levocetirizine profile

ID Source	ID
PubMed CID	1549000
CHEMBL ID	1201191
CHEBI ID	94559
SCHEMBL ID	4914
MeSH ID	M0446925

Synonym
BIDD:GT0791
AC-15295
2-[2-[4-[(r)-(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic acid
gtpl1214
vozet
PDSP1_000269
(2-(4-((r-p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)acetic acid
(-)-cetirizine
acetic acid, (2-(4-((r)-(4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-
PDSP2_000268
xazal (tn)
levocetirizine (usan/inn)
D07402
130018-77-8
PDSP2_000117
MLS001401375
levocetirizine
MLS000759420
smr000466315
PDSP1_000117
HMS2051N10
(r)-cetirizine
cetirizine, (r)-
cetirizine, (-)-
CHEMBL1201191
xazal
cetirizine (r)-form
2-[2-[4-[(r)-(4-chlorophenyl)-phenyl-methyl]piperazin-1-yl]ethoxy]acetic acid
A806002
levocetirizine [usan:inn:ban]
xarlin
6u5ea9rt2o ,
unii-6u5ea9rt2o
bdbm85030
cetirizine (-) isomer
HMS2231M24
CCG-101021
levocetirizine [who-dd]
levocetirizine [vandf]
acetic acid, (2-(4-((r)-(4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)
levocetirizine [mart.]
levocetirizine [usan]
(2-{4-[(r)-(4-chlorophenyl)phenylmethyl]piperazin-1-yl}ethoxy)acetic acid
levocetirizine [inn]
cetirizine (r)-form [mi]
S5864
(-)-cetirizine dihydrochloride
AB00639972-08
SCHEMBL4914
ZKLPARSLTMPFCP-OAQYLSRUSA-N
levocetrizine
(2-(4-((r)-p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)acetic acid
(r)-2-(2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic acid
(2-{4-[(r)-(4-chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethoxy)acetic acid
DTXSID60156294 ,
2-(2-{4-[(r)-(4-chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethoxy)acetic acid
DB06282
2-[2-[4-[(r)-(4-chlorophenyl)-phenylmethyl]-1-piperazinyl]ethoxy]acetic acid
CHEBI:94559
NCGC00263567-04
r-levocetirizine
HY-B0814
CS-0012812
Q421091
H230000000
singulair and xyzal combination
hcp1102
hcp 1102
(r)-cetirizine (dihydrochloride)
levocetirizine (dihydrochloride)
AKOS016844241
acetic acid, 2-[2-[4-[(r)-(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]-
EN300-20600167
levocetirizine (mart.)
2-(2-(4-((r)-(4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)acetic acid
levocetirizinum
r06ae09
dtxcid1078785
levocetirizina
(2-(4-((r)-(4-chlorophenyl)phenylmethyl)piperazin-1-yl)ethoxy)acetic acid

Excerpt	Reference	Relevance
"Levocetirizine is an orally administrated, second-generation antihistaminic active pharmaceutical ingredient that has been used to treat symptoms of allergy and long-term hives for over 25 years. "	( The Elusive Structure of Levocetirizine Dihydrochloride Determined by Electron Diffraction. Alhaddad, Z; Bücker, R; Göb, CR; Karothu, DP; Naumov, P; Schürmann, CJ, 2023)	2.66
"Levocetirizine is a second-generation nonsedative antihistaminic agent that has been demonstrated to be safe and effective for treating allergic disease. "	( A case of levocetirizine-induced liver injury. Cho, JY; Jung, MC; Kim, JK; Kim, SE; Lee, B; Park, JW; Seo, J; Song, JW, 2016)	2.28
"Levocetirizine (LCZ) is a second-generation antihistamine that was approved in January 2008 for the relief of symptoms of seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), and chronic idiopathic urticaria (CIU) in adults and children aged > or = 6 years."	( Levocetirizine for the treatment of allergic rhinitis and chronic idiopathic urticaria in adults and children. Borja-Hart, N; Ghin, HL; Perez, A; Robles, GI; Singh-Franco, D, 2009)	3.24
"Levocetirizine 5 mg/day is an effective and well-tolerated treatment of PAR. "	( Levocetirizine is effective for symptom relief including nasal congestion in adolescent and adult (PAR) sensitized to house dust mites. Potter, PC, 2003)	3.2
"Levocetirizine is a new single-isomer antihistamine with a proven efficacy on chronic urticaria as documented in two recent clinical studies, which have included effectiveness and quality of life assessments."	( Chronic urticaria: clinical aspects and focus on a new antihistamine, levocetirizine. Kapp, A; Wedi, B, )	1.09
"Levocetirizine is a potent and highly selective H1-antihistamine with a proven efficacy in adults."	( Levocetirizine in children: evidenced efficacy and safety in a 6-week randomized seasonal allergic rhinitis trial. Alt, R; Billard, E; de Blic, J; Pujazon, MC; Wahn, U, 2005)	2.49
"Levocetirizine is an antihistamine with high affinity and selectivity for H1-receptors, which exhibits an excellent benefit/risk ratio in the treatment of allergic rhinitis and urticaria. "	( Levocetirizine in 1-2 year old children: pharmacokinetic and pharmacodynamic profile. Cranswick, N; Fuchs, M; Hulhoven, R; Turzíkova, J, 2005)	3.21
"Levocetirizine is an antihistamine from the latest generation approved for CIU."	( Levocetirizine is an effective treatment in patients suffering from chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled, parallel, multicenter study. Kapp, A; Pichler, WJ, 2006)	2.5
"Levocetirizine (Xyzal) is a selective, potent, oral histamine H(1) receptor antagonist of the latest generation that is licensed for the symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis [PER]) and chronic idiopathic urticaria (CIU). "	( Levocetirizine: a review of its use in the management of allergic rhinitis and skin allergies. Hair, PI; Scott, LJ, 2006)	3.22
"Levocetirizine is a welcome new treatment option in the United States for symptomatic treatment of AR and CIU."	( Levocetirizine: The latest treatment option for allergic rhinitis and chronic idiopathic urticaria. Dubuske, LM, )	2.3
"Levocetirizine is an effective and safe treatment for use in adults and children with allergic disease."	( A review of the role of levocetirizine as an effective therapy for allergic disease. Walsh, GM, 2008)	2.1

Excerpt	Reference	Relevance
"Levocetirizine has a favorable pharmacokinetic profile; it is rapidly and extensively absorbed, minimally metabolized, and has a lower volume of distribution (V(d)) than some other second-generation antihistamines."	( Levocetirizine: a new selective H1 receptor antagonist for use in allergic disorders. Day, JH; Ellis, AK; Rafeiro, E, 2004)	2.49
"Levocetirizine has modest sedative effects with a risk ratio of 1.67 when compared with placebo. "	( Sedative Effects of Levocetirizine: A Systematic Review and Meta-Analysis of Randomized Controlled Studies. Chitsuthipakorn, W; Khattiyawittayakun, L; Seresirikachorn, K; Snidvongs, K, 2017)	2.22
"Levocetirizine has several pharmacokinetic properties that are desirable for an antihistamine providing a combination of both potency and safety. "	( Pharmacokinetic evaluation of levocetirizine. Ferrer, M, 2011)	2.1
"Levocetirizine has been shown in observational studies in the west as an effective and satisfactory therapy for patients with allergic respiratory and skin disease. "	( An open-label, multicentre study of levocetirizine for the treatment of allergic rhinitis and urticaria in Taiwanese patients. Fang, SY; Huangs, CY; Lee, JY; Lin, DY; Perng, DW, 2010)	2.08
"Levocetirizine has a favorable pharmacokinetic profile; it is rapidly and extensively absorbed, minimally metabolized, and has a lower volume of distribution (V(d)) than some other second-generation antihistamines."	( Levocetirizine: a new selective H1 receptor antagonist for use in allergic disorders. Day, JH; Ellis, AK; Rafeiro, E, 2004)	2.49
"Levocetirizine has pharmacodynamically and pharmacokinetically favourable characteristics, including high bioavailability, rapid onset of action, limited distribution and a low degree of metabolism."	( Levocetirizine: an update. Walsh, GM, 2006)	2.5
"Levocetirizine has high bioavailability, high affinity for and occupancy of the H1 receptor, rapid onset of action, limited distribution and minimal hepatic metabolism. "	( A review of the role of levocetirizine as an effective therapy for allergic disease. Walsh, GM, 2008)	2.1

Excerpt	Reference	Relevance
"Levocetirizine treatment also correlated with a significant increase in the percentage of CD4+CD25+ T cells (P<0.001)."	( Levocetirizine modulates lymphocyte activation in patients with allergic rhinitis. Arifhodzic, N; Haines, D; Mahmoud, F; Novotney, L, 2008)	2.51
"Levocetirizine treatment inhibited the HRV-induced increase in ICAM-1 mRNA and protein levels, as well as the HRV-induced expression of IL-6 and IL-8 mRNA and protein levels."	( Levocetirizine inhibits rhinovirus-induced ICAM-1 and cytokine expression and viral replication in airway epithelial cells. Jang, YJ; Kim, JS; Kwon, HJ; Lee, BJ; Wang, JH; Yeo, NK, 2009)	2.52
"Levocetirizine treatment showed no side effects on salivary glands function."	( Evaluation by (99m)Tc-pertechnetate scintigraphy of the effect of levocetirizine on salivary glands function, in allergic rhinitis patients. Kursad Ayan, A; Sahin, A; Seven, B; Sutbeyaz, Y; Ucuncu, H; Varoglu, E; Yoruk, O, )	1.09
"Levocetirizine treatment induced significant symptom relief (P=0.0009) and improved nasal airflow (P=0.038). "	( Levocetirizine improves nasal obstruction and modulates cytokine pattern in patients with seasonal allergic rhinitis: a pilot study. Ciprandi, G; Cirillo, I; Tosca, MA; Vizzaccaro, A, 2004)	3.21
"Levocetirizine treatment induced: significant symptom relief (p<0.001), improved nasal airflow (p<0.001), reduction of reversibility percentage (p<0.05), and increase of total airflow after decongestion test (p<0.03). "	( Levocetirizine improves nasal symptoms and airflow in patients with persistent allergic rhinitis: a pilot study. Ciprandi, G; Cirillo, IG; Tosca, MA; Vizzaccaro, A, 2005)	3.21
"Treatment with levocetirizine caused significant decreases in AUCOGTT, AUCITT, HOMA-IR, hepatic GSH and MDA levels and serum CRP level and LDH activity and significant increases in hepatic SOD activity and HOMA-β when compared with the HFD group."	( Levocetirizine ameliorates high fructose diet-induced insulin resistance, vascular dysfunction and hepatic steatosis in rats. Abdel Rahim, M; Gameil, NM; Shawky, NM; Shehatou, GS; Suddek, GM, 2014)	2.18
"Treatment with levocetirizine reduces the cost of persistent allergic rhinitis and its comorbidities to the society by 152.93/patient/month while improving symptoms and health-related quality of life."	( Costs associated with persistent allergic rhinitis are reduced by levocetirizine. Bachert, C; Bousquet, J; Demarteau, N; Mullol, J; van den Akker-van Marle, ME; Van Ganse, E, 2005)	0.91

Excerpt	Reference	Relevance
" Incidence of treatment-emergent adverse events was similar in both groups (33."	( Levocetirizine in children: evidenced efficacy and safety in a 6-week randomized seasonal allergic rhinitis trial. Alt, R; Billard, E; de Blic, J; Pujazon, MC; Wahn, U, 2005)	1.77
"01), and the frequency of adverse events did not differ significantly from those seen in the placebo group."	( Efficacy and safety of levocetirizine on symptoms and health-related quality of life of children with perennial allergic rhinitis: a double-blind, placebo-controlled randomized clinical trial. Potter, PC, 2005)	0.64
" Safety was assessed by: reporting of adverse events, numbers of children discontinuing the study because of adverse events, height and body mass measurements, assessment of developmental milestones, and hematology and biochemistry tests."	( Safety of levocetirizine treatment in young atopic children: An 18-month study. Simons, FE, 2007)	0.74
" Safety was assessed according to adverse events, laboratory tests and electrocardiograms."	( Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Antépara, I; Bogacka, E; Jáuregui, I; Medina, I; Oanta, A; Uhl, P; Valiente, R; Wesel, F; Zuberbier, T, 2010)	0.6
" Comparison with levocetirizine indicated both treatments to be equally efficacious as well as equally safe and well tolerated as compared with placebo."	( Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Antépara, I; Bogacka, E; Jáuregui, I; Medina, I; Oanta, A; Uhl, P; Valiente, R; Wesel, F; Zuberbier, T, 2010)	0.94
"Bilastine 20 mg is a novel effective and safe treatment option for the management of CU."	( Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Antépara, I; Bogacka, E; Jáuregui, I; Medina, I; Oanta, A; Uhl, P; Valiente, R; Wesel, F; Zuberbier, T, 2010)	0.6
" 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)	0.35
" Overall incidence of treatment-emergent adverse events was 14."	( Efficacy and safety of levocetirizine in improving symptoms and health-related quality of life in US adults with seasonal allergic rhinitis: a randomized, placebo-controlled study. Gawchik, S; Georges, G; Haeusler, JM; Segall, N, 2010)	0.67
" Incidence of adverse effects was less in the rupatadine group compared with the levocetirizine group."	( Rupatadine and levocetirizine for seasonal allergic rhinitis: a comparative study of efficacy and safety. Allala, U; Jaida, J; Maiti, R; Palani, A; Rahman, J, 2010)	0.94
" Safety evaluations included treatment-emergent adverse events (TEAEs), vital signs, electrocardiographic (ECG) assessments, and laboratory tests."	( Safety and tolerability of levocetirizine dihydrochloride in infants and children with allergic rhinitis or chronic urticaria. Haeusler, JM; Hampel, F; Ratner, P, )	0.43
" The first-generation H(1)-antihistamines are associated with marked adverse effects such as sedation, sleepiness/drowsiness as well as difficulties in learning and cognitive processing; thus, they are recommended for limited or discontinued use in children with AR or CIU."	( Evidence for clinical safety, efficacy, and parent and physician perceptions of levocetirizine for the treatment of children with allergic disease. Kurzawa, R; Pampura, AN; Papadopoulos, NG; Spičák, V, 2011)	0.6
" The overall incidence of adverse drug reactions was also found to be less in rupatadine group."	( Rupatadine and levocetirizine in chronic idiopathic urticaria: a comparative study of efficacy and safety. Ahmed, I; Goud, P; Jaida, J; Maiti, R; Palani, A; Raghavendra, BN, 2011)	0.72
" Routine hematological and biochemical tests and treatment-emergent adverse events were monitored for safety."	( Olopatadine versus levocetirizine in chronic urticaria: an observer-blind, randomized, controlled trial of effectiveness and safety. Bagchi, C; Chaudhuri, A; Das, NK; Hazra, A; Islam, CN; Sil, A; Tripathi, SK, 2013)	0.72
" Adverse event profiles were comparable with sedation being the commonest complaint."	( Olopatadine versus levocetirizine in chronic urticaria: an observer-blind, randomized, controlled trial of effectiveness and safety. Bagchi, C; Chaudhuri, A; Das, NK; Hazra, A; Islam, CN; Sil, A; Tripathi, SK, 2013)	0.72
"Olopatadine is a safe and more effective alternative to levocetirizine in the treatment of CU."	( Olopatadine versus levocetirizine in chronic urticaria: an observer-blind, randomized, controlled trial of effectiveness and safety. Bagchi, C; Chaudhuri, A; Das, NK; Hazra, A; Islam, CN; Sil, A; Tripathi, SK, 2013)	0.96
" 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, )	0.43
"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)	0.94
" Safety was assessed by recording drug-related adverse events, biochemical investigations, and electrocardiogram, along with tolerability and compliance."	( Effectiveness, safety, and tolerability of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic spontaneous urticaria: A double-blind, parallel group, randomized controlled trial. Biswas, D; Chowdhury, SN; Das, A; Ghosh, S; Podder, I; Sengupta, S, 2020)	0.8
"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)	1.13
" 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

