
NCT04425902 (171) [back to overview]Tmax for Digoxin
NCT04425902 (171) [back to overview]Tmax for Flurbiprofen
NCT04425902 (171) [back to overview]Tmax for Metoprolol
NCT04425902 (171) [back to overview]Tmax for Midazolam
NCT04425902 (171) [back to overview]Tmax for Montelukast
NCT04425902 (171) [back to overview]Tmax for Omeprazole
NCT04425902 (171) [back to overview]Tmax for Pravastatin
NCT04425902 (171) [back to overview]Treatment A: Change From Baseline in Erythrocytes
NCT04425902 (171) [back to overview]Treatment A: Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
NCT04425902 (171) [back to overview]Treatment A: Change From Baseline in Erythrocytes Mean Corpuscular Volume
NCT04425902 (171) [back to overview]Treatment A: Change From Baseline in Hematocrit
NCT04425902 (171) [back to overview]Treatment A: Change From Baseline in Hemoglobin
NCT04425902 (171) [back to overview]Treatment A: Change From Baseline in Oral Temperature
NCT04425902 (171) [back to overview]Treatment A: Change From Baseline in Pulse Rate
NCT04425902 (171) [back to overview]Treatment A: Change From Baseline in Respiratory Rate
NCT04425902 (171) [back to overview]Cmax for Montelukast
NCT04425902 (171) [back to overview]Treatment B: Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin
NCT04425902 (171) [back to overview]Treatment B: Change From Baseline in Erythrocytes Mean Corpuscular Volume
NCT04425902 (171) [back to overview]Treatment B: Change From Baseline in Hematocrit
NCT04425902 (171) [back to overview]Treatment B: Change From Baseline in Hemoglobin
NCT04425902 (171) [back to overview]Treatment B: Change From Baseline in Oral Temperature
NCT04425902 (171) [back to overview]Treatment B: Change From Baseline in Pulse Rate
NCT04425902 (171) [back to overview]Treatment B: Change From Baseline in Respiratory Rate
NCT04425902 (171) [back to overview]Treatment C: AUC From Time Zero to the End of the Dosing Interval at Steady State (AUC[0-tau]) for GSK3640254
NCT04425902 (171) [back to overview]Treatment C: AUC(0-t) for GSK3640254
NCT04425902 (171) [back to overview]Treatment C: Cmax for GSK3640254
NCT04425902 (171) [back to overview]Treatment C: Plasma Concentration at the End of the Dosing Interval (Ctau) for GSK3640254
NCT04425902 (171) [back to overview]Treatment C: t1/2 for GSK3640254
NCT04425902 (171) [back to overview]Treatment C: Tmax for GSK3640254
NCT04425902 (171) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT04425902 (171) [back to overview]Treatment A: Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF)
NCT04425902 (171) [back to overview]Treatment A: Absolute Values of Albumin, Globulin, Protein
NCT04425902 (171) [back to overview]Treatment A: Absolute Values of Amylase, Lipase
NCT04425902 (171) [back to overview]Treatment A: Absolute Values of Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase
NCT04425902 (171) [back to overview]Treatment A: Absolute Values of Erythrocytes
NCT04425902 (171) [back to overview]Treatment A: Absolute Values of Erythrocytes Mean Corpuscular Hemoglobin
NCT04425902 (171) [back to overview]Treatment A: Absolute Values of Erythrocytes Mean Corpuscular Volume
NCT04425902 (171) [back to overview]Treatment A: Absolute Values of Glucose, Carbon Dioxide, Cholesterol, Triglycerides, Anion Gap, Calcium, Chloride, Phosphate, Potassium, Sodium, Urea
NCT04425902 (171) [back to overview]Treatment A: Absolute Values of Hematocrit
NCT04425902 (171) [back to overview]Treatment A: Absolute Values of Hemoglobin
NCT04425902 (171) [back to overview]Treatment A: Absolute Values of Oral Temperature
NCT04425902 (171) [back to overview]Treatment A: Absolute Values of Platelet Count, Leukocyte Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils
NCT04425902 (171) [back to overview]Treatment A: Absolute Values of Pulse Rate
NCT04425902 (171) [back to overview]Treatment A: Absolute Values of Respiratory Rate
NCT04425902 (171) [back to overview]Treatment A: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
NCT04425902 (171) [back to overview]Treatment A: Absolute Values of Urate, Creatinine, Bilirubin, Direct Bilirubin
NCT04425902 (171) [back to overview]Treatment B: Change From Baseline in Erythrocytes

Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose

(NCT00090142)
Timeframe: 0-90 minutes after the exercise challenge performed at 12 hours postdose

,
InterventionParticipants (Number)
Patients requiring rescue medicationPatients not requiring rescue medication
Montelukast 10 mg250
Placebo448

[back to top]

Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose

(NCT00090142)
Timeframe: 0-90 minutes after the exercise challenge performed at 24 hours postdose

,
InterventionParticipants (Number)
Patients requiring rescue medicationPatients not requiring rescue medication
Montelukast 10 mg250
Placebo250

[back to top]

Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 12 Hours Postdose

The measure included only the area below the pre-exercise baseline. (NCT00090142)
Timeframe: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose

Intervention(percent change) *minutes (Mean)
Placebo314.0
Montelukast 10 mg241.7

[back to top]

Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose

The measure included only the area below the pre-exercise baseline. (NCT00090142)
Timeframe: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose

Intervention(percent change) *minutes (Mean)
Placebo582.6
Montelukast 10 mg284.7

[back to top]

Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose

The measure included only the area below the pre-exercise baseline. (NCT00090142)
Timeframe: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose

Intervention(percent change) *minutes (Mean)
Placebo269.6
Montelukast 10 mg223.1

[back to top]

Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB

In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (12 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge. (NCT00090142)
Timeframe: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose

InterventionPercent Change (Mean)
Placebo11.73
Montelukast 10 mg9.87

[back to top]

Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Post-dose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)

In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge. (NCT00090142)
Timeframe: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose

InterventionPercent Change (Mean)
Placebo17.50
Montelukast 10 mg11.70

[back to top]

Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB

In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge. (NCT00090142)
Timeframe: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose

InterventionPercent Change (Mean)
Placebo10.69
Montelukast 10 mg7.95

[back to top]

Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose

The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time. (NCT00090142)
Timeframe: Exercise challenge at 12 hours postdose

InterventionMinutes (Mean)
Placebo23.40
Montelukast 10 mg9.42

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Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose

The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time. (NCT00090142)
Timeframe: Exercise challenge at 2 hours postdose

InterventionMinutes (Mean)
Placebo34.23
Montelukast 10 mg15.87

[back to top]

Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose

The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time. (NCT00090142)
Timeframe: Exercise challenge at 24 hours postdose

InterventionMinutes (Mean)
Placebo13.81
Montelukast 10 mg9.47

[back to top]

Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose

(NCT00090142)
Timeframe: 0-90 minutes after the exercise challenge performed at 2 hours postdose

,
InterventionParticipants (Number)
Patients requiring rescue medicationPatients not requiring rescue medication
Montelukast 10 mg252
Placebo747

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Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period

An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], in answer to a single question regarding the change in symptoms as compared to the beginning of the study. (NCT00092118)
Timeframe: At the end of the 6 week treatment period

InterventionScore on a scale (Least Squares Mean)
Placebo2.42
Montelukast 10 mg2.27

[back to top]

Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis

Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale [Score 0 (best) to 3 (worst)]. (NCT00092118)
Timeframe: 6 week treatment period (from baseline though the end of week 6)

InterventionScore on a scale (Least Squares Mean)
Placebo-0.37
Montelukast 10 mg-0.44

[back to top]

Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period

Patients completed the validated, self-administered RQLQ which included 28 items on a 7-point scale [Score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, nonnose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then scores for the 7 domains were averaged to obtain the overall score. (NCT00092118)
Timeframe: Baseline and Week 6

InterventionScore on a scale (Least Squares Mean)
Placebo-0.69
Montelukast 10 mg-0.84

[back to top]

Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)

In Participants with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge. (NCT00092131)
Timeframe: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose

InterventionPercent Change (Mean)
Placebo22.33
Montelukast 10 mg10.80

[back to top]

Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose

(NCT00092131)
Timeframe: 0-90 minutes after the exercise challenge performed at 24 hours postdose

,
InterventionParticipants (Number)
Number of Patients Requiring Rescue MedicationNumber of Patients Not Requiring Rescue Medication
Montelukast 10 mg145
Placebo343

[back to top]

Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose

(NCT00092131)
Timeframe: 0-90 minutes after the exercise challenge performed at 12 hours postdose

,
InterventionParticipants (Number)
Number of Patients Requiring Rescue MedicationNumber of Patients Not Requiring Rescue Medication
Montelukast 10 mg147
Placebo543

[back to top]

Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose

The measure included only the area below the pre-exercise baseline. (NCT00092131)
Timeframe: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose

Intervention(percent change) *minutes (Mean)
Placebo409.50
Montelukast 10 mg120.06

[back to top]

Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 2 Hours Postdose

The measure included only the area below the pre-exercise baseline. (NCT00092131)
Timeframe: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose

Intervention(percent change) *minutes (Mean)
Placebo702.13
Montelukast 10 mg182.46

[back to top]

Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 12 Hours Postdose

The measure included only the area below the pre-exercise baseline. (NCT00092131)
Timeframe: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose

Intervention(percent change) *minutes (Mean)
Placebo389.55
Montelukast 10 mg152.27

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Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)

In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (12 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge. (NCT00092131)
Timeframe: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose

InterventionPercent Change (Mean)
Placebo16.12
Montelukast 10 mg8.35

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Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose

(NCT00092131)
Timeframe: 0-90 minutes after the exercise challenge performed at 2 hours postdose

,
InterventionParticipants (Number)
Number of Patients Requiring Rescue MedicationNumber of Patients Not Requiring Rescue Medication
Montelukast 10 mg148
Placebo742

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Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose

The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time. (NCT00092131)
Timeframe: Exercise challenge at 24 hours postdose

InterventionMinutes (Mean)
Placebo23.14
Montelukast 10 mg5.74

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Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose

The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time. (NCT00092131)
Timeframe: Exercise challenge at 2 hours postdose

InterventionMinutes (Mean)
Placebo37.67
Montelukast 10 mg10.82

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Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose

The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time. (NCT00092131)
Timeframe: Exercise challenge at 12 hours postdose

InterventionMinutes (Mean)
Placebo24.50
Montelukast 10 mg7.97

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Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)

In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge. (NCT00092131)
Timeframe: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose

InterventionPercent Change (Mean)
Placebo16.86
Montelukast 10 mg8.33

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Number of Wheezing-free Days of Infant (Observed by Primary Caregiver)

(NCT00115297)
Timeframe: First 56 days of study

InterventionDays (Median)
Montelukast25.5
Placebo30.5

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The Number of Participants Requiring Rescue Beta Agonist Use

(NCT00115297)
Timeframe: Measured during the daytime

Interventionparticipants (Number)
Montelukast15
Placebo26

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Wheezing at Day 7

(NCT00115297)
Timeframe: Study day 7

Interventionparticipants (Number)
Montelukast10
Placebo22

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Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)

Treatment Failure is defined as a.) patients who required hospitalization, or b.) patients for whom a decision to discharge home has not been reached by 2 hours following the end of study drug administration. (NCT00117338)
Timeframe: 120 minutes

,
InterventionParticipants (Number)
HospitalizationDecision to Discharge Home not Reached by 2 Hours
Montelukast Intravenous (IV) 5.25 mg2837
Placebo3326

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Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration

Improvement in FEV1 as time-weighted average change from baseline over 45 minutes following the end of study drug administration: Time-weighted average of the changes from baseline obtained over the 45 minutes (at 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor. (NCT00117338)
Timeframe: Baseline and (time-weighed average over) 45 Minutes

InterventionLiters (Least Squares Mean)
Montelukast Intravenous (IV) 5.25 mg0.07
Placebo0.05

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Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration

Improvement in FEV1 as the time-weighted average change from baseline over 30 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 30 minutes (at 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor. (NCT00117338)
Timeframe: Baseline and (time-weighted average over) 30 Minutes

InterventionLiters (Least Squares Mean)
Montelukast Intravenous (IV) 5.25 mg0.06
Placebo0.05

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Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration

Improvement in FEV1 as the time-weighted average change from baseline over 60 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 60 minutes (at 60, 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor. (NCT00117338)
Timeframe: Baseline and (time weighted average over) 60 Minutes

InterventionLiters (Least Squares Mean)
Montelukast Intravenous (IV) 5.25 mg0.08
Placebo0.07

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Change in FEV1 After 15 Minutes Following the End of Study Drug Administration

Improvement in FEV1 as the time-weighted average change from baseline over the first 15 minutes following the end of study drug administration. Change = 15 minutes value minus Baseline value (NCT00117338)
Timeframe: Baseline and 15 Minutes

InterventionLiters (Least Squares Mean)
Montelukast Intravenous (IV) 5.25 mg0.06
Placebo0.01

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Change From Baseline in Modified Pulmonary Index [mPI] Score

"Change from baseline in modified pulmonary index [mPI] score assessed 60 minutes following the end of study drug administration. mPI questionnaire scores each component on a scale of 0 to 3 (low to high) with a total possible score of 12.~The components are respiratory rate, wheezing, prolongation of expiration (Inspiratory:Expiratory ratio), and accessory muscle use." (NCT00117338)
Timeframe: Baseline and 60 minutes

InterventionScore on a scale (Least Squares Mean)
Montelukast Intravenous (IV) 5.25 mg-2.95
Placebo-2.96

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Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration

Median total dose of β-agonist administered per patient over a period of 2 hours following the end of study drug administration. (NCT00117338)
Timeframe: 120 minutes

Interventionmg (Median)
Montelukast Intravenous (IV) 5.25 mg1.0
Placebo0.6

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Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period

"Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (itchy nose/eyes and post-nasal drip) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24.~The baseline TNSS used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms." (NCT00119015)
Timeframe: Baseline and 2 weeks

Interventionunits on a scale (Median)
Fluticasone Propionate + Montelukast-1.66
Fluticasone Propionate + Placebo-2.21

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Change From Baseline in Stuffy Nose Symptom Score Over 2 Week Randomized Treatment Period

"Patients recorded the severity of stuffy nose twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The stuffy nose symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.~The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms." (NCT00119015)
Timeframe: Baseline and 2 weeks

Interventionunits on a scale (Median)
Fluticasone Propionate + Montelukast-0.41
Fluticasone Propionate + Placebo-0.47

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Change From Baseline in Sneezing Symptom Score Over 2 Week Randomized Treatment Period

"Patients recorded the severity of sneezing twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The sneezing symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.~The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms." (NCT00119015)
Timeframe: Baseline and 2 weeks

Interventionunits on a scale (Median)
Fluticasone Propionate + Montelukast-0.22
Fluticasone Propionate + Placebo-0.25

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Change From Baseline in Runny Nose Symptom Score Over 2 Week Randomized Treatment Period

"Patients recorded the severity of runny nose twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The runny nose symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.~The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms." (NCT00119015)
Timeframe: Baseline and 2 weeks

Interventionunits on a scale (Median)
Fluticasone Propionate + Montelukast-0.52
Fluticasone Propionate + Placebo-0.29

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Change From Baseline in Other Symptom Score Over 2 Week Randomized Treatment Period

"Patients recorded the severity of other symptoms, including itchy nose/eyes and post-nasal drip, twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The other symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.~The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms." (NCT00119015)
Timeframe: Baseline and 2 weeks

Interventionunits on a scale (Median)
Fluticasone Propionate + Montelukast-0.24
Fluticasone Propionate + Placebo-0.14

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Maximum FEV1 % Predicted Following First Beta-agonist Use

The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting β-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first β-agonist use. (NCT00127166)
Timeframe: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)

InterventionPercent of predicted value (Least Squares Mean)
Montelukast104.03
Salmeterol99.92

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Maximum Post-exercise Percent (%) Fall in FEV1

The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1. (NCT00127166)
Timeframe: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)

InterventionPercent change from baseline (Least Squares Mean)
Montelukast10.57
Salmeterol13.82

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Time to Recovery to Within 5% of Baseline FEV1

The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge. (NCT00127166)
Timeframe: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)

Interventionminutes (Median)
Montelukast5.9
Salmeterol11.1

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Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))

The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline. (NCT00127166)
Timeframe: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)

InterventionPercent times Minutes (Least Squares Mean)
Montelukast116.04
Salmeterol168.75

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Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use

The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first β-agonist intake and prior to second β-agonist use. (NCT00127166)
Timeframe: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)

InterventionPercent change from baseline (Least Squares Mean)
Montelukast6.51
Salmeterol2.72

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Treatment Failure

The primary outcome measure was treatment failure, defined as the occurrence of any one of the following events: hospitalization or an urgent medical visit for asthma initiated by the patient or physician; use of systemic corticosteroids for asthma or need for open-label use of inhaled corticosteroids for asthma, as determined by the study physician or an asthma care provider; a decrease in prebronchodilator forced expiratory volume in 1 second (FEV1) to more than 20% below the baseline value measured at randomization; a decrease in the morning peak expiratory flow rate to more than 35% below the baseline value (the mean over the final 2 weeks of the run-in period) on 2 consecutive days; use of 10 puffs or more per day of rescue beta-agonist for 2 consecutive days (except as medication before exercise); refusal of the patient to continue because of lack of satisfaction with treatment; or judgment by a physician that the patient should stop treatment for reasons of safety. (NCT00156819)
Timeframe: 16 weeks

Interventionparticipants (Number)
Fluticasone34
Montelukast50
Fluticasone Plus Salmeterol33

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Incidence of Acute Otitis Media

(NCT00189462)
Timeframe: 16 weeks

Interventionparticipants with AOM (Number)
Montelukast30
Placebo27

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Nasal Secretion Weights

(NCT00189475)
Timeframe: 6 days after naturally acquiring an upper respiratory infection

,
Interventiongrams (Mean)
Day 1Day 6
Montelukast3.51.2
Placebo4.22.6

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The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)

The Time Weighed Average Changes in Forced Expiratory Volume in One Second (FEV1) from pre-allocation baseline over the first 60 minutes after study drug administration with time interval between any measurement and the measurement prior to it is used as the weighting factor (NCT00229970)
Timeframe: baseline over the first 60 minutes

InterventionLiter (Least Squares Mean)
Montelukast 7 mg0.09
Montelukast 14 mg0.17
Placebo0.01

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Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB

In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (8.5 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge. (NCT00245570)
Timeframe: 0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose

InterventionPercent Change from Baseline (Mean)
Montelukast 10 mg11.60
Salmeterol 50-μg11.01
Placebo16.65

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Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose

"The measure included only the area below the pre-exercise~baseline" (NCT00245570)
Timeframe: 0-60 minutes after the exercise challenge at 2 hours postdose

InterventionPercent * minutes (Mean)
Montelukast 10 mg254.60
Salmeterol 50-μg293.05
Placebo710.43

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Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 24 Hours Postdose

The measure included only the area below the pre-exercise baseline (NCT00245570)
Timeframe: 0-60 minutes after the exercise challenge at 24 hours postdose

InterventionPercent * minutes (Mean)
Montelukast 10 mg231.09
Salmeterol 50-μg554.93
Placebo395.96

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Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 8.5 Hours Postdose

The measure included only the area below the pre-exercise baseline (NCT00245570)
Timeframe: 0-60 minutes after the exercise challenge at 8.5 hours postdose

InterventionPercent * minutes (Mean)
Montelukast 10 mg191.01
Salmeterol 50-μg276.26
Placebo511.28

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Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB

In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge. (NCT00245570)
Timeframe: 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose

InterventionPercent Change from Baseline (Mean)
Montelukast 10 mg10.09
Salmeterol 50-μg16.22
Placebo13.64

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Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB)

In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge. (NCT00245570)
Timeframe: 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose

InterventionPercent Change from Baseline (Mean)
Montelukast 10 mg13.15
Salmeterol 50-μg10.46
Placebo21.86

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Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose

The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time. (NCT00245570)
Timeframe: Exercise challenge at 2 hours postdose

InterventionMinutes (Mean)
Montelukast 10 mg16.63
Salmeterol 50-μg17.58
Placebo42.70

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Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose

"The time to recovery from maximum percent fall is the~duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the~time when FEV1 returns to within 5% of the preexercise baseline for the first time." (NCT00245570)
Timeframe: Exercise challenge at 8.5 hours postdose

InterventionMinutes (Mean)
Montelukast 10 mg10.70
Salmeterol 50-μg13.82
Placebo32.34

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Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose

(NCT00245570)
Timeframe: 0-90 minutes after the exercise challenge performed at 2 hours postdose

,,
InterventionParticipants (Number)
Patients Requiring Rescue MedicationPatients Not Requiring Rescue Medication
Montelukast 10 mg344
Placebo938
Salmeterol 50-μg442

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Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose

(NCT00245570)
Timeframe: 0-90 minutes after the exercise challenge performed at 24 hours postdose

,,
InterventionParticipants (Number)
Patients Requiring Rescue MedicationPatients Not Requiring Rescue Medication
Montelukast 10 mg343
Placebo640
Salmeterol 50-μg640

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Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose

(NCT00245570)
Timeframe: 0-90 minutes after the exercise challenge performed at 8.5 hours postdose

,,
InterventionParticipants (Number)
Patients Requiring Rescue MedicationPatients Not Requiring Rescue Medication
Montelukast 10 mg040
Placebo433
Salmeterol 50-μg039

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Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose

"The time to recovery from maximum percent fall is the~duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the~time when FEV1 returns to within 5% of the preexercise baseline for the first time." (NCT00245570)
Timeframe: Exercise challenge at 24 hours postdose

InterventionMinutes (Mean)
Montelukast 10 mg11.04
Salmeterol 50-μg29.75
Placebo23.31

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Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period

PEFR measurements were performed daily, in the morning before using any medication. The on-treatment AM PEFR was computed by averaging over Period II (treatment period) the AM PEFR recorded daily in the diary, while the baseline AM PEFR was obtained by averaging the AM PEFR across the daily diary entries of the Baseline Period or Period I (placebo run-in period). The change from baseline in average AM PEFR is computed as the difference between mean on-treatment AM PEFR and mean baseline AM PEFR. (NCT00284856)
Timeframe: Baseline and 6 months

,,
InterventionLiters/minute (Mean)
BaselineAverage Change from Baseline During Period II
Fluticasone354.2819.31
Montelukast363.7512.84
Placebo347.988.27

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Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period

4 daytime symptoms were evaluated daily on a 7-point scale from 0 (best)- 6 (worst). The on-treatment daytime symptom score was computed by averaging over Period II the mean of the 4 daily symptom scores recorded daily in the diary while the baseline daytime symptom score was obtained by averaging the mean of the 4 daily symptom scores across the daily diary entries of the Baseline period (Period I). The change from baseline in mean daytime symptom score is computed as the difference between the mean on-treatment daytime symptom score & the mean baseline daytime symptom score. (NCT00284856)
Timeframe: Baseline and 6 months

,,
InterventionScore on a scale (Mean)
BaselineAverage Change from Baseline During Period II
Fluticasone1.78-0.44
Montelukast1.82-0.41
Placebo1.90-0.27

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Percentage of Asthma-control Days Over the 6-month Treatment Period

An asthma-control day, computed from daily diaries, was any day with no unscheduled visit for asthma care, no use of > than 2 puffs of β-agonist, no use of other asthma rescue medication, and no nocturnal awakening. The percentage of asthma-control days was the number of days with asthma-control divided by the total number of days with non-missing values for this endpoint. The patient diary had questions concerning daytime and nighttime symptoms, morning (AM) and evening (PM) peak expiratory flow rate (PEFR), β-agonist use, asthma attacks and smoking activity. (NCT00284856)
Timeframe: 6 months

InterventionPercentage of days (Mean)
Montelukast50.70
Fluticasone53.30
Placebo43.84

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"Percent Change From Baseline in Mean Daily as Needed β-agonist Use Over the 3-week Treatment Period"

Percent change from baseline in average daily β-agonist use over the 3-week treatment period (NCT00289874)
Timeframe: Baseline and Week 3

InterventionPercent Change (Median)
Montelukast 5 mg-18.88
Placebo-12.40

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Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3

Percent change from baseline in FEV1, a measure of airway function, at Week 3 (NCT00289874)
Timeframe: Baseline and week 3

InterventionPercent Change (Least Squares Mean)
Montelukast 5 mg9.53
Placebo9.15

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Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I

"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]

Interventionunits on a scale (Least Squares Mean)
Placebo (PBO)-6.16
Levocetirizine (LCTZ)-10.53
Montelukast (MLKT)-9.01

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Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III)

"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline to Day 2

Interventionunits on a scale (Least Squares Mean)
Placebo (PBO)-3.16
Levocetirizine (LCTZ)-7.37
Montelukast (MLKT)-5.48

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Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II

"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]

Interventionunits on a scale (Least Squares Mean)
Placebo (PBO)-2.45
Levocetirizine (LCTZ)-9.54
Montelukast (MLKT)-5.12

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Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III

"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]

Interventionunits on a scale (Least Squares Mean)
Placebo (PBO)-5.91
Levocetirizine (LCTZ)-13.39
Montelukast (MLKT)-9.73

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Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III)

"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline to Day 2

Interventionunits on a scale (Least Squares Mean)
Placebo (PBO)-5.53
Levocetirizine (LCTZ)-11.54
Montelukast (MLKT)-8.68

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Change From Baseline in the TSC Score + Nasal Congestion Score Over Period I

"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]

Interventionunits on a scale (Least Squares Mean)
Placebo (PBO)-6.57
Levocetirizine (LCTZ)-11.15
Montelukast (MLKT)-9.65

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Change From Baseline in the TSC Score + Nasal Congestion Score Over Period II

"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]

Interventionunits on a scale (Least Squares Mean)
Placebo (PBO)-2.65
Levocetirizine (LCTZ)-9.97
Montelukast (MLKT)-5.47

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Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III

"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]

Interventionunits on a scale (Least Squares Mean)
Placebo (PBO)-6.35
Levocetirizine (LCTZ)-14.18
Montelukast (MLKT)-10.39

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Global Satisfaction of the Subjects at the End of Period III

Global satisfaction was evaluated at the end of Period III by the subject on a Visual Analog Scale (VAS) ranging from 0 (very dissatisfied) to 100 mm (very satisfied). (NCT00295022)
Timeframe: At the end of Period III (Day 2)

Interventionunits on a scale (Mean)
Placebo (PBO)32.42
Levocetirizine (LCTZ)53.94
Montelukast (MLKT)41.80

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Onset of Action During Period I

The onset of action was defined as the first time point during Period I after initiation of the treatment when the reduction from Baseline in the MSC score for the active treatment group became statistically different from the placebo group and when this significant change was maintained for some period of time. (NCT00295022)
Timeframe: During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]

Interventionhours (Number)
Placebo (PBO)NA
Levocetirizine (LCTZ)1.5
Montelukast (MLKT)1.5

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Intensity of Action From Baseline in the MSC Score Over Period I

The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period I. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline. (NCT00295022)
Timeframe: Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]

,,
Interventionpercentage of participants (Number)
< 20%>= 20%< 50%>= 50%< 70%>= 70%
Levocetirizine (LCTZ)21.079.068.831.287.912.1
Montelukast (MLKT)32.767.367.932.192.37.7
Placebo (PBO)54.345.780.020.095.24.8

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Time to First Feeling of Improvement During Period I

During Period I, the subjects had to record the moment (hh:mm) of first feeling of improvement (compared to Baseline intensity of symptoms). (NCT00295022)
Timeframe: During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]

Interventionminutes (Median)
Placebo (PBO)101.02
Levocetirizine (LCTZ)70.02
Montelukast (MLKT)63.02

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Change From Baseline in the Individual Symptom Scores Over Period I

"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score.~The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]

,,
Interventionunits on a scale (Least Squares Mean)
Runny Nose ScoreItchy Nose ScoreSniffles ScorePostnasal Drip ScoreWatery Eyes ScoreItchy Eyes/Ears ScoreItchy Throat ScoreCough ScoreSneezes ScoreNose Blows ScoreNasal Congestion Score
Levocetirizine (LCTZ)-0.89-0.93-0.93-0.99-0.94-1.14-1.00-0.81-1.07-1.77-0.62
Montelukast (MLKT)-0.86-0.85-0.87-0.89-0.82-0.90-0.85-0.71-0.68-1.59-0.64
Placebo (PBO)-0.55-0.52-0.53-0.65-0.58-0.69-0.66-0.71-0.28-1.03-0.41

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Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I

"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]

Interventionunits on a scale (Least Squares Mean)
Placebo (PBO)-3.46
Levocetirizine (LCTZ)-6.58
Montelukast (MLKT)-5.65

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Change From Baseline in the MSC Score Over Period II

"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]

Interventionunits on a scale (Least Squares Mean)
Placebo (PBO)-1.22
Levocetirizine (LCTZ)-6.35
Montelukast (MLKT)-3.24

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Change From Baseline in the MSC Score Over Period III

"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]

Interventionunits on a scale (Least Squares Mean)
Placebo (PBO)-3.50
Montelukast (MLKT)-8.62
Levocetirizine (LCTZ)-6.19

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Change From Baseline in the Individual Symptom Scores Over Period II

"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score.~The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]

,,
Interventionunits on a scale (Least Squares Mean)
Runny Nose ScoreItchy Nose ScoreSniffles ScorePostnasal Drip ScoreWatery Eyes ScoreItchy Eyes/Ears ScoreItchy Throat ScoreCough ScoreSneezes ScoreNose Blows ScoreNasal Congestion Score
Levocetirizine (LCTZ)-0.85-0.84-0.83-0.90-0.66-0.81-0.78-0.70-1.28-1.84-0.43
Montelukast (MLKT)-0.53-0.40-0.48-0.52-0.46-0.40-0.39-0.58-0.40-0.99-0.35
Placebo (PBO)-0.18-0.22-0.10-0.37-0.20-0.18-0.19-0.49-0.19-0.38-0.19

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Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III)

"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline to Day 2

Interventionunits on a scale (Least Squares Mean)
Placebo (PBO)-5.92
Levocetirizine (LCTZ)-12.21
Montelukast (MLKT)-9.28

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Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III)

"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score.~The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline to Day 2

,,
Interventionunits on a scale (Least Squares Mean)
Runny Nose ScoreItchy Nose ScoreSniffles ScorePostnasal Drip ScoreWatery Eyes ScoreItchy Eyes/Ears ScoreItchy Throat ScoreCough ScoreSneezes ScoreNose Blows ScoreNasal Congestion Score
Levocetirizine (LCTZ)-1.02-1.05-1.05-1.11-0.97-1.17-1.03-0.86-1.23-2.00-0.67
Montelukast (MLKT)-0.84-0.79-0.85-0.87-0.77-0.81-0.78-0.74-0.67-1.58-0.61
Placebo (PBO)-0.48-0.46-0.45-0.62-0.44-0.51-0.54-0.71-0.35-1.02-0.38

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Variability of Action From Baseline in the MSC Score Over Period III

"The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following:~< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%." (NCT00295022)
Timeframe: Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]

,,
Interventionpercentage of participants (Number)
< 20%20%-35%35%-50%50%-65%65%-80%>=80%
Levocetirizine (LCTZ)16.717.913.514.117.919.9
Montelukast (MLKT)31.814.617.217.214.64.6
Placebo (PBO)48.121.215.43.88.72.9

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Variability of Action From Baseline in the MSC Score Over Period II

"The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following:~< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%." (NCT00295022)
Timeframe: Treatment Period II [Day 2, from 9:30 am to 11:00 am]

,,
Interventionpercentage of participants (Number)
< 20%20%-35%35%-50%50%-65%65%-80%>=80%
Levocetirizine (LCTZ)32.119.212.217.310.39.0
Montelukast (MLKT)53.616.617.26.63.32.6
Placebo (PBO)67.317.38.73.81.91.0

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Variability of Action From Baseline in the MSC Score Over Period I

"The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following:~< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%." (NCT00295022)
Timeframe: Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]

,,
Interventionpercentage of participants (Number)
< 20%20%-35%35%-50%50%-65%65%-80%>=80%
Levocetirizine (LCTZ)21.022.924.812.715.33.2
Montelukast (MLKT)32.719.216.020.58.33.2
Placebo (PBO)54.315.210.512.44.82.9

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Intensity of Action From Baseline in the MSC Score Over Period III

The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period III. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline. (NCT00295022)
Timeframe: Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]

,,
Interventionpercentage of participants (Number)
< 20%>= 20%< 50%>= 50%< 70%>= 70%
Levocetirizine (LCTZ)16.783.348.151.969.930.1
Montelukast (MLKT)31.868.263.636.486.113.9
Placebo (PBO)48.151.984.615.489.410.6

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Intensity of Action From Baseline in the MSC Score Over Period II

The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period II. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline. (NCT00295022)
Timeframe: Treatment Period II [Day 2, from 9:30 am to 11:00 am]

,,
Interventionpercentage of participants (Number)
< 20%>= 20%< 50%>= 50%< 70%>= 70%
Levocetirizine (LCTZ)32.167.963.536.583.316.7
Montelukast (MLKT)53.646.487.412.695.44.6
Placebo (PBO)67.332.793.36.798.11.9

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Change From Baseline in the Individual Symptom Scores Over Period III

"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score.~The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]

,,
Interventionunits on a scale (Least Squares Mean)
Runny Nose ScoreItchy Nose ScoreSniffles ScorePostnasal Drip ScoreWatery Eyes ScoreItchy Eyes/Ears ScoreItchy Throat ScoreCough ScoreSneezes ScoreNose Blows ScoreNasal Congestion Score
Levocetirizine (LCTZ)-1.23-1.25-1.26-1.32-1.11-1.34-1.15-0.97-1.40-2.32-0.79
Montelukast (MLKT)-0.93-0.89-0.96-0.97-0.84-0.87-0.86-0.84-0.78-1.82-0.67
Placebo (PBO)-0.52-0.47-0.50-0.67-0.36-0.42-0.54-0.78-0.48-1.22-0.43

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Rhinitis: Mean Change From Baseline at 1-2 Weeks in Nightime Total Nasal Symptom Scores (N-TNSS)

The scores of 3 nighttime symptoms (nasal congestion upon awakening, difficulty going to sleep due to nasal symptoms, nighttime awakenings due to nasal symptoms). Scale: 0=not noticeable, 1=noticeable but not bothersome, 2=noticeable and bothersome some of the time, 3=bothersome most of the time and/or very bothersome some of the time. (NCT00296491)
Timeframe: Baseline To 1-2 Weeks

InterventionPoints on a Scale (Mean)
Flut Prop/Salmeterol/Flut Nasal Spray (FSC+FPANS)-2.0
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)1.7

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Rhinitis: Mean Change From Baseline at 1-2 Weeks in Daytime Total Nasal Symptom Scores (D-TNNS).