Excerpt	Reference	Relevance
"This study was performed to investigate levocetirizine pharmacokinetic disposition and pharmacodynamics in relation to skin reactivity to histamine in children aged 6 to 11 years."	( Levocetirizine: pharmacokinetics and pharmacodynamics in children age 6 to 11 years. Simons, FE; Simons, KJ, 2005)	2.04
" It is concluded that estimating in vivo receptor occupancy, which takes into account both the affinity of the drug for the receptor and its free plasma concentration, is a far better predictor for human pharmacodynamics and hence antihistamine potency, than considering in vitro affinity and plasmatic half-life only."	( Histamine H1 receptor occupancy and pharmacodynamics of second generation H1-antihistamines. Baltes, E; Benedetti, MS; Chatelain, P; Gillard, M, 2005)	0.33
" The recommended dose of levocetirizine is 5 mg once daily, while its pharmacokinetic half-life is about 7 h in humans."	( Physicochemical, pharmacological and pharmacokinetic properties of the zwitterionic antihistamines cetirizine and levocetirizine. Chen, C, 2008)	0.86
"Levocetirizine has several pharmacokinetic properties that are desirable for an antihistamine providing a combination of both potency and safety."	( Pharmacokinetic evaluation of levocetirizine. Ferrer, M, 2011)	2.1
" The validated method was applied in a pharmacokinetic study to determine the concentration of levocetirizine in plasma samples."	( Determination of levocetirizine in human plasma by LC-MS-MS: validation and application in a pharmacokinetic study. Jithavech, P; Rojsitthisak, P; Sanphanya, K; Vicheantawatchai, P; Wichitnithad, W, )	0.69
"The aim of this study is to assess the bioequivalence of a new generic formulation and the branded formulation of levocetirizine dihydrochloride in healthy Chinese volunteers under fasting and fed conditions, and food-intake effect on the pharmacokinetic properties is also evaluated."	( The Effect Of Food On The Pharmacokinetic Properties And Bioequivalence Of Two Formulations Of Levocetirizine Dihydrochloride In Healthy Chinese Volunteers. Chen, XF; Cheng, Y; Fang, LP; Guo, JH; Huang, BL; Lin, BJ; Liu, MB; Qiu, HQ; Que, WC, 2019)	0.94
"The two formulations demonstrated essentially identical pharmacokinetic profiles and were all well within the FDA/CFDA bioequivalence standards."	( The Effect Of Food On The Pharmacokinetic Properties And Bioequivalence Of Two Formulations Of Levocetirizine Dihydrochloride In Healthy Chinese Volunteers. Chen, XF; Cheng, Y; Fang, LP; Guo, JH; Huang, BL; Lin, BJ; Liu, MB; Qiu, HQ; Que, WC, 2019)	0.73
" 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)	1.04
"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)	0.82
"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)	1.07

Excerpt	Reference	Relevance
"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, )	0.37
"Levocetirizine dihydrochloride is known to interact with some anti-inflammatory drugs."	( In vitro drug interaction of levocetirizine and diclofenac: Theoretical and spectroscopic studies. Abdel Gaber, SA; Abo Dena, AS, 2017)	2.19

Excerpt	Reference	Relevance
" The absolute bioavailability is 50-65% for mizolastine; it is high for levocetirizine as the percentage of the drug eliminated unchanged in the 48 h urine is 77% of the oral dose; the estimation for fexofenadine is at least 33%; no estimation was found for desloratadine."	( Comparison of pharmacokinetics and metabolism of desloratadine, fexofenadine, levocetirizine and mizolastine in humans. Benedetti, MS; Diquet, B; Molimard, M, 2004)	0.78
" Validation results on linearity, specificity, accuracy, precision and stability, as well as its application to the analysis of plasma samples taken up to 48h after oral administration of 5mg of levocetirizine dichloridrate in healthy volunteers demonstrate its applicability to bioavailability studies."	( Determination of levocetirizine in human plasma by liquid chromatography-electrospray tandem mass spectrometry: application to a bioequivalence study. Abib, E; Amarante, AR; Barros, FA; Berton, D; Boldin, R; Calafatti, SA; Campos, DR; Meurer, EC; Morita, MR; Pedrazolli, J; Pereira, R, 2008)	0.87
" No major cytochrome P450 inhibition has been reported with desloratadine, fexofenadine and levocetirizine, and the bioavailability of desloratadine is minimally affected by drugs interfering with transporter molecules."	( Clinical pharmacokinetics and pharmacodynamics of desloratadine, fexofenadine and levocetirizine : a comparative review. Devillier, P; Faisy, C; Roche, N, 2008)	0.79
" Cetirizine exhibits high intestinal absorption in humans and its oral bioavailability is estimated to be greater than 70%."	( Physicochemical, pharmacological and pharmacokinetic properties of the zwitterionic antihistamines cetirizine and levocetirizine. Chen, C, 2008)	0.56
" The compound shows a rapid onset of action, high bioavailability and affinity for the H1 receptor."	( Levocetirizine in the treatment of allergic diseases. Baiardini, I; Canonica, GW; Compalati, E; Scordamaglia, A; Scordamaglia, F, 2009)	1.8
" Moreover, the use of these effervescent tablets in an orodispersible dosage form can improve oral drug bioavailability and act as an attractive pediatric dosage form."	( Novel levocetirizine HCl tablets with enhanced palatability: synergistic effect of combining taste modifiers and effervescence technique. Labib, GS, 2015)	0.9
" Moreover, levocetirizine attenuated the elevated renal levels of TNF-α and TGF-β1, ameliorated renal oxidative stress and restored NO bioavailability in diabetic kidney."	( Comparison of the effects of levocetirizine and losartan on diabetic nephropathy and vascular dysfunction in streptozotocin-induced diabetic rats. Anbar, HS; Gameil, NM; Shehatou, GS; Suddek, GM, 2016)	1.12
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."	( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein. Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019)	0.51
" Meanwhile, food intake can delay the absorption rate and reduced the bioavailability of levocetirizine in healthy Chinese volunteers."	( The Effect Of Food On The Pharmacokinetic Properties And Bioequivalence Of Two Formulations Of Levocetirizine Dihydrochloride In Healthy Chinese Volunteers. Chen, XF; Cheng, Y; Fang, LP; Guo, JH; Huang, BL; Lin, BJ; Liu, MB; Qiu, HQ; Que, WC, 2019)	0.95
" Part 1 compared the bioavailability of levocetirizine oral disintegrating tablet (ODT) and levocetirizine immediate-release tablet (IRT) taken with water in the fasted state in 24 subjects; all subjects completed this part of the trial."	( Levocetirizine Oral Disintegrating Tablet: A Randomized Open-Label Crossover Bioequivalence Study in Healthy Japanese Volunteers. Eto, T; Haranaka, M; Hoyano, K; Ino, H; Irie, S; Nakano, A; Ogura, H; Shiramoto, M; Terao, T; Wakamatsu, A, 2020)	2.27
" Levocetirizine's solubility and permeability properties, as well as its dissolution from commercial products, its therapeutic uses, therapeutic index, pharmacokinetics and pharmacodynamic traits, were reviewed in accordance with the BCS, along with any reports in the literature about failure to meet bioequivalence (BE) requirements, bioavailability issues, drug-excipient interactions as well as other relevant information."	( Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Levocetirizine Dihydrochloride. Abdallah, DB; Abrahamsson, B; Ahmed, DT; Charoo, NA; Cristofoletti, R; Dressman, J; Kambayashi, A; Langguth, P; Mehta, M; Parr, A; Polli, JE; Shah, VP, 2023)	2.06
" However, the bioavailability of levocetirizine hydrochloride granules remains to be determined."	( Bioequivalence of Levocetirizine Hydrochloride Granules (Kangzhitai) in Healthy Subjects. Tan, H; Xiang, H; Yang, G, 2023)	1.53
" The relative bioavailability (F, assessed by AUC0-48) of Kangzhitai® vs."	( Bioequivalence of Levocetirizine Hydrochloride Granules (Kangzhitai) in Healthy Subjects. Tan, H; Xiang, H; Yang, G, 2023)	1.24

Excerpt	Relevance	Reference
" Compliance with cetirizine dosing was documented."	( Population pharmacokinetics of levocetirizine in very young children: the pediatricians' perspective. Simons, FE, 2005)	0.61
" Once-daily dosing may be optimal in children aged 6 to 11 years, as it is in adults."	( Levocetirizine: pharmacokinetics and pharmacodynamics in children age 6 to 11 years. Simons, FE; Simons, KJ, 2005)	1.77
" DAD detection was utilized for the characterization of composition of each separated zone via match of corresponding tested (analyte in dosage form) and reference (standard analyte in water) UV-VIS spectrum (scanned in interval 200-800 nm) being expressed mathematically through Pearson's correlation coefficient (PCC)."	( Enantiomeric purity control of levocetirizine in pharmaceuticals using anionic cyclodextrin mediated capillary electrophoresis separation and fiber-based diode array detection. Havránek, E; Maráková, K; Mikus, P; Valásková, I, 2009)	0.64
" 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)	0.35
"Increasing the dosage of levocetirizine and desloratadine up to 4-fold improves chronic urticaria symptoms without compromising safety in approximately three quarters of patients with difficult-to-treat chronic urticaria."	( The effectiveness of levocetirizine and desloratadine in up to 4 times conventional doses in difficult-to-treat urticaria. Church, DS; Church, MK; Dimitrov, V; Kraeva, S; Kralimarkova, T; Lazarova, C; Popov, TA; Popova, D; Staevska, M, 2010)	0.98
" Thus, the proposed method is suitable for the simultaneous analysis of active ingredients in tablet dosage forms and human serum."	( Simultaneous determination of gliquidone, fexofenadine, buclizine, and levocetirizine in dosage formulation and human serum by RP-HPLC. Arayne, MS; Mirza, AZ; Siddiqui, FA; Sultana, N, )	0.36
" These results suggest that double-dosed levocetirizine treatment suppresses histamine-induced skin symptoms more rapidly, profoundly and sustainably than conventionally dosed levocetirizine treatment."	( A double dose of levocetirizine leads to better control of histamine-induced flare, wheal and itch in healthy donors. Kabashima, K; Miyachi, Y; Nakahigashi, K; Nakamizo, S; Tanizaki, H, 2013)	1
" Moreover, the use of these effervescent tablets in an orodispersible dosage form can improve oral drug bioavailability and act as an attractive pediatric dosage form."	( Novel levocetirizine HCl tablets with enhanced palatability: synergistic effect of combining taste modifiers and effervescence technique. Labib, GS, 2015)	0.9
" The developed methods have been successfully applied to the simultaneous determination of both drugs in commercial tablet dosage form."	( Validated derivative and ratio derivative spectrophotometric methods for the simultaneous determination of levocetirizine dihydrochloride and ambroxol hydrochloride in pharmaceutical dosage form. Ali, OI; Elgohary, RM; Ismail, NS, 2016)	0.65
" 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, )	0.43
" One oral dose of vehicle, LEVO (10 mg/kg/species) or moxifloxacin (MOXI; 30 mg/kg/dog; 80 mg/kg/NHP) was administered to instrumented animals (N = 8/species) using a cross-over dosing design; MOXI was the in-study positive control."	( Evaluation of levocetirizine in beagle dog and cynomolgus monkey telemetry assays: Defining the no QTc effect profile by timepoint and concentration-QTc analysis. Baublits, J; Chandra, FA; Chui, RW; Engwall, MJ; Jones, ZW; Vargas, HM; Wahlstrom, J, 2023)	1.27
"One of the most important issues for bitter-tasting drugs such as levocetirizine dihydrochloride (LCD) is the production of palatable dosage forms."	( Palatable Levocetirizine Dihydrochloride Solid Dispersed Fast-Dissolving Films: Formulation and Ahmed, MA; Al-Kubati, SS; Emad, NA, 2022)	1.36
" In this monograph, the practicality of using Biopharmaceutics Classification System (BCS) based methodologies as a substitute for pharmacokinetic studies in human volunteers to appraise the bioequivalence of immediate-release (IR) oral, solid dosage forms containing levocetirizine dihydrochloride was investigated, using data from the literature and in-house testing."	( Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Levocetirizine Dihydrochloride. Abdallah, DB; Abrahamsson, B; Ahmed, DT; Charoo, NA; Cristofoletti, R; Dressman, J; Kambayashi, A; Langguth, P; Mehta, M; Parr, A; Polli, JE; Shah, VP, 2023)	1.33
"A novel potentiometric sensor which consists of a silver wire coated with zinc oxide (ZnO) nanorod modified with a polymeric membrane (combining β-cyclodextrin and tetraphenyl borate, and plasticized with di-butyl phthalate) was constructed for the determination of LVZ·2HCl in its pure form and its combination dosage form."	( Construction of a Zinc Oxide Nanorod-Modified Coated Wire Electrode for Potentiometric Determination of Levocetirizine Dihydrochloride in Its Pure and Combined Form. Alhaj Sakur, A; Nashed, D; Noureldin, I, 2023)	1.12
"The method was validated according to International Council for Harmonisation of Technical Requirments for Registration of Pharmaceuticals for Human Use (ICH) rules and applied to the determination of LVZ in its pure and combined pharmaceutical dosage forms."	( Construction of a Zinc Oxide Nanorod-Modified Coated Wire Electrode for Potentiometric Determination of Levocetirizine Dihydrochloride in Its Pure and Combined Form. Alhaj Sakur, A; Nashed, D; Noureldin, I, 2023)	1.12