The sum of scores of each of the four daytime symptoms (nasal congestion, itching, rhinorrhea, and sneezing). Scale: 0=none (no sign/symptom evident)1=mild (sign/symptom clearly present; easily tolerated)2=moderate (definite awareness of sign/symptom that is bothersome but tolerable)3=severe (sign/symptom is hard to tolerate) (NCT00296491)
Timeframe: Baseline to 1-2 Weeks

InterventionPoints on a Scale (Mean)
Fluticasone Prop/Salmeterol/Montelukast (FSC+MON)-2.3
Fluticasone Prop/Salmeterol/Flut Nasal Spray (FSC+FPANS)-3.0

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Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population

Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work. (NCT00296491)
Timeframe: Baseline to Endpoint (weeks 3-4)

InterventionL/min (Mean)
Flut Prop/Salmeterol/Montelukast (FSC+MON)30.9
Fluticasone Propionate/Salmeterol (FSC)35.2

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Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population

Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work. (NCT00296491)
Timeframe: Baseline to Endpoint (weeks 3-4)

InterventionL/min (Mean)
Fluticasone Prop/Salmeterol (FSC)26.4
Montelukast (MON)3.6

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Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Per Protocol Population

Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second. (NCT00296491)
Timeframe: Baseline to Endpoint (weeks 3-4)

InterventionL/sec (Mean)
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)0.27
Fluticasone Propionate/Salmeterol (FSC)0.13

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Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Intent-to-Treat Population

Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second. (NCT00296491)
Timeframe: Baseline to Endpoint (weeks 3-4)

InterventionL/sec (Mean)
Fluticasone Propionate/Salmeterol (FSC)0.15
Montelukast (MON)0.04

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Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Per Protocol Population

Asthma symptom score:0=no symptoms,1=symptoms 1 short period,2=symptoms 2 or more short periods,3=symptoms most of day not affect activities,4=symptoms most of day did affect activities,5=symptoms severe.Overall satisfaction score:0=very dissatisfied,1=dissatisfied,2=slightly dissatisfied,3=neutral,4=slightly satisfied,5=satisfied 6=very satisfied (NCT00296491)
Timeframe: Baseline to Endpoint (weeks 3-4)

InterventionPercentage of asthma symptom-free days (Mean)
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)34.8
Fluticasone Propionate/Salmeterol (FSC)37.1

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Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol/Salbutamol-Free Days for Per Protocol Population

Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days). (NCT00296491)
Timeframe: Baseline to Endpoint (weeks 3-4)

InterventionPercentage of rescue-free days (Mean)
Fluticasone Propionate + Salmeterol & Montelukast (FSC+MON)41.2
Fluticasone Propionate/Salmeterol (FSC)42.9

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Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol-Salbutamol Free Days for Intent-to-Treat Population

Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days). (NCT00296491)
Timeframe: Baseline to Endpoint (weeks 3-4)

InterventionPercentage of rescue-free days (Mean)
Fluticasone Propionate/Salmeterol (FSC)37.5
Montelukast (MON)26.7

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Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Intent-to-Treat Population

Endpoint was defined as the average of the data reported from the last week of treatment.Asthma symptom scores and the subject-rated overall satisfaction with treatment, related to the percentage of asthma symptom-free days. Same scale used as in outcome 8. (NCT00296491)
Timeframe: Baseline to Endpoint (weeks 3-4)

InterventionPercentage of asthma symptom-free days (Mean)
Fluticasone Propionate/Salmeterol (FSC)34.8
Montelukast (MON)26.1

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Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes

Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of Wheeze, Difficulty Breathing, Interference with Activity, and Daytime Cough on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 12 days of intermittent treatment for an episode (before the first attack) was reported. If a patient had multiple episodes over 1 year, the symptom scores were averaged across all the episodes. (NCT00337675)
Timeframe: 1 Year

InterventionUnits on a Scale (Least Squares Mean)
Daily Montelukast1.08
Intermittent Montelukast1.09
Placebo1.20

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Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode

Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of wheeze and difficulty breathing on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 3 days prior to an asthma attack was reported. If a patient had multiple episodes during 1 year, the symptom scores were averaged across all the episodes. (NCT00337675)
Timeframe: 1 Year

InterventionUnits on a Scale (Least Squares Mean)
Daily Montelukast1.69
Intermittent Montelukast1.70
Placebo1.88

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Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period

The rate per year of asthma episodes culminating in an asthma attack for each of the 3 treatment groups. Asthma attacks were defined as respiratory symptoms requiring healthcare resource utilization (HRU), which comprised unscheduled visits to a physician or emergency department, treatment with corticosteroids (oral, rectal, or inhaled), or hospitalization. Each day during an episode, the patient's legal guardian recorded all the HRU that was required specifically for breathing problems. (NCT00337675)
Timeframe: 1-year treatment period

InterventionAsthma attacks within episodes per year (Mean)
Daily Montelukast0.99
Intermittent Montelukast1.06
Placebo1.05

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Peak Viral Shedding

Viral shedding was measured in both groups. Viral titers from nasal lavage were calculated after 4 tissue culture tubes containing WI38 cells (human lung diploid cells) were inoculated for each serial 10-fold dilution of samples and incubated while rolling at 33 degrees Celsius for 10 days (measurement for analysis was taken at baseline and 7 days). Tubes were read at baseline and 7 days later. TCID50 was calculated as the concentration that was capable of infecting 50% of the tubes. Viral titers are expressed as TCID50 per milliliter. Time frame measurement was at baseline and 7 days. (NCT00359073)
Timeframe: Baseline and 7 days

InterventionTCID50 per milliliter (Median)
Montelukast2.5
Placebo3.5

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Sputum Eosinophil Count

Sputum was collected from both groups over 14 days after inoculation with the cold virus. Cell counts and differentials were made from sputum samples after treatment with 0.1% dithiothreitol. Eosinophils were counted and are expressed as as percentage of cells (percent of the total number counted) at the 14 day timepoint. (NCT00359073)
Timeframe: 14 days

Interventionpercentage of eosinophils (Median)
Montelukast0.3
Placebo2.0

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Mean Asthma Symptom Score

Asthma symptom scores were assessed twice per day with subjects completing a validated daytime diary card before bed and a nocturnal diary card on awakening. Subjects answered 4 questions about their asthma symptoms (0, none of the time; 6, all of the time). Daily score were calculated as the average of the 4 questions and an overall score for the week was assessed as the average of the daily scores. Time frame measurement was Day 7. (NCT00359073)
Timeframe: Day 7

InterventionAsthma symptom score (Median)
Montelukast2.3
Placebo2.1

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Triglycerides

measured by a clinical laboratory; Quest Laboratories (NCT00379808)
Timeframe: 1 month

Interventionmg/dl (Median)
Placebo94
Montelukast104

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Interleukin 1 Receptor Antagonist (IL1ra)

IL1ra was determined by enzyme-linked immunosorbant assay (ELISA) (NCT00379808)
Timeframe: 1 month

Interventionpg/ml (Median)
Placebo518
Montelukast587

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High-sensitivity C-reactive Protein

measured in a CLIA clinical laboratory facility (Quest Diagnostics, Tampa, FL) (NCT00379808)
Timeframe: 1 month

Interventionmg/dl (Median)
Placebo1.0
Montelukast1.0

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High Density Lipoprotein (HDL)-Cholesterol

Lipid levels were determined at a clinical laboratory (Quest Diagnostics) (NCT00379808)
Timeframe: 1 month

Interventionmg/dl (Median)
Placebo52
Montelukast50

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Epithelial Cell-derived Neutrophil-activating Peptide 78 (ENA-78)

biomarker determined by enzyme-linked immunosorbant assay. (NCT00379808)
Timeframe: 1 month

Interventionpg/ml (Median)
Placebo631
Montelukast527

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Monocyte Chemotactic Protein-1 (MCP-1)

biomarker was measured by enzyme-linked immunosorbant assay (ELISA) (NCT00379808)
Timeframe: 1 month

Interventionpg/ml (Median)
Placebo84
Montelukast94

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Summary of Change From Baseline to Endpoint in FEV1 (Forced Expiratory Volume in One Second).

Mean percent change from Baseline (the last non-missing value prior to treatment) in pulmonary function test FEV1 from in-office visits and at Endpoint (last non-missing postbaseline value carried forward) (NCT00394355)
Timeframe: Baseline and up to ~ one year of treatment

Interventionpercentage of FEV1 (Mean)
MF DPI 200 mcg QD PM0.29
MF DPI 400 mcg QD PM0.38
FP MDI 250 mcg BID0.31
ML 10 mg QD PM0.19

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Mean Percent Change in the Left Total Femur From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point

The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward. (NCT00394355)
Timeframe: Baseline and up to ~ one year of treatment

Interventionpercentage of BMD (Mean)
MF DPI 200 mcg QD PM0.3
MF DPI 400 mcg QD PM0.2
FP MDI 250 mcg BID0.2
ML 10 mg QD PM0.5

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Mean Percent Change in the Femoral Neck BMD From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point

The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward. (NCT00394355)
Timeframe: Baseline and up to ~ one year of treatment

Interventionpercentage of BMD (Mean)
MF DPI 200 mcg QD PM-0.2
MF DPI 400 mcg QD PM0.4
FP MDI 250 mcg BID-0.4
ML 10 mg QD PM-0.2

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Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From the Averaged Baseline Value to the Endpoint of Treatment Time Point

The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward. (NCT00394355)
Timeframe: Baseline and up to ~ one year of treatment

Interventionpercentage of BMD (Mean)
MF DPI 200 mcg QD PM0.7
MF DPI 400 mcg QD PM0.9
FP MDI 250 mcg BID1.1
ML 10 mg QD PM1.2

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Change From Baseline in the Post-bronchodilator FEV1 Percent Predicted

(NCT00395304)
Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Interventionpercentage points (Mean)
2xICS-0.2
1xICS + LABA-1.2
1xICS + LTRA-0.8

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Change From Baseline in the Logarithm Base 2 of the Methacholine PC20

The methacholine PC20 is the concentration of methacholine that causes a 20% decrease in the pre-bronchodilator FEV1. The logarithm base 2 transformation converts the PC20 into doubling dilutions. (NCT00395304)
Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Interventiondoubling dilutions (Mean)
2xICS1.11
1xICS + LABA1.20
1xICS + LTRA1.00

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The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1.

One treatment period was ranked as better than another if the total amount of prednisone received during the period was at least 180 mg less, if the number of annualized asthma-control days during the final 12 weeks of the period was increased by at least 31 days, or if the FEV1 at the end of the period was at least 5% higher. If the prednisone threshold was met, then we ignored the number of asthmacontrol days and the FEV1. If the threshold for asthma-control days was met, then we ignored the FEV1. Otherwise, the order of response was determined by the FEV1. (NCT00395304)
Timeframe: Measured during the last 12 weeks of each 16-week treatment period

InterventionParticipants (Number)
All Participants161

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Number of Participants With Asthma Exacerbations

An asthma exacerbation was defined as the administration of a course of oral/systemic prednisone for the treatment of asthma. (NCT00395304)
Timeframe: Measured during the last 12 weeks of each 16-week treatment period

InterventionParticipants (Count of Participants)
2xICS49
1xICS + LABA35
1xICS + LTRA37

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Change From Baseline in the Pre-bronchodilator Forced Vital Capacity (FVC) % Predicted

(NCT00395304)
Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Interventionpercentage points (Mean)
2xICS-1.00
1xICS + LABA-1.58
1xICS + LTRA-1.56

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Change From Baseline in the Natural Logarithm of Exhaled Nitric Oxide (eNO)

(NCT00395304)
Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Interventionnatural logarithm of parts per billion (Mean)
2xICS-0.04
1xICS + LABA-0.05
1xICS + LTRA-0.02

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Change From Baseline in the Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) % Predicted

(NCT00395304)
Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Interventionpercentage points (Mean)
2xICS0.26
1xICS + LABA1.07
1xICS + LTRA-0.84

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Change From Baseline in the Morning Peak Expiratory Flow Rate (PEFR) % Predicted

(NCT00395304)
Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Interventionpercentage points (Mean)
2xICS4.44
1xICS + LABA6.26
1xICS + LTRA4.04

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Change From Baseline in the Pre-bronchodilator FEV1/FVC Ratio

(NCT00395304)
Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Interventionratio (Mean)
2xICS0.98
1xICS + LABA2.13
1xICS + LTRA0.55

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Change From Baseline in the Peak Expiratory Flow Rate (PEFR) Variability

PEFR variability is calculated as 100% times the difference between the evening and morning PEFR values, divided by the average of the evening and morning PEFR values, i.e., PEFR variability = 100% x (morning PEFR - evening PEFR)/((morning PEFR + evening PEFR)/2) (NCT00395304)
Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Interventionpercentage points (Mean)
2xICS2.09
1xICS + LABA1.61
1xICS + LTRA1.72

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Change From Baseline in the Impulse Oscillometry Resistance at 5 Hertz

Change from baseline in the impulse oscillometry resistance at 5 Hertz, measured in kiloPascals per liters per second (NCT00395304)
Timeframe: Measured during the last 12 weeks of each 16-week treatment period

InterventionkiloPascals per liters per second (Mean)
2xICS-0.08
1xICS + LABA-0.09
1xICS + LTRA-0.06

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Change From Baseline in the Evening Peak Expiratory Flow Rate (PEFR) % Predicted

(NCT00395304)
Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Interventionpercentage points (Mean)
2xICS2.84
1xICS + LABA4.87
1xICS + LTRA2.29

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Change From Baseline in the Asthma Control Test (ACT)

The ACT consists of five items, each scored as 1 (worst) to 5 (best). The five items are averaged. (NCT00395304)
Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Interventionunits on a scale (Mean)
2xICS1.49
1xICS + LABA1.87
1xICS + LTRA1.69

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Change From Baseline in Asthma Quality of Life

Asthma quality of life is measured as the average of 23 questions, each of which is scored from 1 (worse) to 7 (best) (NCT00395304)
Timeframe: Measured during the last 12 weeks of each 16-week treatment period

Interventionunits on a scale (Mean)
2xICS0.2
1xICS + LABA0.3
1xICS + LTRA0.3

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Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration

The time weighted average change from Baseline in Forced Expiratory Volume in One Second (FEV1) over the first 60 minutes after study drug administration (average change FEV1 (0-60 min)). Baseline (pre-allocation) was the last measurement obtained during the screening period. (NCT00442338)
Timeframe: Baseline and 60 minutes after study drug administration

InterventionLiter (Least Squares Mean)
Montelukast 7 mg0.07
Montelukast 14 mg0.05
Aminophylline 250 mg0.06

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Change From Baseline for Daytime Asthma Symptom Score

The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome. (NCT00442559)
Timeframe: Baseline and Week 12

InterventionUnits on scale (Mean)
Daytime Asthma Symptom Score at Baseline - Montelukast0.32
Daytime Asthma Symptom Score at 12 Weeks - Montelukast0.16
Daytime Asthma Symptom Score at Baseline - ICS0.29
Daytime Asthma Symptom Score at 12 Weeks - ICS0.13

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Change From Baseline for Daily Allergic Rhinitis Symptom Score

The score is an ordinal scale from 0 (no symptoms) to 3 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome. (NCT00442559)
Timeframe: Baseline and Week 12

InterventionUnits on scale (Mean)
Daily Allergic Rhinitis Symptom Score at Baseline- Montelukast0.45
Daily Allergic Rhinitis Symptom Score at 12 Weeks- Montelukast0.23
Daily Allergic Rhinitis Symptom Score at Baseline - ICS0.31
Daily Allergic Rhinitis Symptom Score 12 Weeks - ICS0.19

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Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)

Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting. (NCT00461032)
Timeframe: 8 Week treatment period initiated at the beginning of a school year

,
InterventionParticipants (Number)
Participants requiring Health Care UtilizationParticipants not requiring Health Care Utilization
Montelukast 5 mg55411
Placebo70406

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Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants

(NCT00461032)
Timeframe: 8 Week treatment period initiated at the beginning of a school year

InterventionPercentage of Days (Least Squares Mean)
Placebo7.02
Montelukast 5 mg6.04

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Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants

"A day of worsening asthma is a day with: increase from baseline in β-agonist use (> 70% and a min increase of 2 puffs); > 50% increase from baseline in daytime symptoms score; awake all night; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization." (NCT00461032)
Timeframe: 8 Week treatment period initiated at the beginning of a school year

InterventionPercentage of Days (Least Squares Mean)
Placebo27.23
Montelukast 5 mg24.26

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Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants

Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions. (NCT00461032)
Timeframe: 8 Week treatment period initiated at the beginning of a school year

InterventionPercentage of Days (Least Squares Mean)
Placebo17.4
Montelukast 5 mg16.03

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Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 2 Hours Post-dose

AUC0-60min was defined as the Area Under the Curve for FEV1 percent change from pre-exercise baseline to the 60 mins following exercise challenge. The area was computed by applying the trapezoidal rule, and including only the area below the pre-exercise baseline. If a participant received β-agonist during the 60 mins after the exercise challenge, the FEV1 measurements obtained after β-agonist administration were excluded and the last pre-rescue FEV1 measurement was carried forward to the 60 mins time point in the calculation of the AUC0-60 min. Smaller values mean greater response to therapy. (NCT00534976)
Timeframe: Pre-exercise baseline to 60 minutes after the exercise challenge performed 2 hours post-dose

Interventionpercent fall * minute (Mean)
Montelukast294.50
Placebo415.37

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Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 24 Hours Post-dose

AUC0-60min was defined as the Area Under the Curve for FEV1 percent change from pre-exercise baseline to the 60 mins following exercise challenge. The area was computed by applying the trapezoidal rule, and including only the area below the pre-exercise baseline. If a participant received β-agonist during the 60 mins after the exercise challenge, the FEV1 measurements obtained after β-agonist administration were excluded and the last pre-rescue FEV1 measurement was carried forward to the 60 mins time point in the calculation of the AUC0-60 min. Smaller values mean greater response to therapy. (NCT00534976)
Timeframe: Pre-exercise baseline to 60 minutes after the exercise challenge performed 24 hours post-dose

Interventionpercent fall * minute (Mean)
Montelukast229.19
Placebo349.59

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Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose

Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of study medication. The calculation used to produce the resulted results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise & Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy. (NCT00534976)
Timeframe: Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 24 hours post-dose

Interventionpercent fall in FEV1 (Mean)
Montelukast12.96
Placebo17.22

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Number of Participants Requiring Rescue Medication at 2 Hours Postdose

This endpoint was defined as the number of participants requiring rescue medication with β-agonist within the 90 mins following exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication. (NCT00534976)
Timeframe: 0-90 minutes after the exercise challenge at 2 hours postdose

Interventionparticipants (Number)
Montelukast1
Placebo2

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Number of Participants Requiring Rescue Medication at 24 Hours Postdose

This endpoint was defined as the number of participants requiring rescue medication with β-agonist within the 90 mins following exercise challenge. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of study medication. (NCT00534976)
Timeframe: 0-90 minutes after the exercise challenge at 24 hours postdose

InterventionParticipants (Number)
Montelukast0
Placebo2

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Time to Recovery From Maximum Percent Fall in FEV1 at 2 Hours Post-dose

"This endpoint was defined as the duration between the time at which the maximum percent fall in FEV1 occurred & the time when the percent fall in FEV1 returned to within 5% of the pre-exercise baseline for the first time.~Spirometry measurements were taken 5 mins prior to each exercise challenge & immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. If participant had not returned to within 5% of the pre-exercise FEV1 value by 60 mins, then measurements were obtained at 75 & 90 mins.~The 2-hour exercise challenges occurred 2 hours after the witnessed dose of medication." (NCT00534976)
Timeframe: 0-60 minutes and 0-90 minutes after the exercise challenge at 2 hours postdose

InterventionMinutes (Mean)
Montelukast16.21
Placebo24.48

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Time to Recovery From Maximum Percent Fall in FEV1 at 24 Hours Post-dose

This endpoint was defined as the duration between the time at which the maximum percent fall in FEV1 occurred & the time when the percent fall in FEV1 returned to within 5% of the pre-exercise baseline for the first time. Spirometry measurements were taken 5 mins prior to each exercise challenge & immediately, 5, 10, 15, 30, 45 & 60 mins after each exercise challenge. If participant had not returned to within 5% of the pre-exercise FEV1 value by 60 mins, then measurements were obtained at 75 & 90 mins. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of medication. (NCT00534976)
Timeframe: 0-60 minutes and 0-90 minutes after the exercise challenge at 24 hours postdose

InterventionMinutes (Mean)
Montelukast11.58
Placebo18.46

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Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose

Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins (minutes) after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication. The calculation used to produce the results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise & Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy. (NCT00534976)
Timeframe: Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 2 hours post-dose

InterventionPercent fall in FEV1 (Mean)
Montelukast15.35
Placebo20.00

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The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score

Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) consists of 14 questions to assess patient's overall quality of life related to allergic rhinitis on a scale of 0 (least impairment) to 6 (greatest impairment). The score is the mean of the 14 questions, ranging from 0 to 6. Change is computed as Week 8 score - Week 0 score (NCT00545844)
Timeframe: 8 weeks (from Week 0 to Week 8)

InterventionUnits on a Scale (Mean)
Treatment Phase (All Patients) Week 8-1.45

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Asthma Control

"Asthma control was assessed by the Canadian Asthma Consensus Guidelines at week 0 and week 8. Patients were considered uncontrolled if they answered yes to at least 2 of the 8 asthma control parameters." (NCT00545844)
Timeframe: 8 weeks (from Week 0 to Week 8)

,
InterventionParticipants (Number)
UncontrolledControlledMissing
Treatment Phase (All Patients) Week 031201
Treatment Phase (All Patients) Week 8722290

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Patient Global Allergic Rhinitis Symptoms Assessment

At week 0 and week 8, patients were asked to complete one question describing their perception of their allergic rhinitis symptoms. (NCT00545844)
Timeframe: 8 weeks (from Week 0 to Week 8)

,
InterventionParticipants (Number)
A non-issue as I do not have these symptomsNot really bothersomeBothersome a little of the timeBothersome some of the timeBothersome a good bit of the timeMissing
Treatment Phase (All Patients) Week 011357391949
Treatment Phase (All Patients) Week 8411297740131

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Patient Global Satisfaction

At week 0 and week 8, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication. (NCT00545844)
Timeframe: 8 weeks (from Week 0 to Week 8)

,
InterventionParticipants (Number)
Very satisfiedSatisfiedNeither satisfied or dissatisfiedDissatisfiedVery dissatisfiedMissing
Treatment Phase (All Patients) Week 0247710497110
Treatment Phase (All Patients) Week 8136110361612

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Physician Global Satisfaction

At week 0 and week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient's asthma controller medication. (NCT00545844)
Timeframe: 8 weeks (from Week 0 to Week 8)

,
InterventionParticipants (Number)
Very satisfiedSatisfiedNeither satisfied or dissatisfiedDissatisfiedVery dissatisfiedMissing
Treatment Phase (All Patients) Week 075410414242
Treatment Phase (All Patients) Week 8135110302510

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Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ)

The Asthma Control Questionnaire consists of 7 specific questions that were used to assess patient asthma control at week 0 and week 8. The mean score per question is used to determine the level of control, with a final score ranging from 0 (well-controlled) to 6 (extremely poorly controlled) units on a scale. (NCT00545844)
Timeframe: 8 weeks (from Week 0 to Week 8)

InterventionUnits on a Scale (Mean)
Treatment Phase (All Patients) Week 02.03
Treatment Phase (All Patients) Week 80.92

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Mean Change in Pruritus

"Mean change in pruritus scores from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. Pruritus assessments (itch) will be recorded for the previous 24 hours using a 4 point-scale, ranging from none (0) to severe (3). Scores are cumulative per week." (NCT00557284)
Timeframe: Baseline and 9 weeks

Interventionunits on a scale (Mean)
Treatment Arm-0.82
Placebo Arm0.32

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Mean Change in Serum IgE Levels

Mean change in serum levels of IgE from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. (NCT00557284)
Timeframe: Baseline and 9 weeks

InterventionkU/L (Mean)
Treatment Arm100.5
Placebo Arm216.1

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Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream

Average of weekly use of cetirizine and/or 10% hydrocortisone cream will be compared for all subjects in each arm from week 1 to week 9. Flare-up is defined as a worsening of the disease that is unacceptable to the participants and leads to second line topical steroid use and/or liquid anti-histamine use. Measurement is noted as 1 for daily use (does not correspond to multiple uses per day). (NCT00557284)
Timeframe: Baseline and 9 weeks

,
Interventiondays/week (Mean)
Cetirizine use10% Hydrocortisone cream use
Placebo Arm0.912.0
Treatment Arm-0.560.78

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Mean Change in Serum and Urinary Inflammatory Marker Levels

Mean change in levels from baseline to study visit 4 (week 1 compared to week 9)for interleukin 3 (IL3), tumor necrosis factor alpha (TNF alpha), nerve growth factor (NGF), and urinary leukotriene E4 (LTE4) (NCT00557284)
Timeframe: Baseline and 9 weeks

,
Interventionpg/ml (Mean)
IL3TNF alphaNGFUrine LTE4
Placebo Arm-7.9-16.4-58.8-20.42
Treatment Arm-9.02.330.9-2.1

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Change in Percentage of Body Involvement

Change in percentage of body involvement from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm for AD as measured by study investigator (NCT00557284)
Timeframe: Baseline and 9 weeks

InterventionChange of percentage in body involvement (Mean)
Treatment Arm-2.0
Placebo Arm0.15

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Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS

The mean change from baseline to study visit 4 (week 1 compared to week 9) in GRGS scores (GI symptoms will be recorded on *GSRS validated scale adjusted for pediatrics (*Gastrointestinal Symptoms in Patients with Irritable Bowel Syndrome and Peptic Ulcer Disease) for all subjects in each arm.This scale measures 7 different GI symptoms (1. abdominal pain; 2. nausea and vomiting; 3. abdominal dissention; 4. decreased passage of stools; 5. increased passage of stools; 6. loose stools; 7. hard stools) with severity ranges from 0 - 3 for each point (0 being no complaint and 3 being most severe for a maximum total of 21). (NCT00557284)
Timeframe: Baseline and 9 weeks

Interventionunits on a scale (Mean)
Treatment Arm-3.03
Placebo Arm-4.1

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Mean Change in Investigator Global Assessment (IGA)

The mean change in IGA from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. The IGA is a six-point measure of disease severity and is evaluated by the investigator based on the overall assessment of skin lesions: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5= very severe. (NCT00557284)
Timeframe: Baseline and 9 weeks

Interventionunits on a scale (Mean)
Treatment Arm-.11
Placebo Arm-.70

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Mean Change in PADC (Caregivers Perception of Disease Control)

Mean change in PADC from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. Caregiver's evaluation of disease control over the previous 7 days and will consist of a four-point scale ranging from complete control (0) to uncontrolled disease (3) (NCT00557284)
Timeframe: Baseline and 9 weeks

Interventionunits on a scale (Mean)
Treatment Arm-.78
Placebo Arm-0.10

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Change From Baseline in Fatigue and Daytime Sleepiness at 2 Weeks

"Daytime sleepiness was assessed on a scale of 0 (none) to 4 with 4 being severe.~To determine improvement of daytime sleepiness with active therapy we used a scale of 0 to 4 with 0 being no improvement and 4 being maximal improvement.~To determine improvement of daytime fatigue with active therapy we used a scale of 0 to 4 with 0 being no improvement and 4 being significant improvement.~For all three above we used data from the last 3 days were averaged and mean of change for each day." (NCT00590772)
Timeframe: baseline and 2 weeks

,
Interventionunits on a scale (Mean)
daytime sleepinessimproved daytime sleepinessimproved daytime fatigue
Montelukast-0.640.460.43
Placebo0.13-0.25-0.32

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Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose

Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I. (NCT00636207)
Timeframe: Up to 24 hours postdose

Interventionng/mL*hr (Mean)
Montelukast 0.1 mgNA
Montelukast 0.3 mgNA
Montelukast 0.3 mg RepeatNA
Montelukast 1 mg155
Montelukast 3 mg491
Montelukast 10 mg1600

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Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose

Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I. (NCT00636207)
Timeframe: Up to 24 hours postdose

Interventionng/mL (Mean)
Montelukast 0.1 mgNA
Montelukast 0.3 mg5.10
Montelukast 0.3 mg Repeat5.24
Montelukast 1 mg18.5
Montelukast 3 mg54.3
Montelukast 10 mg224

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Number of Participants Who Discontinued Study Drug Due to an Adverse Event

(NCT00636207)
Timeframe: Up to 7 days after last dose of study drug

Interventionparticipants (Number)
Montelukast 0.1 mg0
Montelukast 0.3 mg1
Montelukast 1 mg0
Montelukast 3 mg0
Montelukast 10 mg0
Placebo0

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Number of Participants Who Experienced At Least One Adverse Event

(NCT00636207)
Timeframe: Up to 14 days after last dose of study drug

Interventionparticipants (Number)
Montelukast 0.1 mg2
Montelukast 0.3 mg4
Montelukast 1 mg6
Montelukast 3 mg9
Montelukast 10 mg5
Placebo6

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Time to Cmax (Tmax) of Montelukast - Single Dose

Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I. (NCT00636207)
Timeframe: Up to 24 hours postdose

Interventionhours (Median)
Montelukast 0.1 mgNA
Montelukast 0.3 mg2.5
Montelukast 0.3 mg Repeat4.0
Montelukast 1 mg2.4
Montelukast 3 mg0.8
Montelukast 10 mg0.5

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AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses

The AUC 0-24hr Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of AUC 0-24hr on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III. (NCT00636207)
Timeframe: up to 10 days after first dose of study drug

,,
Interventionratio (Number)
Part II (n=6)Part III (n=6)
Montelukast 1 mg1.61NA
Montelukast 10 mg1.21.26
Montelukast 3 mg1.441.19

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AUC 0-24hr of Montelukast - Multiple Doses

Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III. (NCT00636207)
Timeframe: Up to 24 hours postdose

,,
Interventionng/mL*hr (Mean)
Part II Day 1 (n=6)Part II Day 5 (n=6)Part III Day 1 (n=6)Part III Day 10 (n=6)
Montelukast 1 mg132214NANA
Montelukast 10 mg1576185015001880
Montelukast 3 mg403576357526

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Tmax of Montelukast - Multiple Doses

Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III. (NCT00636207)
Timeframe: Up to 24 hours postdose

,,
Interventionhours (Median)
Part II Day 1 (n=6)Part II Day 5 (n=6)Part III Day 1 (n=6)Part III Day 10 (n=6)
Montelukast 1 mg2.40.7NANA
Montelukast 10 mg0.50.60.50.5
Montelukast 3 mg0.50.50.50.5

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Cmax Accumulation Ratio of Montelukast - Multiple Doses

The Cmax Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of Cmax on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III. (NCT00636207)
Timeframe: up to 10 days after first dose of study drug

,,
Interventionratio (Number)
Part II (n=6)Part III (n=6)
Montelukast 1 mg1.73NA
Montelukast 10 mg1.031.22
Montelukast 3 mg1.271.03

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Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose

Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I. (NCT00636207)
Timeframe: Up to 24 hours postdose

Interventionhours (Mean)
Montelukast 0.1 mgNA
Montelukast 0.3 mgNA
Montelukast 0.3 mg RepeatNA
Montelukast 1 mg5.7
Montelukast 3 mg6.9
Montelukast 10 mg5.7

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Cmax of Montelukast - Multiple Doses

Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III. (NCT00636207)
Timeframe: Up to 24 hours postdose

,,
Interventionng/mL (Mean)
Part II Day 1 (n=6)Part II Day 5 (n=6)Part III Day 1 (n=6)Part III Day 10 (n=6)
Montelukast 1 mg13.823.4NANA
Montelukast 10 mg233242184225
Montelukast 3 mg607644.364.8

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t1/2 of Montelukast - Multiple Doses

Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III. (NCT00636207)
Timeframe: Up to 24 hours postdose

,,
Interventionhours (Mean)
Part II Day 5 (n=6)Part III Day 10 (n=6)
Montelukast 1 mg8.2NA
Montelukast 10 mg7.77.4
Montelukast 3 mg7.68.1

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Number of Participants With Stable or Improved Predicted Forced Expiratory Volume 1 (FEV-1) With Published Literature

Responsive disease (RD) will be defined as ≥15% absolute improvement in the percentage predicted FEV-1. Progressive disease (PD) will be defined as >15% decrease in FEV-1 documented on 2 pulmonary function test (PFT) evaluations greater than 2 weeks apart. Stable disease (SD) will be defined as <15% change in the absolute FEV-1. (NCT00656058)
Timeframe: 180 days

InterventionParticipants (Count of Participants)
Increased 5-13% of predictedStableDeclinedMissing
Montelukast to Treat Bronchiolitis Obliterans5761

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Number of Participants With Improved, Stable or Declined Forced Expiratory Volume 1 (FEV-1) Slope at 6 Months

FEV-1 slope of decline was generated using regression line of FEV-1 value vs. days post hematopoietic stem cell transplant. Responsive disease (RD) for the slope of FEV-1 change will be an increase in the slope of absolute FEV-1. Progressive disease (PD) for the slope of FEV-1 change will be a decrease in the slope of absolute FEV-1. Stable disease (SD) for the slope of FEV-1 change will be a 0 change in FEV-1 slope. (NCT00656058)
Timeframe: 180 days

InterventionParticipants (Count of Participants)
ImprovedStableDeclined
Montelukast to Treat Bronchiolitis Obliterans991

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Number of Participants With Adverse Events

Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT00656058)
Timeframe: Date treatment consent signed to date off study, approximately 71 months and 17 days

InterventionParticipants (Count of Participants)
Montelukast to Treat Bronchiolitis Obliterans20

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Number of Non-Infected Participants at Baseline With Cysteinyl Leukotriene Receptor Expression on Cluster of Differentiation (CD4) and CD8 T Cells, Granulocytes, and Eosinophils in Bronchoalveolar Lavage (BAL) Fluid

Fluid from the bronchoalveolar lavage in adult participants (pediatric optional) will be collected and sent to the lab to be evaluated for infectious diseases by flow cytometry (NCT00656058)
Timeframe: Day 1 of study

InterventionParticipants (Count of Participants)
Montelukast to Treat Bronchiolitis Obliterans19

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Forced Expiratory Volume 1 (FEV-1)/Vital Capacity (VC)

Pulmonary function test performed for eligibility and baseline. (NCT00656058)
Timeframe: Baseline

InterventionRatio (Median)
Montelukast to Treat Bronchiolitis Obliterans0.5

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Percentage Overall 2-Year Survival

Percentage of participants alive at 2 years. (NCT00656058)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Montelukast to Treat Bronchiolitis Obliterans84

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Change From Baseline in Daytime Asthma Symptom Score

To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in daytime asthma symptom score (which could range from 0 [best] to 6 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. (NCT00666679)
Timeframe: Baseline and 2 weeks

InterventionUnits on a Scale (Least Squares Mean)
Montelukast + Mometasone-0.39
Placebo + Mometasone-0.24

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Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)

To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. (NCT00666679)
Timeframe: Baseline and 2 weeks

InterventionL (Liter) (Least Squares Mean)
Montelukast + Mometasone0.22
Placebo + Mometasone0.17

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Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) in Patients Who Met Lung Function Eligibility Criteria Specifically at the Randomization Visit.

To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period in patients who met lung function eligibility criteria at randomization; measurements taken at 1 and 2 weeks contributed to average. (NCT00666679)
Timeframe: Baseline and 2 Weeks

InterventionL (Liter) (Least Squares Mean)
Montelukast + Mometasone0.27
Placebo + Mometasone0.19

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Change From Baseline in Nighttime Asthma Symptom Score

To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in nighttime asthma symptom score (which could range from 0 [best] to 3 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. (NCT00666679)
Timeframe: Baseline and 2 weeks

InterventionUnits on a Scale (Least Squares Mean)
Montelukast + Mometasone-0.28
Placebo + Mometasone-0.18

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Change From Baseline in Total Daily β-agonist Use

To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on as-needed β-agonist use assessed by average change from baseline in total daily β-agonist use over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. (NCT00666679)
Timeframe: Baseline and 2 weeks

InterventionPuffs (Least Squares Mean)
Montelukast + Mometasone-0.87
Placebo + Mometasone-0.27

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Change From Baseline in Total Peripheral Blood Eosinophils

To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on change from baseline in total peripheral blood eosinophils during the 2 week treatment period. (NCT00666679)
Timeframe: Baseline and 2 weeks

Intervention10^3/microliter (Least Squares Mean)
Montelukast + Mometasone-0.05
Placebo + Mometasone0.02

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Percentage of Days With Asthma Control

To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma control assessed by average percentage of days with asthma control over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. (NCT00666679)
Timeframe: 2 weeks

InterventionPercentage of Days (Least Squares Mean)
Montelukast + Mometasone35.13
Placebo + Mometasone29.04

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Percentage of Days With Asthma Exacerbations

To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on worsening of asthma assessed by percentage of days with asthma exacerbations during the 2 week treatment period. (NCT00666679)
Timeframe: 2 Weeks

InterventionPercentage of Days (Least Squares Mean)
Montelukast + Mometasone9.71
Placebo + Mometasone15.14

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Sputum RANTES Levels

Week 24 sputum RANTES levels in active treatment groups were measured. (NCT00712335)
Timeframe: 24 weeks

Interventionpg/ml (Mean)
Asthmatic Smokers Treated With Combination Therapy42.79
Asthmatic Smoker Treated With Montelukast Only44.03
Non-smoking Asthmatic Treated With Combination Therapy41.78
Non-smoking Asthmatic Treated With Montelukast Only36.41

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Sputum Eosinophil Percentages

Secondary endpoints of inflammatory markers (sputum eosinophil percentages at 24 weeks) were measured in active treatment groups (NCT00712335)
Timeframe: 24 weeks

Interventionpercentage of eosinophils (Mean)
Asthmatic Smokers Treated With Combination Therapy2.33
Asthmatic Smoker Treated With Montelukast Only3.60
Non-smoking Asthmatic Treated With Combination Therapy1.60
Non-smoking Asthmatic Treated With Montelukast Only3.26

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Sputum IL-8 Levels

Week 24 sputum IL-8 levels in active treatment groups (NCT00712335)
Timeframe: 24 weeks

Interventionpg/ml (Mean)
Asthmatic Smokers Treated With Combination Therapy334545
Asthmatic Smoker Treated With Montelukast Only26,300
Non-smoking Asthmatic Treated With Combination Therapy3602
Non-smoking Asthmatic Treated With Montelukast Only317778

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Sputum Neutrophil Percentages

Week 24 sputum neutrophil percentages were measured in active treatment groups. (NCT00712335)
Timeframe: 24 weeks

Interventionpercentage of neutrophils (Mean)
Asthmatic Smokers Treated With Combination Therapy86.00
Asthmatic Smoker Treated With Montelukast Only72.53
Non-smoking Asthmatic Treated With Combination Therapy89.33
Non-smoking Asthmatic Treated With Montelukast Only79.84

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Sputum IFN-gamma/IL-5 Ratios

Week 24 sputum IFN-gamma/IL-5 ratios were determined in active treatment groups. (NCT00712335)
Timeframe: 24 weeks

Interventionratio (Mean)
Asthmatic Smokers Treated With Combination Therapy627.4
Asthmatic Smoker Treated With Montelukast Only272.4
Non-smoking Asthmatic Treated With Combination Therapy183.8
Non-smoking Asthmatic Treated With Montelukast Only279.0

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Sputum GM-CSF Levels

Week 24 sputum GM-CSF levels in active treatment groups were measured. (NCT00712335)
Timeframe: 24 weeks

Interventionpg/ml (Mean)
Asthmatic Smokers Treated With Combination Therapy17.60
Asthmatic Smoker Treated With Montelukast Only15.18
Non-smoking Asthmatic Treated With Combination Therapy13.92
Non-smoking Asthmatic Treated With Montelukast Only12.16

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Sputum Eotaxin Levels

Week 24 sputum eotaxin levels in active treatment groups were measured. (NCT00712335)
Timeframe: 24 weeks

Interventionpg/ml (Mean)
Asthmatic Smokers Treated With Combination Therapy47.13
Asthmatic Smoker Treated With Montelukast Only87.90
Non-smoking Asthmatic Treated With Combination Therapy65.14
Non-smoking Asthmatic Treated With Montelukast Only64.61

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Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration

FEV1 measurements taken at 0 (=baseline), 15, 30, 60, and 90 minutes after albuterol/placebo administration contributed to the average change from baseline over 90 minutes. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement. (NCT00739297)
Timeframe: 4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast

InterventionL (Least Squares Mean)
Montelukast+Albuterol0.34
Montelukast+ Placebo0.15

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Change From Baseline in FEV1 Over 4 Hours

FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement. (NCT00739297)
Timeframe: 0 (=baseline) to 4 hours after treatment with montelukast

InterventionL (Liter) (Least Squares Mean)
Placebo0.03
25 mcg Montelukast0.07
100 mcg Montelukast0.13
250 mcg Montelukast0.10
500 mcg Montelukast0.09
1000 mcg Montelukast0.12

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Change From Baseline in FEV1 at 8 Hours After Treatment With Montelukast

Average change from baseline in FEV1 at 8 hours after single dose montelukast administration. (NCT00739297)
Timeframe: 0 (baseline) and 8 hours after treatment with montelukast

InterventionL (Least Squares Mean)
Placebo0.06
25 mcg Montelukast0.11
100 mcg Montelukast0.13
250 mcg Montelukast0.11
500 mcg Montelukast0.12
1000 mcg Montelukast0.14

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Change From Baseline in FEV1 at 24 Hours After Treatment With Montelukast

Average change from baseline in FEV1 at 24 hours after single dose montelukast administration. (NCT00739297)
Timeframe: 0 (baseline) and 24 hours after treatment with montelukast

InterventionL (Least Squares Mean)
Placebo0.02
25 mcg Montelukast0.05
100 mcg Montelukast0.10
250 mcg Montelukast0.06
500 mcg Montelukast0.08
1000 mcg Montelukast0.09

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Physician Global Satisfaction

At week 0, 4, 8 and 12, physicians were asked to complete a single question describing how satisfied they were regarding the asthma controller medication for each of their enrolled patients. (NCT00832455)
Timeframe: week 0, 4, 8 and 12

,,,
InterventionParticipants (Number)
Very satisfiedSatisfiedNeither Satisfied or DissatisfiedDissatisfiedVery DissatisfiedMissing
Montelukast ITT at Week 022396266267
Montelukast ITT at Week 12186136321432
Montelukast ITT at Week 41301481012813
Montelukast ITT at Week 811610022702

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Patient Global Satisfaction

At week 0, 4, 8 and 12, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication. (NCT00832455)
Timeframe: Week 0, 4, 8 and 12

,,,
InterventionParticipants (Number)
Very SatisfiedSatisfiedNeither Satisfied or DissatisfiedDissatisfiedVery DissatisfiedMissing
Montelukast ITT at Week 01162137190182
Montelukast ITT at Week 1219412048722
Montelukast ITT at Week 4145161742632
Montelukast ITT at Week 81298724601

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Asthma Control Questionnaire (ACQ)

ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms. (NCT00832455)
Timeframe: Week 0, 4, and 12

,,
InterventionParticipants (Number)
Not tapered and Not well controlledNot tapered and Well controlledTapered and Not well controlledTapered and Well controlledMissing
Montelukast ITT at Week 014420815431
Montelukast ITT at Week 128221614601
Montelukast ITT at Week 46012114520

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Asthma Control Questionnaire (ACQ)

ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms. (NCT00832455)
Timeframe: Week 0, 4, and 12

,,
InterventionParticipants (Number)
Not well controlledWell controlledMissing
Montelukast ITT at Week 0328911
Montelukast ITT at Week 12962761
Montelukast ITT at Week 41592511

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Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)

"The change in the quality of life of the caregivers of patients treated with montelukast for the control of asthma used in combination with inhaled corticosteroids, using the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ).~PACQLQ score ranges between 1 (severe impairment) and 7 (no impairment) where a higher score indicates better quality of life. An average change in overall score ≥0.7 is considered clinically significant. Changes between visits and baseline are described." (NCT00832455)
Timeframe: Weeks 4, 8, and 12

InterventionUnits on a Scale (Mean)
Montelukast ITT at Week 41.06
Montelukast ITT at Week 81.39
Montelukast ITT at Week 121.36

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Duration of Cough

(NCT00863317)
Timeframe: up to 4 weeks

Interventiondays (Median)
Montelukast13
Placebo11

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Changes in SCORAD Index

Changes of SCORAD(SCORing Atopic Dermatitis) index after taking Montelukast or placebo drug. SCORAD calculation: Extent(%)/5 + 7*Intensity/2 + subjective symptoms (minimum score 0, maximum score 103) (SCORAD index >40: severe, 15-40:moderate, <15: mild) (NCT00903357)
Timeframe: 18 weeks after patient recruitment

Interventionunits on a scale (Mean)
Montelukast Sodium-3.0
Placebo Drug-5.7

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Changes in Urinary EDN

Changes of Urinary EDN(Eosinophil Derived Neurotoxin) after taking Montelukast or placebo drug. Urinary EDN levels were measured using an ELISA (MBL, Woburn, MA, USA) and the intra-assay and inter-assay variations were 3.0 ± 0.5 and 7.7 ± 1.5, respectively. Minimum value: 0, Maximum value: 2040 ng/ml. (NCT00903357)
Timeframe: 18 weeks after participants recruitment

InterventionUrine EDN (ng/ml) (Mean)
Montelukast Sodium37.0
Placebo Drug-195.8

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Changes in Urinary LTE4

Changes of Urinary LTE4(Leukotrien E4) after taking Montelukast or placebo drug. Urinary LTE4 levels were measured using an enzyme-linked immunoassay (ELISA) (Cayman Chemical, Michigan, USA) and the intra-assay and inter-assay variations were 7.4 ± 2.1 and 12.4 ± 7.8, respectively. Minimum value : 0 Maximum vlaue: 1000 pg/ml. (NCT00903357)
Timeframe: 18 weeks after patient recruitment

InterventionUrinary LTE4 (pg/ml) (Mean)
Montelukast Sodium-65.9
Placebo Drug87.7

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Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use

Beta-agonist medication use from the daytime and overnight asthma symptoms diaries for each 24-hour period was added to determine the daily total number of puffs used. The average daily number of puffs for the visit was determined as the average daily number of puffs over all days between consecutive visits. (NCT00911547)
Timeframe: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

InterventionPercent Change (Least Squares Mean)
Placebo59.20
Montelukast44.48
Beclomethasone6.04
Montelukast+ Beclomethasone-5.51

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Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma

Mean percent change from baseline in FEV1 in patients with chronic asthma averaged over 16 weeks for the Beclo and MK+ Beclo groups and averaged over last 10 weeks for the Placebo and MK groups (NCT00911547)
Timeframe: Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups

InterventionPercentage of Change (Least Squares Mean)
Placebo-11.96
Montelukast-5.31
Beclomethasone0.72
Montelukast+ Beclomethasone5.08

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Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only

"Mean change from baseline in Nocturnal asthma score; the patient scored his/her symptoms [from 0 (best) to 3 (worst)] on a daily basis. Responses to the question, Did you wake up with asthma symptoms? (no, once, more than once, awake all night), were assigned numerical values (0, 1, 2, 3, respectively).~The average score for the visit was determined by averaging the daily scores over all days between consecutive visits." (NCT00911547)
Timeframe: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

InterventionUnits on a Scale (Least Squares Mean)
Placebo0.17
Montelukast0.18
Beclomethasone-0.06
Montelukast+ Beclomethasone-0.20

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Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma

Morning PEFR was measured in triplicate immediately upon arising before taking any medication and the best value recorded on the overnight asthma symptoms diary. The mean morning PEFR for the visit was determined by averaging all valid PEFR measurements for the days between consecutive visits. (NCT00911547)
Timeframe: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

InterventionLiters/minute (Least Squares Mean)
Placebo-27.10
Montelukast-15.37
Beclomethasone2.65
Montelukast+ Beclomethasone10.41

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Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma

"The daily daytime symptom score was determined by averaging the daily scores (the patient scored his/her symptoms [from 0 (best) to 6 (worst)] on a daily basis.) for the four questions on the Daytime Asthma Symptoms Diary.~The average daytime symptom score for the visit was determined by averaging the daily symptom scores over all days between two consecutive visits." (NCT00911547)
Timeframe: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

InterventionUnits on a Scale (Least Squares Mean)
Placebo0.31
Montelukast0.27
Beclomethasone-0.02
Montelukast+ Beclomethasone-0.13

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Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product (NCT00943397)
Timeframe: Up to 52 weeks of treatment

,
InterventionParticipants (Number)
With CAEsWithout CAEs
Montelukast1562
Usual Care311

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Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product (NCT00943683)
Timeframe: During the 6 weeks of treatment

,
InterventionParticipants (Number)
With CAEsWithout CAEs
Montelukast13243
Placebo6219

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Patient's Global Evaluation of Allergic Rhinitis

An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, in answer to a single question regarding the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse). (NCT00960141)
Timeframe: Week 2 (or upon discontinuation)

InterventionUnits on a Scale (Least Squares Mean)
Placebo2.62
Montelukast2.43
Loratadine2.27

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Mean Change From Baseline in Daytime Eye Symptoms Score

Mean change from baseline in Daytime Eye Symptoms scores on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual eye symptoms scores (tearing, itchy, red, and puffy eyes) was reported as the Daytime Eye Symptoms Score. (NCT00960141)
Timeframe: Baseline and Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo-0.23
Montelukast-0.29
Loratadine-0.35

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Physician's Global Evaluation of Allergic Rhinitis

An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse). (NCT00960141)
Timeframe: Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo2.53
Montelukast2.35
Loratadine2.26

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Mean Change From Baseline in Daytime Nasal Symptoms Score

Mean change from baseline in Daytime Nasal Symptoms score on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) was reported as the Daytime Nasal Symptoms Score. (NCT00960141)
Timeframe: Baseline and Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo-0.32
Montelukast-0.38
Loratadine-0.47

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Mean Change From Baseline in Nighttime Symptoms Score

Mean change from baseline in Nighttime Symptoms Score on a 4-point scale [0(best) to 3(worst)]. The average of 3 scores (Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings) was reported as the Nighttime Symptoms Score. (NCT00960141)
Timeframe: Baseline and Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo-0.18
Montelukast-0.28
Loratadine-0.26

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Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score

Patients completed a validated, self-administered questionnaire, which included 28 questions on a 7-point scale [score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then the scores for the 7 domains were averaged for the overall score. (NCT00960141)
Timeframe: Baseline and Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo-0.75
Montelukast-0.85
Loratadine-0.97

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Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment

An evaluation by the patient, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study. (NCT00963469)
Timeframe: After first 2 weeks of treatment

InterventionScores on a scale (Least Squares Mean)
Placebo2.73
Montelukast2.43
Loratadine2.30

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Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period

Composite Symptoms Scores were computed as the average of Daytime Nasal Scores [Score 0 (best) to 3 (worst)] and Nighttime Symptoms Scores [Score 0 (best) to 3 (worst)]. (NCT00963469)
Timeframe: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)

InterventionScores on a scale (Least Squares Mean)
Placebo-0.21
Montelukast-0.30
Loratadine-0.36

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Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment

An evaluation by the physician, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study. (NCT00963469)
Timeframe: After first 2 weeks of treatment

InterventionScores on a scale (Least Squares Mean)
Placebo2.75
Montelukast2.36
Loratadine2.38

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Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period

"Mean change from baseline in Nighttime Symptoms Score.~Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worse)], and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score." (NCT00963469)
Timeframe: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)

InterventionScores on a scale (Least Squares Mean)
Placebo-0.18
Montelukast-0.28
Loratadine-0.25

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Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period

Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activity,sleep,non-nose/eye symptoms,practical problems,nasal symptoms, eye symptoms, and emotions. The scores for each domain were averaged, then scores for the 7 domains were averaged for an overall score. (NCT00963469)
Timeframe: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)

InterventionScores on a scale (Least Squares Mean)
Placebo-0.55
Montelukast-0.85
Loratadine-0.85

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Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period

"Mean change from baseline in Daytime Nasal Symptoms Score.~Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4- point scale [Score 0 (best) to 3 (worse)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score." (NCT00963469)
Timeframe: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)

InterventionScores on a scale (Least Squares Mean)
Placebo-0.23
Montelukast-0.33
Loratadine-0.45

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Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period

"Mean change from baseline in Daytime Eye Symptoms scores.~Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score." (NCT00963469)
Timeframe: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)

InterventionScores on a scale (Least Squares Mean)
Placebo-0.18
Montelukast-0.28
Loratadine-0.33

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Mean Change From Baseline in Nasal Congestion Upon Awakening

Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)). (NCT00963599)
Timeframe: Baseline and Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo-0.15
Montelukast-0.35
Loratadine-0.30
Montelukast/Loratadine-0.32

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Mean Change From Baseline in Daytime Sneezing Score

Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)). (NCT00963599)
Timeframe: Baseline and Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo-0.26
Montelukast-0.46
Loratadine-0.59
Montelukast/Loratadine-0.67

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Mean Change From Baseline in Daytime Rhinorrhea Score

Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)). (NCT00963599)
Timeframe: Baseline and Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo-0.25
Montelukast-0.53
Loratadine-0.51
Montelukast/Loratadine-0.59

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Mean Change From Baseline in Daytime Nasal Symptoms Score

Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale (0 (best) to 3 (worst)). The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. (NCT00963599)
Timeframe: Baseline and Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo-0.26
Montelukast-0.48
Loratadine-0.52
Montelukast/Loratadine-0.58

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Mean Change From Baseline in Daytime Nasal Itching Score

Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)). (NCT00963599)
Timeframe: Baseline and Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo-0.26
Montelukast-0.49
Loratadine-0.56
Montelukast/Loratadine-0.62

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Mean Change From Baseline in Daytime Nasal Congestion Score

Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)). (NCT00963599)
Timeframe: Baseline and Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo-0.19
Montelukast-0.41
Loratadine-0.39
Montelukast/Loratadine-0.43

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Mean Change From Baseline in Daytime Eye Symptoms Score

Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale (0 (best) to 3 (worst)). The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. (NCT00963599)
Timeframe: Baseline and Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo-0.14
Montelukast-0.35
Loratadine-0.38
Montelukast/Loratadine-0.41

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Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)

Composite Symptoms scores were computed as the average of the Daytime Nasal Symptoms scores and Nighttime Symptoms scores collected on a 4 point scale (0 (best) to 3 (worst)). (NCT00963599)
Timeframe: Baseline and Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo-0.2
Montelukast-0.40
Loratadine-0.41
Montelukast/Loratadine-0.45

[back to top]

Patient's Global Evaluation of Allergic Rhinitis

An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse). (NCT00963599)
Timeframe: Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo2.37
Montelukast2.10
Loratadine2.00
Montelukast/Loratadine1.92

[back to top]

Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score

Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire, 28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional. Scores per domain were averaged, then scores for the 7 domains were averaged for an overall score. (NCT00963599)
Timeframe: Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo-0.80
Montelukast-1.09
Loratadine-1.06
Montelukast/Loratadine-1.16

[back to top]

Mean Change From Baseline in Nighttime Symptoms Score

Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale (0 (best) to 3 (worst)), and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. (NCT00963599)
Timeframe: Baseline and Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo-0.12
Montelukast-0.29
Loratadine-0.26
Montelukast/Loratadine-0.28

[back to top]

Physician's Global Evaluation of Allergic Rhinitis

An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse). (NCT00963599)
Timeframe: Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo2.35
Montelukast2.13
Loratadine2.05
Montelukast/Loratadine1.99

[back to top]

Number of Patients Who Were Discontinued Due to LAEs

(NCT00968149)
Timeframe: 2 weeks

,
InterventionParticipants (Number)
Discontinued Due to LAEsDid Not Discontinue Due to LAEs
Montelukast 4 mg and 5 mg0272
Placebo0129

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Number of Patients With Laboratory Adverse Experiences (LAEs)

A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product (NCT00968149)
Timeframe: 2 weeks

,
InterventionParticipants (Number)
With LAEsWithout LAEs
Montelukast 4 mg and 5 mg2270
Placebo3126

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Number of Patients With Clinical Adverse Experiences (CAEs)

A clinical adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product (NCT00968149)
Timeframe: 2 weeks

,
InterventionParticipants (Number)
With CAEsWithout CAEs
Montelukast 4 mg and 5 mg73207
Placebo3598

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Number of Patients Who Were Discontinued Due to CAEs

(NCT00968149)
Timeframe: 2 weeks

,
InterventionParticipants (Number)
Discontinued Due to CAEsDid Not Discontinue Due to CAEs
Montelukast 4 mg and 5 mg5275
Placebo1132

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Number of Patients With Serious LAEs

Serious LAEs are any LAEs occurring at any dose that: Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose (NCT00968149)
Timeframe: 2 weeks

,
InterventionParticipants (Number)
With Serious LAEsWithout Serious LAEs
Montelukast 4 mg and 5 mg0272
Placebo0129

[back to top]

Number of Patients With Serious CAEs

Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose (NCT00968149)
Timeframe: 2 weeks

,
InterventionParticipants (Number)
With Serious CAEsWithout Serious CAEs
Montelukast 4 mg and 5 mg1279
Placebo0133

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Number of Patients Who Were Discontinued Due to CAEs - Extension

Patients who were discontinued due to CAEs up to 2.8 years of treatment (NCT00968201)
Timeframe: up to 2.8 years

,
InterventionParticipants (Number)
Discontinued Due to CAEsDid Not Discontinue Due to CAEs
Montelukast18346
Usual Care5152

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Number of Patients Who Were Discontinued Due to CAEs - Base Study

Patients who were discontinued due to CAEs during 12 weeks of treatment (NCT00968201)
Timeframe: 12 weeks of treatment

,
InterventionParticipants (Number)
Discontinued Due to CAEsDid Not Discontinue Due to CAEs
Montelukast16445
Placebo7221

[back to top]

Number of Patients Who Were Discontinued Due to LAEs - Extension

Patients who were discontinued due to LAEs up to 2.8 years of treatment (NCT00968201)
Timeframe: up to 2.8 years

,
InterventionParticipants (Number)
Discontinued Due to LAEsDid Not Discontinue Due to LAEs
Montelukast4353
Usual Care0154

[back to top]

Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study

Patients who were discontinued due to serious CAEs during 12 weeks of treatment (NCT00968201)
Timeframe: 12 weeks of treatment

,
InterventionParticipants (Number)
Discontinued Due to Serious CAEsDid Not Discontinue Due to Serious CAEs
Montelukast8453
Placebo2226

[back to top]

Number of Patients With Serious LAEs - Extension

Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose (NCT00968201)
Timeframe: up to 2.8 years

,
InterventionParticipants (Number)
With Serious LAEsWithout Serious LAEs
Montelukast1356
Usual Care0154

[back to top]

Number of Patients Who Were Discontinued Due to Serious CAEs - Extension

Patients who were discontinued due to serious CAEs with up to 2.8 years of treatment (NCT00968201)
Timeframe: up to 2.8 years

,
InterventionParticipants (Number)
Discontinued Due to Serious CAEsDid Not Discontinue Due to Serious CAEs
Montelukast9355
Usual Care1156

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Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product (NCT00968201)
Timeframe: 12 weeks of treatment

,
InterventionParticipants (Number)
With CAEsWithout CAEs
Montelukast40655
Placebo20226

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Number of Patients Who Were Discontinued Due to Serious LAEs - Extension

Patients who were discontinued due to serious LAEs with up to 2.8 years of treatment (NCT00968201)
Timeframe: up to 2.8 years

,
InterventionParticipants (Number)
Discontinued Due to Serious LAEsDid Not Discontinue Due to Serious LAEs
Montelukast1356
Usual Care0154

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Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product (NCT00968201)
Timeframe: up to 2.8 years

,
InterventionParticipants (Number)
With CAEWithout CAE
Montelukast35311
Usual Care1498

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Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study

A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product (NCT00968201)
Timeframe: 12 weeks of treatment

,
InterventionParticipants (Number)
With LAEsWithout LAEs
Montelukast16435
Placebo12212

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Number of Patients With Serious CAEs Reported by Patients - Extension

Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose (NCT00968201)
Timeframe: up to 2.8 years

,
InterventionParticipants (Number)
With Serious CAEsWithout Serious CAEs
Montelukast38326
Usual Care15142

[back to top]

Number of Patients With Serious CAEs Reported by Patients - Base Study

Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose (NCT00968201)
Timeframe: 12 weeks of treatment

,
InterventionParticipants (Number)
With Serious CAEsWithout Serious CAEs
Montelukast17444
Placebo9219

[back to top]

Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension

A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product (NCT00968201)
Timeframe: up to 2.8 years

,
InterventionParticipants (Number)
With LAEsWithout LAEs
Montelukast42315
Usual Care14140

[back to top]

Number of Patients Who Were Discontinued Due to LAEs - Base Study

Patients who were discontinued due to LAEs during 12 weeks of treatment (NCT00968201)
Timeframe: 12 weeks of treatment

,
InterventionParticipants (Number)
Discontinued Due to LAEsDid Not Discontinue Due to LAEs
Montelukast0451
Placebo1223

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Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period

An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study. (NCT00972738)
Timeframe: End of the 2-week treatment period

InterventionScores on a scale (Least Squares Mean)
Montelukast 10 mg2.18
Loratadine 10 mg2.19
Placebo2.49

[back to top]

Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period

Patients completed a validated, self-administered Rhinoconjunctivitis Quality-of-Life Questionnaire, which included 28 questions on a 7-point scale [Score 0 (best) to 6 (worst)], across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The individual domain scores were calculated as the average values of all scores within a domain, then the scores for the 7 domains were averaged for the overall score. (NCT00972738)
Timeframe: Baseline and at the end of 2-week treatment period

InterventionScores on a scale (Least Squares Mean)
Montelukast 10 mg-0.90
Loratadine 10 mg-0.98
Placebo-0.66

[back to top]

Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period

Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptoms of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point [Scale 0 (best) to 3 (worst)]. The average of the individual symptoms scores was reported as the Nighttime Symptoms Score. (NCT00972738)
Timeframe: Baseline and over the 2-week treatment period

InterventionScores on a scale (Least Squares Mean)
Montelukast 10 mg-0.28
Loratadine 10 mg-0.28
Placebo-0.20

[back to top]

Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period

Mean change from baseline in Daytime Nasal Symptoms. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. (NCT00972738)
Timeframe: Baseline and over the 2-week treatment period

InterventionScores on a scale (Least Squares Mean)
Montelukast 10 mg-0.38
Loratadine 10 mg-0.47
Placebo-0.29

[back to top]

Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period

Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale [0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. (NCT00972738)
Timeframe: Baseline and over the 2-week treatment period

InterventionScores on a scale (Least Squares Mean)
Montelukast 10 mg-0.28
Loratadine 10 mg-0.40
Placebo-0.21

[back to top]

Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period

An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study. (NCT00972738)
Timeframe: End of the 2-week treatment period

InterventionScores on a scale (Least Squares Mean)
Montelukast 10 mg2.18
Loratadine 10 mg2.16
Placebo2.41

[back to top]

Physician's Global Evaluation of Allergic Rhinitis

An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study. (NCT00974571)
Timeframe: End of the first 4 weeks in 6-week treatment period

InterventionScores on a scale (Least Squares Mean)
Montelukast 10 mg2.26
Cetirizine 10 mg2.20
Placebo2.33

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Patient's Global Evaluation of Allergic Rhinitis

An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study. (NCT00974571)
Timeframe: End of the first 4 weeks in 6-week treatment period

InterventionScores on a scale (Least Squares Mean)
Montelukast 10 mg2.22
Cetirizine 10 mg2.15
Placebo2.41

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Mean Change From Baseline in Nighttime Symptoms Score

"Mean change from baseline in Nighttime Symptoms Score.~Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worst)], and the average score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score." (NCT00974571)
Timeframe: Baseline and first 4 weeks in 6-week treatment period

InterventionScores on a scale (Least Squares Mean)
Montelukast 10 mg-0.28
Cetirizine 10 mg-0.30
Placebo-0.26

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Mean Change From Baseline in Composite Symptoms Score

Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores [Score 0 (best) to 3 (worst)]. and Nighttime Symptoms Scores collected [Score 0 (best) to 3 (worst)]. (NCT00974571)
Timeframe: Baseline and first 4 weeks in 6-week treatment period

InterventionScore 0 (best) to 3 (worst) (Least Squares Mean)
Montelukast 10 mg-0.34
Cetirizine 10 mg-0.38
Placebo-0.30

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Mean Change From Baseline in Daytime Nasal Symptoms Score

"Mean change from baseline in Daytime Nasal Symptoms score.~Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score." (NCT00974571)
Timeframe: Baseline and first 4 weeks of a 6-week treatment period

InterventionScores on a scale (Least Squares Mean)
Montelukast 10 mg-0.39
Cetirizine 10 mg-0.45
Placebo-0.36

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Patient's Global Evaluation of Allergic Rhinitis at Week 2

"An evaluation by the patient, administered at the last visit (or~upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the~study. Scores were measured as 0 (best) to 6 (worst)." (NCT00979901)
Timeframe: Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo2.62
Montelukast 10 mg2.20
Loratadine 10 mg2.13

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Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2

Patients completed the validated, self-administered RQLQ, which included 28 items on a 7-point scale across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Scores for each domain were averaged, then scores for the 7 domains were averaged for the overall score. Scores were measured as 0 (best) to 6 (worst). (NCT00979901)
Timeframe: Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo-0.65
Montelukast 10 mg-0.89
Loratadine 10 mg-0.99

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Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks

"Mean change from baseline in Nighttime Symptoms Score.~Patients were asked to rate each symptom daily on a 4-point scale, and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. Scores were measured as 0 (best) to 3 (worst)." (NCT00979901)
Timeframe: Baseline and Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo-0.14
Montelukast 10 mg-0.27
Loratadine 10 mg-0.23

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Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks

"Mean change from baseline in Daytime Nasal Symptoms score.~Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily~on a 4-point scale. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal~Symptoms Score. Scores were measured as 0 (best) to 3 (worst)." (NCT00979901)
Timeframe: Baseline and Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo-0.24
Montelukast 10 mg-0.37
Loratadine 10 mg-0.47

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Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks

"Mean change from baseline in Daytime Eye Symptoms scores.~Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. Scores were measured as 0 (best) to 3 (worst)." (NCT00979901)
Timeframe: Baseline and Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo-0.12
Montelukast 10 mg-0.26
Loratadine 10 mg-0.32

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Physician's Global Evaluation of Allergic Rhinitis at Week 2

An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Scores were measured as 0 (best) to 6 (worst). (NCT00979901)
Timeframe: Week 2

InterventionUnits on a Scale (Least Squares Mean)
Placebo2.53
Montelukast 10 mg2.23
Loratadine 10 mg2.17

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Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes

Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge (NCT01061333)
Timeframe: Pre-allergen challenge and 5 minutes post allergen challenge

InterventionFold change over baseline (Geometric Mean)
Placebo0.77
Nedocromil0.97
Montelukast1.08
Mometasone1.00

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Change in Plasma 9P at 20 Minutes

Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge (NCT01061333)
Timeframe: Pre-allergen challenge and 20 minutes post allergen challenge

InterventionFold change over baseline (Geometric Mean)
Placebo1.22
Nedocromil0.72
Montelukast0.72
Mometasone1.06

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Change in Forced Expiratory Volume in 1 Second (FEV1)

Maximal percent drop in FEV1 at 20 minutes post allergen challenge (NCT01061333)
Timeframe: Pre-allergen challenge and 20 minutes after allergen challenge

InterventionPercentage drop in FEV1 (Least Squares Mean)
Placebo-24.66
Nedocromil-8.44
Montelukast-9.15
Mometasone-16.17

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Allergen-induced Concentrations of Sputum LTE4

Concentrations of LTE4 in sputum at 2 hours post-allergen challenge (NCT01061333)
Timeframe: 2 hours post allergen challenge

Interventionpg/mL (Geometric Mean)
Placebo115.5
Nedocromil149.8
Montelukast181.3
Mometasone140.3

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Allergen-induced Concentrations of Sputum LTD4

Concentrations of LTD4 in sputum at 2 hours post-allergen challenge (NCT01061333)
Timeframe: 2 hours post allergen challenge

Interventionpg/mL (Geometric Mean)
Placebo17.48
Nedocromil18.04
Montelukast18.52
Mometasone17.37

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Allergen-induced Concentrations of Sputum LTC4

Concentrations of LTC4 in sputum at 2 hours post-allergen challenge (NCT01061333)
Timeframe: 2 hours post allergen challenge

Interventionpg/mL (Geometric Mean)
Placebo13.63
Nedocromil14.02
Montelukast13.76
Mometasone12.14

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Allergen-induced Changes in Urinary Leukotriene (LT) E4

Fold change over baseline in urinary LTE4 at 2 hours post-allergen challenge (NCT01061333)
Timeframe: Baseline and 2 hours post allergen challenge

InterventionFold change over baseline (Geometric Mean)
Placebo1.77
Nedocromil1.19
Montelukast1.40
Mometasone1.62

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Allergen-induced Changes in Urinary 9P

Fold change over baseline in Urinary 9P at 2 hours post allergen challenge (NCT01061333)
Timeframe: Baseline and 2 hours post allergen challenge

InterventionFold change over baseline (Geometric Mean)
Placebo1.54
Nedocromil1.39
Montelukast1.45
Mometasone1.40

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Number of Participants With a Decrease in the Number of Apnea and/or Hypopnea Events to <5 Per Hour of Sleep

by decreasing nasal congestion, we hope to decrease the number of respiratory events per hour of sleep back to the normal range (NCT01089647)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Budesonide and Montelukast5
Placebo3

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Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment

"Forced expiratory volume in one second (FEV1) % predicted trough change from baseline (mean observed in the 2 weeks prior to treatment) after 6 weeks of treatment, where trough FEV1 % predicted was defined as the mean of the FEV1 % predicted trough values at 25 minutes and 10 minutes prior to dosing on clinic visit.~MMRM in the statistical test comments is Mixed effects model with repeated measures." (NCT01103349)
Timeframe: Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.