Class	Description
diarylmethane	Any compound containing two aryl groups connected by a single C atom.
[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]

Pathway	Proteins	Compounds
Levocetirizine H1-Antihistamine Action	8	7

Protein	Taxonomy	Measurement	Average (µ)	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
Chain A, JmjC domain-containing histone demethylation protein 3A	Homo sapiens (human)	Potency	89.1251	0.6310	35.7641	100.0000	AID504339
USP1 protein, partial	Homo sapiens (human)	Potency	89.1251	0.0316	37.5844	354.8130	AID743255
cytochrome P450 2D6	Homo sapiens (human)	Potency	26.8370	0.0010	8.3798	61.1304	AID1645840
bromodomain adjacent to zinc finger domain 2B	Homo sapiens (human)	Potency	79.4328	0.7079	36.9043	89.1251	AID504333
euchromatic histone-lysine N-methyltransferase 2	Homo sapiens (human)	Potency	39.8107	0.0355	20.9770	89.1251	AID504332
beta-2 adrenergic receptor	Homo sapiens (human)	Potency	10.0000	0.0058	6.0263	32.6427	AID492947
transcriptional regulator ERG isoform 3	Homo sapiens (human)	Potency	7.9433	0.7943	21.2757	50.1187	AID624246
geminin	Homo sapiens (human)	Potency	28.1838	0.0046	11.3741	33.4983	AID624297
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Assay ID	Title	Year	Journal	Article
AID504812	Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign	2010	Endocrinology, Jul, Volume: 151, Issue:7	A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID504810	Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign	2010	Endocrinology, Jul, Volume: 151, Issue:7	A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1202698	Plasma protein binding in guinea pig	2015	Journal of medicinal chemistry, Mar-26, Volume: 58, Issue:6	CNS drug design: balancing physicochemical properties for optimal brain exposure.
AID1578091	Unbound brain-to-plasma concentration ratio in guinea pig	2019	European journal of medicinal chemistry, Nov-15, Volume: 182	Practical approaches to evaluating and optimizing brain exposure in early drug discovery.
AID1202697	Ratio of unbound drug in brain to plasma in iv dosed guinea pig	2015	Journal of medicinal chemistry, Mar-26, Volume: 58, Issue:6	CNS drug design: balancing physicochemical properties for optimal brain exposure.
AID1202696	Ratio of drug uptake in brain to plasma in iv dosed guinea pig	2015	Journal of medicinal chemistry, Mar-26, Volume: 58, Issue:6	CNS drug design: balancing physicochemical properties for optimal brain exposure.
AID1578088	Brain to plasma partition coefficient, Kp of the compound in guinea pig	2019	European journal of medicinal chemistry, Nov-15, Volume: 182	Practical approaches to evaluating and optimizing brain exposure in early drug discovery.
AID1578089	Plasma protein binding in guinea pig	2019	European journal of medicinal chemistry, Nov-15, Volume: 182	Practical approaches to evaluating and optimizing brain exposure in early drug discovery.
AID1202699	Plasma protein binding in human	2015	Journal of medicinal chemistry, Mar-26, Volume: 58, Issue:6	CNS drug design: balancing physicochemical properties for optimal brain exposure.
AID588499	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set	2010	Current protocols in cytometry, Oct, Volume: Chapter 13	Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set	2006	Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5	Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set	2010	Assay and drug development technologies, Feb, Volume: 8, Issue:1	High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID1745845	Primary qHTS for Inhibitors of ATXN expression
AID588497	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set	2010	Current protocols in cytometry, Oct, Volume: Chapter 13	Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set	2006	Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5	Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set	2010	Assay and drug development technologies, Feb, Volume: 8, Issue:1	High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588501	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set	2010	Current protocols in cytometry, Oct, Volume: Chapter 13	Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set	2006	Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5	Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set	2010	Assay and drug development technologies, Feb, Volume: 8, Issue:1	High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID651635	Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1296008	Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening	2020	SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1	Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346987	P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen	2019	Molecular pharmacology, 11, Volume: 96, Issue:5	A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346986	P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen	2019	Molecular pharmacology, 11, Volume: 96, Issue:5	A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347160	Primary screen NINDS Rhodamine qHTS for Zika virus inhibitors	2020	Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49	Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347159	Primary screen GU Rhodamine qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay	2020	Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49	Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1159607	Screen for inhibitors of RMI FANCM (MM2) intereaction	2016	Journal of biomolecular screening, Jul, Volume: 21, Issue:6	A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1346037	Human H1 receptor (Histamine receptors)	2004	European journal of biochemistry, Jul, Volume: 271, Issue:13	Large-scale overproduction, functional purification and ligand affinities of the His-tagged human histamine H1 receptor.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	115 (45.28)	29.6817
2010's	106 (41.73)	24.3611
2020's	33 (12.99)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	110 (37.16%)	5.53%
Reviews	43 (14.53%)	6.00%
Case Studies	30 (10.14%)	4.05%
Observational	2 (0.68%)	0.25%
Other	111 (37.50%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (69)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
Efficacy and Safety of Levocetirizine Alone or in Combination With Tranexamic Acid in the Treatment of Spontaneous Chronic Urticaria. Multicentric Controlled Randomized Study in Cross-over, Double-blind [NCT03789422]	Phase 4	80 participants (Anticipated)	Interventional	2019-12-10	Recruiting
Efficacy and Safety of 20 mg Levocetirizine and 15 mg Levocetirizine + 50 mg Bed-Time Hydroxyzine in Severe Chronic Urticaria in Adults: a Pilot, Randomized, Double-blind, Cross-over and Parallel, Active-controlled, Single-centre Study [NCT01250652]	Phase 4	24 participants (Actual)	Interventional	2011-03-31	Completed
A Single Centre, Single Dose, Open-label, Randomized, 2-part, 2-way Crossover Study to Determine the Bioequivalence of Levocetirizine Oral Disintegrating Tablet Given With Water and Without Water Compared to Levocetirizine Immediate Release Tablet in Heal [NCT03555890]	Phase 1	72 participants (Actual)	Interventional	2018-05-18	Completed
The Early Prevention of Asthma in Atopic Children (EPAAC™) Study. A Multi-country, Double Blind, Placebo (PLC) Controlled, Randomized, Parallel Group Trial: Evaluation of the Efficacy and Safety of Levocetirizine (LCTZ) (5 mg/ml Oral Drops -0.125 mg/kg b. [NCT00152464]	Phase 3	514 participants (Actual)	Interventional	2002-03-20	Completed
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months With Symptoms of Allergic Rhinitis or Chronic Urticaria. [NCT00628108]	Phase 3	69 participants (Actual)	Interventional	2008-03-31	Completed
A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Levocetirizine Dihydrochloride 5 mg Tablets With Xyzal® 5 mg Tablets in Normal, Healthy, Adult, Human Subjects Under Fed Condition [NCT01567501]	Phase 1	28 participants (Actual)	Interventional	2012-02-29	Completed
The Effects of Desloratadine and Levocetirizine on Nasal Obstruction in Subjects With Induced Allergic Rhinitis in the VCC Assessed Clinically and With Nasal Rhinomanometry and Nasal Flowmetry [NCT00789152]	Phase 3	81 participants (Actual)	Interventional	2003-12-01	Completed
A Multi-Center, Randomized, Double Blind, Placebo Controlled Parallel Group Study of the Safety of Levocetirizine Dihydrochloride Oral Liquid Formulation b.i.d Dosing in Children Aged 1 to < 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of [NCT00619801]	Phase 3	173 participants (Actual)	Interventional	2008-03-31	Completed
A Phase 1, Randomized, Placebo-controlled, Participant- and Investigator-blind, Single-dose Study of the Pharmacokinetics of LY3471851 Following Subcutaneous Dosing of LY3471851 in Healthy Participants [NCT05565729]	Phase 1	41 participants (Actual)	Interventional	2022-10-05	Completed
Management of Pruritus With Xyzal in Atopic Dermatitis in a Randomized, Double-Blind, Placebo Controlled Study [NCT00884325]	Phase 4	40 participants (Actual)	Interventional	2009-02-28	Completed
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine 5 mg Once Daily Given for 2 Weeks in Subjects 18 yr of Age and Older With Seasonal Al [NCT00621959]	Phase 4	596 participants (Actual)	Interventional	2008-03-31	Completed
A Randomised Controlled Trial to Evaluate the Effect of Vitamin D Supplementation in Patients With Chronic Urticaria [NCT03991845]	Phase 4	262 participants (Actual)	Interventional	2019-06-21	Enrolling by invitation
A Placebo Controlled Trial to Evaluate The Effects of Levocetirizine on Nasal Allergen Challenge And Adenosine Monophosphate Challenge In Patients With Intermittent and Persistent Allergic Rhinitis [NCT00679250]	Phase 4	25 participants (Actual)	Interventional	2005-11-30	Completed
Is Levocetirizine Less Sedating Than Cetirizine? A Randomized, Double-blind, Placebo Controlled Trial. [NCT00826943]	Phase 4	30 participants (Actual)	Interventional	2009-01-31	Completed
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine 5 mg Once Daily Given for 2 Weeks in Subjects 18 yr of Age and Older With Seasonal Al [NCT00653224]	Phase 4	580 participants (Actual)	Interventional	2008-04-30	Completed
Levocetirizine Effect on Nasal Nitric Oxide and Nasal Eosinophils in Subjects With Perennial Allergic Rhinitis [NCT00894231]	Phase 4	30 participants (Anticipated)	Interventional	2009-01-31	Completed
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 4	70 participants (Actual)	Interventional	2014-04-30	Completed
A Randomized, Parallel, Double-blind, Multi-center, Comparative Study to Exploratively Evaluate the Efficacy and Safety of Cosalin® Monotherapy vs. Cosalin® and Xarlin® Combination Therapy in Patients With Allergic Rhinitis [NCT01062139]	Phase 4	100 participants (Actual)	Interventional	2009-10-31	Enrolling by invitation
3-D Visualization of the Anti-Obstructive Effect of Levocetirizine - A Monocentric Clinical Trail With One Patient (Phase-IV-Study) [NCT01000792]	Phase 3	1 participants (Actual)	Interventional	2009-11-30	Completed
The Effect of Levocetirizine (Xyzal®) on the Skin Levels of Inflammatory Mediators Histamine, Serine Proteases, Prostaglandin E2, Leukotriene B4 and Cathepsins in Patients With Symptomatic Dermatographism and Chronic Idiopathic Urticaria [NCT01008592]		11 participants (Actual)	Observational	2009-04-30	Terminated(stopped due to Mediators of interest were not consistently detectable with the analytical methods employed.)
Evaluation of Efficacy, Using the Number of Comfortable Days and the Safety of Levocetirizine Dihydrochloride, Administered Once Daily in the Evening for 30 Days, to Subjects Suffering From Perennial Allergic Rhinitis to House Dust Mites [NCT00521131]	Phase 4	453 participants (Actual)	Interventional	2002-09-30	Completed
Randomized, Monocenter, Double Blind, Placebo-controlled, Single Oral Dose, Three-way Cross Over Study, to Compare Levocetirizine and Desloratadine on Allergen-induced Wheal and Flare Reaction During 24 Hours in 18 Adult Allergic Volunteers. [NCT00521170]	Phase 1	0 participants	Interventional	2004-11-30	Completed
A Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Perennial Allergic Rhinitis. [NCT00524836]	Phase 3	71 participants (Actual)	Interventional	2003-09-30	Completed
A Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Chronic Idiopathic Urticaria (CIU) [NCT00525382]	Phase 3	134 participants (Actual)	Interventional	2003-08-31	Completed
A Multicentre, Double-blind, Parallel, Randomized, Placebo-controlled Study : Evaluation of the Efficacy and Safety of Levocetirizine 5 mg and Desloratadine 5 mg Administered Orally as Capsules Once Daily, in the Morning, Over 2 Weeks in Patients Sufferin [NCT00160589]	Phase 4	729 participants	Interventional	2005-04-30	Completed
A Comparative Study on Clinical Efficacy and Safety of Levocetirizine 5 mg Oral Capsules Once Daily in the Morning vs. Desloratadine 5 mg Oral Capsules Once Daily in the Morning in Patients Suffering From Chronic Idiopathic Urticaria (CIU) [NCT00264303]	Phase 4	886 participants (Actual)	Interventional	2005-12-31	Completed
COrticosteroids in acUte uRticAria in emerGency dEpartment [NCT03545464]	Phase 3	240 participants (Anticipated)	Interventional	2019-09-21	Recruiting
The Prolongation of the EPAAC™ Trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children). A Multi-country, Double Blind, Placebo (PLC) Controlled, Follow-up Trial With 3 Parallel Groups (LCTZ-LCTZ, LCTZ-PLC and PLC-PLC) : Evaluation of the L [NCT00160563]	Phase 3	207 participants (Actual)	Interventional	2004-06-30	Terminated(stopped due to The predecessor study A00309 (NCT00152464) did not show statistical significance in time to onset of asthma between the levocetirizine and placebo groups.)
Double Blind, Double-dummy, Five Parallel Groups, Randomized, Exploratory Clinical Trial to Compare the Efficacy of Single Dose of Levocetirizine 2.5 mg Oral Drops (5 mg/mL), Levocetirizine 5 mg Oral Tablets, Cetirizine 5 mg Oral Drops (10 mg/mL) and Ceti [NCT00291642]	Phase 2	551 participants (Actual)	Interventional	2006-01-01	Completed
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 4	418 participants (Actual)	Interventional	2006-07-29	Completed
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 3	283 participants (Actual)	Interventional	2012-06-30	Completed
Trial to Compare the Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects Exposed to Pollen Challenge in an Environmental Exposure Unit (EEU). [NCT00544388]	Phase 3	570 participants (Actual)	Interventional	2004-04-30	Completed
A Multi-center, Open, Randomized, Three-arm, Parallel-group, Phase IV Study to Compare the Efficacy of Ciclesonide Nasal Spray and Levocetirizine, Alone and in Combination for the Patient With Allergic Rhinitis [NCT01430260]	Phase 4	349 participants (Actual)	Interventional	2011-01-31	Completed
Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Seasonal Allergic Rhinitis (SAR) [NCT00525278]	Phase 3	67 participants (Actual)	Interventional	2003-08-31	Completed
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 1	30 participants (Anticipated)	Interventional	2011-11-30	Completed
Evaluation of the Efficacy and Safety of Levocetirizine During 8 Weeks Preceding and Following the Anticipated Onset of the Grass Pollen Season in Subjects Suffering From Seasonal Allergic Rhinitis Associated With Pollen-induced Asthma [NCT00521040]		459 participants (Actual)	Interventional	2004-02-29	Completed
The Efficacy and Safety of Levocetirizine Dihydrochloride Oral Drops Given 0.125 mg/kg b.i.d. During 90 Days in the Treatment of Recurrent Cough Associated With Other Allergic Symptoms, e.g. Wheezing, in Children Aged 1-2 Years. [NCT00520754]	Phase 2	15 participants (Actual)	Interventional	2001-12-31	Completed
Trial to Compare the Efficacy and Safety of Levocetirizine 5 mg od and Fexofenadine 120 mg od in Reducing Symptoms of Seasonal Allergic Rhinitis in Grass Pollen Sensitized Adults [NCT00542607]	Phase 4	94 participants (Actual)	Interventional	2002-09-30	Completed
Influence of H1-antihistamines on the Dermal Blood Flow Response After a Histamine Skin Prick as Well as After the Topical Application of Cinnamaldehyde and Capsaicin [NCT04399525]		12 participants (Actual)	Interventional	2019-10-28	Completed
Double-blind, 3 Parallel Randomized Groups, Therapeutic Confirmatory. Clinical Trial to Compare the Efficacy of Levocetirizine 5 mg and Montelukast 10 mg to Placebo in Reducing SAR Symptoms in Ragweed Sensitive Subjects in an EEC. [NCT00315523]	Phase 3	403 participants	Interventional	2006-07-31	Completed
A 4 Week Open, Multi-center Study Evaluating the Safety of Levocetirizine 1.25 mg b.i.d. Given as 0.5 mg/mL Oral Solution in 2 to 6 Year-old Children Suffering From Allergic Rhinitis. [NCT00152412]	Phase 2	30 participants	Interventional	2004-06-30	Completed
A Randomized, Double-blind, Double Dummy, Placebo Controlled, Cross-over Exploratory Trial in Healthy Male Adult Subjects: Comparison by Means of Infrared Thermography of the Anti-H1 Potency of Levocetirizine 5 mg and Cetirizine 10 mg Tablet Single Oral D [NCT00150761]	Phase 4	60 participants	Interventional	2004-07-31	Completed
Double-blind, Randomised, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Levocetirizine 5 mg for the Treatment of Chronic Idiopathic Urticaria [NCT00421109]	Phase 3	522 participants (Actual)	Interventional	2006-07-31	Completed
Efficacy of Levocetirizine in the Treatment of Nasal Obstruction Due to Perennial Rhinitis [NCT00439712]	Phase 4	60 participants (Actual)	Interventional	2007-02-28	Completed
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Oral Dose, Crossover, Bioequivalence Study of Levocetirizine DiHCl Tablets 5mg With XYZAL® Tablets 5 mg in Healthy Subjects Under Fasting Conditions [NCT01506076]	Phase 1	29 participants (Actual)	Interventional	2007-12-31	Completed
A Monocenter, Double-blind, Randomized Trial, With Two Parallel Groups Comparing the Clinical Efficacy of Levocetirizine 5 mg Capsules and Desloratadine 5 mg Capsules Taken Once a Day Over 3 Weeks of Treatment in Adult Subjects Suffering From Seasonal All [NCT00160537]	Phase 4	200 participants	Interventional	2005-05-31	Completed
A Single Blind, Randomized, Single Oral Dose Study to Compare the Oral Disposition of Levocetirizine When Given Alone (5mg) or as the Racemate (Cetirizine 10mg), and to Investigate the Safety and Tolerability and the Pharmacokinetics of Levocetirizine and [NCT02447393]	Phase 1	20 participants (Actual)	Interventional	2008-03-18	Completed
A Multi-centre, Double-blind, Double-dummy, Randomized, Active-controlled Phase III Study to Evaluate the Efficacy and Safety of Xyzal® 5mg od vs Zyrtec® 10mg od in Subjects Aged 15 Years and Above With Dermatitis and Eczema [NCT00375713]	Phase 3	466 participants (Actual)	Interventional	2005-10-31	Completed
Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion (OME) Compared to That of Combination of Antibiotic, Antihistaminic, and Nasal Decongestant [NCT03590912]	Phase 4	160 participants (Actual)	Interventional	2018-09-05	Completed
A Double-blind, Double-dummy, Parallel-group, Placebo-controlled, Randomized Study to Assess the Duration of the Suppressive Effects of Desloratadine on the Cutaneous Allergen-induced Wheal and Flare (1) Response After Discontinuation [NCT00359138]	Phase 4	36 participants (Actual)	Interventional	2006-02-28	Completed
A Pilot, Open, Monocenter, Randomized Two Parallel Groups, Clinical Efficacy Trial: Comparison Continuous Versus on Demand Regimen of Treatment With Levocetirizine 5 mg Oral Tablets, Once a Day, in Adults Suffering From Persistent Allergic Rhinitis (PER) [NCT00160680]	Phase 4	62 participants (Actual)	Interventional	2005-03-01	Completed
Camillian Saint Mary's Hospital Luodong [NCT05348148]		450 participants (Anticipated)	Interventional	2020-06-16	Recruiting
Study to Investigate the Effects of Levocetirizine and Hydroxyzine on Cognitive and Psychomotor Functioning During Simulated Diving at 2 Bar and 4 Bar in Professional Navy Divers [NCT01496911]	Phase 4	24 participants (Actual)	Interventional	2012-04-30	Completed
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Oral Dose, Crossover, Bioequivalence Study of Levocetirizine DiHCl Tablets 5mg With XYZAL® Tablets 5 mg in Healthy Subjects Under Fed Conditions [NCT01506063]	Phase 1	31 participants (Actual)	Interventional	2008-01-31	Completed
Efficacy and Safety of Cossac L Tablet in Vasomotor Rhinitis Patients : A Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial [NCT01509209]	Phase 3	137 participants (Actual)	Interventional	2011-05-31	Completed
Pharmacokinetic Study of Levocetirizine Oral Solution-An Open-label, Randomized, Cross-over Study to Evaluate the Pharmacokinetics, the Safety and Tolerability of Levocetirizine Oral Solution (5 mg) and Cetirizine Dry Syrup (10 mg), Following a Single Dos [NCT01622283]	Phase 1	20 participants (Actual)	Interventional	2012-05-02	Completed
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 1	28 participants (Actual)	Interventional	2012-07-31	Completed
Phase II Study of Levocetirizine in Combination With Capecitabine + Bevacizumab to Overcome Resistance to Anti-angiogenic Therapy in Patients With Refractory Colorectal Cancer [NCT01722162]	Phase 2	47 participants (Actual)	Interventional	2013-04-30	Completed
Drug Use Investigation for XYZAL [NCT01445262]		10,728 participants (Actual)	Observational	2011-02-28	Completed
A Multi-Center, Open-labelled Study to Evaluate the Safety of Levocetirizine Hydrochloride Oral Solution in Children Aged 6 Months to 2 Years With Allergic Rhinitis or Pruritus Associated With the Skin Diseases. [NCT01563081]	Phase 3	60 participants (Actual)	Interventional	2012-04-30	Completed
Comparison of Efficacy and Consistency of Action of Levocetirizine 5 mg Once Daily With Fexofenadine 60 mg Twice Daily in the Histamine Induced Wheal, Flare and Itch Response [NCT01586091]	Phase 4	18 participants (Actual)	Interventional	2011-02-28	Completed
A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma [NCT04699604]	Phase 3	300 participants (Anticipated)	Interventional	2021-04-28	Recruiting
A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Levocetirizine Dihydrochloride 5 mg Tablets With Xyzal® 5 mg Tablets in Normal, Healthy, Adult, Human Subjects Under Fasting Condi [NCT01557439]	Phase 1	28 participants (Actual)	Interventional	2012-02-29	Completed
Clinical Study to Evaluate the Possible Efficacy and Safety of Levocetirizine in Patients With Diabetic Kidney Disease [NCT05638880]	Phase 2	60 participants (Anticipated)	Interventional	2022-12-20	Recruiting
Placebo Controlled Pilot Study on the Efficacy of Levocetirizine 5 mg in Reducing Symptoms, Airway Resistance, and Sleep Impairment in Patients With Persistent Allergic Rhinitis [NCT00355771]	Phase 4	100 participants (Actual)	Interventional	2006-06-30	Completed
Efficacy of Levocetirizine Fourfold Dosage in Chronic Spontaneous Urticaria Resistant to the Licensed Dosage [NCT02372604]	Phase 3	15 participants (Actual)	Interventional	2015-07-31	Completed
Characterization of the Role of Histamine in Children With Asthma [NCT01392859]	Phase 2/Phase 3	211 participants (Actual)	Interventional	2011-06-30	Completed
In Vivo Anti-inflammatory Effect of H1 Antihistamines in Allergic Rhinitis [NCT02507635]	Phase 4	115 participants (Actual)	Interventional	2009-02-28	Completed
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 1	24 participants (Actual)	Interventional	2017-07-19	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT00152464 (10) [back to overview]	Percentage of Days With Symptoms of Nocturnal Cough
NCT00152464 (10) [back to overview]	Percentage of Subjects Using Medication for Atopic Dermatitis
NCT00152464 (10) [back to overview]	Number of Episodes of Urticaria Per Subject
NCT00152464 (10) [back to overview]	Percentage of Days With Symptoms of Either Wheezing or Nocturnal Cough
NCT00152464 (10) [back to overview]	Percentage of Days With Symptoms of Wheezing
NCT00152464 (10) [back to overview]	Percentage of Subjects With Urticaria
NCT00152464 (10) [back to overview]	Time to Onset of Asthma During the Treatment Period
NCT00152464 (10) [back to overview]	Percentage of Days of Use of Asthma Medication
NCT00152464 (10) [back to overview]	Percentage of Days of Use of Medication for Atopic Dermatitis
NCT00152464 (10) [back to overview]	Percentage of Subjects Using Asthma Medication
NCT00160680 (14) [back to overview]	Mean Weekly Individual Symptoms Scores During the Treatment Period
NCT00160680 (14) [back to overview]	Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period
NCT00160680 (14) [back to overview]	Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period
NCT00160680 (14) [back to overview]	Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period
NCT00160680 (14) [back to overview]	Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period
NCT00160680 (14) [back to overview]	Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period
NCT00160680 (14) [back to overview]	Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period
NCT00160680 (14) [back to overview]	Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period
NCT00160680 (14) [back to overview]	Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period
NCT00160680 (14) [back to overview]	Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period
NCT00160680 (14) [back to overview]	Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period
NCT00160680 (14) [back to overview]	Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period
NCT00160680 (14) [back to overview]	Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period
NCT00160680 (14) [back to overview]	Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period
NCT00264303 (6) [back to overview]	Mean Score for Pruritus Duration Over the Four Weeks of Treatment
NCT00264303 (6) [back to overview]	Mean Pruritus Severity Score Over the Four Weeks of Treatment
NCT00264303 (6) [back to overview]	Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment
NCT00264303 (6) [back to overview]	Mean Pruritus Severity Score Over the First Week of Treatment
NCT00264303 (6) [back to overview]	Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment
NCT00264303 (6) [back to overview]	Mean Score for Pruritus Duration Over the First Week of Treatment
NCT00291642 (9) [back to overview]	Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I
NCT00291642 (9) [back to overview]	Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II)
NCT00291642 (9) [back to overview]	Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I
NCT00291642 (9) [back to overview]	Change From Baseline in the MSC Score Over Period II
NCT00291642 (9) [back to overview]	Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II
NCT00291642 (9) [back to overview]	Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II)
NCT00291642 (9) [back to overview]	Change From Baseline in the Individual Symptom Scores Over Period I
NCT00291642 (9) [back to overview]	Change From Baseline in the Individual Symptom Scores Over Period II
NCT00291642 (9) [back to overview]	Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II)
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]	Onset of Action During Period I
NCT00295022 (26) [back to overview]	Global Satisfaction of the Subjects at the End of Period III
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 TSC Score + Nasal Congestion Score Over Period III
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 I
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 Total Symptom Complex (TSC) Score Over 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 Individual Symptom Scores 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 MSC Score Over Period III
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 Major Symptom Complex (MSC) Score Over Period I
NCT00295022 (26) [back to overview]	Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I
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]	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]	Intensity of Action From Baseline in the MSC Score Over Period I
NCT00295022 (26) [back to overview]	Variability of Action From Baseline in the MSC Score Over Period I
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]	Change From Baseline in the Individual Symptom Scores Over Period III
NCT00295022 (26) [back to overview]	Change From Baseline in the Individual Symptom Scores Over Period II
NCT00295022 (26) [back to overview]	Time to First Feeling of Improvement During Period I
NCT00359138 (1) [back to overview]	Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment
NCT00375713 (4) [back to overview]	Global Improvement at Endpoint During the 14 Day Treatment Period
NCT00375713 (4) [back to overview]	Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).
NCT00375713 (4) [back to overview]	Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period
NCT00375713 (4) [back to overview]	Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period
NCT00619801 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)
NCT00619801 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin
NCT00619801 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval
NCT00619801 (13) [back to overview]	Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)