InterventionFEV1 percent predicted (Mean)
Placebo-0.859
BI 671800 400 mg Bid3.011
Montelukast 10 mg qd1.510

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Asthma Control Questionnaire (ACQ) Mean Change in Score on a Scale From Baseline After Six Weeks of Treatment

"Asthma Control Questionnaire (ACQ) mean score change from baseline (mean ACQ score obtained at Week 0) after six weeks of treatment.~The Asthma Control Questionnaire (ACQ) is a patient-reported outcome questionnaire containing 7 items. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore between 0 (well controlled) and 6 (extremely poorly controlled) These questions based on recall of the previous 7 days comprise breathlessness, nocturnal waking, symptoms on waking, activity limitation, wheeze, frequency of Short-acting beta-adrenergic (SABA) use, and categorized pre-bronchodilator FEV1% predicted." (NCT01103349)
Timeframe: Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment.

InterventionScore on a scale (Mean)
Placebo-0.418
BI 671800 400 mg Bid-0.698
Montelukast 10 mg qd-0.598

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Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period

The number of inhalations of rescue SABA, salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. Participants who used salbutamol/albuterol inhalation aerosol at day-time were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged number of day-time salbutamol/albuterol inhalation aerosol used during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants). (NCT01147744)
Timeframe: Baseline up to Week

InterventionDay-time number of inhalations (Least Squares Mean)
Placebo-0.42
GSK2190915 10mg-0.55
GSK2190915 30mg-0.68
GSK2190915 100mg-0.50
GSK2190915 300mg-0.47
Fluticasone Propionate 100 mcg-0.67
Montelukast 10mg-0.63

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Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period

Participants recorded their night-time asthma symptom score in an eDiary each AM upon rising and before taking any rescue or study medication and before assessing the PEF measurement during the 8-Week treatment period. Night-time asthma symptom scores, as: 0=no asthma symptoms, 1= one awakening or waking early due to asthma symptoms, 2= two or more awakenings due to asthma symptoms (including waking early), 3= asthma symptoms almost prevented the participant from sleeping, 4= severe asthma symptoms completely prevented from sleeping. Change from Baseline was calculated as the averaged of night-time asthma symptom score during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants). (NCT01147744)
Timeframe: Baseline up to Week 8

InterventionNight-time symptom scores on a scale (Least Squares Mean)
Placebo-0.23
GSK2190915 10mg-0.21
GSK2190915 30mg-0.33
GSK2190915 100mg-0.26
GSK2190915 300mg-0.22
Fluticasone Propionate 100 mcg-0.29
Montelukast 10mg-0.32

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Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period

Asthma symptoms were recorded in a daily electronic diary (eDiary) by the participants every day in the evening at bedtime and before taking any rescue or study medication and before the assessment of the PEF measurement. Participant's responses to evening assessments indicated no symptoms were considered to be symptom free. For participants, the symptom free days were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of symptom-free days during the 8-Week treatment period minus the Baseline value. Baseline was defined as the last 7 days prior to randomization of the participants. (NCT01147744)
Timeframe: Baseline up to Week 8

InterventionPercentage of symptom-free days (Least Squares Mean)
Placebo13.98
GSK2190915 10 mg15.15
GSK2190915 30 mg18.54
GSK2190915 100 mg15.31
GSK2190915 300 mg14.06
Fluticasone Propionate 100 mcg22.18
Montelukast 10 mg16.87

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Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period

The number of inhalations of rescue salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. For participants, the rescue-free days were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of rescue-free days during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants). (NCT01147744)
Timeframe: Baseline up to Week 8

InterventionPercentage of rescue-free days (Least Squares Mean)
Placebo16.80
GSK2190915 10 mg22.91
GSK2190915 30 mg20.91
GSK2190915 100 mg18.95
GSK2190915 300 mg18.51
Fluticasone Propionate 100 mcg26.39
Montelukast 10 mg23.55

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Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period

The number of inhalations of rescue salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. For participants, the rescue-free nights were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of rescue-free nights during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants). (NCT01147744)
Timeframe: Baseline up to Week 8

InterventionPercentage of rescue-free nights (Least Squares Mean)
Placebo16.93
GSK2190915 10 mg19.28
GSK2190915 30 mg17.36
GSK2190915 100 mg19.63
GSK2190915 300 mg15.71
Fluticasone Propionate 100 mcg24.42
Montelukast 10 mg20.54

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Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period

Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning upon rising and before taking any rescue or study medication and before the assessment of the PEF measurement. Participant's responses to the morning assessments indicated no symptoms were considered to be symptom free. For participants, the symptom free nights were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of symptom-free nights during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants). (NCT01147744)
Timeframe: Baseline up to Week 8

InterventionPercentage of symptom-free nights (Least Squares Mean)
Placebo13.99
GSK2190915 10 mg14.83
GSK2190915 30 mg16.71
GSK2190915 100 mg16.12
GSK2190915 300 mg12.21
Fluticasone Propionate 100 mcg19.94
Montelukast 10 mg19.39

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Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1)

Pulmonary function was measured by forced expiratory volume in one second, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the morning (AM) pre-dose and pre-rescue bronchodilator FEV1 at the clinic visit. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the end of Week 8 value minus the Baseline value. Analysis of covariance (ANCOVA) model used for statistical analysis. ITT Population was comprised of all participant randomized to treatment who received at least one dose of double-blind study medication. (NCT01147744)
Timeframe: Baseline and Week 8

InterventionLiters (Least Squares Mean)
Placebo0.12
GSK2190915 10 mg0.18
GSK2190915 30 mg0.23
GSK2190915 100 mg0.19
GSK2190915 300 mg0.19
Fluticasone Propionate 100 mcg0.31
Montelukast 10 mg0.19

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Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period

The participants who met any of the following withdrawal criteria were considered to be withdrawn due to lack of efficacy: 1) Clinic FEV1 below stability limit calculated at Visit 3. 2) More than three days between two consecutive visits, PEF has fallen below stability limit calculated at Visit 3. 3) Use of 12 or more inhalations of SABA per day for more than two days between consecutive visits. 4) Asthma exacerbation defined as worsening requiring any treatment other than study medication or rescue medication. This included requiring the use of systemic or inhaled corticosteroids and /or emergency room visit or hospitalization for the treatment of asthma. The stability limit was calculated as best pre-salbutamol/albuterol FEV1 at Visit 3 x 80 percent (%). (NCT01147744)
Timeframe: Upto 8 Weeks

InterventionParticipants (Count of Participants)
Placebo11
GSK2190915 10mg11
GSK2190915 30mg9
GSK2190915 100mg11
GSK2190915 300mg13
Fluticasone Propionate 100 mcg8
Montelukast 10mg7

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Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period

The numbers of inhalations of rescue SABA, salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. Participants who used salbutamol/albuterol inhalation aerosol at night-time were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged number of night-time salbutamol/albuterol inhalation aerosol used during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants). (NCT01147744)
Timeframe: Baseline up to Week 8

InterventionNight-time number of inhalations (Least Squares Mean)
Placebo-0.30
GSK2190915 10 mg-0.40
GSK2190915 30 mg-0.44
GSK2190915 10 0mg-0.42
GSK2190915 300 mg-0.30
Fluticasone Propionate 100 mcg-0.47
Montelukast 10 mg-0.46

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Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period

Peak expiratory flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily (pre-dose and pre-rescue bronchodilator) evening over the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants) (NCT01147744)
Timeframe: Baseline up to Week 8

InterventionLiters per minute (Least Squares Mean)
Placebo8.01
GSK2190915 10 mg7.62
GSK2190915 30 mg9.37
GSK2190915 100 mg6.21
GSK2190915 300 mg10.33
Fluticasone Propionate 100 mcg10.46
Montelukast 10 mg8.53

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Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period

The PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough AM PEF is defined as the AM pre-dose and pre-rescue bronchodilator at the clinic visit. Change from Baseline was calculated as the value of the averaged PEF daily (pre-dose and pre-rescue bronchodilator) AM over the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants). (NCT01147744)
Timeframe: Baseline up to Week 8

InterventionLiters per minute (Least Squares Mean)
Placebo11.77
GSK2190915 10 mg13.23
GSK2190915 30 mg15.52
GSK2190915 100 mg8.72
GSK2190915 300 mg16.35
Fluticasone Propionate 100 mcg15.25
Montelukast 10 mg17.38

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Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period

Participants recorded their day-time asthma symptom score in an eDiary each PM at bedtime and before taking any rescue or study medication and before assessing the PEF measurement during the 8-Week treatment period. Day-time asthma symptom scores, as: 0=no asthma symptoms, 1=one episode of short-time asthma symptoms, 2=two or more episodes of short-time asthma symptoms, 3=asthma symptoms occurring during most part of daytime without interference with daily life activities, 4=asthma symptoms occurring during most part of daytime with interference with daily life activities, 5=severe asthma symptoms that disable working or perform normal daily activities. Change from Baseline was calculated as the averaged of day-time asthma symptom score during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants). (NCT01147744)
Timeframe: Baseline up to Week 8

InterventionDay-time symptom scores on a scale (Least Squares Mean)
Placebo-0.34
GSK2190915 10mg-0.34
GSK2190915 30mg-0.50
GSK2190915 100mg-0.36
GSK2190915 300mg-0.34
Fluticasone Propionate 100 mcg-0.43
Montelukast 10mg-0.41

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Percentage of Symptom-free Nights During the Last 3 Weeks of the 6 Week Treatment Period

"Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale ranging from '0' (implying no symptoms) to 4 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of nights when symptoms were not experienced (symptom-free nights) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant." (NCT01156792)
Timeframe: Week 4 to Week 6

InterventionPercentage of nights (Least Squares Mean)
FP + Placebo37.21
FP + GSK2190915 100 mg38.22
FP + GSK2190915 300 mg40.55
FP + Montelukast37.70
FP / Salmeterol38.47

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Number of Participants Withdrawn Due to Lack of Efficacy During the Last 3 Weeks of the 6-week Treatment Period

Participants were withdrawn if they met any of the following three criteria for 'lack of efficacy': 1) Clinic FEV1 below the FEV1 'Stability Limit' value, 2) During any consecutive 7-day period, the participant experienced PEF fallen below the PEF 'Stability Limit' for more than 3 days, or if >= 12 inhalations per day of albuterol were used for more than 2 days, and 3) Ashtma exacerbation. The number of withdrawals due to lack of efficacy were summarized for each treatment and Fisher's Exact test was used for comparison with placebo add-on. Withdrawals occurring during active washout periods are not included. (NCT01156792)
Timeframe: Week 4 to Week 6

InterventionNumber of participants (Number)
FP + Placebo9
FP + GSK2190915 100 mg5
FP + GSK2190915 300 mg3
FP + Montelukast7
FP / Salmeterol5

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Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically using spirometry, prior to study medication and any rescue albuterol (bronchodilator) use. At the end of the 6-week treatment period, FEV1 was measured approximately 24 hours after the participant's last morning dose of study medication and approximately 12 hours after the evening dose of study medication. Trough FEV1 was analyzed using mixed effect analysis of covariance (ANCOVA) model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effect of participant. Intent-to-Treat Population is defined as all participants who were randomized and received at least one dose of study drug. (NCT01156792)
Timeframe: End of Week 6

InterventionLiters (L) (Least Squares Mean)
FP + Placebo2.36
FP + GSK2190915 100 mg2.39
FP + GSK2190915 300 mg2.40
FP + Montelukast2.42
FP / Salmeterol2.43

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Percentage of Nights Without Awakenings Due to Asthma During the Last 3 Weeks of the 6-week Treatment Period

Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale: 0 = no symptoms during the night, 1 = symptoms causing to wake once, 2 = symptoms causing to wake twice or more, 3 = symptoms causing to be awake most of the night, 4 = could not sleep due to severe symptoms. Participants recorded the symptoms in a daily eDiary. The number of nights with no awakenings due to asthma during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. (NCT01156792)
Timeframe: Week 4 to Week 6

InterventionPercentage of nights (Least Squares Mean)
FP + Placebo37.21
FP + GSK2190915 100 mg38.22
FP + GSK2190915 300 mg40.55
FP + Montelukast37.70
FP / Salmeterol38.47

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Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period

The PEF is a measure of lung function and measures how fast a person can breathe out. Trough PEF was measured every morning prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily electronic diary (eDiary). Daily trough morning PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. (NCT01156792)
Timeframe: Week 4 to Week 6

InterventionLiters/minute (L/min) (Least Squares Mean)
FP + Placebo349.19
FP + GSK2190915 100 mg350.14
FP + GSK2190915 300 mg354.96
FP + Montelukast354.17
FP / Salmeterol361.33

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Percentage of Rescue-free Days During the Last 3 Weeks of the 6-week Treatment Period

"Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of days when rescue medication was not used (rescue-free days) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant." (NCT01156792)
Timeframe: Week 4 to Week 6

InterventionPercentage of days (Least Squares Mean)
FP + Placebo40.44
FP + GSK2190915 100 mg42.43
FP + GSK2190915 300 mg42.59
FP + Montelukast42.77
FP / Salmeterol41.96

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Percentage of Rescue-free Nights During the Last 3 Weeks of the 6-week Treatment Period

"Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of nights when rescue medication was not used (rescue-free nights) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant." (NCT01156792)
Timeframe: Week 4 to Week 6

InterventionPercentage of nights (Least Squares Mean)
FP + Placebo45.12
FP + GSK2190915 100 mg45.69
FP + GSK2190915 300 mg48.79
FP + Montelukast45.32
FP / Salmeterol43.98

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Percentage of Symptom-free Days During the Last 3 Weeks of the 6-week Treatment Period

"Daytime asthma symptoms were recorded every evening at bedtime, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 6-point scale ranging from '0' (implying no symptoms) to 5 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of days when symptoms were not experienced (symptom-free days) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant." (NCT01156792)
Timeframe: Week 4 to Week 6

InterventionPercentage of days (Least Squares Mean)
FP + Placebo30.84
FP + GSK2190915 100 mg33.51
FP + GSK2190915 300 mg36.14
FP + Montelukast34.88
FP / Salmeterol35.45

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Daily Rescue Short-acting beta2-agonist (SABA) Use Averaged Over the Last 3 Weeks of the 6-week Treatment Period

A SABA (albuterol) was provided to participants as a rescue medication, to use as needed for symptomatic relief of asthma symptoms. Participants were required to record their albuterol use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The daily rescue SABA use was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. (NCT01156792)
Timeframe: Week 4 to Week 6

InterventionNumber of inhalations (Least Squares Mean)
FP + Placebo2.17
FP + GSK2190915 100 mg2.14
FP + GSK2190915 300 mg2.03
FP + Montelukast2.09
FP / Salmeterol2.08

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Daily Evening PEF Averaged Over the Last 3 Weeks of the 6-week Treatment Period

The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. (NCT01156792)
Timeframe: Week 4 to Week 6

InterventionL/min (Least Squares Mean)
FP + Placebo354.06
FP + GSK2190915 100 mg355.71
FP + GSK2190915 300 mg359.16
FP + Montelukast358.88
FP / Salmeterol364.35

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Daily Asthma Symptom Score Averaged Over the Last 3 Weeks of the 6-week Treatment Period

Daytime and night time asthma symptoms were recorded every evening at bedtime and every morning upon rising, respectively, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on scales ranging from '0' (implying no symptoms) to either 5 (for daytime symptoms) or 4 (for night time symptoms) (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. 24-hour period asthma symptom scores were averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. (NCT01156792)
Timeframe: Week 4 to Week 6

InterventionScore on a scale (Least Squares Mean)
FP + Placebo2.26
FP + GSK2190915 100 mg2.26
FP + GSK2190915 300 mg2.15
FP + Montelukast2.22
FP / Salmeterol2.25

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Daily (Average of Morning and Evening) PEF Averaged Over the Last 3 Weeks of the 6 -Week Treatment Period Between GSK2190915 and Montelukast Groups

The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every morning and evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily average of morning and evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. This outcome measure explored the efficacy between GSK2190915 and montelukast due to the dosing time difference. (NCT01156792)
Timeframe: Week 4 to Week 6

InterventionL/min (Least Squares Mean)
FP + GSK2190915 100 mg352.37
FP + GSK2190915 300 mg356.16
FP + Montelukast356.52

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Changes in Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)

SF-36 subscales have min=0 and max=100; results are given as change in 6mo score compared to baseline score, not actual score, and a positive change is correlated with improvement in clinical outcome. (NCT01307462)
Timeframe: Baseline and 6 months

Interventionunits on a scale (Median)
SF-36 norm-based physical functioning scoreSF-36 norm-based role-physical scoreSF-36 norm-based bodily pain scoreSF-36 norm-based general health scoreSF-36 norm-based vitality scoreSF-36 norm-based social functioning scoreSF-36 norm-based role-emotional scoreSF-36 norm-based mental health scoreSF-36 standardized physical component scoreSF-36 standardized mental component score
Treatment (BOS Therapy)0.00.00.0-2.381.565.450.00.0-1.211.64

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Number of Subjects Who Experienced Grade 3-5 SAEs Attributable to FAM and Number of Subjects Who Stopped FAM as a Result

National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) (v4.0) (NCT01307462)
Timeframe: From baseline to 6 months

InterventionParticipants (Count of Participants)
SAEs attributable to FAMStopped FAM during study
Treatment (BOS Therapy)111

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Number of Subjects Who Failed Treatment

Treatment failure is defined as sustained, absolute decrease (worsening) of the FEV1 by >= 10% predicted in comparison to the baseline FEV1. Must be confirmed by a second PFT 2 weeks after the first measurement. (NCT01307462)
Timeframe: Within 3 months after initiation of study medications

InterventionParticipants (Count of Participants)
Treatment (BOS Therapy)2

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Changes in Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)

"FACT-BMT subscales have various min/max, see below; results are given as change in 6mo score compared to baseline score, not actual score, and a positive change is correlated with improvement in clinical outcome.~FACT physical well-being (0-28) FACT social/family well-being (0-28) FACT emotional well-being (0-24) FACT functional well-being (0-28) FACT Bone Marrow Transplant (BMT) subscale (0-40) FACT trial outcome index (0-96) FACT-General (G) (0-108) FACT-BMT total (0-148)" (NCT01307462)
Timeframe: Baseline and 6 months

Interventionunits on a scale (Median)
FACT physical well-beingFACT social/family well-beingFACT emotional well-beingFACT functional well-beingFACT BMT subscaleFACT trial outcome indexFACT-GFACT-BMT total
Treatment (BOS Therapy)0.5-101-0.7822.52.17

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Number of Subjects Were Able to Reduce Their Systemic Steroid Exposure by >=50%

(NCT01307462)
Timeframe: Baseline to 6 months

InterventionParticipants (Count of Participants)
Treatment (BOS Therapy)17

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Number of Subjects Who Experienced Statistically Significant Changes in FVC, TLC, RV, DLCO

(NCT01307462)
Timeframe: Baseline and 6 months

InterventionParticipants (Count of Participants)
Treatment (BOS Therapy)0

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Changes in Symptoms as Measured by Patient Self-report--Human Activities Profile (HAP)

"HAP subscales have min=0 and max=94; results are given as change in 6mo score compared to baseline score, not actual score, and a positive change is correlated with improvement in clinical outcome.~Maximum Activity Score (MAS) is highest item number answered still doing. Represents highest oxygen demanding activity that respondent still performs.~Adjusted Activity Score (AAS) is MAS minus total number of stopped doing responses below MAS. A measure of usual daily activities.~Modified AAS is MAS minus total number of stopped doing responses below MAS but not penalized for not doing activities not permitted post transplant. The following items are not counted against the score:11,15,19,20,22,25,34,41,42,47,49,50,52,53,54,57,72,73,77,78." (NCT01307462)
Timeframe: Baseline and 6 months

Interventionunits on a scale (Median)
HAP MASHAP AASModified HAP AAS
Treatment (BOS Therapy)0.54.53.5

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Changes in Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale

Lee symptom scale (LSS) has subscales with min=0, max=100; results are given as change in 6mo score compared to baseline score, not actual score, and a negative change is correlated with improvement in clinical outcome. (NCT01307462)
Timeframe: Baseline and 6 months

Interventionunits on a scale (Median)
LSS skin scaleLSS energy scaleLSS lung scaleLSS eye scaleLSS nutrition scaleLSS psychological scaleLSS mouth scaleLSS overall summary scale
Treatment (BOS Therapy)-5.63-7.14-5-8.33000-7.77

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Number of Subjects With Improvements in Other Chronic GVHD Characteristics

Only includes subjects who had complete or partial response according to the National Institute of Health (NIH) consensus criteria. (NCT01307462)
Timeframe: Baseline and 3 months

InterventionParticipants (Count of Participants)
Treatment (BOS Therapy)12

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Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period

The mean total asthma costs are a sum of pharmacy and medical costs. Costs were determined monthly from the pharmacy and medical encounters recorded in the managed care insurance database. All costs were summed for each participant over the 3-12 month follow-up period (post-index period), and a mean monthly cost was calculated by dividing by the follow-up for each participant. (NCT01328964)
Timeframe: 12 months prior to January 1, 2000 to June 30, 2008

,,
InterventionUnited States dollars (Mean)
Monthly Medical CostsMonthly Pharmacy CostsMonthly Total Costs
Budesonide273259
Fluticasone Propionate252045262148
Montelukast274875

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Serum Leptin Levels

Leptin levels, measured through blood, mediate appetite and are elaborated by adipose tissue. Levels correlate positively with body fat percentage. In addition, leptin plays a role in producing an inflammatory state. Adiponectin, which is also secreted by adipose tissue, regulates metabolism, however its levels are inversely correlated with body fat percentage. (NCT01329939)
Timeframe: 24 weeks

,,,
Interventionng/mL (Mean)
Serum leptin levelserum adiponectin
Normal Weight Atopic Asthmatics, Montelukast10.9013.08
Normal-weight Atopic Asthmatics, Placebo4.1311.35
Overweight/Obese Atopic Asthmatics, Montelukast44.3510.27
Overweight/Obese Atopic Asthmatics, Placebo34.889.52

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Beclomethasone Equivalents

The total daily dose of inhaled corticosteroids in beclomethasone equivalents. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. (NCT01329939)
Timeframe: 24 weeks

Interventionmicrograms (Mean)
Overweight/Obese Atopic Asthmatics, Montelukast680
Normal-weight Atopic Asthmatics, Placebo740
Normal Weight Atopic Asthmatics, Montelukast580
Overweight/Obese Atopic Asthmatics, Placebo1210.00

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Urinary Leukotriene E4 (LTE4) Levels

LTE4 levels, measured in the urine, reflect the degree of inflammation in the asthmatic airway. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. (NCT01329939)
Timeframe: 24 weeks

Interventionpg/mL (Mean)
Overweight/Obese Atopic Asthmatics, Montelukast171.50
Normal-weight Atopic Asthmatics, Placebo195.67
Normal Weight Atopic Asthmatics, Montelukast198.00
Overweight/Obese Atopic Asthmatics, Placebo313.00

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Urinary Creatinine (Cr) Levels/Leukotriene E4 (LTE4) Ratio

The ratio of urinary LTE4 to Cr provides a standardization of the LTE4 level based on the patients weight and muscle mass, therefore normalizing it across the different subjects. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. (NCT01329939)
Timeframe: 24 weeks

Interventionpg/mg (Mean)
Overweight/Obese Atopic Asthmatics, Montelukast105.87
Normal-weight Atopic Asthmatics, Placebo99.61
Normal Weight Atopic Asthmatics, Montelukast159.84
Overweight/Obese Atopic Asthmatics, Placebo177.92

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Urinary Creatinine (Cr) Levels

Creatinine, measured in the urine, reflects how well the kidneys are working, and provide a standard to which one can compare other metabolites in the urine. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. (NCT01329939)
Timeframe: 24 weeks

Interventionmg/mL (Mean)
Overweight/Obese Atopic Asthmatics, Montelukast1.7
Normal-weight Atopic Asthmatics, Placebo1.69
Normal Weight Atopic Asthmatics, Montelukast1.77
Overweight/Obese Atopic Asthmatics, Placebo2.77

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Exhaled Nitric Oxide Measurement

A non-invasive measure of eosinophilic airway inflammation. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. (NCT01329939)
Timeframe: 24 weeks

Interventionppb (Mean)
Overweight/Obese Atopic Asthmatics, Montelukast14.33
Normal-weight Atopic Asthmatics, Placebo27.25
Normal Weight Atopic Asthmatics, Montelukast25.75
Overweight/Obese Atopic Asthmatics, Placebo39.5

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Asthma Control Test (ACT) Scores

The ACT is a validated questionaire-based tool designed to assess asthma control. Scale range for 7-11 year olds is 0-27 and for 12 years and older 5-25, with lower scores indicating poorer asthma control for all ages. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. (NCT01329939)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Overweight/Obese Atopic Asthmatics, Montelukast25.00
Normal-weight Atopic Asthmatics, Placebo20.5
Normal Weight Atopic Asthmatics, Montelukast24.00
Overweight/Obese Atopic Asthmatics, Placebo15.75

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Spirometric Measures

Breathing maneuvers which help to measure obstruction of airways. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis. (NCT01329939)
Timeframe: 24 weeks

,,,
Interventionpercent predicted (Mean)
FEV1%FVC%FEV1/FVCFEF 25-75%PEF (peak expiratory flow)%
Normal Weight Atopic Asthmatics, Montelukast97.87101.6888.25103.77108.09
Normal-weight Atopic Asthmatics, Placebo85.3188.8789.3578.5774.44
Overweight/Obese Atopic Asthmatics, Montelukast83.3791.0183.1387.62100.19
Overweight/Obese Atopic Asthmatics, Placebo71.7976.2180.4266.9992.79

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Eosinophil Count

Eosinophils/high powered field(hpf) in the mid esophagus will be measured after 12 weeks of therapy. (NCT01458418)
Timeframe: 12 weeks

InterventionEosinophils/HPF (Mean)
Subjects Whose Arm is Unknown Due to Not Being Unblinded8

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Baseline Lung Function of FEV1/FVC Before the Bronchodilator

baseline lung function in forced expiratory volume in 1 second/forced vital capacity before the administration of bronchodilator (NCT01581710)
Timeframe: up to 2 weeks

Interventionnone (ratio) (Mean)
Baseline Lung Function83.55
2 Weeks After Placebo Administration83.04
2 Weeks After Montelukast Administration85.93

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Baseline Lung Function of FEV1 Before the Bronchodilator

baseline lung function in forced expiratory volume in 1 second before the administration of bronchodilator (NCT01581710)
Timeframe: up to 2 weeks

InterventionL/s (Mean)
Baseline Lung Function1.28
2 Weeks After Placebo Administration1.25
2 Weeks After Montelukast Administration1.28

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Baseline Lung Function in MMEF

Baseline lung function in maximal mid-expiratory flow before the administration of bronchodilator (NCT01581710)
Timeframe: up to 2 weeks

InterventionL/s (Mean)
Baseline Lung Function1.40
2 Weeks After Placebo Administration1.38
2 Weeks After Montelukast Administration1.46

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Relative Change (%) of FEV1 After the Bronchodilator

Relative change in percentage of FEV1 after the bronchodilator, 2weeks after placebo and montelukast administration Relative change (%) in FEV1 = (((FEV1 post-bronchodilator)-(FEV1 pre-bronchodilator))/baseline FEV1) x 100 (NCT01581710)
Timeframe: up to 2 weeks

Intervention% (relative change) (Mean)
2 Weeks After Placebo Administration9.68
2 Weeks After Montelukast Administration5.65

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Baseline Lung Function of Xrs5 With IOS Before the Bronchodilator (Pre-Xrs 5)

Pre Xrs 5: Reactance at 5Hz before the administration of bronchodilator (NCT01581710)
Timeframe: up to 2 weeks

InterventionkPa/L/s (Mean)
Baseline Lung Function-0.34
2 Weeks After Placebo Administration-0.36
2 Weeks After Montelukast Administration-0.34

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Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5)

Pre Rrs 5: Resistance at 5Hz before the administration of bronchodilator (NCT01581710)
Timeframe: up to 2 weeks

InterventionkPa/L/s (Mean)
Baseline Lung Function0.73
2 Weeks After Placebo Administration0.74
2 Weeks After Montelukast Administration0.73

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Baseline Lung Function of Xrs10 With IOS Before the Bronchodilator (Pre-Xrs10)

Pre Xrs 10: Reactance at 10Hz before the administration of bronchodilator (NCT01581710)
Timeframe: up to 2 weeks

InterventionkPa/L/s (Mean)
Baseline Lung Function-0.15
2 Weeks After Placebo Administration-0.20
2 Weeks After Montelukast Administration-0.19

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Baseline Lung Function of Rrs10 With IOS Before the Bronchodilator

Pre Rrs10: Resistance at 10Hz before the administration of bronchodilator (NCT01581710)
Timeframe: up to 2 weeks

InterventionkPa/L/s (Mean)
Baseline Lung Function0.57
2 Weeks After Placebo Administration0.55
2 Weeks After Montelukast Administration0.55

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Differential Response to the Three Therapies Based on Fixed Threshold Criteria for the Following Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations and Asthma Control Days.

The primary outcome was differential response to the three therapies on the basis of fixed threshold criteria for the following asthma control measures, which encompassed domains of risk and impairment: the time from the start of the treatment period to an asthma exacerbation treated with systemic corticosteroids, and the annualized number of asthma control days (ACDs) from within that period. ACDs were defined as full calendar days without symptoms, rescue medication use, or unscheduled healthcare visits. Children were defined as differential responders if, first, the time to an asthma exacerbation was at least four weeks longer, or second, if the number of annualized ACDs was at least 31 days more for one treatment than another, in that order. If neither threshold was met, the participant was considered a non differential responder. Differential response was determined in children completing at least two treatment periods and at least 50% of the daily diary entries for each period. (NCT01606306)
Timeframe: The last 14 weeks of each 16-week treatment period

Interventionprobability (Number)
Non-differential respondersResponded best to daily ICSResponded best to daily LTRAResponded best to as-needed ICS
All Evaluable Participants.26.40.18.16

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Change From Baseline in Short-Acting Beta Agonist (SABA) Use at Week 4

The change from baseline in SABA use at Week 4 after treatment with MK-1029 + ML or placebo + ML was assessed. Participants used the e-Diary upon arising and before going to sleep to enter the total number of SABA puffs used for asthma relief. The number of SABA puffs recorded was the number of canister actuations (e. g., when SABA use was required and 3 puffs were inhaled, this was recorded as 3). Participants also recorded the number of nebulizer treatments (1 nebulized SABA use = 3 puffs). The average daily number of puffs for an individual participant was calculated over the week-long assessment periods. The change from baseline in SABA use was evaluated using the LDA model with repeated measurements of SABA use, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect. (NCT01624974)
Timeframe: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V

,
InterventionNumber of puffs (Mean)
BaselineChange from Baseline at Week 4
MK-1029 + ML3.203-0.595
Placebo + ML3.597-0.561

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Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 4

The change from baseline in FEV1 at Week 4 following treatment with MK-1029 + ML or placebo + ML was assessed. The pre-bronchodilator FEV1 was evaluated to assess the response to treatment for asthma. The primary efficacy evaluation period was the last week of each treatment period: Period III (Initial Therapy, Week 4) and Period V (Crossover Therapy, Week 4). The change from baseline in FEV1 was evaluated using a longitudinal data analysis (LDA) model with repeated measurements of FEV1, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect. Baseline FEV1 is defined as the measurement taken before dosing in each treatment period (i. e., at Visit 3 [Week 0], prior to Period III and at Visit 6 [Week 8], prior to Period V). The Baseline Characteristics section shows FEV1 values at baseline. (NCT01624974)
Timeframe: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V

InterventionLiters (Least Squares Mean)
MK-1029 + ML0.065
Placebo + ML0.017

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Adverse Events During Treatment and Follow-up

The number of participants who had at least one adverse event (AE) during study treatment and follow-up was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. The number of participants with at least one AE was assessed. The number of participants in any treatment group with at least one AE was assessed. (NCT01624974)
Timeframe: Up to 14 days after the last dose in Period III or Period V (up to 6 weeks)

InterventionParticipants (Count of Participants)
MK-1029 + ML30
Placebo + ML33

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Change From Baseline in Daytime Symptom Score (DSS) at Week 4

The change from baseline in DSS at Week 4 following treatment was assessed. Participants used an electronic diary (e-Diary) to enter their asthma symptom scores every evening. Participants scored daily symptoms (chest discomfort, wheezing, shortness of breath, and cough) by responding to 4 questions: 1) Symptom frequency (0 = None of the time, 6 = All of the time); 2) Bothersomeness (0 = Not bothered, 6 = Severely bothered); 3) Activity limitation (0 = Not limited, 6 = Totally limited); 4) Frequency of activity limitation (0 = None of the time, 6 = All of the time). The average of the 4 scores for overall DSS ranges from 0 to 6 where a higher average indicates greater symptom severity. The average overall DSS was calculated over the week-long assessment periods. The change from baseline in DSS was evaluated using the LDA model with repeated measurements of DSS, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect. (NCT01624974)
Timeframe: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V

,
InterventionScore on a scale (Mean)
BaselineChange from Baseline at Week 4
MK-1029 + ML1.93-0.18
Placebo + ML1.98-0.08

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Change From Baseline in Asthma Control Questionnaire (ACQ) Score at Week 4

The change from baseline in the ACQ score at Week 4, after treatment, was assessed in 97 participants. Participants completed 6 items of the ACQ (i. e., ACQ-6) and provided the average of responses over the past week: 1) Frequency of nocturnal awakenings (0 = Never, 6 = Unable to sleep); 2) Symptom severity (0 = None, 6 = Very severe); 3) Activity limitations (0 = Not limited, 6 = Totally limited); 4) Breathlessness (0 = None, 6 = Very great deal); 5) Wheezing (0 = Not at all, 6 = All the time); 6) Daily SABA use (0 = None, 6 = More than 16 puffs on most days). The ACQ score ranges from 0 to 6 where a lower score indicates greater performance. The investigator reviewed the participant-completed ACQ-6 to ensure its completeness. The change from baseline in the ACQ score was evaluated using the LDA model with repeated measurements of the ACQ score, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect. (NCT01624974)
Timeframe: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V

,
InterventionScore on a scale (Mean)
BaselineChange from Baseline at Week 4
MK-1029 + ML2.09-0.49
Placebo + ML2.25-0.48

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Discontinuation of Treatment Due to An Adverse Event

The number of participants who discontinued study treatment due to an AE was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. (NCT01624974)
Timeframe: Up to the last dose in Period III or Period V (up to 4 weeks)