NCT00619801 (13) [back to overview]	Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)
NCT00619801 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)
NCT00619801 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST)
NCT00619801 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine
NCT00619801 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen
NCT00619801 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval
NCT00619801 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration
NCT00619801 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval
NCT00619801 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)
NCT00621959 (2) [back to overview]	Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)
NCT00621959 (2) [back to overview]	Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score
NCT00628108 (13) [back to overview]	Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)
NCT00628108 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)
NCT00628108 (13) [back to overview]	Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)
NCT00628108 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)
NCT00628108 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminontransferase (AST)
NCT00628108 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine
NCT00628108 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen
NCT00628108 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval
NCT00628108 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration
NCT00628108 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval
NCT00628108 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)
NCT00628108 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval
NCT00628108 (13) [back to overview]	Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin
NCT00653224 (90) [back to overview]	Total Nasal Symptom Score (TNSS) Over the Second Week
NCT00653224 (90) [back to overview]	Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days)
NCT00653224 (90) [back to overview]	Total Ocular Symptom Score (TOSS) Over the First Week
NCT00653224 (90) [back to overview]	Total Ocular Symptom Score (TOSS) Over the Second Week
NCT00653224 (90) [back to overview]	Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days)
NCT00653224 (90) [back to overview]	Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period
NCT00653224 (90) [back to overview]	Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period
NCT00653224 (90) [back to overview]	Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period
NCT00653224 (90) [back to overview]	Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Endpoint During the Two-week Treatment Period
NCT00653224 (90) [back to overview]	Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1
NCT00653224 (90) [back to overview]	Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2
NCT00653224 (90) [back to overview]	Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period
NCT00653224 (90) [back to overview]	Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1
NCT00653224 (90) [back to overview]	Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1
NCT00653224 (90) [back to overview]	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2
NCT00653224 (90) [back to overview]	Ocular Pruritus Score Over the Total Treatment Period (14 Days)
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 1
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 2
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Endpoint During the Two-week Treatment Period
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 1
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 2
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Endpoint During the Two-week Treatment Period
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 1
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 2
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 1
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 2
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Endpoint During the Two-week Treatment Period
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 1
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 2
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Endpoint During the Two-week Treatment Period
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 1
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 2
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Endpoint During the Two-week Treatment Period
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 1
NCT00653224 (90) [back to overview]	Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 2
NCT00653224 (90) [back to overview]	Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days)
NCT00653224 (90) [back to overview]	Nasal Congestion Score Over the First Week
NCT00653224 (90) [back to overview]	Nasal Congestion Score Over the Second Week
NCT00653224 (90) [back to overview]	Nasal Congestion Score Over the Total Treatment Period (14 Days)
NCT00653224 (90) [back to overview]	Nasal Pruritus Score Over the First Week
NCT00653224 (90) [back to overview]	Nasal Pruritus Score Over the Second Week
NCT00653224 (90) [back to overview]	Nasal Pruritus Score Over the Total Treatment Period (14 Days)
NCT00653224 (90) [back to overview]	Ocular Itching/Burning Score Over the First Week
NCT00653224 (90) [back to overview]	Ocular Itching/Burning Score Over the Second Week
NCT00653224 (90) [back to overview]	Ocular Itching/Burning Score Over the Total Treatment Period (14 Days)
NCT00653224 (90) [back to overview]	Ocular Pruritus Score Over the First Week
NCT00653224 (90) [back to overview]	Ocular Pruritus Score Over the Second Week
NCT00653224 (90) [back to overview]	Ocular Redness Score Over the First Week
NCT00653224 (90) [back to overview]	Ocular Redness Score Over the Second Week
NCT00653224 (90) [back to overview]	Ocular Redness Score Over the Total Treatment Period (14 Days)
NCT00653224 (90) [back to overview]	Ocular Tearing/Watering Score Over the First Week
NCT00653224 (90) [back to overview]	Ocular Tearing/Watering Score Over the Second Week
NCT00653224 (90) [back to overview]	Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days)
NCT00653224 (90) [back to overview]	Post-nasal Drip Score Over the First Week
NCT00653224 (90) [back to overview]	Post-nasal Drip Score Over the Second Week
NCT00653224 (90) [back to overview]	Post-nasal Drip Score Over the Total Treatment Period (14 Days)
NCT00653224 (90) [back to overview]	Rhinorrhea Score Over the First Week
NCT00653224 (90) [back to overview]	Rhinorrhea Score Over the Second Week
NCT00653224 (90) [back to overview]	Rhinorrhea Score Over the Total Treatment Period (14 Days)
NCT00653224 (90) [back to overview]	Sneezing Score Over the First Week
NCT00653224 (90) [back to overview]	Sneezing Score Over the Second Week
NCT00653224 (90) [back to overview]	Sneezing Score Over the Total Treatment Period (14 Days)
NCT00653224 (90) [back to overview]	Total 4 Symptoms Score (T4SS) Over the First Week
NCT00653224 (90) [back to overview]	Total 4 Symptoms Score (T4SS) Over the Second Week
NCT00653224 (90) [back to overview]	Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days)
NCT00653224 (90) [back to overview]	Total 5 Symptoms Score (T5SS) Over the First Week
NCT00653224 (90) [back to overview]	Total 5 Symptoms Score (T5SS) Over the Second Week
NCT00653224 (90) [back to overview]	Total Nasal Symptom Score (TNSS) Over the First Week
NCT00826943 (3) [back to overview]	Modified Epworth Sleepiness Scale
NCT00826943 (3) [back to overview]	Likert Score Rating Global Sedation
NCT00826943 (3) [back to overview]	Total Four Symptom Scores (Allergy Symptoms)
NCT00884325 (2) [back to overview]	Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4
NCT00884325 (2) [back to overview]	Pruritus VAS Scores at Baseline, Week 2 and Week 4
NCT01392859 (1) [back to overview]	Characterize Contribution of Histamine in Children With Asthma
NCT01563081 (5) [back to overview]	Cmax and Cmin of Levocetirizine in Plasma
NCT01563081 (5) [back to overview]	Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal
NCT01563081 (5) [back to overview]	Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs)
NCT01563081 (5) [back to overview]	Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression
NCT01563081 (5) [back to overview]	Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator
NCT01586091 (3) [back to overview]	Flaire Diameter (mm)
NCT01586091 (3) [back to overview]	Pruritus as Assessed by the VAS Score
NCT01586091 (3) [back to overview]	Wheal Volume (cm3)
NCT01722162 (3) [back to overview]	Progression Free Survival (Arm A)
NCT01722162 (3) [back to overview]	Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events
NCT01722162 (3) [back to overview]	Progression Free Survival (Arm B)
NCT03555890 (64) [back to overview]	Part 2: Number of Participants With AEs and SAEs
NCT03555890 (64) [back to overview]	Part 2: Change From Baseline in SBP and DBP
NCT03555890 (64) [back to overview]	Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
NCT03555890 (64) [back to overview]	Part 2: Change From Baseline in Platelet Count and White Blood Cell Count
NCT03555890 (64) [back to overview]	Part 2: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration
NCT03555890 (64) [back to overview]	Part 2: Change From Baseline in Heart Rate (ECG)
NCT03555890 (64) [back to overview]	Part 2: Change From Baseline in Heart Rate
NCT03555890 (64) [back to overview]	Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels
NCT03555890 (64) [back to overview]	Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels
NCT03555890 (64) [back to overview]	Part 2: Change From Baseline in Body Temperature
NCT03555890 (64) [back to overview]	Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count
NCT03555890 (64) [back to overview]	Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
NCT03555890 (64) [back to overview]	Part 2: Change From Baseline in Albumin and Total Protein Levels
NCT03555890 (64) [back to overview]	Part 1: Urine Specific Gravity
NCT03555890 (64) [back to overview]	Part 1: Urine Potential of Hydrogen (pH)
NCT03555890 (64) [back to overview]	Part 1: Number of Participants With Urinalysis Results by Dipstick Method
NCT03555890 (64) [back to overview]	Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT03555890 (64) [back to overview]	Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
NCT03555890 (64) [back to overview]	Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
NCT03555890 (64) [back to overview]	Part 1: Change From Baseline in Platelet Count and White Blood Cell Count
NCT03555890 (64) [back to overview]	Part 1: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration
NCT03555890 (64) [back to overview]	Part 1: Change From Baseline in Heart Rate (12-Lead Electrocardiogram [ECG])
NCT03555890 (64) [back to overview]	Part 1: Change From Baseline in Heart Rate
NCT03555890 (64) [back to overview]	Part 1: Apparent Terminal Phase Half-life (t1/2) of Levocetirizine
NCT03555890 (64) [back to overview]	Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels
NCT03555890 (64) [back to overview]	Part 1: Change From Baseline in Body Temperature
NCT03555890 (64) [back to overview]	Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count
NCT03555890 (64) [back to overview]	Part 1: Change From Baseline in Albumin and Total Protein Levels
NCT03555890 (64) [back to overview]	Part 2: Vz/F of Levocetirizine
NCT03555890 (64) [back to overview]	Part 2: Tmax of Levocetirizine
NCT03555890 (64) [back to overview]	Part 1: Apparent Clearance Following Oral Dosing (CL/F) of Levocetirizine
NCT03555890 (64) [back to overview]	Part 2: t1/2 of Levocetirizine
NCT03555890 (64) [back to overview]	Part 2: MRT of Levocetirizine
NCT03555890 (64) [back to overview]	Part 2: Kel (lambda_z) of Levocetirizine
NCT03555890 (64) [back to overview]	Part 2: Cmax of Levocetirizine
NCT03555890 (64) [back to overview]	Part 2: CL/F of Levocetirizine
NCT03555890 (64) [back to overview]	Part 2: Change From Baseline in Reticulocytes
NCT03555890 (64) [back to overview]	Part 2: Change From Baseline in Red Blood Cell Count
NCT03555890 (64) [back to overview]	Part 2: Change From Baseline in Mean Corpuscle Volume
NCT03555890 (64) [back to overview]	Part 2: Change From Baseline in Mean Corpuscle Hemoglobin
NCT03555890 (64) [back to overview]	Part 2: Change From Baseline in Amylase Levels
NCT03555890 (64) [back to overview]	Part 2: Change Form Baseline in Hematocrit
NCT03555890 (64) [back to overview]	Part 2: AUC(0-t) of Levocetirizine
NCT03555890 (64) [back to overview]	Part 1: Apparent Volume of Distribution Following Oral Dosing (Vz/F) of Levocetirizine
NCT03555890 (64) [back to overview]	Part 2: %AUCex of Levocetirizine
NCT03555890 (64) [back to overview]	Part 1: Time to First Occurrence of Cmax (Tmax) of Levocetirizine
NCT03555890 (64) [back to overview]	Part 1: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) of Levocetirizine
NCT03555890 (64) [back to overview]	Part 1: Mean Residence Time (MRT) of Levocetirizine
NCT03555890 (64) [back to overview]	Part 1: Maximum Observed Concentration (Cmax) of Levocetirizine
NCT03555890 (64) [back to overview]	Part 1: Elimination Rate Constant (Kel) (lambda_z) of Levocetirizine
NCT03555890 (64) [back to overview]	Part 1: Change From Baseline in Reticulocytes
NCT03555890 (64) [back to overview]	Part 1: Change From Baseline in Red Blood Cell Count
NCT03555890 (64) [back to overview]	Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero Time (Pre-dose) to the Time of Last Quantifiable Concentration (AUC[0-t]) of Levocetirizine
NCT03555890 (64) [back to overview]	Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels
NCT03555890 (64) [back to overview]	Part 1: Area Under the Concentration-time Curve From Zero Time (Pre-dose) Extrapolated to Infinite Time AUC(0-inf) of Levocetirizine
NCT03555890 (64) [back to overview]	Part 1: Change Form Baseline in Hematocrit
NCT03555890 (64) [back to overview]	Part 1: Change From Baseline in Amylase Levels
NCT03555890 (64) [back to overview]	Part 1: Change From Baseline in Mean Corpuscle Hemoglobin
NCT03555890 (64) [back to overview]	Part 1: Change From Baseline in Mean Corpuscle Volume
NCT03555890 (64) [back to overview]	Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
NCT03555890 (64) [back to overview]	Part 2: Urine Specific Gravity
NCT03555890 (64) [back to overview]	Part 2: Urine Potential of Hydrogen (pH)
NCT03555890 (64) [back to overview]	Part 2: Number of Participants With Urinalysis Results by Dipstick Method
NCT03555890 (64) [back to overview]	Part 2: AUC(0-inf) of Levocetirizine