InterventionParticipants (Count of Participants)
MK-1029 + ML2
Placebo + ML2

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Change From Baseline in Nocturnal Awakenings at Week 4

"The change from baseline in nocturnal awakenings due to asthma at Week 4 after treatment with MK-1029 + ML or placebo + ML was assessed. The participant scored nocturnal awakenings by answering the question, Did you wake up with asthma symptoms in the middle of the night or upon awakening in the morning? (No or Yes). Participants recorded in the e-Diary the number of nights per week in which they awakened with asthma, as determined by dividing the number of nights of awakening with asthma by the total number of nights and then multiplying by 7 (standardized to a 7-day period). The change from baseline in nocturnal awakenings was evaluated using the LDA model with repeated measurements of nocturnal awakenings, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect." (NCT01624974)
Timeframe: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V

,
InterventionNumber of nocturnal awakenings (Mean)
BaselineChange from Baseline at Week 4
MK-1029 + ML4.97-1.13
Placebo + ML4.90-1.30

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Change From Baseline in Morning (AM) Peak Expiratory Flow (PEF) at Week 4

The change from baseline in AM PEF at Week 4 after treatment with MK-1029 + ML or placebo + ML was assessed in 97 participants. Participants performed triplicate AM PEF measurements in the morning upon rising. Participants entered all 3 measurements and the greatest AM PEF value was recorded by the e-Diary. Participants refrained from SABA use within the 4 hours prior to performing PEF measurements. The average AM PEF for an individual participant was calculated over the week-long assessment periods. The change from baseline in AM PEF was evaluated using the LDA model with repeated measurements of AM PEF, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect. (NCT01624974)
Timeframe: The week before the first dose in Period III or V (Baseline) and the last week of Period III or V

,
InterventionLiters/min (Mean)
BaselineChange from Baseline at Week 4
MK-1029 + ML336.577.14
Placebo + ML333.07-2.70

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Change From Baseline in Evening (PM) PEF at Week 4

The change from baseline in PM PEF at Week 4 after treatment with MK-1029 + ML or placebo + ML was assessed. Participants performed triplicate PM PEF measurements in the evening, immediately before study drug administration, at bedtime. Participants entered all 3 measurements and the greatest PM PEF value was recorded by the e-Diary. Participants refrained from SABA use within the 4 hours prior to performing PEF measurements. The average PM PEF for an individual participant was calculated over the week-long assessment periods. The change from baseline in PM PEF was evaluated using the LDA model with repeated measurements of PM PEF, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect. (NCT01624974)
Timeframe: Baseline (Week 0 and Week 8), Last week of the 4-week treatment period

,
InterventionLiters/min (Mean)
BaselineChange from Baseline at Week 4
MK-1029 + ML350.348.25
Placebo + ML342.30-4.68

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Average Change From Baseline in Use of Short-Acting Beta-Agonists (SABAs)

Twice daily (upon arising and before going to sleep), participants recorded the total number of puff (actuations) of SABA used for asthma symptoms in their eDiaries. The number of SABA puffs used in one day was calculated based on eDiary entries as the sum of daytime and nighttime number of puffs of SABA. The average change from baseline over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) in the daily number of SABA puffs was estimated using a cLDA model. In the cLDA analysis, Baseline was the average number of SABA puffs used in one day during the placebo run-in period and the post-baseline value was calculated as the average number of SABA puffs used in one day over Week 6 to Week 12. (NCT01656395)
Timeframe: Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)

InterventionNumber of SABA Puffs (Least Squares Mean)
MK-1029 10 mg-1.373
MK-1029 30 mg-0.920
MK-1029 60 mg-0.955
MK-1029 150 mg-0.571
Montelukast 10 mg-1.234
Placebo-0.845

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Change From Baseline in Asthma Control Questionnaire (ACQ) Score

The ACQ is a validated 6-item measure of asthma control to evaluate asthma control in response to therapy. Participants evaluate their asthma over the previous week by answering 6 questions: How often were you woken by your asthma during the night? How bad were your asthma symptoms when you woke up in the morning? How limited were you in your activities because of your asthma? How much shortness of breath did you experience because of your asthma? How much of the time did you wheeze? How many puffs/inhalations of short-acting bronchodilator have you used each day? Each response to a question was scored on a 7-point scale (0=best to 6=worst). The ACQ score is the average of the scores for the 6 items. Change from baseline to Week 12 in ACQ was estimated using a cLDA model. In the cLDA analysis, the Baseline value was the last measurement taken prior to the first double-blind study drug and the post-baseline value was calculated as the average ACQ Score at Week 12. (NCT01656395)
Timeframe: Baseline and Week 12

InterventionScore on a scale (Least Squares Mean)
MK-1029 10 mg-0.807
MK-1029 30 mg-0.736
MK-1029 60 mg-0.855
MK-1029 150 mg-1.066
Montelukast 10 mg-0.931
Placebo-0.704

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Percentage of Asthma Attack Days

An asthma attack was defined as asthma symptoms during the previous 24 hours requiring one or more of the following: corticosteroid use (systemic), unscheduled visit to the doctor or urgent care clinic, unscheduled visit to the emergency department or hospitalization. Information on asthma attacks was recorded throughout the study in the participant's e-Diary, and an Analysis of Variance (ANOVA) was used to calculate the average percentage of asthma attack days over Week 6 to Week 12 of a 12-week treatment period. (NCT01656395)
Timeframe: Week 6 to Week 12

InterventionPercentage (Least Squares Mean)
MK-1029 10 mg0.482
MK-1029 30 mg0.182
MK-1029 60 mg0.017
MK-1029 150 mg0.637
Montelukast 10 mg0.248
Placebo0.557

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Percentage of Asthma Exacerbation Days

"An asthma exacerbation day was defined as a day with ANY of the following: a decrease from Baseline in morning (AM) Peak Expiratory Flow (PEF) of more than 20%, an AM PEF of less than 180 liters (L)/min, an increase in Short Acting Beta2 Agonist (SABA) use of more than 70% (and a minimum increase of at least 2 puffs), an increase from Baseline in Daytime Asthma Symptom Score of more than 50%, an overnight asthma symptom of: Awake all night, or an asthma attack. Information on asthma exacerbation days was recorded throughout the study in the participant's electronic diary (e-Diary), and an Analysis of Variance (ANOVA) was used to calculate the average percentage of days with asthma exacerbations over Week 6 to Week 12." (NCT01656395)
Timeframe: Week 6 to Week 12

InterventionPercentage of Asthma Exacerbation Days (Least Squares Mean)
MK-1029 10 mg17.704
MK-1029 30 mg15.812
MK-1029 60 mg15.435
MK-1029 150 mg20.238
Montelukast 10 mg19.657
Placebo24.904

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Percentage of Participants Who Discontinue Study Due to AEs

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE. (NCT01656395)
Timeframe: Up to 14 weeks

InterventionPercentage of participants (Number)
MK-1029 10 mg1.7
MK-1029 30 mg10.3
MK-1029 60 mg3.7
MK-1029 150 mg7.7
Montelukast 10 mg8.3
Placebo5.6

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Percentage of Participants Who Experience Adverse Events (AEs)

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE. (NCT01656395)
Timeframe: Up to 14 weeks

InterventionPercentage of participants (Number)
MK-1029 10 mg44.8
MK-1029 30 mg48.4
MK-1029 60 mg47.4
MK-1029 150 mg53.8
Montelukast 10 mg56.7
Placebo57.9

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Percentage of Participants With a ≥0.5 Change From Baseline in ACQ Score

The ACQ is a validated 6-item measure of asthma control to evaluate asthma control in response to therapy. Participants evaluate their asthma over the previous week by answering 6 questions: How often were you woken by your asthma during the night? How bad were your asthma symptoms when you woke up in the morning? How limited were you in your activities because of your asthma? How much shortness of breath did you experience because of your asthma? How much of the time did you wheeze? How many puffs/inhalations of short-acting bronchodilator have you used each day? Each response to a question was scored on a 7-point scale (0=best to 6=worst). The ACQ score is the average of the scores for the 6 items. The percentage of participants who experienced a ≥0.5 decrease in ACQ Score at Week 12 compared to Baseline was calculated using the MN method. (NCT01656395)
Timeframe: Baseline and Week 12

InterventionPercentage of participants (Number)
MK-1029 10 mg65.51
MK-1029 30 mg59.57
MK-1029 60 mg66.60
MK-1029 150 mg71.11
Montelukast 10 mg64.72
Placebo62.43

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Percentage of Participants With a ≥0.5 Change From Baseline in AQLQ(S) Overall and Domain Scores

The AQLQ(S) is a 32-item questionnaire with questions on 4 domains (asthma symptoms, activity limitation, emotional function and environmental stimuli) over the previous 2 weeks. Responses were scored on a 7-point scale (1=worst to 7=best). Each domain score is defined as the average score of all answered questions in that domain. The AQLQ(S) Overall Score is defined as the average of all available item scores (1=worst to 7=best). The percentage of participants who experienced a ≥0.5 increase in AQLQ(S) Overall and Domain Scores at Week 12 compared to baseline was calculated using the Miettinen and Nurminen (MN) method. Statistical analyses are provide for the AQLQ(S) Overall Score response rate only. (NCT01656395)
Timeframe: Baseline and Week 12

,,,,,
InterventionPercentage of participants (Number)
Overall ScoreActivity DomainSymptoms DomainEmotional Function DomainEnvironmental Stimuli Domain
MK-1029 10 mg48.9947.1952.5956.1941.79
MK-1029 150 mg64.4860.0757.7657.7659.97
MK-1029 30 mg40.4940.4642.6331.9542.60
MK-1029 60 mg57.2250.0059.6662.1059.66
Montelukast 10 mg64.0852.3664.0853.9153.16
Placebo46.1442.6148.1349.9048.13

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Average Change From Baseline in Daytime Symptom Score (DSS)

The Daytime Symptom Score assessed daytime asthma symptoms. In the evening just before going to bed, participants scored their asthma symptoms for the period since arising by answering the following 4 questions in eDiaries: 1) How often did you experience asthma symptoms today?, 2) How much did your asthma symptoms bother you?, 3) How much activity could you do today? and 4) How often did your asthma affect your activities today? The 4 questions were scored on a 7-point scale (0=best to 6=worst) and averaged for a single score. The average change from baseline in DSS over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a cLDA model. In the cLDA analysis, baseline was the average DSS score during the placebo run-in period and the post-baseline value was the average DSS Score over Week 6 to Week 12. (NCT01656395)
Timeframe: Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)

InterventionScore on a scale (Least Squares Mean)
MK-1029 10 mg-0.398
MK-1029 30 mg-0.134
MK-1029 60 mg-0.364
MK-1029 150 mg-0.120
Montelukast 10 mg-0.411
Placebo-0.276

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Change From Baseline in Asthma Quality of Life Questionnaire With Standardised Activities [AQLQ(S)] Overall and Domain Scores

The AQLQ(S) is a 32-item questionnaire with questions on 4 domains (asthma symptoms, activity limitation, emotional function and environmental stimuli) over the previous 2 weeks. Responses were scored on a 7-point scale (1=worst to 7=best). Each domain score is defined as the average score of all answered questions in that domain. The AQLQ(S) Overall Score is defined as the average of all available item scores (1=worst to 7=best). The changes from baseline are presented for the overall scores and the individual domain scores. Baseline was the last measurement taken prior to the first double-blind study drug. The ending values were calculated as the average AQLQ(S) Overall Score and domain scores at Week 12 of a 12-week treatment period. Statistical analyses are provided for the AQLQ(S) Overall Scores only. (NCT01656395)
Timeframe: Baseline and Week 12

,,,,,
InterventionScore on a scale (Mean)
Overall ScoreActivity DomainSymptoms DomainEmotional Function DomainEnvironmental Stimuli Domain
MK-1029 10 mg0.5330.460.590.550.53
MK-1029 150 mg0.9990.961.021.120.89
MK-1029 30 mg0.2560.270.340.060.21
MK-1029 60 mg0.6960.620.800.750.54
Montelukast 10 mg0.7360.660.830.700.70
Placebo0.4580.440.470.450.49

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Average Change From Baseline in Number of Nocturnal Awakenings

"The number of nights per week (between consecutive visits) that a participant awakened with asthma was based on eDiary entries and was calculated by dividing the number of nights a participant awakened with asthma (positive responses of once, more than once, awake all night) by the total number of nights (all responses) and then multiplying by 7 (standardized to a 7-day period). The average change from baseline in number of nocturnal awakenings over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a cLDA model. In the cLDA analysis, baseline was the average number of nocturnal awakenings during the placebo run-in period and the post-baseline value was calculated as the average number of nocturnal awakenings over Week 6 to Week 12." (NCT01656395)
Timeframe: Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)

InterventionNumber of awakenings (Least Squares Mean)
MK-1029 10 mg-1.277
MK-1029 30 mg-0.900
MK-1029 60 mg-1.286
MK-1029 150 mg-1.277
Montelukast 10 mg-1.107
Placebo-1.036

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Average Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)

FEV1 is the amount of air (in liters) forcibly exhaled in one second. Repeated measurements of FEV1 were collected at visits during the 12 week active treatment period and the average change from baseline in FEV1 over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a constrained longitudinal data analysis (cLDA) model. In the cLDA analysis, baseline was the average FEV1 during the placebo run-in period and the post-baseline value was the average FEV1 over Week 6 to Week 12. (NCT01656395)
Timeframe: Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)

InterventionLiters (Least Squares Mean)
MK-1029 10 mg0.065
MK-1029 30 mg0.004
MK-1029 60 mg0.063
MK-1029 150 mg0.036
Montelukast 10 mg0.039
Placebo0.043

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Average Change From Baseline in Morning/Evening Peak Expiratory Flow (AM/PM PEF)

PEF was defined as a person's maximum speed (rate) of expiration as measured with a peak flow meter in liters per minute. Participants performed triplicate PEF measurements twice daily using a PEF meter, in the AM upon rising and in the PM immediately before study drug administration at bedtime. All three values were recorded and the average of the best morning PEF and the best evening PEF for each day (AM/PM) was determined through the e-Diary. The average change from Baseline in AM/PM PEF over the last 6 weeks of a 12-week treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a cLDA model. In the cLDA analysis, baseline was the average AM/PM PEF value during the placebo run-in period and the post-baseline value was calculated as the average AM/PM PEF over Week 6 to Week 12. (NCT01656395)
Timeframe: Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)

InterventionLiters/minutes (Least Squares Mean)
MK-1029 10 mg-1.857
MK-1029 30 mg3.850
MK-1029 60 mg7.174
MK-1029 150 mg2.713
Montelukast 10 mg-4.005
Placebo-2.401

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Number of Participants Discontinuing Study Treatment Due to AEs

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment. (NCT01673620)
Timeframe: Up to 2 weeks

Interventionparticipants (Number)
Montelukast 10 mg/Loratadine 10 mg1
Placebo0

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Number of Participants Experiencing at Least One Adverse Event (AE)

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment. (NCT01673620)
Timeframe: Up to 4 weeks

Interventionparticipants (Number)
Montelukast 10 mg/Loratadine 10 mg6
Placebo2

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Asthma Control Test

The primary symptomatic measure, the Asthma Control Test (ACT), has been shown to be valid for measuring poor asthma control in asthmatic children and non-smoking adults. The ACT is a tool developed by Nathan and collaborators a decade ago for evaluating asthma control. It consists of five questions with five possible answers each. A maximum score of 25 points indicates complete asthma control. A score between 20 and 24 represents partially controlled asthma, while a score 19 or below indicates poorly controlled asthma and a score <16 indicates uncontrolled asthma. The minimally important clinical difference has been determined to be 3. (NCT01696214)
Timeframe: Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and at follow-up visit 1 month off study drug. Median scores over the 24 weeks of treatment were compared.

Interventionunits on a scale (Median)
Ipratropium17.5
Theophylline13
Montelukast12
Fluticasone 250 mg/Salmeterol 50mg10

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Percent (%) Perdicted FEV1 Changes

Physiologic measures of % predicted FEV1 (NCT01696214)
Timeframe: Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks. Median scores over the 24 weeks of treatment were compared

Interventionpercent predicted FEV1 (Median)
Ipratropium-1.62
Theophylline4.73
Montelukast0.87
Fluticasone 250 mg/Salmeterol 50mg-5.71

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The Asthma Symptom Utility Index (ASUI)

The Asthma Symptom Utility Index (ASUI), an important secondary outcome in the proposed full-scale TOM Trial, has also been shown to be useful in tracking the frequency and severity of asthma-related symptoms in non-smoking asthmatics. ASUI is a brief, interviewer-administered, patient preference-based scale assessing frequency and severity of selected asthma-related symptoms and treatment side effects. 11 items are reviewed, with 2-week recall to assess four symptoms (cough, wheeze, shortness of breath, and awakening at night) and medication side-effects each on two dimensions (frequency and severity). 4-point Likert scale is used to assess frequency (not at all, 1 to 3 days, 4 to 7 days, and 8 to 14 days) and severity (not applicable, mild, moderate and severe). Scores range from 0 (worst possible symptoms) to 1 (no symptoms). The change between two time points, initial visit and after 24 weeks of treatment, is reported. The median value is reported with the standard deviation. (NCT01696214)
Timeframe: Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and a follow-up visit 1 month off study drug. Median scores, change from initial visit and end of treatment, were compared

Interventionunits on a scale (Median)
Ipratropium0.16
Theophylline0.24
Montelukast0.14
Fluticasone 250 mg/Salmeterol 50mg0.13

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Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Peak Expiratory Flow (PEF)

PEF is a person's maximum speed of expiration. It measures the airflow through the bronchi and thus the degree of obstruction in the airways. PEF will be measured using spirometry in accordance with ATS/ERS consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline PEF measurement as the covariate was used for analysis. (NCT01765192)
Timeframe: Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)

Interventionliters/minute (L/min) (Least Squares Mean)
Roflumilast Plus Montelukast15.05
Placebo Plus Montelukast7.85

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Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Vital Capacity (FVC)

FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be measured using spirometry in accordance with ATS/ERS consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline FVC measurement as the covariate was used for analysis. (NCT01765192)
Timeframe: Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)

Interventionliters (Least Squares Mean)
Roflumilast Plus Montelukast0.12
Placebo Plus Montelukast0.06

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Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured using spirometry in accordance with the American Thoracic Society / European Respiratory Society (ATS/ERS) consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline FEV1 measurement as the covariate was used for analysis. (NCT01765192)
Timeframe: Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)

Interventionliters (Least Squares Mean)
Roflumilast Plus Montelukast0.18
Placebo Plus Montelukast0.08

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Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Expiratory Flow (FEF) 25-75%

FEF is a measure of how much air can be exhaled from the lungs. It is an indicator of obstruction of the smaller airways. FEF25-75% is the mid-flow rate or forced expiratory flow occurring in the middle 50% of the patient's exhaled volume, and will be measured using spirometry in accordance with ATS/ERS consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline FEF measurement as the covariate was used for analysis. (NCT01765192)
Timeframe: Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)

Interventionliters/second (Least Squares Mean)
Roflumilast Plus Montelukast0.23
Placebo Plus Montelukast0.11

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Change From Baseline in Nighttime Asthma Symptoms

Patients will assess their daily night-time asthma symptoms according to the following scale: 0: No symptoms, slept through the night. 1: Slept well but some complaints in the morning. 2: Woke up once because of asthma (inclusive early awakening). 3: Woke up several times because of asthma (inclusive early awakening). 4: Bad night, awake most of the night because of asthma. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Nighttime Asthma Symptoms measurement as the covariate was used for analysis. A negative change from Baseline indicates improvement. (NCT01765192)
Timeframe: Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)

Interventionunits on a scale (Least Squares Mean)
Roflumilast Plus Montelukast-0.27
Placebo Plus Montelukast-0.17

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Change From Baseline in Morning Peak Expiratory Flow (PEF)

PEF will be measured at home using portable electronic peak flow meter. The participant will record PEF daily in the morning immediately after getting up. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline PEF measurement as the covariate was used for analysis. (NCT01765192)
Timeframe: Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)

InterventionL/min (Least Squares Mean)
Roflumilast Plus Montelukast20.85
Placebo Plus Montelukast7.23

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Change From Baseline in Daytime Asthma Symptoms

Patients will assess their daily day-time asthma symptoms according to the following scale: 0: Very well, no symptoms. 1: One episode of wheezing, cough or breathlessness. 2: More than one episode of wheezing, cough or breathlessness without interfering with normal activities. 3: Wheezing, cough or short of breath most of the day which interfered to some extent with normal activities. 4: Asthma very bad. Unable to carry out daily activities as usual. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Daytime Asthma Symptoms measurement as the covariate was used for analysis. A negative change from Baseline indicates improvement. (NCT01765192)
Timeframe: Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)

Interventionunits on a scale (Least Squares Mean)
Roflumilast Plus Montelukast-0.39
Placebo Plus Montelukast-0.18

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Apparent Elimination Half-life (t1/2) of Montelukast CT and Montelukast OG

Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28. (NCT01852812)
Timeframe: Up to Day 28 after first dose of study drug

InterventionHours (Mean)
Montelukast 4 mg OG/1-5 Year Olds1.27
Montelukast 5 mg CT/6-9 Year Olds2.01
Montelukast 5 mg CT/10-15 Year Olds2.08

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Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG

Blood samples for pharmacokinetic (PK) assessments were collected at either 1 hour (h) or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28. (NCT01852812)
Timeframe: Up to Day 28 after first dose of study drug

Interventionh*ng/mL (Mean)
Montelukast 4 mg OG/1-5 Year Olds4300
Montelukast 5 mg CT/6-9 Year Olds4350
Montelukast 5 mg CT/10-15 Year Olds3500

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Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG

Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28. (NCT01852812)
Timeframe: Up to Day 28 after first dose of study drug

Interventionng/mL (Mean)
Montelukast 4 mg OG/1-5 Year Olds510
Montelukast 5 mg CT/6-9 Year Olds438
Montelukast 5 mg CT/10-15 Year Olds344

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Percentage of Participants Who Discontinue Study Drug Due to an AE

An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of study drug is also an AE. Discontinuations due to an AE were reported based on the dose of study drug participants received. (NCT01852812)
Timeframe: Up to 12 weeks

InterventionPercentage of participants (Number)
Montelukast 4 mg OG/1-5 Year Olds0.0
Montelukast 5 mg CT/6-15 Year Olds2.8

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Percentage of Participants Who Experience at Least One Adverse Event (AE)

An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of study drug is also an AE. Participants were monitored for the occurrence of AEs for up to 14 days after last dose of study drug (up to a total of 14 weeks). AEs were reported based on the dose of study drug participants received. (NCT01852812)
Timeframe: Up to 14 days after last dose of study drug (Up to 14 weeks)

InterventionPercentage of participants (Number)
Montelukast 4 mg OG/1-5 Year Olds74.5
Montelukast 5 mg CT/6-15 Year Olds55.6

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Time to Cmax (Tmax) of Montelukast CT and Montelukast OG

Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28. (NCT01852812)
Timeframe: Up to Day 28 after first dose of study drug

InterventionHours (Mean)
Montelukast 4 mg OG/1-5 Year Olds2.74
Montelukast 5 mg CT/6-9 Year Olds3.55
Montelukast 5 mg CT/10-15 Year Olds3.65

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Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure

The Nasal Congestion Score was assessed as 0 = No symptoms of nasal congestion to 4 = Completely obstructed all day, with a possible Nasal Congestion Score ranging from 0 to 4 and a higher score indicating more severe nasal congestion. The baseline Nasal Congestion Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Nasal Congestion Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken. (NCT01857063)
Timeframe: Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period

Interventionscore on a scale (Least Squares Mean)
Montelukast0.68
Placebo0.68

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Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure

The Nasal Discharge Score was assessed as 0 = 0 times participant blew his/her nose to 4 = 21 or more times participant blew his/her nose, with a possible Nasal Discharge Score ranging from 0 to 4 and a higher score indicating more severe nasal discharge. The baseline Nasal Discharge Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Nasal Discharge Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken. (NCT01857063)
Timeframe: Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period

Interventionscore on a scale (Least Squares Mean)
Montelukast0.29
Placebo0.32

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Change From Baseline in Sneezing Score Averaged During 3 Hours of Exposure

The Sneezing Score was assessed as 0 = 0 times participant sneezed to 4 = 21 or more times participant sneezed, with a possible Sneezing Score ranging from 0 to 4 and a higher score indicating more severe sneezing. The baseline Sneezing Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Sneezing Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken. (NCT01857063)
Timeframe: Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period

Interventionscore on a scale (Least Squares Mean)
Montelukast0.20
Placebo0.18

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Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure

The TNSS is the sum of the three nasal symptom scores for nasal congestion, nasal discharge and sneezing. Participants completed a questionnaire about their nasal symptoms. Score ranged from 0 to 4 for each of the three nasal symptoms, with a total possible score ranging from 0 to 12 and a higher score indicating more severe nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period during 3 hours of exposure to Japanes cedar (JC) pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken. (NCT01857063)
Timeframe: Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period

Interventionscore on a scale (Least Squares Mean)
Montelukast1.17
Placebo1.18

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Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure

TNSS was weighted as 2:1:1 for nasal congestion, nasal discharge and sneezing. The Weighted TNSS ranged from 0 to 16, with a higher score indicating more severe weighted total nasal symptoms. The baseline Weighted TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken. (NCT01857063)
Timeframe: Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period

Interventionscore on a scale (Least Squares Mean)
Montelukast1.85
Placebo1.86

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Percentage of Participants Who Experience at Least One Adverse Event

An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence adverse events for up to 14 days after last dose of study drug. Analysis was done by study drug as taken. (NCT01857063)
Timeframe: Up to 5 weeks

Interventionpercentage of participants (Number)
Montelukast10.2
Placebo16.5

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Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room

The Nasal Congestion Score was assessed as 0 = No symptoms of nasal congestion to 4 = Completely obstructed all day. The possible Nasal Congestion Score ranged from 0 to 4, with a higher score indicating more severe nasal congestion.The Nasal Congestion Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken. (NCT01857063)
Timeframe: Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period

,
Interventionscore on a scale (Least Squares Mean)
30 minutes after entering chamber room60 minutes after entering chamber room90 minutes after entering chamber room120 minutes after entering chamber room150 minutes after entering chamber room180 minutes after entering chamber room
Montelukast0.320.550.740.800.830.83
Placebo0.330.560.730.820.810.81

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Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room

The Nasal Discharge Score was assessed as 0 = 0 times participant blew his/her nose to 4 = 21 or more times participant blew his/her nose. The possible Nasal Discharge Score ranged from 0 to 4, with a higher score indicating more severe nasal discharge.The Nasal Discharge Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken. (NCT01857063)
Timeframe: Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period

,
Interventionscore on a scale (Least Squares Mean)
30 minutes after entering chamber room60 minutes after entering chamber room90 minutes after entering chamber room120 minutes after entering chamber room150 minutes after entering chamber room180 minutes after entering chamber room
Montelukast0.130.270.390.340.310.33
Placebo0.170.330.380.360.320.37

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Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room

The Sneezing Score was assessed as 0 = 0 times participant sneezed to 4 = 21 or more times participant sneezed. The possible Sneezing Score ranged from 0 to 4, with a higher score indicating more severe sneezing. The Sneezing Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken. (NCT01857063)
Timeframe: Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period

,
Interventionscore on a scale (Least Squares Mean)
30 minutes after entering chamber room60 minutes after entering chamber room90 minutes after entering chamber room120 minutes after entering chamber room150 minutes after entering chamber room180 minutes after entering chamber room
Montelukast0.090.180.230.250.240.23
Placebo0.090.180.200.170.210.23

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Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room

The TNSS is the sum of the three nasal symptom scores for nasal congestion, nasal discharge and sneezing. The possible TNSS ranged from 0 to 12, with a higher score indicting more severe total nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken. (NCT01857063)
Timeframe: Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period

,
Interventionscore on a scale (Least Squares Mean)
30 minutes after entering chamber room60 minutes after entering chamber room90 minutes after entering chamber room120 minutes after entering chamber room150 minutes after entering chamber room180 minutes after entering chamber room
Montelukast0.541.001.361.381.381.39
Placebo0.591.071.311.351.351.40

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Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room

TNSS was weighted as 2:1:1 for nasal congestion, nasal discharge and sneezing. The possible Weighted TNSS ranged from 0 to 16, with a higher score indicating more severe total nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Weighted TNSS was assessed on Day 7 of a treatment period at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken. (NCT01857063)
Timeframe: Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period

,
Interventionscore on a scale (Least Squares Mean)
30 minutes after entering chamber room60 minutes after entering chamber room90 minutes after entering chamber room120 minutes after entering chamber room150 minutes after entering chamber room180 minutes after entering chamber room
Montelukast0.861.552.112.172.212.22
Placebo0.911.632.042.172.162.21

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Change in Soluble Vascular Cell Adhesion Molecule-1 (sVCAM)

The primary outcome measure is based on a 30% reduction, which would be ~106 ng/ml reduction. The study was designed with 25 in each group in order to explore all three aims and potential confounders. However, if the investigators are not able to accrue 25 subjects in each arm, the investigators would still be able to detect a 30% difference in sVCAM with 17 subjects in each group. The 95% confidence interval for detecting a 30% difference is between 204 ng/ml and 290 ng/ml (or an 18-42% reduction in sVCAM). Importantly, the lower limit of the 95% confidence interval (18%) is still a clinically relevant reduction in sVCAM. Thus, if the investigators detect a 30% or larger difference in sVCAM in this study, the investigators will be assured that, based on the 95% confidence interval, these data are clinically important. (NCT01960413)
Timeframe: baseline to eight weeks

Interventionng/mL (Median)
Montelukast Added to Hydroxyurea-3.2
Placebo Added to Hydroxyurea4.17

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Area Under the Curve (AUC) of Methyl Hydroxymontelukast

(NCT02321748)
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention

Interventionh*ng/mL (Geometric Mean)
Montelukast150.19
ASP2151188.62

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Area Under the Curve (AUC) of Montelukast

(NCT02321748)
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention

Interventionh*ng/mL (Geometric Mean)
Montelukast2799.2
ASP21513418.5

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Half-Life (t1/2) of ASP2151

(NCT02321748)
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24h after post doses in first or second intervention

Interventionh (Geometric Mean)
ASP21518.406

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Half-Life (t1/2) of Methyl Hydroxymontelukast

(NCT02321748)
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention

Interventionh (Geometric Mean)
Montelukast4.87
ASP21514.83

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Half-Life (t1/2) of Montelukast

(NCT02321748)
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention

Interventionh (Geometric Mean)
Montelukast4.87
ASP21515.37

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Peak Plasma Concentration (Cmax) of ASP2151

(NCT02321748)
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24h after post doses in first or second intervention

Interventionng/mL (Geometric Mean)
ASP21511679.7

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Peak Plasma Concentration (Cmax) of Methyl Hydroxymontelukast

(NCT02321748)
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention

Interventionng/mL (Geometric Mean)
Montelukast19.18
ASP215123.28

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Peak Plasma Concentration (Cmax) of Montelukast

(NCT02321748)
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention

Interventionng/mL (Geometric Mean)
Montelukast415.6
ASP2151505.9

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Time of Peak Concentration (Tmax) of ASP2151

(NCT02321748)
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24h after post doses in first or second intervention

Interventionh (Median)
ASP21513

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Time of Peak Concentration (Tmax) of Methyl Hydroxymontelukast

(NCT02321748)
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention

Interventionh (Median)
Montelukast4.51
ASP21515

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Time of Peak Concentration (Tmax) of Montelukast

(NCT02321748)
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention

Interventionh (Median)
Montelukast3
ASP21513

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Number of Participants With Serious and Non-Serious Adverse Events

Refer to the result of adverse event. (NCT02321748)
Timeframe: Up to 32 days after the last dose

,
Interventionparticipants (Number)
Non-serious adverse eventserious adverse event
Montelukast Alone70
Montelukast With ASP215120

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Apparent Volume of Distribution (Vd/f) of Montelukast

(NCT02321748)
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention

InterventionL (Mean)
Montelukast26.72
ASP215123.76

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Apparent Total Body Clearance (CL/f) of ASP2151

(NCT02321748)
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24h after post doses in first or second intervention

InterventionL/h (Mean)
ASP215119.95

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Apparent Total Body Clearance (CL/f) of Montelukast

(NCT02321748)
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention

InterventionL/h (Mean)
Montelukast3.72
ASP21513.04

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Apparent Volume of Distribution (Vd/f) of ASP2151

(NCT02321748)
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24h after post doses in first or second intervention

InterventionL (Mean)
ASP2151246.9

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Area Under the Curve (AUC) of ASP2151

(NCT02321748)
Timeframe: Blood samples were taken at pre-dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24h after post doses in first or second intervention

Interventionh*ng/mL (Geometric Mean)
ASP215120928.2

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Efavirenz AUC0-inf (Single Dose) and AUC0-24(Multiple Dose)

After the samples collection, blood from phase 2 and phase 4 were used to perform the quantification of Efavirenz in plasma. The composite of the efavirenz concentration (blood collection between 0 to 120 hrs) were used to calculate the area under the plasma concentration time curve (AUC0-inf for single dose and AUC0-24 for multiple dose) of efavirenz. (NCT02401256)
Timeframe: Single dose pharmacokinetics (PK) versus multiple doses (after 17 day pretreatment) PK (total 38 days for each subject)

,,
Interventionh*uM (Mean)
Efavirenz AUC0-inf (Single Dose)Efavirenz AUC0-24 (Multiple Dose)
CYP2B6*1/*1411.53183.97
CYP2B6*1/*6620.36254.40
CYP2B6*6/*6522.42321.86

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Average Change From Baseline in GSRS Overall Score at Day 1 to Day 10

The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). This endpoint reports the average change from baseline (Day 0) at Day 1 to Day 10. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose. A negative change from baseline indicates that symptoms decreased. (NCT02410278)
Timeframe: Baseline (Day 0), Day 1 (1 day after Day 0), Day 10 (10 days after Day 0)

,
Interventionunits on a scale (Mean)
Day 0Change From Day 1 to Day 10
MITT-Montelukast0.84-0.23
MITT-Placebo0.80-0.28

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Average Change From Baseline in GSRS Overall Score at Day 1 to Weeks 1 to 8

The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). This endpoint reports the average change from baseline (Day 0) between Day 1 and the specified time point. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose. A negative change from baseline indicates that symptoms decreased. (NCT02410278)
Timeframe: Baseline (Day 0), Day 1 (1 Day after Day 0), Weeks 1 to 8 (1-8 weeks after Day 0)

,
Interventionunit on scale (Mean)
Day 0Change from Day 1 to Week 1Change from Day 1 to Week 2Change from Day 1 to Week 3Change from Day 1 to Week 4Change from Day 1 to Week 5Change from Day 1 to Week 6Change from Day 1 to Week 7Change from Day 1 to Week 8
MITT-Montelukast0.84-0.21-0.25-0.26-0.26-0.28-0.29-0.30-0.31
MITT-Placebo0.80-0.30-0.29-0.31-0.33-0.35-0.35-0.36-0.36

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Percentage of Participants Who Required GI Symptomatic Therapy During the Study

Symptomatic therapies were not permitted during the first 10 days after starting montelukast or placebo. From Day 10 onward, participants were allowed to use the following symptomatic therapies to treat DMF-related GI events: bismuth subsalicylate, simethicone, calcium carbonate, loperamide, proton-pump inhibitors and ondansetron. (NCT02410278)
Timeframe: Day 10 to Week 10

Interventionpercentage of participants (Number)
MITT-Placebo33
MITT-Montelukast33

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Percentage of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the GSRS From Day 0 to Day 10

The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). Worsening in severity was defined as a positive average change from baseline (Day 0) to Day 10 in the GSRS score. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose. Average change is the sum of changes from baseline in GSRS score over the first 10 days divided by the total of days with a GSRS score. (NCT02410278)
Timeframe: Baseline (Day 0), Day 10 (10 days after Day 0)

Interventionpercentage of participants (Number)
MITT-Placebo17
MITT-Montelukast33

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Time to First Worsening From Baseline in GSRS Overall Score at Day 1 to Day 10

The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose.. Time to the first worsening was defined as the number of days from Day 1 to the first date with a worsened GSRS score. Censoring occurred at Day 10. (NCT02410278)
Timeframe: Baseline (Day 0), Day 1 (1 day after Day 0) to Day 10 (10 days after Day 0)

Interventiondays (Median)
MITT-Placebo10
MITT-Montelukast7

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Time to Recovery to Baseline GSRS Score From Last Occurrence of Worst GSRS Score at Day 1 to Week 8

The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). Recovery was defined as a GSRS score less than or equal to the Day 0 score. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose. Time to recovery was defined as the date of recovery minus the date of the last occurrence of the worst score. (NCT02410278)
Timeframe: Baseline (Day 0), Day 1 (1 Day after Day 0) to Week 8 (8 weeks after Day 0)

Interventiondays (Median)
MITT-Placebo1
MITT-Montelukast1

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Average Change From Baseline in GSRS Overall Score at Day 0 to 72 Hours From the Initiation of Randomized Study Treatment

The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). This endpoint reports the average change from baseline (Day 0) at Day 1 to Day 3. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 is the last day when the threshold was reached, prior to the first dose. A negative change from baseline indicates that symptoms decreased. (NCT02410278)
Timeframe: Baseline (Day 0), Day 3 (72 hours after Day 0)

,
Interventionunits on scale (Mean)
Day 0Change from Day 0 to Day 3
MITT-Montelukast0.84-0.18
MITT-Placebo0.80-0.28

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Average Change From Baseline in GSRS Overall Score at Day 1 to Week 10

The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). This endpoint reports the average change from baseline (Day 0) between Day 1 and Week 10. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose. A negative change from baseline indicates that symptoms decreased. (NCT02410278)
Timeframe: Baseline (Day 0), Day 1 (1 day after Day 0), Week 10 (10 weeks after Day 0)

,
Interventionunits on scale (Mean)
Day 0Change From Day 1 to Week 10
MITT-Montelukast0.84-0.31
MITT-Placebo0.80-0.37

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Change From Baseline (Expressed as a Ratio) in 0-24 Hour Weighted Mean Serum Cortisol at the End of the Six Week Treatment Period (Day 42) in SC Population

The blood samples for statistical analysis of serum cortisol (SC) endpoints were collected on D0 and D42 at indicated time points. The weighted mean was calculated by dividing the area under curve (AUC) over the 24-hr time period by time period. Change from Baseline in 0-24 hr weighted mean SC was calculated as a ratio from baseline defined as SC weighted mean (0-24 hrs) at Wk 6 divided by the baseline SC weighted mean (0-24 hrs). The ratio as treatment ratios, using an analysis of covariance (ANCOVA) model, allowing for the effects of baseline (loge transformed from baseline was loge transformed prior to analysis. The loge transformed ratios were compared between treatment groups), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between Least square (LS) means. Using the pooled estimate of variance, 95% CIs) was calculated for the difference. (NCT02483975)
Timeframe: Baseline, Day 0 (Predose, 2hr, 4hr, 8hr, 12hr, 16hr and 24hr) and Day 42 (0hr, 2hr, 4hr, 8hr, 16hr and 24hr)

InterventionRatio (Geometric Mean)
Fluticasone Furoate 50 mcg1.02
Placebo1.00

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Change From Baseline (Expressed as a Ratio) in 0-24 Hour Weighted Mean Serum Cortisol at the End of the Six Week Treatment Period (D 42) in Intention-to-treat (ITT) Population

The blood samples for statistical analysis of serum cortisol (SC) endpoints were collected on D 0 and D 42 at the indicated time points. The weighted mean was calculated by dividing the area under the curve (AUC) over the 24-hour (hr) time period by the time period. Change from Baseline in 0-24 hr weighted mean SC was calculated as a ratio from Baseline defined as the SC weighted mean (0-24 hours) at Week 6 divided by the Baseline SC weighted mean (0-24 hours).The ratio from Baseline was loge transformed prior to analysis. The loge transformed ratios were compared between treatment groups as treatment ratios, using an analysis of covariance (ANCOVA) model, allowing for the effects of Baseline (loge transformed), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between the Least square (LS) means. Using the pooled estimate of variance, 95% Confidence Intervals (CIs) was calculated for the difference. (NCT02483975)
Timeframe: Baseline, D 0 (Pre-dose, 2hr, 4hr, 8hr, 12hr, 16hr and 24hr) and Day 42 (0hr, 2hr, 4hr, 8hr, 16hr and 24hr)

InterventionRatio (Geometric Mean)
Fluticasone Furoate 50 mcg1.02
Placebo1.01

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Change From Baseline (Expressed as a Ratio) in 24-hour 6-beta Hydroxycortisol Excretion at the End of the Six Week Treatment Period (Day 42).

The 24 hr urinary 6-beta hydroxycortisol excretion was collected over a 24 hour period on Day 0 and Day 42. Change from baseline in 24- hr urinary 6-beta hydroxycortisol excretion was calculated as a ratio from baseline defined as 24-hr urinary 6-beta hydroxycortisol excretion at Week 6 divided by the baseline 24-hr urinary 6-beta hydroxycortisol excretion. The ratio from baseline was loge transformed prior to analysis. The loge transformed ratio was compared between treatment groups using an analysis of covariance (ANCOVA) model, allowing for the effects of baseline (loge transformed), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between the Least square (LS) means. Using the pooled estimate of variance, 95% Confidence Intervals (CIs) was calculated for the difference. Participants with 24-hr urinary cortisol excretion at baseline and Week 6 were analyzed. (NCT02483975)
Timeframe: Baseline (Day 0) Day 42

InterventionRatio (Geometric Mean)
Fluticasone Furoate 50 mcg0.78
Placebo0.90

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Change From Baseline (Expressed as a Ratio) in 24-hour Urinary Cortisol Excretion at the End of the Six Week Treatment Period (Day 42)

The 24 hr urinary cortisol excretion was collected over a 24 hour period on Day 0 and Day 42. Change from baseline in 24- hr urinary cortisol excretion was calculated as a ratio from baseline defined as 24-hr urinary cortisol excretion at Week 6 divided by the baseline 24-hr urinary cortisol excretion. The ratio from baseline was loge transformed prior to analysis. The loge transformed ratio was compared between treatment groups using an analysis of covariance (ANCOVA) model, allowing for the effects of baseline (loge transformed), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between the Least square (LS) means. Using the pooled estimate of variance, 95% Confidence Intervals (CIs) was calculated for the difference. Participants with 24-hr urinary cortisol excretion at baseline and Week 6 were analyzed. (NCT02483975)
Timeframe: Baseline (Day 0) Day 42

InterventionRatio (Geometric Mean)
Fluticasone Furoate 50 mcg0.69
Placebo1.05

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Change From Baseline (Expressed as a Ratio) in Area Under the Curve (AUC) 0-24 Hour Serum Cortisol at the End of the Six Week Treatment Period (Day 42).

The blood samples for statistical analysis of area under the curve over the 24 hours (AUC 0-24 hours) endpoints were collected on Day 0 and Day 42 at the indicated time points. The AUC 0-24 hours was calculated using trapezoidal rule. Change from baseline in AUC 0-24 hour was calculated as a ratio from baseline defined as the AUC (0-24 hours) at Week 6 divided by the baseline AUC (0-24 hours) The ratio from baseline was loge transformed prior to analysis. The loge transformed ratios were compared between treatment groups as treatment ratios using an analysis of covariance (ANCOVA) model, allowing for the effects of baseline (loge transformed), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between the Least square (LS) means. Using the pooled estimate of variance, 95% Confidence Intervals (CIs) was calculated for the difference. Par. with SC weighted mean (0-24hr) calculated at baseline and Week 6 were analyzed (NCT02483975)
Timeframe: Baseline and Week Baseline, Day 0 (Predose, 2hr, 4hr, 8hr, 12hr, 16hr and 24hr) and Day 42 (0hr, 2hr, 4hr, 8hr, 16hr and 24hr)

InterventionRatio (Geometric Mean)
Fluticasone Furoate 50 mcg1.02
Placebo1.00

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Change From Baseline in Eosinophil (Percent [%]) at Week 6

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 6

,
InterventionPercent of White Blood Cells (Mean)
BaselineChange at Week 6
MK-1029 150 mg + Montelukast 10 mg4.400.11
MK-1029 Placebo + Montelukast 10 mg3.580.51

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Change From Baseline in Hematocrit (%) at Week 6

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 6

,
InterventionPercent (Mean)
BaselineChange at Week 6
MK-1029 150 mg + Montelukast 10 mg42.79-0.10
MK-1029 Placebo + Montelukast 10 mg42.64-0.33

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Change From Baseline in Diastolic Blood Pressure at Week 6

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 6

,
InterventionmmHg (Mean)
BaselineChange at Week 6
MK-1029 150 mg + Montelukast 10 mg74.60-1.18
MK-1029 Placebo + Montelukast 10 mg74.29-0.95

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Change From Baseline in Diastolic Blood Pressure at Week 4

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 4

,
InterventionmmHg (Mean)
BaselineChange at Week 4
MK-1029 150 mg + Montelukast 10 mg74.60-1.56
MK-1029 Placebo + Montelukast 10 mg74.42-1.60

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Change From Baseline in Diastolic Blood Pressure at Week 2

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 2

,
InterventionmmHg (Mean)
BaselineChange at Week 2
MK-1029 150 mg + Montelukast 10 mg74.40-1.31
MK-1029 Placebo + Montelukast 10 mg74.45-0.97

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Change From Baseline in Heart Rate at Week 4

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 4

,
Interventionbeats/min (Mean)
BaselineChange at Week 4
MK-1029 150 mg + Montelukast 10 mg73.25-1.82
MK-1029 Placebo + Montelukast 10 mg73.961.40

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Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6

"A day with worsening asthma was defined as any day during which any of the following occurred: a decrease from baseline in morning (AM) peak expiratory flow (PEF) of more than 20%; AM PEF less than 180 liters/minute (L/min); an increase in β-agonist use of more than 70% (and a minimum increase of at least 2 puffs); an increase from baseline in daytime asthma symptom score of more than 50%; overnight asthma symptom of: Awake all night; an asthma attack, as defined by any day when one or more of the following events due to asthma has occurred: corticosteroid use (systemic); unscheduled visit to the doctor or urgent care clinic; unscheduled visit to the emergency department; and/or hospitalization. Participants needed at least 80% of days with a complete diary during Weeks 3 to 6. A diary is considered complete if none of the above 6 components used to determine asthma worsening are missing." (NCT02720081)
Timeframe: Up to 4 weeks

InterventionPercentage of days (Least Squares Mean)
MK-1029 150 mg + Montelukast 10 mg16.970
MK-1029 Placebo + Montelukast 10 mg21.746

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Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1)

FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. (NCT02720081)
Timeframe: Before the first dose of study investigational product (Baseline)

InterventionLiter (Mean)
MK-1029 150 mg + Montelukast 10 mg2.264
MK-1029 Placebo + Montelukast 10 mg2.234

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Average Change From Baseline in Pre-dose FEV1 at Week 4 and Week 6

FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. Data presented represents the average change from baseline at Week 4 and Week 6. (NCT02720081)
Timeframe: Before the first dose (Baseline) and at the end of Weeks 4 and 6 of treatment

InterventionLiter (Least Squares Mean)
MK-1029 150 mg + Montelukast 10 mg0.152
MK-1029 Placebo + Montelukast 10 mg0.046

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Change From Baseline in Alanine Aminotransferase (ALT) at Week 6

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 6

,
InterventionIU/L (Mean)
BaselineChange at Week 6
MK-1029 150 mg + Montelukast 10 mg22.33-0.99
MK-1029 Placebo + Montelukast 10 mg19.350.34

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Percentage of Participants Who Experienced an Adverse Event (AE)

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02720081)
Timeframe: Up to 8 weeks

InterventionPercentage of participants (Number)
MK-1029 150 mg + Montelukast 10 mg25.7
MK-1029 Placebo + Montelukast 10 mg26.1

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Change From Baseline in Neutrophil (%) at Week 6

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 6

,
InterventionPercent of White Blood Cells (Mean)
BaselineChange at Week 6
MK-1029 150 mg + Montelukast 10 mg59.13-1.32
MK-1029 Placebo + Montelukast 10 mg57.860.12

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Change From Baseline in Heart Rate at Week 6

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 6

,
Interventionbeats/min (Mean)
BaselineChange at Week 6
MK-1029 150 mg + Montelukast 10 mg73.25-0.84
MK-1029 Placebo + Montelukast 10 mg73.801.06

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Percentage of Participants Who Discontinued Study Drug Due to an AE

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02720081)
Timeframe: Up to 6 weeks

InterventionPercentage of participants (Number)
MK-1029 150 mg + Montelukast 10 mg0.0
MK-1029 Placebo + Montelukast 10 mg4.3

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Change From Baseline in Heart Rate at Week 2

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 2

,
Interventionbeats/min (Mean)
BaselineChange at Week 2
MK-1029 150 mg + Montelukast 10 mg73.21-0.60
MK-1029 Placebo + Montelukast 10 mg74.200.45

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Change From Baseline in Bilirubin at Week 6

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 6

,
Interventionmg/dL (Mean)
BaselineChange at Week 6
MK-1029 150 mg + Montelukast 10 mg0.62-0.00
MK-1029 Placebo + Montelukast 10 mg0.54-0.01

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Change From Baseline in Aspartate Aminotransferase (AST) at Week 6

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 6

,
InterventionIU/L (Mean)
BaselineChange at Week 6
MK-1029 150 mg + Montelukast 10 mg23.53-0.09
MK-1029 Placebo + Montelukast 10 mg20.640.76

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Change From Baseline in Alkaline Phosphatase (ALP) at Week 6

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 6

,
InterventionIU/L (Mean)
BaselineChange at Week 6
MK-1029 150 mg + Montelukast 10 mg61.16-0.83
MK-1029 Placebo + Montelukast 10 mg67.960.44

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Change From Baseline in Platelet Count at Week 6

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 6

,
Intervention10^9 cells/L (Mean)
BaselineChange at Week 6
MK-1029 150 mg + Montelukast 10 mg256.85-4.97
MK-1029 Placebo + Montelukast 10 mg258.442.65

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Change From Baseline in Respiratory Rate at Week 2

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 2

,
Interventionbreaths/min (Mean)
BaselineChange at Week 2
MK-1029 150 mg + Montelukast 10 mg16.40-0.30
MK-1029 Placebo + Montelukast 10 mg17.23-1.17

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Change From Baseline in Respiratory Rate at Week 4

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 4

,
Interventionbreaths/min (Mean)
BaselineChange at Week 4
MK-1029 150 mg + Montelukast 10 mg16.43-0.12
MK-1029 Placebo + Montelukast 10 mg17.18-0.97

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Change From Baseline in Respiratory Rate at Week 6

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 6

,
Interventionbreaths/min (Mean)
BaselineChange at Week 6
MK-1029 150 mg + Montelukast 10 mg16.43-0.09
MK-1029 Placebo + Montelukast 10 mg17.20-1.17

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Change From Baseline in Systolic Blood Pressure at Week 2

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 2

,
InterventionmmHg (Mean)
BaselineChange at Week 2
MK-1029 150 mg + Montelukast 10 mg118.89-1.61
MK-1029 Placebo + Montelukast 10 mg118.83-1.23

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Change From Baseline in Systolic Blood Pressure at Week 4

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 4

,
InterventionmmHg (Mean)
BaselineChange at Week 4
MK-1029 150 mg + Montelukast 10 mg119.40-2.13
MK-1029 Placebo + Montelukast 10 mg118.82-1.99

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Change From Baseline in Systolic Blood Pressure at Week 6

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 6

,
InterventionmmHg (Mean)
BaselineChange at Week 6
MK-1029 150 mg + Montelukast 10 mg119.40-0.34
MK-1029 Placebo + Montelukast 10 mg118.77-2.26

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Change From Baseline in White Blood Cell Count at Week 6

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. (NCT02720081)
Timeframe: Baseline and Week 6

,
Intervention10^9 cells/L (Mean)
BaselineChange at Week 6
MK-1029 150 mg + Montelukast 10 mg6.76-0.08
MK-1029 Placebo + Montelukast 10 mg6.530.09

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Change From Baseline With Montelukast+Bilastine Compared With Bilastine Monotherapy in SARC Symptoms

"To demonstrate that concomitant administration of montelukast and bilastine is superior to bilastine monotherapy in SARC symptoms, as assessed by Total Symptoms Scores (TSS) after 4 weeks of treatment.~Total Symptoms Scores (TSS) assesses nasal (nasal congestion, rhinorrhea, nasal itching, sneezing) and non nasal symptoms (ocular redness, ocular itching, tearing) of rhinoconjuctivits.~Each of the 7 symptoms is scored from 0 (absent) to 3 (severe) as follows:~0 (absent) Symptom not present~1 (mild) Symptom is clearly present but easily tolerated, a nuisance, minimal awareness~2 (moderate) Symptom is bothersome but tolerable, does not interfere with daily activities or sleep~3 (severe) Symptom is hard to tolerate and interferes with daily activities or sleep.~TSS assessment comprises of scoring (0-3) of all 7 above mentioned symptoms. Final TSS scores is in a range from 0-21." (NCT02761252)
Timeframe: 4 weeks of treatment (from baseline to 4 weeks of treatment)

Interventionscore on a scale (Mean)
Bilastine+Montelukast-3.2522
Bilastine Monotherapy-3.4462

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Change From Baseline With Montelukast+Bilastine Compared With Montelukast and Bilastine Monotherapies in Asthma Control

"To evaluate the efficacy of concomitant montelukast and bilastine compared with montelukast and bilastine monotherapies in asthma control, as assessed by Asthma Quality of Life Questionnaire (AQLQ) after 4 weeks.~The AQLQ was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma.~Each of the 32 questionnaire's items will be scored on a 7-point scale (where 7 means not impaired at all and 1 means severely impaired). The overall AQLQ score is the mean of all 32 responses (https://www.qoltech.co.uk/aqlq.html).~The change in AQLQ score from baseline to 4 weeks after treatment - AQLQ score at baseline for patients with both available values has been the secondary endpoint." (NCT02761252)
Timeframe: After 4 weeks of treatments

Interventionscore on a scale (Mean)
Bilastine+Montelukast0.6250
Bilastine Monotherapy0.6399
Montelukast Monotherapy0.5849

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Change From Baseline With Montelukast+Bilastine Compared With Montelukast and Bilastine Monotherapies in SARC Symptoms (DNSS)

"To evaluate the efficacy of concomitant montelukast and bilastine compared with montelukast and bilastine monotherapies in daytime symptoms of SARC, as assessed by Daytime Nasal Symptom Score (DNSS) after 4 weeks of treatment.~Daytime Nasal Symptom Score (DNSS) is the average of individual scores of nasal congestion, rhinorrhea, nasal itching, sneezing of rhinoconjuctivits.~Each of the 4 symptoms is scored from 0 (absent) to 3 (severe) as follows:~0 (absent) Symptom not present~1 (mild) Symptom is clearly present but easily tolerated, a nuisance, minimal awareness~2 (moderate) Symptom is bothersome but tolerable, does not interfere with daily activities or sleep~3 (severe) Symptom is hard to tolerate and interferes with daily activities or sleep.~DNSS assessment comprises of scoring (0-3) of all 4 above mentioned symptoms. Final DNSS scores is in a range from 0-12." (NCT02761252)
Timeframe: After 4 weeks of treatment (from baseline)

Interventionscore on a scale (Mean)
Bilastine+Montelukast-1.9713
Bilastine Monotherapy-2.1106
Montelukast Monotherapy-1.8678

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Usage of Relief Medication for Asthma

Number of days without any relief medication for Asthma. (NCT02761252)
Timeframe: From baseline to 4 weeks of treatment

InterventionDays (Least Squares Mean)
Bilastine+Montelukast53.2548
Bilastine Monotherapy52.4177
Montelukast Monotherapy50.7146

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Usage of Relief Medication for SARC

Number of days without any relief medication for SARC (NCT02761252)
Timeframe: From baseline to 4 weeks of treatment

InterventionDays (Least Squares Mean)
Bilastine+Montelukast15.0057
Bilastine Monotherapy15.8416
Montelukast Monotherapy15.4179

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Change From Baseline With Montelukast + Bilastine Compared With Montelukast and Bilastine Monotherapies in SARC Symptoms (DNNSS)

"To evaluate the efficacy of concomitant montelukast and bilastine compared with montelukast and bilastine monotherapies in daytime symptoms of SARC, as assessed by Daytime Non Nasal Symptom Score (DNNSS) after 4 weeks of treatment.~Daytime Non Nasal Symptom Score (DNSS) is the average of individual scores of ocular redness, ocular itching and tearing of rhinoconjuctivits.~Each of the 3 symptoms is scored from 0 (absent) to 3 (severe) as follows:~0 (absent) Symptom not present~1 (mild) Symptom is clearly present but easily tolerated, a nuisance, minimal awareness~2 (moderate) Symptom is bothersome but tolerable, does not interfere with daily activities or sleep~3 (severe) Symptom is hard to tolerate and interferes with daily activities or sleep.~DNNSS assessment comprises of scoring (0-3) of all 3 above mentioned symptoms. Final DNNSS scores is in a range from 0-9." (NCT02761252)
Timeframe: After 4 weeks of treatment (from baseline)

Interventionscore on a scale (Mean)
Bilastine+Montelukast-1.2824
Bilastine Monotherapy-1.3185
Montelukast Monotherapy-1.1574

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Number of Participants With On-treatment Asthma Exacerbations Over Double-blind Treatment Period

An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or a single depot corticosteroid injection, or an in-patient hospitalization or emergency department (ED) visit due to asthma that required systemic corticosteroids. Number of participants with on-treatment asthma exacerbations during double-blind treatment period is presented. (NCT02889809)
Timeframe: Up to 52 weeks

InterventionParticipants (Count of Participants)
Placebo22
FF 50 mcg7

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Growth Velocity Over the First 12 Weeks of Double-blind Treatment Period

Growth velocity was calculated for each participant over double blind period by fitting regression line to height measurements recorded for that participant during period.Slope of this regression line was participant's growth velocity for double-blind treatment period.In order to be included in this analysis,participant must have data from Visit8(Wk 12) stadiometric height assessment.Baseline was included as covariate which was calculated based on stadiometric height measurements recorded at Visits 1(wk -16),3(wk-8),& 5(wk0),data from at least two of these visits were used to fit simple linear regression line against time&slope of fitted regression line was participant's Baseline growth velocity.All available height data collected during double-blind treatment period upto Visit8(Wk12) while participant was on randomized double-blind treatment was considered.ANCOVA model was used to estimate mean treatment difference in growth velocity over 1st 12weeks of double-blind treatment period. (NCT02889809)
Timeframe: Up to 12 weeks (Visit 8) of double-blind treatment period

InterventionCentimeter per year (Least Squares Mean)
Placebo6.222
FF 50 mcg6.281

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Percentage of Participants Below the Third Percentile of Growth Velocity During Double-blind Treatment Period

Three reproducible height measurements were taken using stadiometer at each visit&were recorded to nearest 1/10th of a centimeter.Each set of triplicate measurements was averaged to derive one estimated height per participant per visit.Growth velocity(GV)was calculated for each participant over double-blind treatment(up to 52 weeks)period by fitting regression line to height measurements recorded for that participant during period.Each participant's double-blind(DB) treatment period GV was calculated based on all on &off treatment height data &was programmatically compared to data values from Standards from Birth to Maturity for Height,Weight,Height Velocity, established in British Children(1965)&further updated for North American children(1985)using 3rd percentile value of age closest to participant's age at end of endpoint(i.e.either end of participant's DB treatment period [Visit18 Wk 52]/withdrawal from study[Early Withdrawal Visit]).Percentage values presented is rounded off. (NCT02889809)
Timeframe: Up to 52 weeks

InterventionPercentage of participants (Number)
Placebo9
FF 50 mcg7

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Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's judgement. (NCT02889809)
Timeframe: Up to 76 weeks

,
InterventionParticipants (Count of Participants)
Any SAEsAny Non-serious AEs
FF 50 mcg699
Placebo8105

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Percentage of Participants With Change in Growth Velocity Quartiles From Baseline to Endpoint

Growth velocity(GV) quartile(defined as 1st quartile(1Q)=1st-25th percentile,2Q=26th-50th percentile,3Q=51st-75th percentile,4Q=76th-100th percentile) was determined at Baseline&endpoint.Endpoint was defined as slope of simple linear regression of average stadiometric height recorded at week 28& upto wk52.Baseline growth velocity was calculated as slope from simple linear regression of average stadiometric height recorded at wk-16,-8&0.Baseline GV was programmatically compared to reference for standard height data using participant's estimated age at wk0& age in reference data closest to actual age of participant to determine Baseline GV quartile.Endpoint GV was programmatically compared to reference data using participant's age at endpoint & age in reference data that was closest to actual age of participant to determine endpoint GV quartile. Any increase/decrease indicates any increase/decrease in quartiles with reference to Baseline. Percentage values presented is rounded off. (NCT02889809)
Timeframe: Baseline and Endpoint (Week 28[Visit 12] up to and including Week 52 [Visit 18])

,
InterventionPercentage of Participants (Number)
Any increaseAny decrease
FF 50 mcg3238
Placebo3334

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Change in Height Standard Deviation Scores (SDS) From Baseline to Endpoint

Each participant's SDS for each of three required stadiometric height measurements was calculated as:(observed height measurement-standard median height for age at Visit [week-16]) divided by (/) ([standard 95th height percentile for age at visit-standard 5th height percentile for age at visit]/[2*1.645]).Standard median, 95th percentile, & 5th percentile values were obtained from standard tables (Guidance for Industry Orally Inhaled & Intranasal Corticosteroid). SDS for each height stadiometric measurement at each visit was calculated using percentiles from standard tables & averaged for each participant before being summarized by treatment group. A reduction in SDS over time indicates growth deceleration & an increase in SDS over time means growth acceleration.Baseline was defined as height SD score at Visit 5 (week 0). Endpoint was defined as height SD score at Visit 18 (week52) (on- & off-treatment data). Change from Baseline was calculated as Endpoint value minus Baseline value. (NCT02889809)
Timeframe: Baseline (Week 0 [Visit 5]) and up to Endpoint (Week 52 [Visit 18])

InterventionStandard Deviation Score (Mean)
Placebo-0.02
FF 50 mcg-0.04

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Growth Velocity (Centimeter Per Year) Over the Double-blind Treatment Period, as Determined by Stadiometry

Three reproducible height measurements were taken using a stadiometer at each visit and were recorded to nearest 1/10th of centimeter. Each set of triplicate measurements was averaged to derive one estimated height per participant per visit. Growth velocity was calculated for each participant over double-blind treatment period (up to 52 weeks [wk]) by fitting a regression line to averaged height measurements at each visit for that participant during period. Slope of this regression line was participant's growth velocity for double-blind treatment period. Treatment policy estimand was assessed, including all on- and post-treatment data. Baseline was included as covariate which was calculated based on stadiometric height measurements recorded at Visits 1(wk -16), 3(wk-8), and 5(wk0), data from at least two of these visits were used to fit a simple linear regression line against time and the slope of the fitted regression line was the participant's Baseline growth velocity. (NCT02889809)
Timeframe: Up to 52 weeks

InterventionCentimeter per year (Least Squares Mean)
Placebo6.065
FF 50 mcg5.905

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Number of Participants With Anti-Human Leukocyte Antigen (HLA)-Antibody Reduction

Number of participants with anti-HLA-antibody (Baseline MFI >=3000) reduced to <2000 as measured using a SAB assay per central laboratory assessment was reported in this outcome measure. Participants were categorized in various categories of number of antibodies which were reduced as: none, 1-5, >5-10, >10-15, and >15. If multiple visits had the same number of total anti-HLA antibody reduction, the last visit data was summarized. (NCT04294459)
Timeframe: From first dose of study drug until end of follow-up period (maximum duration: up to 39.1 weeks)

,
InterventionParticipants (Count of Participants)
None1-5 antibodies>5-10 antibodies>10-15 antibodies>15 antibodies
Cohort A: Participants With cPRA >=99.90%24411
Cohort B: Participants With cPRA 80.00% to 99.89%24401

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Number of Participants With Hematological Abnormalities

Abnormal hematological parameters assessed were anemia, platelet count decreased, neutrophil count decreased, lymphocyte count decreased and monocytes. The hematological abnormality grades were based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Monocytes were assessed as per potentially clinically significant abnormality (PCSA) criteria defined as: greater than (>) 0.7*10^9/L. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
Anemia: Grade 1Anemia: Grade 2Anemia: Grade 3Anemia: Grade 4Platelet count decreased: Grade 1Platelet count decreased: Grade 2Platelet count decreased: Grade 3Platelet count decreased: Grade 4Neutrophil count decreased: Grade 1Neutrophil count decreased: Grade 2Neutrophil count decreased: Grade 3Neutrophil count decreased: Grade 4Lymphocyte count decreased: Grade 1Lymphocyte count decreased: Grade 2Lymphocyte count decreased: Grade 3Lymphocyte count decreased: Grade 4Monocytes (PCSA) > 0.7*10^9/L
Cohort A: Participants With cPRA >=99.90%63002000000041103
Cohort B: Participants With cPRA 80.00% to 99.89%82006000000021003

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Number of Participants With Liver Function Abnormalities

Abnormal liver function parameters assessed were Alanine aminotransferase (ALT) increased, Aspartate aminotransferase (AST) increased, Alkaline phosphatase (ALP) increased, and Total bilirubin (TB) increased. The abnormal grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
ALT increased: Grade 1ALT increased: Grade 2ALT increased: Grade 3ALT increased: Grade 4AST increased: Grade 1AST increased: Grade 2AST increased: Grade 3AST increased: Grade 4ALP increased: Grade 1ALP increased: Grade 2ALP increased: Grade 3ALP increased: Grade 4TB increased: Grade 1TB increased: Grade 2TB increased: Grade 3TB increased: Grade 4
Cohort A: Participants With cPRA >=99.90%1000100030000000
Cohort B: Participants With cPRA 80.00% to 99.89%1000000020000000

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Number of Participants With Renal Function Abnormalities

Abnormal renal parameters assessed were creatinine increased and estimated Glomerular Filtration Rate (eGFR). The renal function abnormality grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. eGFR was assessed as per PCSA criteria: 60 (less than equal to) <= to less than (<) 90 milliliter/minute/1.73 meter square (mL/min/1.73m^2) (Mild), 30<= to <60 mL/min/1.73m^2 (Moderate), 15<=to <30 mL/min/1.73m^2 (Severe), <15 mL/min/1.73m^2 (End Stage Renal Disease). (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
Creatinine increased: Grade 1Creatinine increased: Grade 2Creatinine increased: Grade 3Creatinine increased: Grade 4eGFR: 60<= - <90 mL/min/1.73m^2eGFR: 30<= - <60 mL/min/1.73m^2eGFR: 15<= - <30 mL/min/1.73m^2eGFR: <15 mL/min/1.73m^2
Cohort A: Participants With cPRA >=99.90%0011100012
Cohort B: Participants With cPRA 80.00% to 99.89%003800011

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)

An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Serious adverse events (SAEs) were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (defined as the time from the first dose of study drug until study cut-off date). (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
TEAEsTESAEs
Cohort A: Participants With cPRA >=99.90%30
Cohort B: Participants With cPRA 80.00% to 99.89%40

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PK Parameters: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 168 Hours Over the Dosing Interval (AUC0-168 Hours) After First Infusion of Isatuximab

AUC0-168 hours was defined as the area under the plasma concentration versus time curve from time 0 to 168 hours post dose calculated using trapezoidal method after first infusion of isatuximab. (NCT04294459)
Timeframe: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

Interventionmicrograms*hours/milliliter (mcg*h/mL) (Mean)
Cohort A: Participants With cPRA >=99.90%29400
Cohort B: Participants With cPRA 80.00% to 99.89%20000

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Pharmacokinetics (PK) Parameters: Concentration Observed at the End of First Intravenous Infusion (Ceoi) of Isatuximab

Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab. (NCT04294459)
Timeframe: At End of infusion on Cycle 1 Day 1

Interventionmicrograms per milliliter (mcg/mL) (Mean)
Cohort A: Participants With cPRA >=99.90%290
Cohort B: Participants With cPRA 80.00% to 99.89%270

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Percentage of Participants With Response

Response was defined as the percentage of participants meeting at least one of the predefined desensitization efficacy criteria as measured by single antigen bead (SAB) assay as follows: reduction in cPRA resulting in at least 100% increase of likelihood of finding a compatible donor; reduction in antibody titer (>=75% reduction from Baseline) to achieve target cPRA; elimination of >=1 human leukocyte antigen (HLA) antibody (i.e., mean fluorescence intensity [MFI] reduced to <2000) as measured by a SAB assay, for antibodies with Baseline MFI >=3000. (NCT04294459)
Timeframe: From first dose of study drug until end of follow-up period (maximum duration: up to 39.1 weeks)

Interventionpercentage of participants (Number)
Cohort A: Participants With cPRA >=99.90%83.3
Cohort B: Participants With cPRA 80.00% to 99.89%81.8

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Number of Participants With Graft Survival at 6 Months Post-Transplant

Number of participants with graft survival status as functioning at 6-months post-transplant was reported in this outcome measure. (NCT04294459)
Timeframe: At 6 Months post-transplant

InterventionParticipants (Count of Participants)
Cohort A: Participants With cPRA >=99.90%1
Cohort B: Participants With Calculated Panel Reactive Antibodies (cPRA) 80.00% to 99.89%0

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Number of Participants Achieving Target cPRA