Percentage of Days With Symptoms of Nocturnal Cough

The caring person was to note on the diary card each nocturnal cough event with sleep disturbances occurring from 7:00 pm to 7:00 am (NCT00152464)
Timeframe: During the treatment period (18 months)

Intervention	percentage of days (Mean)
Placebo (PBO)	2.72
Levocetirizine (LCTZ)	2.33

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Percentage of Subjects Using Medication for Atopic Dermatitis

The following medications for Atopic Dermatitis were taken into consideration: Topical corticosteroids/ Local Steroids Class A, non-steroidal anti-inflammatory (NSAI) creams, tar/ Local Steroids Class B/ Local Steroids Class C/ Topical tacrolimus/ Topical pimecrolimus/ Systemic H1 anti-histamines/ Local antibiotics or antiseptics (NCT00152464)
Timeframe: During the treatment period (18 months)

Intervention	percentage of subjects (Number)
	Topical corticosteroids	Local Steroids Class A, NSAI creams, tar	Local Steroids Class B	Local Steroids Class C	Topical tacrolimus	Topical pimecrolimus	Systemic H1 anti-histamines	Local antibiotics or antiseptics
Levocetirizine (LCTZ)	63.9	33.3	27.1	37.3	1.2	5.5	19.6	11.0
Placebo (PBO)	61.6	31.4	28.6	33.7	0.8	2.4	22.0	12.9

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Number of Episodes of Urticaria Per Subject

Urticaria was defined as typical hives or areas of skin swelling, redness and itching distinctly different from the child's usual inflamed skin lesions of Atopic Dermatitis (AD), associated with an infection or food allergen ingestion/contact or other trigger. (NCT00152464)
Timeframe: During the treatment period (18 months)

Intervention	Number of episodes (Mean)
Placebo (PBO)	1.71
Levocetirizine (LCTZ)	0.71

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Percentage of Days With Symptoms of Either Wheezing or Nocturnal Cough

The caring person was to note on the diary card each nocturnal cough event with sleep disturbances occurring from 7:00 pm to 7:00 am and each wheezing event occurring at any time together with the treatment for these symptoms. (NCT00152464)
Timeframe: During the treatment period (18 months)

Intervention	percentage of days (Mean)
Placebo (PBO)	3.5
Levocetirizine (LCTZ)	2.85

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Percentage of Days With Symptoms of Wheezing

The caring person was to note on the diary card each each wheezing event occurring at any time. (NCT00152464)
Timeframe: During the treatment period (18 months)

Intervention	percentage of days (Mean)
Placebo (PBO)	1.31
Levocetirizine (LCTZ)	0.88

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Percentage of Subjects With Urticaria

Intervention	percentage of participants (Number)
Placebo (PBO)	41.6
Levocetirizine (LCTZ)	27.5

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Time to Onset of Asthma During the Treatment Period

"The time to onset of asthma was defined as the period elapsed between the randomization visit (V2) and the date of onset of asthma.~Instead of the median the first Quartile is reported since the median (50%) was not reached." (NCT00152464)
Timeframe: During the treatment period (18 months)

Intervention	months (Median)
Placebo (PBO)	NA
Levocetirizine (LCTZ)	NA

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Percentage of Days of Use of Asthma Medication

The following asthma medications were taken into consideration: Beta 2-mimetics, cromoglycates, inhaled corticoids, systemic corticoids, leukotriene antagonists (NCT00152464)
Timeframe: During the treatment period (18 months)

Intervention	percentage of days (Mean)
	Beta 2 Mimetics	Cromoglycates	Inhaled Corticoids	Systemic Corticoids	Leukotriene antagonists
Levocetirizine (LCTZ)	1.37	0.09	1.98	0.13	0.34
Placebo (PBO)	2.36	0.03	3.60	0.31	0.30

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Percentage of Days of Use of Medication for Atopic Dermatitis

The following medications for Atopic Dermatitis were taken into consideration: Emollients, local antihistamines; Local steroids class (LSC) A, non-steroidal anti-inflammatory (NSAI) creams, tar; Local steroids class B; Local steroids class C; Local antibiotics or antiseptics; Oral H1 anti-histamines (a-h); Local antibiotics (ABs) or antiseptics (NCT00152464)
Timeframe: During the treatment period (18 months)

Intervention	percentage of days (Mean)
	Topical corticosteroids	LSC A, NSAI creams, tar	LSC B	LSC C	Topical tacrolimus	Topical pimecrolimus	Systemic H1 a-h	Local ABs or antiseptics
Levocetirizine (LCTZ)	31.84	18.64	12.30	8.27	0.02	0.31	1.95	2.63
Placebo (PBO)	32.42	15.40	14.23	9.82	0.36	0.52	3.80	2.99

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Percentage of Subjects Using Asthma Medication

Intervention	percentage of participants (Number)
	Beta 2 Mimetics	Cromoglycates	Inhaled Corticoids	Systemic Corticoids	Leukotriene antagonists
Levocetirizine (LCTZ)	33.3	1.2	15.3	12.5	3.5
Placebo (PBO)	33.3	0.8	18.8	18.4	2.7

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Mean Weekly Individual Symptoms Scores During the Treatment Period

"Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.~The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity." (NCT00160680)
Timeframe: During the treatment period until week 24

Intervention	units on a scale (Least Squares Mean)
	Sneezing Score	Rhinorrhea Score	Nasal Pruritus Score	Ocular Pruritus Score	Nasal Congestion Score
Continuous Treatment (CT)	0.82	0.80	0.71	0.55	0.87
On Demand Treatment (ODT)	0.94	0.80	0.74	0.68	1.08

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Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period

Intervention	units on a scale (Least Squares Mean)
	Sneezing Score	Rhinorrhea Score	Nasal Pruritus Score	Ocular Pruritus Score	Nasal Congestion Score
Continuous Treatment (CT)	0.61	0.57	0.59	0.36	0.82
On Demand Treatment (ODT)	1.11	1.00	0.84	0.69	1.15

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Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period

Intervention	units on a scale (Least Squares Mean)
	Sneezing Score	Rhinorrhea Score	Nasal Pruritus Score	Ocular Pruritus Score	Nasal Congestion Score
Continuous Treatment (CT)	0.51	0.51	0.44	0.27	0.63
On Demand Treatment (ODT)	1.00	0.93	0.77	0.63	1.08

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Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period

Intervention	units on a scale (Least Squares Mean)
	Sneezing Score	Rhinorrhea Score	Nasal Pruritus Score	Ocular Pruritus Score	Nasal Congestion Score
Continuous Treatment (CT)	0.78	0.69	0.60	0.44	0.75
On Demand Treatment (ODT)	0.85	0.72	0.59	0.53	1.07

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Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period

Intervention	units on a scale (Least Squares Mean)
	Sneezing Score	Rhinorrhea Score	Nasal Pruritus Score	Ocular Pruritus Score	Nasal Congestion Score
Continuous Treatment (CT)	0.82	0.84	0.74	0.61	0.87
On Demand Treatment (ODT)	0.81	0.66	0.53	0.60	0.91

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Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period

Intervention	units on a scale (Least Squares Mean)
	Sneezing Score	Rhinorrhea Score	Nasal Pruritus Score	Ocular Pruritus Score	Nasal Congestion Score
Continuous Treatment (CT)	1.20	1.14	0.98	0.77	1.03
On Demand Treatment (ODT)	0.87	0.80	0.75	0.77	1.04

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Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period

Intervention	units on a scale (Least Squares Mean)
	Sneezing Score	Rhinorrhea Score	Nasal Pruritus Score	Ocular Pruritus Score	Nasal Congestion Score
Continuous Treatment (CT)	1.31	1.33	1.06	0.90	1.25
On Demand Treatment (ODT)	1.12	0.93	0.97	0.86	1.25

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Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period

The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. (NCT00160680)
Timeframe: During the treatment period until week 24

Intervention	units on a scale (Least Squares Mean)
Continuous Treatment (CT)	2.89
On Demand Treatment (ODT)	3.15

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Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period

Intervention	units on a scale (Least Squares Mean)
Continuous Treatment (CT)	2.19
On Demand Treatment (ODT)	3.64

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Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period

Intervention	units on a scale (Least Squares Mean)
Continuous Treatment (CT)	1.74
On Demand Treatment (ODT)	3.31

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Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period

Intervention	units on a scale (Least Squares Mean)
Continuous Treatment (CT)	2.98
On Demand Treatment (ODT)	2.58

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Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period

Intervention	units on a scale (Least Squares Mean)
Continuous Treatment (CT)	4.04
On Demand Treatment (ODT)	3.14

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Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period

Intervention	units on a scale (Least Squares Mean)
Continuous Treatment (CT)	4.55
On Demand Treatment (ODT)	3.83

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Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period

Intervention	units on a scale (Least Squares Mean)
Continuous Treatment (CT)	2.47
On Demand Treatment (ODT)	2.67

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Mean Score for Pruritus Duration Over the Four Weeks of Treatment

The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the four weeks of treatment. (NCT00264303)
Timeframe: over the four weeks of treatment

Intervention	Units on a scale (Least Squares Mean)
Levocetirizine 5 mg	0.93
Desloratadine 5 mg	1.05

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Mean Pruritus Severity Score Over the Four Weeks of Treatment

Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe/intense). Mean pruritus severity score is averaged over the four weeks of treatment. (NCT00264303)
Timeframe: over the four weeks of treatment

Intervention	Units on a scale (Least Squares Mean)
Levocetirizine 5 mg	0.86
Desloratadine 5 mg	0.99

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Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment

CIU composite score is defined as the sum of 2 scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or <=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or >50 wheals/24 h). Mean is averaged over the 1st week of treatment. (NCT00264303)
Timeframe: over the first week of treatment

Intervention	Units on a scale (Least Squares Mean)
Levocetirizine 5 mg	1.98
Desloratadine 5 mg	2.23

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Mean Pruritus Severity Score Over the First Week of Treatment

Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate). Mean pruritus severity score is averaged over the first week of treatment. (NCT00264303)
Timeframe: over the first week of treatment

Intervention	Units on a scale (Least Squares Mean)
Levocetirizine 5 mg	1.02
Desloratadine 5 mg	1.18

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Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment

CIU composite score is defined as the sum of two scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or <=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or >50 wheals/24 h). Mean is averaged over the 4 weeks of treatment. (NCT00264303)
Timeframe: over the four weeks of treatment

Intervention	Units on a scale (Least Squares Mean)
Levocetirizine 5 mg	1.71
Desloratadine 5 mg	1.88

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Mean Score for Pruritus Duration Over the First Week of Treatment

The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the first week of treatment. (NCT00264303)
Timeframe: over the first week of treatment

Intervention	Units on a scale (Least Squares Mean)
Levocetirizine 5 mg	1.08
Desloratadine 5 mg	1.24

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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." (NCT00291642)
Timeframe: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]

Intervention	units on a scale (Least Squares Mean)
Placebo (PBO)	-3.80
Levocetirizine (LCTZ) 2.5 mg	-7.15
Levocetirizine (LCTZ) 5 mg	-7.05
Cetirizine (CTZ) 5 mg	-7.93
Cetirizine (CTZ) 10 mg	-7.54

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

Intervention	units on a scale (Least Squares Mean)
Placebo (PBO)	-3.61
Levocetirizine (LCTZ) 2.5 mg	-6.80
Levocetirizine (LCTZ) 5 mg	-7.10
Cetirizine (CTZ) 5 mg	-7.43
Cetirizine (CTZ) 10 mg	-7.72

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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." (NCT00291642)
Timeframe: Baseline, Treatment Period I [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]

Intervention	units on a scale (Least Squares Mean)
Placebo (PBO)	-6.55
Levocetirizine (LCTZ) 2.5 mg	-11.33
Levocetirizine (LCTZ) 5 mg	-11.27
Cetirizine (CTZ) 5 mg	-12.71
Cetirizine (CTZ) 10 mg	-11.74

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Change From Baseline in the MSC Score Over Period II

Intervention	units on a scale (Least Squares Mean)
Placebo (PBO)	-3.50
Levocetirizine (LCTZ) 2.5 mg	-6.35
Levocetirizine (LCTZ) 5 mg	-7.07
Cetirizine (CTZ) 5 mg	-6.78
Cetirizine (CTZ) 10 mg	-7.92

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

Intervention	units on a scale (Least Squares Mean)
Placebo (PBO)	-5.73
Levocetirizine (LCTZ) 2.5 mg	-10.25
Levocetirizine (LCTZ) 5 mg	-11.03
Cetirizine (CTZ) 5 mg	-10.73
Cetirizine (CTZ) 10 mg	-12.14

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

Intervention	units on a scale (Least Squares Mean)
Placebo (PBO)	-6.10
Levocetirizine (LCTZ) 2.5 mg	-10.86
Levocetirizine (LCTZ) 5 mg	-11.22
Cetirizine (CTZ) 5 mg	-11.84
Cetirizine (CTZ) 10 mg	-11.92

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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, Watery Eyes Score, Sneezes Score, Nose Blows 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.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00291642)
Timeframe: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]

,,,,

Intervention	units on a scale (Least Squares Mean)
	Runny Nose Score	Itchy Nose Score	Sniffles Score	Nose Blow Score	Sneezes Score	Watery Eyes Score
Cetirizine (CTZ) 10 mg	-1.04	-1.10	-1.10	-1.96	-1.23	-1.07
Cetirizine (CTZ) 5 mg	-1.17	-1.28	-1.24	-1.92	-1.22	-1.13
Levocetirizine (LCTZ) 2.5 mg	-1.01	-1.03	-1.15	-1.87	-1.15	-0.94
Levocetirizine (LCTZ) 5 mg	-0.95	-1.09	-1.06	-1.82	-1.07	-1.08
Placebo (PBO)	-0.60	-0.66	-0.65	-0.98	-0.37	-0.56

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Change From Baseline in the Individual Symptom Scores Over Period II

,,,,

Intervention	units on a scale (Least Squares Mean)
	Runny Nose Score	Itchy Nose Score	Sniffles Score	Nose Blow Score	Sneezes Score	Watery Eyes Score
Cetirizine (CTZ) 10 mg	-1.10	-1.24	-1.21	-2.02	-1.38	-0.93
Cetirizine (CTZ) 5 mg	-0.95	-1.13	-0.90	-1.78	-1.19	-0.83
Levocetirizine (LCTZ) 2.5 mg	-0.86	-1.00	-0.91	-1.61	-1.18	-0.78
Levocetirizine (LCTZ) 5 mg	-0.94	-1.11	-0.96	-1.84	-1.33	-0.91
Placebo (PBO)	-0.62	-0.57	-0.58	-1.00	-0.48	-0.30