Target calculated panel reactive antibodies (cPRA) was defined as the reduction of cPRA required to achieve at least 100% increase of likelihood of compatible donor (LCD). Number of participants who achieved target cPRA was assessed using the Organ Procurement and Transplantation Network (OPTN) calculator during the specified timepoint were reported in this outcome measure. Participants who retained their target cPRA values were censored at the date of the last available laboratory assessment achieving their target cPRA. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

InterventionParticipants (Count of Participants)
Cohort A: Participants With cPRA >=99.90%4
Cohort B: Participants With cPRA 80.00% to 99.89%2

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Number of Kidney Transplant Offers

Number of kidney transplants offers received for each participant was reported in the outcome measure. Data on transplant offers were collected and followed up until study cut-off date. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

Interventiontransplant offers (Number)
Cohort A: Participants With cPRA >=99.90%3
Cohort B: Participants With cPRA 80.00% to 99.89%3

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Duration of Response (DOR)

Duration of response (DOR) was defined as time (in weeks) from laboratory sample collection date used in determining a participant to be a responder (defined as participants meeting at least one of the predefined desensitization efficacy criteria: reduction in cPRA resulting in at least 100% increase of likelihood of finding a compatible donor; reduction in antibody titer [>=75% reduction from Baseline] to achieve target cPRA; elimination of >=1 anti-HLA antibody i.e. MFI reduced to <2000 as measured by a SAB assay, for antibodies with Baseline MFI >=3000) up to the laboratory sample collection date when participant was confirmed as no longer meeting any response criterion (i.e., non-responder) or the date of death due to any cause, whichever occurs first. DOR was analyzed using Kaplan-Meier method. (NCT04294459)
Timeframe: From first dose of study drug until end of follow-up period (maximum duration: up to 39.1 weeks)

Interventionweeks (Median)
Cohort A: Participants With cPRA >=99.90%NA
Cohort B: Participants With cPRA 80.00% to 99.89%NA

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Duration for Achieving Target cPRA

Duration of achieving target cPRA was defined as the time (in weeks) from laboratory sample collection date of achieving target cPRA (defined as the reduction of cPRA required to achieve at least 100% increase of LCD) the first time up to the laboratory sample collection date when no longer achieving target cPRA calculated using OPTN calculator or the date of death due to any cause, whichever occurs first. The duration of achieving target cPRA was assessed using the Kaplan-Meier method. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

Interventionweeks (Median)
Cohort A: Participants With cPRA >=99.90%NA
Cohort B: Participants With cPRA 80.00% to 99.89%7.29

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Number of Participants With Anti-drug Antibodies (ADA) Against Isatuximab

ADA responses were categorized as treatment boosted ADA and treatment-induced ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
Treatment-induced ADATreatment boosted ADA
Cohort A: Participants With cPRA >=99.90%00
Cohort B: Participants With cPRA 80.00% to 99.89%00

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PK Parameters: Last Concentration Observed Above the Lower Limit of Quantification (Clast) After the First Infusion of Isatuximab

Clast was defined as the last concentration of isatuximab observed above the lower limit of quantification calculated using non-compartmental analysis after the first infusion of isatuximab. (NCT04294459)
Timeframe: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

Interventionmcg/mL (Mean)
Cohort A: Participants With cPRA >=99.90%104
Cohort B: Participants With cPRA 80.00% to 99.89%76.3

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PK Parameters: Maximum Concentration Observed (Cmax) After the First Infusion of Isatuximab

Cmax was defined as the maximum concentration observed after the first administration calculated using the noncompartmental analysis after the intravenous infusion of isatuximab. (NCT04294459)
Timeframe: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

Interventionmcg/mL (Mean)
Cohort A: Participants With cPRA >=99.90%295
Cohort B: Participants With cPRA 80.00% to 99.89%285

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PK Parameters: Time of Clast (Tlast) After First Infusion of Isatuximab

Tlast was defined as the time of last concentration observed above the lower limit of quantification, calculated using the non-compartmental analysis after the intravenous infusion of isatuximab. (NCT04294459)
Timeframe: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

Interventionhours (Median)
Cohort A: Participants With cPRA >=99.90%166.00
Cohort B: Participants With cPRA 80.00% to 99.89%167.00

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PK Parameters: Time Taken to Reach Cmax (Tmax) After the First Infusion of Isatuximab

Tmax was defined as the time to reach Cmax, calculated using the non-compartmental analysis after the intravenous infusion of isatuximab. (NCT04294459)
Timeframe: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

Interventionhours (Median)
Cohort A: Participants With cPRA >=99.90%3.67
Cohort B: Participants With cPRA 80.00% to 99.89%3.40

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PK Parameters: Trough Plasma Concentrations (Ctrough) of Isatuximab

Ctrough was the plasma concentration of isatuximab observed just before (pre-dose) treatment administration. (NCT04294459)
Timeframe: Cycle 2 Day 1

Interventionmcg/mL (Mean)
Cohort A: Participants With cPRA >=99.90%308
Cohort B: Participants With cPRA 80.00% to 99.89%246

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Time to First Transplant Offer

Time to first transplant offer was defined as time (in days) from date of first study treatment dose up to date of first kidney transplant offer. Data on transplant status were collected and followed up until study cut-off date. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

Interventiondays (Median)
Cohort A: Participants With cPRA >=99.90%373
Cohort B: Participants With cPRA 80.00% to 99.89%156

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Time to Transplant

Time to transplant was defined as time (in days) from date of first study treatment dose up to date of kidney transplant. Data on transplant status were collected and followed up until study cut-off date. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

Interventiondays (Median)
Cohort A: Participants With cPRA >=99.90%445
Cohort B: Participants With cPRA 80.00% to 99.89%259.5

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Number of Participants With Abnormal Electrolytes Parameters

Abnormal electrolyte parameters assessed were hypernatremia, hyponatremia, hyperkalemia, hypokalemia, hypercalcemia, hypocalcemia, blood bicarbonate decreased, hypermagnesemia, hypomagnesemia and chloride. The abnormal grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Chloride was estimated as per PCSA criteria: <80 millimoles per liter (mmol/L) and >115 mmol/L. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
Hypernatremia: Grade 1Hypernatremia: Grade 2Hypernatremia: Grade 3Hypernatremia: Grade 4Hyponatremia: Grade 1Hyponatremia: Grade 2Hyponatremia: Grade 3Hyponatremia: Grade 4Hyperkalemia: Grade 1Hyperkalemia: Grade 2Hyperkalemia: Grade 3Hyperkalemia: Grade 4Hypokalemia: Grade 1Hypokalemia: Grade 2Hypokalemia: Grade 3Hypokalemia: Grade 4Hypercalcemia: Grade 1Hypercalcemia: Grade 2Hypercalcemia: Grade 3Hypercalcemia: Grade 4Hypocalcemia: Grade 1Hypocalcemia: Grade 2Hypocalcemia: Grade 3Hypocalcemia: Grade 4Hypermagnesemia: Grade 1Hypermagnesemia: Grade 2Hypermagnesemia: Grade 3Hypermagnesemia: Grade 4Hypomagnesemia: Grade 1Hypomagnesemia: Grade 2Hypomagnesemia: Grade 3Hypomagnesemia: Grade 4Chloride (PCSA): <80 mmol/LChloride (PCSA): >115 mmol/L
Cohort A: Participants With cPRA >=99.90%0000400023100001010060002000300000
Cohort B: Participants With cPRA 80.00% to 99.89%0000100061200000100052000000300000

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Number of Participants With Abnormal Metabolism Parameters

Abnormal metabolism parameters assessed were hypoglycemia, hypoalbuminemia and glycated Hemoglobin (HbA1c). The abnormal grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. HbA1c was estimated as per PCSA criteria: >8%. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
Hypoglycemia: Grade 1Hypoglycemia: Grade 2Hypoglycemia: Grade 3Hypoglycemia: Grade 4Hypoalbuminemia: Grade 1Hypoalbuminemia: Grade 2Hypoalbuminemia: Grade 3Hypoalbuminemia: Grade 4
Cohort A: Participants With cPRA >=99.90%11003200
Cohort B: Participants With cPRA 80.00% to 99.89%20000200

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Treatment C: Change From Baseline in Erythrocytes Mean Corpuscular Volume

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

InterventionFemtoliter (Mean)
Day 22Day 25
Treatment C: Probe Substrates + GSK3640254 200 mg-1.64-1.28

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Treatment C: Change From Baseline in Glucose, Carbon Dioxide, Cholesterol, Triglycerides, Anion Gap, Calcium, Chloride, Phosphate, Potassium, Sodium, Urea

Blood samples were collected to analyze the chemistry parameters: glucose, carbon dioxide, cholesterol, triglycerides, anion gap, calcium, chloride, phosphate, potassium, sodium and urea. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

InterventionMillimoles per liter (Mean)
Day 22: GlucoseDay 25: GlucoseDay 22: Carbon DioxideDay 25: Carbon DioxideDay 22: CholesterolDay 25: CholesterolDay 22: TriglyceridesDay 25: TriglyceridesDay 22: Anion GapDay 25: Anion GapDay 22: CalciumDay 25: CalciumDay 22: ChlorideDay 25: ChlorideDay 22: PhosphateDay 25: PhosphateDay 22: PotassiumDay 25: PotassiumDay 22: SodiumDay 25: SodiumDay 22: UreaDay 25: Urea
Treatment C: Probe Substrates + GSK3640254 200 mg0.08760.15190.51.2-0.4355-0.29260.00540.0291-0.6-0.1-0.04070.03021.4-0.8-0.06800.0816-0.04-0.031.20.4-0.8286-0.4265

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Treatment C: Change From Baseline in Hematocrit

Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

InterventionProportion of red blood cells in blood (Mean)
Day 22Day 25
Treatment C: Probe Substrates + GSK3640254 200 mg-0.0217-0.0071

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Treatment C: Change From Baseline in Hemoglobin

Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

InterventionGrams per liter (Mean)
Day 22Day 25
Treatment C: Probe Substrates + GSK3640254 200 mg-5.8-2.3

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Treatment C: Change From Baseline in Oral Temperature

Oral temperature was measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 21, Pre-Dose), before the first dose in Treatment C. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 21, Pre-Dose), Days 22 and 25

InterventionDegrees Celsius (Mean)
Day 22Day 25
Treatment C: Probe Substrates + GSK3640254 200 mg-0.130.01

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Treatment C: Change From Baseline in Platelet Count, Leukocyte Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils

Blood samples were collected to analyze the hematology parameters: platelet count, leukocyte count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

Intervention10^9 cells per liter (Mean)
Day 22: Platelet countDay 25: Platelet countDay 22: Leukocyte countDay 25: Leukocyte countDay 22: NeutrophilsDay 25: NeutrophilsDay 22: LymphocytesDay 25: LymphocytesDay 22: MonocytesDay 25: MonocytesDay 22: EosinophilsDay 25: EosinophilsDay 22: BasophilsDay 25: Basophils
Treatment C: Probe Substrates + GSK3640254 200 mg-13.1-1.6-0.050.12-0.12540.13510.03510.08430.0184-0.09290.0329-0.0115-0.0094-0.0066

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Treatment C: Change From Baseline in Pulse Rate

Pulse rate was measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 21, Pre-Dose), before the first dose in Treatment C. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 21, Pre-Dose), Days 22 and 25

InterventionBeats per minute (Mean)
Day 22Day 25
Treatment C: Probe Substrates + GSK3640254 200 mg-7.1-1.5

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Treatment C: Change From Baseline in Respiratory Rate

Respiratory rate was measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 21, Pre-Dose), before the first dose in Treatment C. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 21, Pre-Dose), Days 22 and 25

InterventionBreaths per minute (Mean)
Day 22Day 25
Treatment C: Probe Substrates + GSK3640254 200 mg-0.10.8

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Treatment C: Change From Baseline in SBP and DBP

SBP and DBP were measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 21, Pre-Dose), before the first dose in Treatment C. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 21, Pre-Dose), Days 22 and 25

InterventionMillimeters of mercury (Mean)
Day 22: SBPDay 25: SBPDay 22: DBPDay 25: DBP
Treatment C: Probe Substrates + GSK3640254 200 mg-1.92.2-4.3-0.5

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Treatment C: Change From Baseline in Urate, Creatinine, Bilirubin, Direct Bilirubin

Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

InterventionMicromoles per liter (Mean)
Day 22: UrateDay 25: UrateDay 22: CreatinineDay 25: CreatinineDay 22: BilirubinDay 25: BilirubinDay 22: Direct bilirubinDay 25: Direct bilirubin
Treatment C: Probe Substrates + GSK3640254 200 mg-40.0707-2.5044-4.7922-1.58191.13400.28800.23400.1530

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AUC(0-t) for 5-hydroxyomeprazole

Blood samples were collected at the indicated time points for pharmacokinetic analysis of 5-hydroxyomeprazole. 5-hydroxyomeprazole is a metabolite of omeprazole. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates713.5
Treatment C: Probe Substrates + GSK3640254 200 mg785.1

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AUC(0-t) for 36-hydroxymontelukast

Blood samples were collected at the indicated time points for pharmacokinetic analysis of 36-hydroxymontelukas. 36-hydroxymontelukast is a metabolite of montelukast. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates234.2
Treatment C: Probe Substrates + GSK3640254 200 mg230.9

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AUC(0-t) for 1-hydroxymidazolam

Blood samples were collected at the indicated time points for pharmacokinetic analysis of 1-hydroxymidazolam. 1-hydroxymidazolam is a metabolite of midazolam. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates31.07
Treatment C: Probe Substrates + GSK3640254 200 mg28.07

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AUC(0-infinity) for Pravastatin

Blood samples were collected at the indicated time points for pharmacokinetic analysis of pravastatin. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates72.09
Treatment C: Probe Substrates + GSK3640254 200 mg43.70

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AUC(0-infinity) for Omeprazole

Blood samples were collected at the indicated time points for pharmacokinetic analysis of omeprazole. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates1127
Treatment C: Probe Substrates + GSK3640254 200 mg1093

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AUC(0-infinity) for Montelukast

Blood samples were collected at the indicated time points for pharmacokinetic analysis of montelukast. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates2859
Treatment C: Probe Substrates + GSK3640254 200 mg3109

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AUC(0-infinity) for Midazolam

Blood samples were collected at the indicated time points for pharmacokinetic analysis of midazolam. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates70.08
Treatment C: Probe Substrates + GSK3640254 200 mg65.46

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AUC(0-infinity) for Metoprolol

Blood samples were collected at the indicated time points for pharmacokinetic analysis of metoprolol. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates659.1
Treatment C: Probe Substrates + GSK3640254 200 mg813.1

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AUC(0-infinity) for Flurbiprofen

Blood samples were collected at the indicated time points for pharmacokinetic analysis of flurbiprofen. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates66700
Treatment C: Probe Substrates + GSK3640254 200 mg68660

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AUC(0-infinity) for Digoxin

Blood samples were collected at the indicated time points for pharmacokinetic analysis of digoxin. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*pg/mL (Geometric Mean)
Treatment A: Probe Substrates19180
Treatment C: Probe Substrates + GSK3640254 200 mg20090

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AUC(0-infinity) for Alpha-hydroxymetoprolol

Blood samples were collected at the indicated time points for pharmacokinetic analysis of alpha-hydroxymetoprolol. Alpha-hydroxymetoprolol is a metabolite of metoprolol. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates682.8
Treatment C: Probe Substrates + GSK3640254 200 mg632.8

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AUC(0-infinity) for 5-hydroxyomeprazole

Blood samples were collected at the indicated time points for pharmacokinetic analysis of 5-hydroxyomeprazole. 5-hydroxyomeprazole is a metabolite of omeprazole. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates767.4
Treatment C: Probe Substrates + GSK3640254 200 mg762.0

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AUC(0-infinity) for 36-hydroxymontelukast

Blood samples were collected at the indicated time points for pharmacokinetic analysis of 36-hydroxymontelukast. 36-hydroxymontelukast is a metabolite of montelukast. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates252.5
Treatment C: Probe Substrates + GSK3640254 200 mg249.3

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AUC(0-t) for Digoxin

Blood samples were collected at the indicated time points for pharmacokinetic analysis of digoxin. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours*picogram per milliliter (h*pg/mL) (Geometric Mean)
Treatment A: Probe Substrates16690
Treatment C: Probe Substrates + GSK3640254 200 mg17840

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AUC(0-t) for Flurbiprofen

Blood samples were collected at the indicated time points for pharmacokinetic analysis of flurbiprofen. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates64930
Treatment C: Probe Substrates + GSK3640254 200 mg66170

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AUC(0-t) for Metoprolol

Blood samples were collected at the indicated time points for pharmacokinetic analysis of metoprolol. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates655.0
Treatment C: Probe Substrates + GSK3640254 200 mg807.3

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AUC(0-infinity) for 1-hydroxymidazolam

Blood samples were collected at the indicated time points for pharmacokinetic analysis of 1-hydroxymidazolam. 1-hydroxymidazolam is a metabolite of midazolam. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates31.86
Treatment C: Probe Substrates + GSK3640254 200 mg28.99

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AUC(0-t) for Midazolam

Blood samples were collected at the indicated time points for pharmacokinetic analysis of midazolam. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates67.11
Treatment C: Probe Substrates + GSK3640254 200 mg62.95

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AUC(0-t) for Montelukast

Blood samples were collected at the indicated time points for pharmacokinetic analysis of montelukast. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates2724
Treatment C: Probe Substrates + GSK3640254 200 mg2940

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AUC(0-t) for Omeprazole

Blood samples were collected at the indicated time points for pharmacokinetic analysis of omeprazole. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates728.1
Treatment C: Probe Substrates + GSK3640254 200 mg817.9

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AUC(0-t) for Pravastatin

Blood samples were collected at the indicated time points for pharmacokinetic analysis of pravastatin. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates69.92
Treatment C: Probe Substrates + GSK3640254 200 mg51.03

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Cmax for 1-hydroxymidazolam

Blood samples were collected at the indicated time points for pharmacokinetic analysis of 1-hydroxymidazolam. 1-hydroxymidazolam is a metabolite of midazolam. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionng/mL (Geometric Mean)
Treatment A: Probe Substrates7.933
Treatment C: Probe Substrates + GSK3640254 200 mg6.722

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Cmax for 36-hydroxymontelukast

Blood samples were collected at the indicated time points for pharmacokinetic analysis of 36-hydroxymontelukast. 36-hydroxymontelukast is a metabolite of montelukast. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionng/mL (Geometric Mean)
Treatment A: Probe Substrates24.62
Treatment C: Probe Substrates + GSK3640254 200 mg23.22

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Cmax for 5-hydroxyomeprazole

Blood samples were collected at the indicated time points for pharmacokinetic analysis of 5-hydroxyomeprazole. 5-hydroxyomeprazole is a metabolite of omeprazole. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionng/mL (Geometric Mean)
Treatment A: Probe Substrates181.1
Treatment C: Probe Substrates + GSK3640254 200 mg203.3

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Cmax for Alpha-hydroxymetoprolol

Blood samples were collected at the indicated time points for pharmacokinetic analysis of alpha-hydroxymetoprolol. Alpha-hydroxymetoprolol is a metabolite of metoprolol. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionng/mL (Geometric Mean)
Treatment A: Probe Substrates45.70
Treatment C: Probe Substrates + GSK3640254 200 mg39.21

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Cmax for Digoxin

Blood samples were collected at the indicated time points for pharmacokinetic analysis of digoxin. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionPicogram per milliliter (pg/mL) (Geometric Mean)
Treatment A: Probe Substrates1026
Treatment C: Probe Substrates + GSK3640254 200 mg1282

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Cmax for Flurbiprofen

Blood samples were collected at the indicated time points for pharmacokinetic analysis of flurbiprofen. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionng/mL (Geometric Mean)
Treatment A: Probe Substrates10220
Treatment C: Probe Substrates + GSK3640254 200 mg10710

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Cmax for Metoprolol

Blood samples were collected at the indicated time points for pharmacokinetic analysis of metoprolol. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionng/mL (Geometric Mean)
Treatment A: Probe Substrates127.4
Treatment C: Probe Substrates + GSK3640254 200 mg141.1

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Cmax for Midazolam

Blood samples were collected at the indicated time points for pharmacokinetic analysis of midazolam. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionng/mL (Geometric Mean)
Treatment A: Probe Substrates15.44
Treatment C: Probe Substrates + GSK3640254 200 mg13.95

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AUC From Time Zero Extrapolated to Infinity (AUC[0-infinity]) for Caffeine

Blood samples were collected at the indicated time points for pharmacokinetic analysis of caffeine. The AUC(0-infinity) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates39720
Treatment C: Probe Substrates + GSK3640254 200 mg44440

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Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Time t (AUC[0-t]) for Caffeine

Blood samples were collected at the indicated time points for pharmacokinetic analysis of caffeine. Area under the plasma concentration-time curve from time zero to time t, to be calculated using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHour*nanograms per milliliter (h*ng/mL) (Geometric Mean)
Treatment A: Probe Substrates37970
Treatment C: Probe Substrates + GSK3640254 200 mg42230

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Apparent Terminal Phase Half-life (t1/2) for Caffeine

Blood samples were collected at the indicated time points for pharmacokinetic analysis of caffeine. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Geometric Mean)
Treatment A: Probe Substrates5.380
Treatment C: Probe Substrates + GSK3640254 200 mg6.085

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Cmax for Omeprazole

Blood samples were collected at the indicated time points for pharmacokinetic analysis of omeprazole. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionng/mL (Geometric Mean)
Treatment A: Probe Substrates224.4
Treatment C: Probe Substrates + GSK3640254 200 mg256.6

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Cmax for Pravastatin

Blood samples were collected at the indicated time points for pharmacokinetic analysis of pravastatin. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionng/mL (Geometric Mean)
Treatment A: Probe Substrates19.45
Treatment C: Probe Substrates + GSK3640254 200 mg15.19

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Maximum Observed Plasma Concentration (Cmax) for Caffeine

Blood samples were collected at the indicated time points for pharmacokinetic analysis of caffeine. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionNanograms per milliliter (ng/mL) (Geometric Mean)
Treatment A: Probe Substrates4340
Treatment C: Probe Substrates + GSK3640254 200 mg4110

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Ratio of AUC(0-infinity) of 1-hydroxymidazolam to Midazolam

Blood samples were collected at the indicated time points for pharmacokinetic analysis of parent drug (midazolam) and its metabolite (1-hydroxymidazolam). Ratio of AUC(0-infinity) of metabolite to parent drug has been presented. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionRatio (Mean)
Treatment A: Probe Substrates0.4677
Treatment C: Probe Substrates + GSK3640254 200 mg0.4618

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Treatment B: Change From Baseline in Urate, Creatinine, Bilirubin, Direct Bilirubin

Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

InterventionMicromoles per liter (Mean)
UrateCreatinineBilirubinDirect bilirubin
Treatment B: GSK3640254 200 mg-27.65824.37580.61560.1112

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Ratio of AUC(0-infinity) of 5-hydroxyomeprazole to Omeprazole

Blood samples were collected at the indicated time points for pharmacokinetic analysis of parent drug (omeprazole) and its metabolite (5-hydroxyomeprazole). Ratio of AUC(0-infinity) of metabolite to parent drug has been presented. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionRatio (Mean)
Treatment A: Probe Substrates1.151
Treatment C: Probe Substrates + GSK3640254 200 mg1.077

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Ratio of AUC(0-infinity) of Alpha-hydroxymetoprolol to Metoprolol

Blood samples were collected at the indicated time points for pharmacokinetic analysis of parent drug (metoprolol) and its metabolite (alpha-hydroxymetoprolol). Ratio of AUC(0-infinity) of metabolite to parent drug has been presented. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionRatio (Mean)
Treatment A: Probe Substrates1.733
Treatment C: Probe Substrates + GSK3640254 200 mg1.449

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Ratio of Cmax of 1-hydroxymidazolam to Midazolam

Blood samples were collected at the indicated time points for pharmacokinetic analysis of parent drug (midazolam) and its metabolite (1-hydroxymidazolam). Ratio of Cmax of metabolite to parent drug has been presented. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionRatio (Mean)
Treatment A: Probe Substrates0.5286
Treatment C: Probe Substrates + GSK3640254 200 mg0.4955

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Ratio of Cmax of 36-hydroxymontelukast to Montelukast

Blood samples were collected at the indicated time points for pharmacokinetic analysis of parent drug (montelukast) and its metabolite (36-hydroxymontelukast). Ratio of Cmax of metabolite to parent drug has been presented. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionRatio (Mean)
Treatment A: Probe Substrates0.06766
Treatment C: Probe Substrates + GSK3640254 200 mg0.06308

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Ratio of Cmax of 5-hydroxyomeprazole to Omeprazole

Blood samples were collected at the indicated time points for pharmacokinetic analysis of parent drug (omeprazole) and its metabolite (5-hydroxyomeprazole). Ratio of Cmax of metabolite to parent drug has been presented. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionRatio (Mean)
Treatment A: Probe Substrates0.9461
Treatment C: Probe Substrates + GSK3640254 200 mg0.8810

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Ratio of Cmax of Alpha-hydroxymetoprolol to Metoprolol

Blood samples were collected at the indicated time points for pharmacokinetic analysis of parent drug (metoprolol) and its metabolite (alpha-hydroxymetoprolol). Ratio of Cmax of metabolite to parent drug has been presented. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionRatio (Mean)
Treatment A: Probe Substrates0.7869
Treatment C: Probe Substrates + GSK3640254 200 mg0.7066

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Treatment A: Change From Baseline in Albumin, Globulin, Protein

Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

InterventionGrams per liter (Mean)
AlbuminGlobulinProtein
Treatment A: Probe Substrates-0.7-1.5-2.2

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Treatment A: Change From Baseline in Amylase, Lipase

Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

InterventionUnits per liter (Mean)
LipaseAmylase
Treatment A: Probe Substrates2.2-2.6

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Treatment A: Change From Baseline in Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase

Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

InterventionInternational units per liter (Mean)
Creatine kinaseLactate dehydrogenaseALTALPASTGamma-glutamyl transferase
Treatment A: Probe Substrates-36.9-16.54.5-1.91.0-0.2

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Treatment A: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF

Twelve-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval and QTcF Interval. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 1, Pre-Dose), before the dose in Treatment A. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 1, Pre-dose) and Day 10

InterventionMilliseconds (Mean)
PR IntervalQRS DurationQT IntervalQTcF Interval
Treatment A: Probe Substrates3.42.57.14.8

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Treatment A: Change From Baseline in Glucose, Carbon Dioxide, Cholesterol, Triglycerides, Anion Gap, Calcium, Chloride, Phosphate, Potassium, Sodium, Urea

Blood samples were collected to analyze the chemistry parameters: glucose, carbon dioxide, cholesterol, triglycerides, anion gap, calcium, chloride, phosphate, potassium, sodium, and urea. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

InterventionMillimoles per liter (Mean)
GlucoseCarbon DioxideCholesterolTriglyceridesAnion GapCalciumChloridePhosphatePotassiumSodiumUrea
Treatment A: Probe Substrates-0.2137-78.7-0.6452-0.04185.9-0.062478.00.0678-0.050.71.1263

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Treatment A: Change From Baseline in Platelet Count, Leukocyte Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils

Blood samples were collected to analyze the hematology parameters: platelet count, leukocyte count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

Intervention10^9 cells per liter (Mean)
Platelet countLeukocyte countNeutrophilsLymphocytesMonocytesEosinophilsBasophils
Treatment A: Probe Substrates7.30.660.59260.0748-0.03750.01500.0110

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t1/2 for 1-hydroxymidazolam

Blood samples were collected at the indicated time points for pharmacokinetic analysis of 1-hydroxymidazolam. 1-hydroxymidazolam is a metabolite of midazolam. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Geometric Mean)
Treatment A: Probe Substrates3.632
Treatment C: Probe Substrates + GSK3640254 200 mg3.717

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Treatment A: Change From Baseline in SBP and DBP

SBP and DBP were measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 1, Pre-Dose), before the dose in Treatment A. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 1, Pre-dose) and Day 10

InterventionMillimeters of mercury (Mean)
SBPDBP
Treatment A: Probe Substrates-3.3-5.4

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Treatment A: Change From Baseline in Urate, Creatinine, Bilirubin, Direct Bilirubin

Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

InterventionMicromoles per liter (Mean)
UrateCreatinineBilirubinDirect bilirubin
Treatment A: Probe Substrates18.14141.4586-1.8297-0.3506

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Treatment B: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval

Twelve-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval and QTcF Interval. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 11, Pre-Dose), before the first dose in Treatment B. (NCT04425902)
Timeframe: Baseline (Day 11, Pre-Dose) and Day 20

InterventionMilliseconds (Mean)
Baseline (Day 11, Pre-dose): PR IntervalDay 20: PR IntervalBaseline (Day 11, Pre-dose): QRS DurationDay 20: QRS DurationBaseline (Day 11, Pre-dose): QT IntervalDay 20: QT IntervalBaseline (Day 11, Pre-dose): QTcF IntervalDay 20: QTcF Interval
Treatment B: GSK3640254 200 mg158.6161.894.296.4403.1408.8403.5408.6

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Treatment B: Absolute Values of Albumin, Globulin, Protein

Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

InterventionGrams per liter (Mean)
Baseline (Day 10): AlbuminDay 20: AlbuminBaseline (Day 10): GlobulinDay 20: GlobulinBaseline (Day 10): ProteinDay 20: Protein
Treatment B: GSK3640254 200 mg42.241.425.926.868.168.2

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Treatment B: Absolute Values of Amylase, Lipase

Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

InterventionUnits per liter (Mean)
Baseline (Day 10): LipaseDay 20: LipaseBaseline (Day 10): AmylaseDay 20: Amylase
Treatment B: GSK3640254 200 mg31.632.456.960.1

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Treatment B: Absolute Values of Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase

Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST, and gamma-glutamyl transferase. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

InterventionInternational units per liter (Mean)
Baseline (Day 10): Creatine kinaseDay 20: Creatine kinaseBaseline (Day 10): Lactate dehydrogenaseDay 20: Lactate dehydrogenaseBaseline (Day 10): ALTDay 20: ALTBaseline (Day 10): ALPDay 20: ALPBaseline (Day 10): ASTDay 20: ASTBaseline (Day 10): Gamma-glutamyl transferaseDay 20: Gamma-glutamyl transferase
Treatment B: GSK3640254 200 mg66.968.9114.8115.920.120.360.858.515.616.118.918.3

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Treatment B: Absolute Values of Erythrocytes

Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

Intervention10^12 cells per liter (Mean)
Baseline (Day 10)Day 20
Treatment B: GSK3640254 200 mg4.6644.746

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Treatment B: Absolute Values of Erythrocytes Mean Corpuscular Hemoglobin

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

InterventionPicograms (Mean)
Baseline (Day 10)Day 20
Treatment B: GSK3640254 200 mg29.5729.52

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Treatment B: Absolute Values of Erythrocytes Mean Corpuscular Volume

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

InterventionFemtoliter (Mean)
Baseline (Day 10)Day 20
Treatment B: GSK3640254 200 mg88.0288.96

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Treatment B: Absolute Values of Glucose, Carbon Dioxide, Cholesterol, Triglycerides, Anion Gap, Calcium, Chloride, Phosphate, Potassium, Sodium, Urea

Blood samples were collected to analyze the chemistry parameters: glucose, carbon dioxide, cholesterol, triglycerides, anion gap, calcium, chloride, phosphate, potassium, sodium, and urea. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

InterventionMillimoles per liter (Mean)
Baseline (Day 10): GlucoseDay 20: GlucoseBaseline (Day 10): Carbon DioxideDay 20: Carbon DioxideBaseline (Day 10): CholesterolDay 20: CholesterolBaseline (Day 10): TriglyceridesDay 20: TriglyceridesBaseline (Day 10): Anion GapDay 20: Anion GapBaseline (Day 10): CalciumDay 20: CalciumBaseline (Day 10): ChlorideDay 20: ChlorideBaseline (Day 10): PhosphateDay 20: PhosphateBaseline (Day 10): PotassiumDay 20: PotassiumBaseline (Day 10): SodiumDay 20: SodiumBaseline (Day 10): UreaDay 20: Urea
Treatment B: GSK3640254 200 mg4.82114.737825.424.93.81183.69151.18141.082513.814.52.31412.3141103.7103.61.17541.25934.434.39138.4138.65.94585.6335

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Treatment B: Absolute Values of Hematocrit

Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

InterventionProportion of red blood cells in blood (Mean)
Baseline (Day 10)Day 20
Treatment B: GSK3640254 200 mg0.40980.4216

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Treatment B: Absolute Values of Hemoglobin

Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

InterventionGrams per liter (Mean)
Baseline (Day 10)Day 20
Treatment B: GSK3640254 200 mg137.7140.0

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Treatment B: Absolute Values of Oral Temperature

Oral temperature was measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 11, Pre-Dose), before the first dose in Treatment B. (NCT04425902)
Timeframe: Baseline (Day 11, Pre-Dose) and Day 20

InterventionDegrees Celsius (Mean)
Baseline (Day 11, Pre-dose)Day 20
Treatment B: GSK3640254 200 mg36.3136.28

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Treatment B: Absolute Values of Platelet Count, Leukocyte Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils

Blood samples were collected to analyze the hematology parameters: platelet count, leukocyte count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

Intervention10^9 cells per liter (Mean)
Baseline (Day 10): Platelet countDay 20: Platelet countBaseline (Day 10): Leukocyte countDay 20: Leukocyte countBaseline (Day 10): NeutrophilsDay 20: NeutrophilsBaseline (Day 10): LymphocytesDay 20: LymphocytesBaseline (Day 10): MonocytesDay 20: MonocytesBaseline (Day 10): EosinophilsDay 20: EosinophilsBaseline (Day 10): BasophilsDay 20: Basophils
Treatment B: GSK3640254 200 mg265.9261.96.305.793.74303.26801.89651.83550.45150.44350.16100.19200.04400.0460

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Treatment B: Absolute Values of Pulse Rate

Pulse rate was measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 11, Pre-Dose), before the first dose in Treatment B. (NCT04425902)
Timeframe: Baseline (Day 11, Pre-Dose) and Day 20

InterventionBeats per minute (Mean)
Baseline (Day 11, Pre-dose)Day 20
Treatment B: GSK3640254 200 mg61.662.8

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Treatment B: Absolute Values of Respiratory Rate

Respiratory rate was measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 11, Pre-Dose), before the first dose in Treatment B. (NCT04425902)
Timeframe: Baseline (Day 11, Pre-Dose) and Day 20

InterventionBreaths per minute (Mean)
Baseline (Day 11, Pre-dose)Day 20
Treatment B: GSK3640254 200 mg15.014.7

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Treatment B: Absolute Values of SBP and DBP

SBP and DBP were measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 11, Pre-Dose), before the first dose in Treatment B. (NCT04425902)
Timeframe: Baseline (Day 11, Pre-Dose) and Day 20