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

,,,,

Intervention	units on a scale (Least Squares Mean)
	Runny Nose Score	Itchy Nose Score	Sniffles Score	Nose Blow Score	Sneezes Score	Watery Eyes Score
Cetirizine (CTZ) 10 mg	-1.06	-1.16	-1.15	-1.99	-1.31	-1.01
Cetirizine (CTZ) 5 mg	-1.07	-1.21	-1.09	-1.86	-1.21	-1.00
Levocetirizine (LCTZ) 2.5 mg	-0.94	-1.02	-1.05	-1.75	-1.17	-0.87
Levocetirizine (LCTZ) 5 mg	-0.95	-1.10	-1.02	-1.83	-1.19	-1.01
Placebo (PBO)	-0.59	-0.61	-0.60	-0.98	-0.41	-0.44

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Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season

"At the end of Period III, each subject without reference to the Symptom Diary Card (SDC) answered to the question: Do you want to take the same treatment during the next pollen season? (yes or no)." (NCT00295022)
Timeframe: At the end of Period III (Day 2)

Intervention	percentage of participants (Number)
Placebo (PBO)	23.1
Levocetirizine (LCTZ)	49.4
Montelukast (MLKT)	32.9

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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)]

Intervention	hours (Number)
Placebo (PBO)	NA
Levocetirizine (LCTZ)	1.5
Montelukast (MLKT)	1.5

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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)

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

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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

Intervention	units 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 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]

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

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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]

Intervention	units 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 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)]

Intervention	units 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 Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III)

Intervention	units 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 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]

Intervention	units 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 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]

Intervention	units 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 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)]

Intervention	units on a scale (Least Squares Mean)
	Runny Nose Score	Itchy Nose Score	Sniffles Score	Postnasal Drip Score	Watery Eyes Score	Itchy Eyes/Ears Score	Itchy Throat Score	Cough Score	Sneezes Score	Nose Blows Score	Nasal 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 MSC Score Over the Total Treatment Period (Period I + Period II + Period III)

Intervention	units 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 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]

Intervention	units 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 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]

Intervention	units 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 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)]

Intervention	units 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 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)]

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

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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]

Intervention	percentage of participants (Number)
	< 20%	20%-35%	35%-50%	50%-65%	65%-80%	>=80%
Levocetirizine (LCTZ)	16.7	17.9	13.5	14.1	17.9	19.9
Montelukast (MLKT)	31.8	14.6	17.2	17.2	14.6	4.6
Placebo (PBO)	48.1	21.2	15.4	3.8	8.7	2.9

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

Intervention	percentage of participants (Number)
	< 20%	20%-35%	35%-50%	50%-65%	65%-80%	>=80%
Levocetirizine (LCTZ)	32.1	19.2	12.2	17.3	10.3	9.0
Montelukast (MLKT)	53.6	16.6	17.2	6.6	3.3	2.6
Placebo (PBO)	67.3	17.3	8.7	3.8	1.9	1.0

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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]

Intervention	percentage of participants (Number)
	< 20%	>= 20%	< 50%	>= 50%	< 70%	>= 70%
Levocetirizine (LCTZ)	16.7	83.3	48.1	51.9	69.9	30.1
Montelukast (MLKT)	31.8	68.2	63.6	36.4	86.1	13.9
Placebo (PBO)	48.1	51.9	84.6	15.4	89.4	10.6

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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]

Intervention	percentage of participants (Number)
	< 20%	>= 20%	< 50%	>= 50%	< 70%	>= 70%
Levocetirizine (LCTZ)	32.1	67.9	63.5	36.5	83.3	16.7
Montelukast (MLKT)	53.6	46.4	87.4	12.6	95.4	4.6
Placebo (PBO)	67.3	32.7	93.3	6.7	98.1	1.9

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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)]

Intervention	percentage of participants (Number)
	< 20%	>= 20%	< 50%	>= 50%	< 70%	>= 70%
Levocetirizine (LCTZ)	21.0	79.0	68.8	31.2	87.9	12.1
Montelukast (MLKT)	32.7	67.3	67.9	32.1	92.3	7.7
Placebo (PBO)	54.3	45.7	80.0	20.0	95.2	4.8

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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)]

Intervention	percentage of participants (Number)
	< 20%	20%-35%	35%-50%	50%-65%	65%-80%	>=80%
Levocetirizine (LCTZ)	21.0	22.9	24.8	12.7	15.3	3.2
Montelukast (MLKT)	32.7	19.2	16.0	20.5	8.3	3.2
Placebo (PBO)	54.3	15.2	10.5	12.4	4.8	2.9

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

Intervention	units on a scale (Least Squares Mean)
	Runny Nose Score	Itchy Nose Score	Sniffles Score	Postnasal Drip Score	Watery Eyes Score	Itchy Eyes/Ears Score	Itchy Throat Score	Cough Score	Sneezes Score	Nose Blows Score	Nasal 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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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]

Intervention	units on a scale (Least Squares Mean)
	Runny Nose Score	Itchy Nose Score	Sniffles Score	Postnasal Drip Score	Watery Eyes Score	Itchy Eyes/Ears Score	Itchy Throat Score	Cough Score	Sneezes Score	Nose Blows Score	Nasal 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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Change From Baseline in the Individual Symptom Scores Over Period II

Intervention	units on a scale (Least Squares Mean)
	Runny Nose Score	Itchy Nose Score	Sniffles Score	Postnasal Drip Score	Watery Eyes Score	Itchy Eyes/Ears Score	Itchy Throat Score	Cough Score	Sneezes Score	Nose Blows Score	Nasal 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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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)]

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

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Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment

The number of days after treatment discontinuation until a measurable wheal and flare response. (NCT00359138)
Timeframe: Starting at Day 8

Intervention	Days (Mean)
Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule	5
Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule	4
Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule	NA

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Global Improvement at Endpoint During the 14 Day Treatment Period

Global improvement is measured on an ordered nominal scale ranging from marked improvement to exacerbation (see categories in the table). The endpoint is visit 4 on day 14 or at an earlier time point at study completion. (NCT00375713)
Timeframe: At endpoint during the 14 day treatment period

Intervention	Participants (Number)
	Marked improvement	Moderate improvement	Mild improvement	No change	Exacerbation
Cetirizine	52	54	47	15	1
Levocetirizine	47	62	39	18	1

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Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).

A participant is a responder if the pruritus severity score is assessed as mild or none, otherwise it is a non-responder. The responder status is defined at day 14, except if the investigator assessed the subject as a responder at day 7. The Pruritus Score is in general defined as: 3 for Severe, 2 for Moderate, 1 for Mild and 0 for None. (NCT00375713)
Timeframe: Day 7 and 14

Intervention	Participants (Number)
	Responder	Non-Responder
Cetirizine	134	38
Levocetirizine	131	37

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Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period

The Pruritus Score Scale ranges from 0 to 3 (3 for Severe, 2 for Moderate, 1 for Mild and 0 for None). Endpoint is at visit 4 on day 14 or at an earlier timepoint at study completion. (NCT00375713)
Timeframe: Baseline and at endpoint during the 14 day treatment period

Intervention	Units on a scale (Mean)
Levocetirizine	1.15
Cetirizine	1.21

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Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period

Duration of pruritus was categorized as follows: 3 if > 6 hours/24hr, 2 if 1 to 6 hours/24hr, 1 if less than 1 hour/24hr, and 0 if No pruritus. The endpoint is visit 4 on day 14 or at an earlier time point at study completion. (NCT00375713)
Timeframe: At endpoint during the 14 day treatment period

Intervention	Units on a scale (Mean)
Levocetirizine	2.13
Cetirizine	2.20

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)

(NCT00619801)
Timeframe: Baseline, 14 days

Intervention	beats per minute (Mean)
Placebo	-1.5
Levocetirizine	1.3

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin

(NCT00619801)
Timeframe: Baseline, 14 days

Intervention	micromole per liter [µmol/L] (Median)
Placebo	0.000
Levocetirizine	0.000

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval

The RR interval refers to the respective time interval in the Electrocardiogram (ECG). (NCT00619801)
Timeframe: Baseline, 14 days

Intervention	milliseconds (Mean)
Placebo	9.2
Levocetirizine	-6.9

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Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)

The QT interval refers to the respective time interval in the Electrocardiogram (ECG). (NCT00619801)
Timeframe: 7 days

Intervention	milliseconds (Mean)
Placebo	372.6
Levocetirizine	368.9

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Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)

The QT interval refers to the respective time interval in the Electrocardiogram (ECG). (NCT00619801)
Timeframe: 14 days

Intervention	milliseconds (Mean)
Placebo	369.8
Levocetirizine	370.5

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)

(NCT00619801)
Timeframe: Baseline, 14 days

Intervention	unit per liter [U/L] (Median)
Placebo	-1.5
Levocetirizine	1.0

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST)

(NCT00619801)
Timeframe: Baseline, 14 days

Intervention	unit per liter [U/L] (Median)
Placebo	-1.0
Levocetirizine	1.0

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine

(NCT00619801)
Timeframe: Baseline, 14 days

Intervention	micromole per liter [µmol/L] (Median)
Placebo	-0.8840
Levocetirizine	1.7680

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen

(NCT00619801)
Timeframe: Baseline, 14 days

Intervention	millimole per liter [mmol/L] (Median)
Placebo	-0.1785
Levocetirizine	0.0000

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval

The PR interval refers to the respective time interval in the Electrocardiogram (ECG). (NCT00619801)
Timeframe: Baseline, 14 days

Intervention	milliseconds (Mean)
Placebo	0.5
Levocetirizine	-0.8

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration

The QRS duration refers to the respective time duration in the Electrocardiogram (ECG). (NCT00619801)
Timeframe: Baseline, 14 days

Intervention	milliseconds (Mean)
Placebo	0.3
Levocetirizine	0.9

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval

The QT interval refers to the respective time interval in the Electrocardiogram (ECG). (NCT00619801)
Timeframe: Baseline, 14 days

Intervention	milliseconds (Mean)
Placebo	-2.8
Levocetirizine	-1.5

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)

The QT interval refers to the respective time interval in the Electrocardiogram (ECG). (NCT00619801)
Timeframe: Baseline, 14 days

Intervention	milliseconds (Mean)
Placebo	-5.5
Levocetirizine	-0.3

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Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)

Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). The total score varies from 0 to 15. (NCT00621959)
Timeframe: Over the total treatment period (14 days)

Intervention	points on a scale (Mean)
Placebo	8.96
LCTZ	8.77

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Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores. The overall RQLQ score varies from 0 to 6. (NCT00621959)
Timeframe: Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)

Intervention	points on a scale (Mean)
Placebo	-1.07
LCTZ	-1.12

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Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7)

The QT interval refers to the respective time interval in the Electrocardiogram (ECG) (NCT00628108)
Timeframe: 7 days

Intervention	milliseconds (Mean)
Placebo	360.3
Levocetirizine	354.5

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)

(NCT00628108)
Timeframe: Baseline, 14 days

Intervention	beats per minute (Mean)
Placebo	-7.6
Levocetirizine	-4.0

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Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)

The QT interval refers to the respective time interval in the Electrocardiogram (ECG) (NCT00628108)
Timeframe: 14 days

Intervention	milliseconds (Mean)
Placebo	355.3
Levocetirizine	351.9

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)

(NCT00628108)
Timeframe: Baseline, 14 days

Intervention	unit per liter [U/L] (Median)
Placebo	-2.0
Levocetirizine	-1.0

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminontransferase (AST)

(NCT00628108)
Timeframe: Baseline, 14 days

Intervention	unit per liter [U/L] (Median)
Placebo	2.0
Levocetirizine	-1.0

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine

(NCT00628108)
Timeframe: Baseline, 14 days

Intervention	micromole per liter [μmol/L] (Median)
Placebo	-0.8840
Levocetirizine	-0.8840

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen

(NCT00628108)
Timeframe: Baseline, 14 days

Intervention	millimole per liter [mmol/L] (Median)
Placebo	0.0000
Levocetirizine	0.0000

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval

The PR interval refers to the respective time interval in the Electrocardiogram (ECG) (NCT00628108)
Timeframe: Baseline, 14 days

Intervention	milliseconds (Mean)
Placebo	0.8
Levocetirizine	3.1

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration

The QRS duration refers to the respective time interval in the Electrocardiogram (ECG) (NCT00628108)
Timeframe: Baseline, 14 days

Intervention	milliseconds (Mean)
Placebo	1.4
Levocetirizine	0.3

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval

The QT interval refers to the respective time in the Electrocardiogram (ECG) (NCT00628108)
Timeframe: Baseline, 14 days

Intervention	milliseconds (Mean)
Placebo	4.5
Levocetirizine	-0.3

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)

The QT interval refers to the respective time interval in the Electrocardiogram (ECG) (NCT00628108)
Timeframe: Baseline, 14 days

Intervention	milliseconds (Mean)
Placebo	-1.3
Levocetirizine	-3.9

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval

The RR interval refers to the respective time interval in the Electrocardiogram (ECG) (NCT00628108)
Timeframe: Baseline, 14 days

Intervention	milliseconds (Mean)
Placebo	28.0
Levocetirizine	14.9

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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin

(NCT00628108)
Timeframe: Baseline, 14 days

Intervention	micromole per liter [µmol/L] (Median)
Placebo	0.000
Levocetirizine	0.000

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Total Nasal Symptom Score (TNSS) Over the Second Week

Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2

Intervention	points on a scale (Mean)
Placebo	8.23
Levocetirizine	7.45

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Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days)

Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)

Intervention	points on a scale (Mean)
Placebo	8.73
Levocetirizine	7.94

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Total Ocular Symptom Score (TOSS) Over the First Week

Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1

Intervention	points on a scale (Mean)
Placebo	4.29
Levocetirizine	3.99

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Total Ocular Symptom Score (TOSS) Over the Second Week

Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2

Intervention	points on a scale (Mean)
Placebo	3.89
Levocetirizine	3.60

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Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days)

Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)

Intervention	points on a scale (Mean)
Placebo	4.13
Levocetirizine	3.82

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Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period

"Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Patient had to tick a box going from Marked worsening to Marked improvement." (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period