InterventionMillimeters of mercury (Mean)
Baseline (Day 11, Pre-dose): SBPDay 20: SBPBaseline (Day 11, Pre-dose): DBPDay 20: DBP
Treatment B: GSK3640254 200 mg107.7107.261.659.6

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Ratio of AUC(0-infinity) of 36-hydroxymontelukast to Montelukast

Blood samples were collected at the indicated time points for pharmacokinetic analysis of parent drug (montelukast) and its metabolite (36-hydroxymontelukast). Ratio of AUC(0-infinity) of metabolite to parent drug has been presented. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionRatio (Mean)
Treatment A: Probe Substrates0.09182
Treatment C: Probe Substrates + GSK3640254 200 mg0.08562

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Treatment B: Absolute Values of Urate, Creatinine, Bilirubin, Direct Bilirubin

Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

InterventionMicromoles per liter (Mean)
Baseline (Day 10): UrateDay 20: UrateBaseline (Day 10): CreatinineDay 20: CreatinineBaseline (Day 10): BilirubinDay 20: BilirubinBaseline (Day 10): Direct bilirubinDay 20: Direct bilirubin
Treatment B: GSK3640254 200 mg365.5046337.846486.411090.78688.00288.61841.70151.8126

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Treatment B: Change From Baseline in Albumin, Globulin, Protein

Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

InterventionGrams per liter (Mean)
AlbuminGlobulinProtein
Treatment B: GSK3640254 200 mg-0.90.90.1

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Treatment B: Change From Baseline in Amylase, Lipase

Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

InterventionUnits per liter (Mean)
LipaseAmylase
Treatment B: GSK3640254 200 mg0.93.2

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Treatment B: Change From Baseline in Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase

Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST, and gamma-glutamyl transferase. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

InterventionInternational units per liter (Mean)
Creatine kinaseLactate dehydrogenaseALTALPASTGamma-glutamyl transferase
Treatment B: GSK3640254 200 mg2.11.10.3-2.40.6-0.6

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Treatment B: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF

Twelve-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval and QTcF Interval. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 11, Pre-Dose), before the first dose in Treatment B. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 11, Pre-Dose) and Day 20

InterventionMilliseconds (Mean)
PR IntervalQRS DurationQT IntervalQTcF Interval
Treatment B: GSK3640254 200 mg3.22.35.75.1

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Treatment B: Change From Baseline in Glucose, Carbon Dioxide, Cholesterol, Triglycerides, Anion Gap, Calcium, Chloride, Phosphate, Potassium, Sodium, Urea

Blood samples were collected to analyze the chemistry parameters: glucose, carbon dioxide, cholesterol, triglycerides, anion gap, calcium, chloride, phosphate, potassium, sodium, and urea. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

InterventionMillimoles per liter (Mean)
GlucoseCarbon DioxideCholesterolTriglyceridesAnion GapCalciumChloridePhosphatePotassiumSodiumUrea
Treatment B: GSK3640254 200 mg-0.0833-0.6-0.1203-0.09890.80.0000-0.10.0840-0.050.3-0.3124

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Treatment B: Change From Baseline in Platelet Count, Leukocyte Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils

Blood samples were collected to analyze the hematology parameters: platelet count, leukocyte count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

Intervention10^9 cells per liter (Mean)
Platelet countLeukocyte countNeutrophilsLymphocytesMonocytesEosinophilsBasophils
Treatment B: GSK3640254 200 mg-4.1-0.51-0.4750-0.0610-0.00800.03100.0020

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Treatment B: Change From Baseline in SBP and DBP

SBP and DBP were measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 11, Pre-Dose), before the first dose in Treatment B. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 11, Pre-Dose) and Day 20

InterventionMillimeters of mercury (Mean)
SBPDBP
Treatment B: GSK3640254 200 mg-0.5-2.0

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AUC(0-t) for Alpha-hydroxymetoprolol

Blood samples were collected at the indicated time points for pharmacokinetic analysis of alpha-hydroxymetoprolol. Alpha-hydroxymetoprolol is a metabolite of metoprolol. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

Interventionh*ng/mL (Geometric Mean)
Treatment A: Probe Substrates531.3
Treatment C: Probe Substrates + GSK3640254 200 mg487.9

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Treatment C: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval

Twelve-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval and QTcF Interval. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 21, Pre-Dose), before the first dose in Treatment C. (NCT04425902)
Timeframe: Baseline (Day 21, Pre-Dose), Days 22 and 25

InterventionMilliseconds (Mean)
Baseline (Day 21, Pre-dose): PR IntervalDay 22: PR IntervalDay 25: PR IntervalBaseline (Day 21, Pre-dose): QRS DurationDay 22: QRS DurationDay 25: QRS DurationBaseline (Day 21, Pre-dose): QT IntervalDay 22: QT IntervalDay 25: QT IntervalBaseline (Day 21, Pre-dose): QTcF IntervalDay 22: QTcF IntervalDay 25: QTcF Interval
Treatment C: Probe Substrates + GSK3640254 200 mg160.8162.3159.695.898.796.8402.6420.6398.7408.7407.3402.5

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Treatment C: Absolute Values of Albumin, Globulin, Protein

Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

InterventionGrams per liter (Mean)
Baseline (Day 20): AlbuminDay 22: AlbuminDay 25: AlbuminBaseline (Day 20): GlobulinDay 22: GlobulinDay 25: GlobulinBaseline (Day 20): ProteinDay 22: ProteinDay 25: Protein
Treatment C: Probe Substrates + GSK3640254 200 mg41.640.542.026.925.126.668.565.668.6

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Treatment C: Absolute Values of Amylase, Lipase

Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

InterventionUnits per liter (Mean)
Baseline (Day 20): LipaseDay 22: LipaseDay 25: LipaseBaseline (Day 20): AmylaseDay 22: AmylaseDay 25: Amylase
Treatment C: Probe Substrates + GSK3640254 200 mg32.933.533.162.264.760.7

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Treatment C: Absolute Values of Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase

Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST, gamma-glutamyl transferase. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

InterventionInternational units per liter (Mean)
Baseline (Day 20): Creatine kinaseDay 22: Creatine kinaseDay 25: Creatine kinaseBaseline (Day 20): Lactate dehydrogenaseDay 22: Lactate dehydrogenaseDay 25: Lactate dehydrogenaseBaseline (Day 20): ALTDay 22: ALTDay 25: ALTBaseline (Day 20): ALPDay 22: ALPDay 25:ALPBaseline (Day 20): ASTDay 22: ASTDay 25: ASTBaseline (Day 20): Gamma-glutamyl transferaseDay 22: Gamma-glutamyl transferaseDay 25: Gamma-glutamyl transferase
Treatment C: Probe Substrates + GSK3640254 200 mg71.365.763.8116.6120.6119.320.417.320.958.557.658.616.214.716.418.517.118.7

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Treatment C: Absolute Values of Erythrocytes

Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

Intervention10^12 cells per liter (Mean)
Baseline (Day 20)Day 22Day 25
Treatment C: Probe Substrates + GSK3640254 200 mg4.7694.6084.756

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Treatment C: Absolute Values of Erythrocytes Mean Corpuscular Hemoglobin

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

InterventionPicograms (Mean)
Baseline (Day 20)Day 22Day 25
Treatment C: Probe Substrates + GSK3640254 200 mg29.5129.2829.12

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Treatment C: Absolute Values of Erythrocytes Mean Corpuscular Volume

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

InterventionFemtoliter (Mean)
Baseline (Day 20)Day 22Day 25
Treatment C: Probe Substrates + GSK3640254 200 mg89.0387.3887.74

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Treatment C: Absolute Values of Glucose, Carbon Dioxide, Cholesterol, Triglycerides, Anion Gap, Calcium, Chloride, Phosphate, Potassium, Sodium, Urea

Blood samples were collected to analyze the chemistry parameters: glucose, carbon dioxide, cholesterol, triglycerides, anion gap, calcium, chloride, phosphate, potassium, sodium and urea. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

InterventionMillimoles per liter (Mean)
Baseline (Day 20): GlucoseDay 22: GlucoseDay 25: GlucoseBaseline (Day 20): Carbon DioxideDay 22: Carbon DioxideDay 25: Carbon DioxideBaseline (Day 20): CholesterolDay 22: CholesterolDay 25: CholesterolBaseline (Day 20): TriglyceridesDay 22: TriglyceridesDay 25: TriglyceridesBaseline (Day 20): Anion GapDay 22: Anion GapDay 25: Anion GapBaseline (Day 20): CalciumDay 22: CalciumDay 25: CalciumBaseline (Day 20): ChlorideDay 22: ChlorideDay 25: ChlorideBaseline (Day 20): PhosphateDay 22: PhosphateDay 25: PhosphateBaseline (Day 20): PotassiumDay 22: PotassiumDay 25: PotassiumBaseline (Day 20): SodiumDay 22: SodiumDay 25: SodiumBaseline (Day 20): UreaDay 22: UreaDay 25: Urea
Treatment C: Probe Substrates + GSK3640254 200 mg4.71844.80604.870324.925.426.23.68983.25433.39721.07831.08361.107414.613.914.52.32172.28102.3519103.4104.8102.61.26611.19811.34774.384.344.35138.6139.8139.05.73644.90785.3099

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Treatment C: Absolute Values of Hematocrit

Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

InterventionProportion of red blood cells in blood (Mean)
Baseline (Day 20)Day 22Day 25
Treatment C: Probe Substrates + GSK3640254 200 mg0.42390.40220.4168

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Treatment C: Absolute Values of Hemoglobin

Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

InterventionGrams per liter (Mean)
Baseline (Day 20)Day 22Day 25
Treatment C: Probe Substrates + GSK3640254 200 mg140.6134.7138.3

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Treatment C: Absolute Values of Oral Temperature

Oral temperature was measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 21, Pre-Dose), before the first dose in Treatment C. (NCT04425902)
Timeframe: Baseline (Day 21, Pre-Dose), Days 22 and 25

InterventionDegrees Celsius (Mean)
Baseline (Day 21, Pre-dose)Day 22Day 25
Treatment C: Probe Substrates + GSK3640254 200 mg36.3136.1836.31

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Treatment C: Absolute Values of Platelet Count, Leukocyte Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils

Blood samples were collected to analyze the hematology parameters: platelet count, leukocyte count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

Intervention10^9 cells per liter (Mean)
Baseline (Day 20): Platelet countDay 22: Platelet countDay 25: Platelet countBaseline (Day 20): Leukocyte countDay 22: Leukocyte countDay 25: Leukocyte countBaseline (Day 20): NeutrophilsDay 22: NeutrophilsDay 25: NeutrophilsBaseline (Day 20): LymphocytesDay 22: LymphocytesDay 25: LymphocytesBaseline (Day 20): MonocytesDay 22: MonocytesDay 25: MonocytesBaseline (Day 20): EosinophilsDay 22: EosinophilsDay 25: EosinophilsBaseline (Day 20): BasophilsDay 22: BasophilsDay 25: Basophils
Treatment C: Probe Substrates + GSK3640254 200 mg262.3249.2260.75.865.815.983.31793.19253.45291.84371.87871.92800.45050.46890.35760.19530.22820.18370.04740.03800.0408

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Treatment C: Absolute Values of Pulse Rate

Pulse rate was measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 21, Pre-Dose), before the first dose in Treatment C. (NCT04425902)
Timeframe: Baseline (Day 21, Pre-Dose), Days 22 and 25

InterventionBeats per minute (Mean)
Baseline (Day 21, Pre-dose)Day 22Day 25
Treatment C: Probe Substrates + GSK3640254 200 mg63.256.261.7

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Treatment C: Absolute Values of Respiratory Rate

Respiratory rate was measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 21, Pre-Dose), before the first dose in Treatment C. (NCT04425902)
Timeframe: Baseline (Day 21, Pre-Dose), Days 22 and 25

InterventionBreaths per minute (Mean)
Baseline (Day 21, Pre-dose)Day 22Day 25
Treatment C: Probe Substrates + GSK3640254 200 mg15.715.716.5

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Treatment C: Absolute Values of SBP and DBP

SBP and DBP were measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 21, Pre-Dose), before the first dose in Treatment C. (NCT04425902)
Timeframe: Baseline (Day 21, Pre-Dose), Days 22 and 25

InterventionMillimeters of mercury (Mean)
Baseline (Day 21, Pre-dose): SBPDay 22: SBPDay 25: SBPBaseline (Day 21, Pre-dose): DBPDay 22: DBPDay 25: DBP
Treatment C: Probe Substrates + GSK3640254 200 mg107.5105.6109.762.758.462.2

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Treatment C: Absolute Values of Urate, Creatinine, Bilirubin, Direct Bilirubin

Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

InterventionMicromoles per liter (Mean)
Baseline (Day 20): UrateDay 22: UrateDay 25: UrateBaseline (Day 20): CreatinineDay 22: CreatinineDay 25: CreatinineBaseline (Day 20): BilirubinDay 22: BilirubinDay 25: BilirubinBaseline (Day 20): Direct bilirubinDay 22: Direct bilirubinDay 25: Direct bilirubin
Treatment C: Probe Substrates + GSK3640254 200 mg343.1057303.0349340.601392.168687.376490.58678.74809.88209.03601.84502.07901.9980

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Treatment C: Change From Baseline in Albumin, Globulin, Protein

Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

InterventionGrams per liter (Mean)
Day 22: AlbuminDay 25: AlbuminDay 22: GlobulinDay 25: GlobulinDay 22: ProteinDay 25: Protein
Treatment C: Probe Substrates + GSK3640254 200 mg-1.10.4-1.8-0.3-2.90.2

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Treatment C: Change From Baseline in Amylase, Lipase

Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

InterventionUnits per liter (Mean)
Day 22: LipaseDay 25: LipaseDay 22: AmylaseDay 25: Amylase
Treatment C: Probe Substrates + GSK3640254 200 mg0.60.22.5-1.5

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Treatment C: Change From Baseline in Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase

Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST, gamma-glutamyl transferase. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

InterventionInternational units per liter (Mean)
Day 22: Creatine kinaseDay 25: Creatine kinaseDay 22: Lactate dehydrogenaseDay 25: Lactate dehydrogenaseDay 22: ALTDay 25: ALTDay 22: ALPDay 25:ALPDay 22: ASTDay 25: ASTDay 22: Gamma-glutamyl transferaseDay 25: Gamma-glutamyl transferase
Treatment C: Probe Substrates + GSK3640254 200 mg-5.6-7.54.02.6-3.10.5-0.90.1-1.50.2-1.50.2

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Treatment C: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF

Twelve-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval and QTcF Interval. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 21, Pre-Dose), before the first dose in Treatment C. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 21, Pre-Dose), Days 22 and 25

InterventionMilliseconds (Mean)
Day 22: PR IntervalDay 25: PR IntervalDay 22: QRS DurationDay 25: QRS DurationDay 22: QT IntervalDay 25: QT IntervalDay 22: QTcF IntervalDay 25: QTcF Interval
Treatment C: Probe Substrates + GSK3640254 200 mg1.5-1.22.91.018.0-3.9-1.4-6.3

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Treatment C: Change From Baseline in Erythrocytes

Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

Intervention10^12 cells per liter (Mean)
Day 22Day 25
Treatment C: Probe Substrates + GSK3640254 200 mg-0.161-0.013

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Treatment C: Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline for treatment C was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 20), before the dose of Treatment C. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 20), Days 22 and 25

InterventionPicograms (Mean)
Day 22Day 25
Treatment C: Probe Substrates + GSK3640254 200 mg-0.23-0.39

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t1/2 for 36-hydroxymontelukast

Blood samples were collected at the indicated time points for pharmacokinetic analysis of 36-hydroxymontelukast. 36-hydroxymontelukast is a metabolite of montelukast. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Geometric Mean)
Treatment A: Probe Substrates5.310
Treatment C: Probe Substrates + GSK3640254 200 mg5.644

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t1/2 for 5-hydroxyomeprazole

Blood samples were collected at the indicated time points for pharmacokinetic analysis of 5-hydroxyomeprazole. 5-hydroxyomeprazole is a metabolite of omeprazole. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Geometric Mean)
Treatment A: Probe Substrates1.580
Treatment C: Probe Substrates + GSK3640254 200 mg1.569

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t1/2 for Alpha-hydroxymetoprolol

Blood samples were collected at the indicated time points for pharmacokinetic analysis of alpha-hydroxymetoprolol. Alpha-hydroxymetoprolol is a metabolite of metoprolol. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Geometric Mean)
Treatment A: Probe Substrates8.040
Treatment C: Probe Substrates + GSK3640254 200 mg8.339

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t1/2 for Digoxin

Blood samples were collected at the indicated time points for pharmacokinetic analysis of digoxin. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Geometric Mean)
Treatment A: Probe Substrates40.279
Treatment C: Probe Substrates + GSK3640254 200 mg38.784

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t1/2 for Flurbiprofen

Blood samples were collected at the indicated time points for pharmacokinetic analysis of flurbiprofen. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Geometric Mean)
Treatment A: Probe Substrates6.123
Treatment C: Probe Substrates + GSK3640254 200 mg6.088

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t1/2 for Metoprolol

Blood samples were collected at the indicated time points for pharmacokinetic analysis of metoprolol. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Geometric Mean)
Treatment A: Probe Substrates4.872
Treatment C: Probe Substrates + GSK3640254 200 mg5.342

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t1/2 for Midazolam

Blood samples were collected at the indicated time points for pharmacokinetic analysis of midazolam. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Geometric Mean)
Treatment A: Probe Substrates5.756
Treatment C: Probe Substrates + GSK3640254 200 mg5.222

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t1/2 for Montelukast

Blood samples were collected at the indicated time points for pharmacokinetic analysis of montelukast. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Geometric Mean)
Treatment A: Probe Substrates5.035
Treatment C: Probe Substrates + GSK3640254 200 mg5.135

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t1/2 for Omeprazole

Blood samples were collected at the indicated time points for pharmacokinetic analysis of omeprazole. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Geometric Mean)
Treatment A: Probe Substrates1.439
Treatment C: Probe Substrates + GSK3640254 200 mg1.219

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t1/2 for Pravastatin

Blood samples were collected at the indicated time points for pharmacokinetic analysis of pravastatin. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Geometric Mean)
Treatment A: Probe Substrates3.189
Treatment C: Probe Substrates + GSK3640254 200 mg3.156

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Time to Cmax (Tmax) for Caffeine

Blood samples were collected at the indicated time points for pharmacokinetic analysis of caffeine. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Median)
Treatment A: Probe Substrates2.000
Treatment C: Probe Substrates + GSK3640254 200 mg3.000

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Tmax for 1-hydroxymidazolam

Blood samples were collected at the indicated time points for pharmacokinetic analysis of 1-hydroxymidazolam. 1-hydroxymidazolam is a metabolite of midazolam. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Median)
Treatment A: Probe Substrates1.000
Treatment C: Probe Substrates + GSK3640254 200 mg1.000

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Tmax for 36-hydroxymontelukast

Blood samples were collected at the indicated time points for pharmacokinetic analysis of 36-hydroxymontelukast. 36-hydroxymontelukast is a metabolite of montelukast. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Median)
Treatment A: Probe Substrates6.000
Treatment C: Probe Substrates + GSK3640254 200 mg6.000

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Tmax for 5-hydroxyomeprazole

Blood samples were collected at the indicated time points for pharmacokinetic analysis of 5-hydroxyomeprazole. 5-hydroxyomeprazole is a metabolite of omeprazole. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Median)
Treatment A: Probe Substrates6.000
Treatment C: Probe Substrates + GSK3640254 200 mg6.000

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Tmax for Alpha-hydroxymetoprolol

Blood samples were collected at the indicated time points for pharmacokinetic analysis of alpha-hydroxymetoprolol. Alpha-hydroxymetoprolol is a metabolite of metoprolol. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Median)
Treatment A: Probe Substrates3.033
Treatment C: Probe Substrates + GSK3640254 200 mg4.000

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Tmax for Digoxin

Blood samples were collected at the indicated time points for pharmacokinetic analysis of digoxin. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Median)
Treatment A: Probe Substrates3.000
Treatment C: Probe Substrates + GSK3640254 200 mg2.000

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Tmax for Flurbiprofen

Blood samples were collected at the indicated time points for pharmacokinetic analysis of flurbiprofen. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Median)
Treatment A: Probe Substrates3.000
Treatment C: Probe Substrates + GSK3640254 200 mg4.000

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Tmax for Metoprolol

Blood samples were collected at the indicated time points for pharmacokinetic analysis of metoprolol. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Median)
Treatment A: Probe Substrates2.000
Treatment C: Probe Substrates + GSK3640254 200 mg3.000

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Tmax for Midazolam

Blood samples were collected at the indicated time points for pharmacokinetic analysis of midazolam. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Median)
Treatment A: Probe Substrates1.000
Treatment C: Probe Substrates + GSK3640254 200 mg1.000

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Tmax for Montelukast

Blood samples were collected at the indicated time points for pharmacokinetic analysis of montelukast. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Median)
Treatment A: Probe Substrates5.000
Treatment C: Probe Substrates + GSK3640254 200 mg6.000

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Tmax for Omeprazole

Blood samples were collected at the indicated time points for pharmacokinetic analysis of omeprazole. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Median)
Treatment A: Probe Substrates6.000
Treatment C: Probe Substrates + GSK3640254 200 mg6.000

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Tmax for Pravastatin

Blood samples were collected at the indicated time points for pharmacokinetic analysis of pravastatin. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionHours (Median)
Treatment A: Probe Substrates1.500
Treatment C: Probe Substrates + GSK3640254 200 mg3.000

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Treatment A: Change From Baseline in Erythrocytes

Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

Intervention10^12 cells per liter (Mean)
Treatment A: Probe Substrates-0.172

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Treatment A: Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

InterventionPicograms (Mean)
Treatment A: Probe Substrates0.20

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Treatment A: Change From Baseline in Erythrocytes Mean Corpuscular Volume

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

InterventionFemtoliter (Mean)
Treatment A: Probe Substrates1.31

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Treatment A: Change From Baseline in Hematocrit

Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

InterventionProportion of red blood cells in blood (Mean)
Treatment A: Probe Substrates-0.0090

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Treatment A: Change From Baseline in Hemoglobin

Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

InterventionGrams per liter (Mean)
Treatment A: Probe Substrates-4.2

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Treatment A: Change From Baseline in Oral Temperature

Oral temperature was measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 1, Pre-Dose), before the dose in Treatment A. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 1, Pre-dose) and Day 10

InterventionDegrees Celsius (Mean)
Treatment A: Probe Substrates-0.12

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Treatment A: Change From Baseline in Pulse Rate

Pulse rate was measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 1, Pre-Dose), before the dose in Treatment A. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 1, Pre-dose) and Day 10

InterventionBeats per minute (Mean)
Treatment A: Probe Substrates0.5

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Treatment A: Change From Baseline in Respiratory Rate

Respiratory rate was measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 1, Pre-Dose), before the dose in Treatment A. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 1, Pre-dose) and Day 2

InterventionBreaths per minute (Mean)
Treatment A: Probe Substrates-0.3

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Cmax for Montelukast

Blood samples were collected at the indicated time points for pharmacokinetic analysis of montelukast. (NCT04425902)
Timeframe: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours post-dose in treatment period 1 and 3

InterventionNanograms per milliliter (ng/mL) (Geometric Mean)
Treatment A: Probe Substrates379.8
Treatment C: Probe Substrates + GSK3640254 200 mg393.5

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Treatment B: Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

InterventionPicograms (Mean)
Treatment B: GSK3640254 200 mg-0.05

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Treatment B: Change From Baseline in Erythrocytes Mean Corpuscular Volume

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

InterventionFemtoliter (Mean)
Treatment B: GSK3640254 200 mg0.94

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Treatment B: Change From Baseline in Hematocrit

Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

InterventionProportion of red blood cells in blood (Mean)
Treatment B: GSK3640254 200 mg0.0118

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Treatment B: Change From Baseline in Hemoglobin

Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

InterventionGrams per liter (Mean)
Treatment B: GSK3640254 200 mg2.3

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Treatment B: Change From Baseline in Oral Temperature

Oral temperature was measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 11, Pre-Dose), before the first dose in Treatment B. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 11, Pre-Dose) and Day 20

InterventionDegrees Celsius (Mean)
Treatment B: GSK3640254 200 mg-0.03

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Treatment B: Change From Baseline in Pulse Rate

Pulse rate was measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 11, Pre-Dose), before the first dose in Treatment B. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 11, Pre-Dose) and Day 20

InterventionBeats per minute (Mean)
Treatment B: GSK3640254 200 mg1.3

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Treatment B: Change From Baseline in Respiratory Rate

Respiratory rate was measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 11, Pre-Dose), before the first dose in Treatment B. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 11, Pre-Dose) and Day 20

InterventionBreaths per minute (Mean)
Treatment B: GSK3640254 200 mg-0.3

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Treatment C: AUC From Time Zero to the End of the Dosing Interval at Steady State (AUC[0-tau]) for GSK3640254

Blood samples were collected at the indicated time points for steady-state pharmacokinetic analysis of GSK3640254. (NCT04425902)
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96, and 120 hours post-dose in treatment period 3

Interventionh*ng/mL (Geometric Mean)
Treatment C: Probe Substrates + GSK3640254 200 mg22920

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Treatment C: AUC(0-t) for GSK3640254

Blood samples were collected at the indicated time points for steady-state pharmacokinetic analysis of GSK3640254. The AUC(0-t) was determined using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. (NCT04425902)
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96, and 120 hours post-dose in treatment period 3

Interventionh*ng/mL (Geometric Mean)
Treatment C: Probe Substrates + GSK3640254 200 mg51840

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Treatment C: Cmax for GSK3640254

Blood samples were collected at the indicated time points for steady-state pharmacokinetic analysis of GSK3640254. (NCT04425902)
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96, and 120 hours post-dose in treatment period 3

Interventionng/mL (Geometric Mean)
Treatment C: Probe Substrates + GSK3640254 200 mg1450

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Treatment C: Plasma Concentration at the End of the Dosing Interval (Ctau) for GSK3640254

Blood samples were collected at the indicated time points for steady-state pharmacokinetic analysis of GSK3640254. (NCT04425902)
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96, and 120 hours post-dose in treatment period 3

Interventionng/mL (Geometric Mean)
Treatment C: Probe Substrates + GSK3640254 200 mg729.5

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Treatment C: t1/2 for GSK3640254

Blood samples were collected at the indicated time points for steady-state pharmacokinetic analysis of GSK3640254. (NCT04425902)
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96, and 120 hours post-dose in treatment period 3

InterventionHours (Geometric Mean)
Treatment C: Probe Substrates + GSK3640254 200 mg29.556

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Treatment C: Tmax for GSK3640254

Blood samples were collected at the indicated time points for steady-state pharmacokinetic analysis of GSK3640254. (NCT04425902)
Timeframe: Pre-dose and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72, 96, and 120 hours post-dose in treatment period 3

InterventionHours (Median)
Treatment C: Probe Substrates + GSK3640254 200 mg4.500

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE was defined as any untoward medical occurrence that, at any dose, results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement. (NCT04425902)
Timeframe: Up to Day 26

,,
InterventionParticipants (Count of Participants)
AEsSAEs
Treatment A: Probe Substrates10
Treatment B: GSK3640254 200 mg50
Treatment C: Probe Substrates + GSK3640254 200 mg50

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Treatment A: Absolute Values for Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF)

Twelve-lead ECGs were obtained to measure PR Interval, QRS Duration, QT Interval and QTcF Interval. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 1, Pre-Dose), before the dose in Treatment A. (NCT04425902)
Timeframe: Baseline (Day 1, Pre-Dose) and Day 10

InterventionMilliseconds (Mean)
Baseline (Day 1, Pre-dose): PR IntervalDay 10: PR IntervalBaseline (Day 1, Pre-dose): QRS DurationDay 10: QRS DurationBaseline (Day 1, Pre-dose): QT IntervalDay 10: QT IntervalBaseline (Day 1, Pre-dose): QTcF IntervalDay 10: QTcF Interval
Treatment A: Probe Substrates154.8158.292.595.0391.2398.3401.0405.8

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Treatment A: Absolute Values of Albumin, Globulin, Protein

Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

InterventionGrams per liter (Mean)
Baseline (Day -1): AlbuminDay 10: AlbuminBaseline (Day -1): GlobulinDay 10: GlobulinBaseline (Day -1): ProteinDay 10: Protein
Treatment A: Probe Substrates42.942.227.425.970.368.1

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Treatment A: Absolute Values of Amylase, Lipase

Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

InterventionUnits per liter (Mean)
Baseline (Day -1): LipaseDay 10: LipaseBaseline (Day -1): AmylaseDay 10: Amylase
Treatment A: Probe Substrates29.431.659.556.9

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Treatment A: Absolute Values of Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase

Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

InterventionInternational units per liter (Mean)
Baseline (Day -1): Creatine kinaseDay 10: Creatine kinaseBaseline (Day -1): Lactate dehydrogenaseDay 10: Lactate dehydrogenaseBaseline (Day -1): ALTDay 10: ALTBaseline (Day -1): ALPDay 10: ALPBaseline (Day -1): ASTDay 10: ASTBaseline (Day -1): Gamma-glutamyl transferaseDay 10: Gamma-glutamyl transferase
Treatment A: Probe Substrates103.766.9131.3114.815.620.162.760.814.615.619.118.9

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Treatment A: Absolute Values of Erythrocytes

Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

Intervention10^12 cells per liter (Mean)
Baseline (Day -1)Day 10
Treatment A: Probe Substrates4.8364.664

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Treatment A: Absolute Values of Erythrocytes Mean Corpuscular Hemoglobin

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

InterventionPicograms (Mean)
Baseline (Day -1)Day 10
Treatment A: Probe Substrates29.3729.57

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Treatment A: Absolute Values of Erythrocytes Mean Corpuscular Volume

Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

InterventionFemtoliter (Mean)
Baseline (Day -1)Day 10
Treatment A: Probe Substrates86.7188.02

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Treatment A: Absolute Values of Glucose, Carbon Dioxide, Cholesterol, Triglycerides, Anion Gap, Calcium, Chloride, Phosphate, Potassium, Sodium, Urea

Blood samples were collected to analyze the chemistry parameters: glucose, carbon dioxide, cholesterol, triglycerides, anion gap, calcium, chloride, phosphate, potassium, sodium, urea. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

InterventionMillimoles per liter (Mean)
Baseline (Day -1): GlucoseDay 10: GlucoseBaseline (Day -1): Carbon DioxideDay 10: Carbon DioxideBaseline (Day -1): CholesterolDay 10: CholesterolBaseline (Day -1): TriglyceridesDay 10: TriglyceridesBaseline (Day -1): Anion GapDay 10: Anion GapBaseline (Day -1): CalciumDay 10: CalciumBaseline (Day -1): ChlorideDay 10: ChlorideBaseline (Day -1): PhosphateDay 10: PhosphateBaseline (Day -1): PotassiumDay 10: PotassiumBaseline (Day -1): SodiumDay 10: SodiumBaseline (Day -1): UreaDay 10: Urea
Treatment A: Probe Substrates5.03484.8211104.125.44.45703.81181.22321.18147.913.82.37652.314125.8103.71.10751.17544.484.43137.7138.44.81955.9458

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Treatment A: Absolute Values of Hematocrit

Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

InterventionProportion of red blood cells in blood (Mean)
Baseline (Day -1)Day 10
Treatment A: Probe Substrates0.41880.4098

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Treatment A: Absolute Values of Hemoglobin

Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

InterventionGrams per liter (Mean)
Baseline (Day -1)Day 10
Treatment A: Probe Substrates141.9137.7

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Treatment A: Absolute Values of Oral Temperature

Oral temperature was measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 1, Pre-Dose), before the dose in Treatment A. (NCT04425902)
Timeframe: Baseline (Day 1, Pre-dose) and Day 10

InterventionDegrees Celsius (Mean)
Baseline (Day 1, Pre-dose)Day 10
Treatment A: Probe Substrates36.3836.26

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Treatment A: Absolute Values of Platelet Count, Leukocyte Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils

Blood samples were collected to analyze the hematology parameters: platelet count, leukocyte count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

Intervention10^9 cells per liter (Mean)
Baseline (Day -1): Platelet countDay 10: Platelet countBaseline (Day -1): Leukocyte countDay 10: Leukocyte countBaseline (Day -1): NeutrophilsDay 10: NeutrophilsBaseline (Day -1): LymphocytesDay 10: LymphocytesBaseline (Day -1): MonocytesDay 10: MonocytesBaseline (Day -1): EosinophilsDay 10: EosinophilsBaseline (Day -1): BasophilsDay 10: Basophils
Treatment A: Probe Substrates258.6265.95.646.303.15043.74301.82171.89650.48900.45150.14610.16100.03310.0440

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Treatment A: Absolute Values of Pulse Rate

Pulse rate was measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 1, Pre-Dose), before the dose in Treatment A. (NCT04425902)
Timeframe: Baseline (Day 1, Pre-dose) and Day 10

InterventionBeats per minute (Mean)
Baseline (Day 1, Pre-dose)Day 10
Treatment A: Probe Substrates64.565.0

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Treatment A: Absolute Values of Respiratory Rate

Respiratory rate was measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 1, Pre-Dose), before the dose in Treatment A. (NCT04425902)
Timeframe: Baseline (Day 1, Pre-dose) and Day 2

InterventionBreaths per minute (Mean)
Baseline (Day 1, Pre-dose)Day 2
Treatment A: Probe Substrates16.115.8

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Treatment A: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

SBP and DBP were measured in the supine position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 1, Pre-Dose), before the dose in Treatment A. (NCT04425902)
Timeframe: Baseline (Day 1, Pre-dose) and Day 10

InterventionMillimeters of mercury (Mean)
Baseline (Day 1, Pre-dose): SBPDay 10: SBPBaseline (Day 1, Pre-dose): DBPDay 10: DBP
Treatment A: Probe Substrates111.0107.765.159.7

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Treatment A: Absolute Values of Urate, Creatinine, Bilirubin, Direct Bilirubin

Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline for treatment A was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day -1), before the dose of Treatment A. (NCT04425902)
Timeframe: Baseline (Day -1) and Day 10

InterventionMicromoles per liter (Mean)
Baseline (Day -1): UrateDay 10: UrateBaseline (Day -1): CreatinineDay 10: CreatinineBaseline (Day -1): BilirubinDay 10: BilirubinBaseline (Day -1): Direct bilirubinDay 10: Direct bilirubin
Treatment A: Probe Substrates347.3632365.504684.952486.41109.83258.00282.05201.7015

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Treatment B: Change From Baseline in Erythrocytes

Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline for treatment B was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits (Day 10), before the first dose of Treatment B. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. (NCT04425902)
Timeframe: Baseline (Day 10) and Day 20

Intervention10^12 cells per liter (Mean)
Treatment B: GSK3640254 200 mg0.083

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