Intervention	participants (Number)
	Marked Worsening	Moderate Worsening	Slight Worsening	No Change	Slight Improvement	Moderate Improvement	Marked Improvement
Levocetirizine	6	11	8	69	95	62	33
Placebo	14	16	21	86	81	52	22

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Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period

"Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Physician had to tick a box going from Marked worsening to Marked improvement." (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period

Intervention	participants (Number)
	Marked Worsening	Moderate Worsening	Slight Worsening	No Change	Slight Improvement	Moderate Improvement	Marked Improvement
Levocetirizine	5	7	7	70	92	65	38
Placebo	5	13	18	106	75	50	25

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Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period

The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period

Intervention	participants (Number)
	ESS score < 8 at Baseline and < 8 at Endpoint	ESS score < 8 at Baseline and ≥ 8 at Endpoint	ESS score ≥ 8 at Baseline and < 8 at Endpoint	ESS score ≥ 8 at Baseline and ≥ 8 at Endpoint
Levocetirizine	63	13	57	151
Placebo	66	16	46	165

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Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period

The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period

Intervention	percent change (Mean)
Placebo	-1.01
Levocetirizine	-2.68

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Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Endpoint During the Two-week Treatment Period

Intervention	points on a scale (Mean)
Placebo	-1.02
Levocetirizine	-1.79

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Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1

Intervention	points on a scale (Mean)
Placebo	-0.67
Levocetirizine	-0.91

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Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2

Intervention	points on a scale (Mean)
Placebo	-1.05
Levocetirizine	-1.78

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Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period

Intervention	points on a scale (Mean)
Placebo	-0.93
Levocetirizine	-1.31

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Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6. (NCT00653224)
Timeframe: Baseline and week 1

Intervention	points on a scale (Mean)
Placebo	-0.60
Levocetirizine	-0.94

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

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6. (NCT00653224)
Timeframe: Baseline and week 2

Intervention	points on a scale (Mean)
Placebo	-0.95
Levocetirizine	-1.34

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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period

Intervention	points on a scale (Mean)
Placebo	-1.28
Levocetirizine	-1.55

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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1

Intervention	points on a scale (Mean)
Placebo	-0.80
Levocetirizine	-1.13

[back to top]

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2

Intervention	points on a scale (Mean)
Placebo	-1.30
Levocetirizine	-1.58

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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period

Intervention	points on a scale (Mean)
Placebo	-0.80
Levocetirizine	-1.21

[back to top]

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1

Intervention	points on a scale (Mean)
Placebo	-0.51
Levocetirizine	-0.91

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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2

Intervention	points on a scale (Mean)
Placebo	-0.82
Levocetirizine	-1.24

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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period

Intervention	points on a scale (Mean)
Placebo	-0.88
Levocetirizine	-1.36

[back to top]

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1

Intervention	points on a scale (Mean)
Placebo	-0.62
Levocetirizine	-1.04

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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2

Intervention	points on a scale (Mean)
Placebo	-0.89
Levocetirizine	-1.40

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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period

Intervention	points on a scale (Mean)
Placebo	-1.05
Levocetirizine	-1.45

[back to top]

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1

Intervention	points on a scale (Mean)
Placebo	-0.68
Levocetirizine	-1.05

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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2

Intervention	points on a scale (Mean)
Placebo	-1.08
Levocetirizine	-1.49

[back to top]

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period

Intervention	points on a scale (Mean)
Placebo	-0.71
Levocetirizine	-1.05

[back to top]

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1

Intervention	points on a scale (Mean)
Placebo	-0.42
Levocetirizine	-0.70

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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2

Intervention	points on a scale (Mean)
Placebo	-0.73
Levocetirizine	-1.08

[back to top]

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period

Intervention	points on a scale (Mean)
Placebo	-1.22
Levocetirizine	-1.62

[back to top]

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1

Intervention	points on a scale (Mean)
Placebo	-0.76
Levocetirizine	-1.14

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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2

Intervention	points on a scale (Mean)
Placebo	-1.24
Levocetirizine	-1.66

[back to top]

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period

The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period

Intervention	points on a scale (Mean)
Placebo	-0.90
Levocetirizine	-1.19

[back to top]

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1

Intervention	points on a scale (Mean)
Placebo	-0.59
Levocetirizine	-0.84

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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2

Intervention	points on a scale (Mean)
Placebo	-0.93
Levocetirizine	-1.20

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Ocular Pruritus Score Over the Total Treatment Period (14 Days)

The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)

Intervention	points on a scale (Mean)
Placebo	1.59
Levocetirizine	1.51

[back to top]

Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 1

Intervention	percent change (Mean)
Placebo	-1.33
Levocetirizine	-2.48

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Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 2

Intervention	percent change (Mean)
Placebo	-0.93
Levocetirizine	-2.83

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Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Endpoint During the Two-week Treatment Period

Intervention	percent change (Mean)
Placebo	-8.06
Levocetirizine	-13.98

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Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 1

Intervention	percent change (Mean)
Placebo	-5.64
Levocetirizine	-11.23

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Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 2

Intervention	percent change (Mean)
Placebo	-8.59
Levocetirizine	-14.34

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Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Endpoint During the Two-week Treatment Period

Intervention	percent change (Mean)
Placebo	-8.61
Levocetirizine	-14.49

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Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 1

Intervention	percent change (Mean)
Placebo	-5.80
Levocetirizine	-11.77

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Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 2

Intervention	percent change (Mean)
Placebo	-9.14
Levocetirizine	-14.89

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Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period

Intervention	percent change (Mean)
Placebo	0.25
Levocetirizine	-3.64

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Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 1

Intervention	percent change (Mean)
Placebo	-2.82
Levocetirizine	-3.27

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Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 2

Intervention	percent change (Mean)
Placebo	-0.03
Levocetirizine	-3.64

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Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Endpoint During the Two-week Treatment Period

Intervention	percent change (Mean)
Placebo	-6.33
Levocetirizine	-7.73

[back to top]

Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 1

Intervention	percent change (Mean)
Placebo	-2.86
Levocetirizine	-6.00

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Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 2

Intervention	percent change (Mean)
Placebo	-6.55
Levocetirizine	-7.73

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Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Endpoint During the Two-week Treatment Period

Intervention	percent change (Mean)
Placebo	-5.22
Levocetirizine	-8.65

[back to top]

Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 1

Intervention	percent change (Mean)
Placebo	-3.05
Levocetirizine	-7.18

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Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 2

Intervention	percent change (Mean)
Placebo	-5.52
Levocetirizine	-8.65

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Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Endpoint During the Two-week Treatment Period

Intervention	percent change (Mean)
Placebo	-11.71
Levocetirizine	-18.46

[back to top]

Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 1

Intervention	percent change (Mean)
Placebo	-6.85
Levocetirizine	-14.29

[back to top]

Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 2

Intervention	percent change (Mean)
Placebo	-12.05
Levocetirizine	-18.84

[back to top]

Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days)

Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). Total score ranges from 0 to 15. (NCT00653224)
Timeframe: Over the total treatment period (14 days)

Intervention	points on a scale (Mean)
Placebo	8.68
Levocetirizine	7.87

[back to top]

Nasal Congestion Score Over the First Week

The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1

Intervention	points on a scale (Mean)
Placebo	1.98
Levocetirizine	1.92

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Nasal Congestion Score Over the Second Week

The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2

Intervention	points on a scale (Mean)
Placebo	1.81
Levocetirizine	1.67

[back to top]

Nasal Congestion Score Over the Total Treatment Period (14 Days)

The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)

Intervention	points on a scale (Mean)
Placebo	1.91
Levocetirizine	1.80

[back to top]

Nasal Pruritus Score Over the First Week

The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1

Intervention	points on a scale (Mean)
Placebo	1.80
Levocetirizine	1.61

[back to top]

Nasal Pruritus Score Over the Second Week

The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2

Intervention	points on a scale (Mean)
Placebo	1.63
Levocetirizine	1.45

[back to top]

Nasal Pruritus Score Over the Total Treatment Period (14 Days)

The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)

Intervention	points on a scale (Mean)
Placebo	1.73
Levocetirizine	1.54

[back to top]

Ocular Itching/Burning Score Over the First Week

The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1

Intervention	points on a scale (Mean)
Placebo	1.58
Levocetirizine	1.53

[back to top]

Ocular Itching/Burning Score Over the Second Week

The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2

Intervention	points on a scale (Mean)
Placebo	1.42
Levocetirizine	1.39

[back to top]

Ocular Itching/Burning Score Over the Total Treatment Period (14 Days)

The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)

Intervention	points on a scale (Mean)
Placebo	1.52
Levocetirizine	1.47

[back to top]

Ocular Pruritus Score Over the First Week

The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1

Intervention	points on a scale (Mean)
Placebo	1.65
Levocetirizine	1.56

[back to top]

Ocular Pruritus Score Over the Second Week

The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2

Intervention	points on a scale (Mean)
Placebo	1.52
Levocetirizine	1.44

[back to top]

Ocular Redness Score Over the First Week

The ocular redness score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1

Intervention	points on a scale (Mean)
Placebo	1.31
Levocetirizine	1.21

[back to top]

Ocular Redness Score Over the Second Week

The ocular redness score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2

Intervention	points on a scale (Mean)
Placebo	1.20
Levocetirizine	1.05

[back to top]

Ocular Redness Score Over the Total Treatment Period (14 Days)

The ocular redness score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)

Intervention	points on a scale (Mean)
Placebo	1.27
Levocetirizine	1.14

[back to top]

Ocular Tearing/Watering Score Over the First Week

The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1

Intervention	points on a scale (Mean)
Placebo	1.40
Levocetirizine	1.26

[back to top]

Ocular Tearing/Watering Score Over the Second Week

The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2

Intervention	points on a scale (Mean)
Placebo	1.27
Levocetirizine	1.16

[back to top]

Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days)

The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)

Intervention	points on a scale (Mean)
Placebo	1.34
Levocetirizine	1.22

[back to top]

Post-nasal Drip Score Over the First Week

The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1

Intervention	points on a scale (Mean)
Placebo	1.72
Levocetirizine	1.65

[back to top]

Post-nasal Drip Score Over the Second Week

The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2

Intervention	points on a scale (Mean)
Placebo	1.55
Levocetirizine	1.48

[back to top]

Post-nasal Drip Score Over the Total Treatment Period (14 Days)

The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)

Intervention	points on a scale (Mean)
Placebo	1.64
Levocetirizine	1.57

[back to top]

Rhinorrhea Score Over the First Week

The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1

Intervention	points on a scale (Mean)
Placebo	1.81
Levocetirizine	1.59

[back to top]

Rhinorrhea Score Over the Second Week

The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2

Intervention	points on a scale (Mean)
Placebo	1.63
Levocetirizine	1.44

[back to top]

Rhinorrhea Score Over the Total Treatment Period (14 Days)

The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)

Intervention	points on a scale (Mean)
Placebo	1.73
Levocetirizine	1.53

[back to top]

Sneezing Score Over the First Week

The sneezing score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1

Intervention	points on a scale (Mean)
Placebo	1.80
Levocetirizine	1.57

[back to top]

Sneezing Score Over the Second Week

The sneezing score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2

Intervention	points on a scale (Mean)
Placebo	1.62
Levocetirizine	1.41

[back to top]

Sneezing Score Over the Total Treatment Period (14 Days)

The sneezing score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)

Intervention	points on a scale (Mean)
Placebo	1.72
Levocetirizine	1.50

[back to top]

Total 4 Symptoms Score (T4SS) Over the First Week

Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1

Intervention	points on a scale (Mean)
Placebo	7.07
Levocetirizine	6.32

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Total 4 Symptoms Score (T4SS) Over the Second Week

Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2

Intervention	points on a scale (Mean)
Placebo	6.39
Levocetirizine	5.74

[back to top]

Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days)

Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the total treatment period of 14 days is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)

Intervention	points on a scale (Mean)
Placebo	6.78
Levocetirizine	6.07

[back to top]

Total 5 Symptoms Score (T5SS) Over the First Week

Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T5SS ranges from 0 to 15. An average over the first week is provided. (NCT00653224)
Timeframe: Over week 1

Intervention	points on a scale (Mean)
Placebo	9.04
Levocetirizine	8.24

[back to top]

Total 5 Symptoms Score (T5SS) Over the Second Week

Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T5SS ranges from 0 to 15. An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2

Intervention	points on a scale (Mean)
Placebo	8.20
Levocetirizine	7.41

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Total Nasal Symptom Score (TNSS) Over the First Week

Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1

Intervention	points on a scale (Mean)
Placebo	9.11
Levocetirizine	8.34

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Modified Epworth Sleepiness Scale

"Epworth Sleepiness Scale ratings (0 to 24); higher scores = increased sedation. This was measured over the 36 days of the study (at the end of each washout period and each intervention period); measured on days 5, 12, 17, 24, 29, and 36.~This was mean data for all interventions." (NCT00826943)
Timeframe: 36 days of the study

Intervention	units on a scale (Mean)
Placebo	6.14
Levocetirizine	6.69
Cetirizine	7.48

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Likert Score Rating Global Sedation

"Likert score range 1 to 9 (no sedation to extreme sedation). Highers scores indicate increased sedation. This was measured on days days 5, 12, 17, 24, 29, and 36 of the study.~This was mean data for all interventions." (NCT00826943)
Timeframe: duration of study (36 days)

Intervention	Likert score (Mean)
Placebo	2.80
Levocetirizine	3.07
Cetirizine	3.54

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Total Four Symptom Scores (Allergy Symptoms)

"Total Four Symptom Scores (TFSS) ranging 0 to 12. Increased scores indicate increased symptoms. This was measured on days 5, 12, 17, 24, 29, and 36 of the study. The mean TFSS for patients receiving placebo, cetirizine, and levocetirizine was then calculated.~This was mean data for all interventions." (NCT00826943)
Timeframe: same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36)

Intervention	TFSS scores (Mean)
Placebo	4.41
Levocetirizine	3.14
Cetirizine	2.67

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Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4

Consented subjects who met inclusion/exclusion criteria were asked to complete a DLQI (Dermatology Life Quality Index)at Baseline, Week 2 and Week 4. The DLQI is a 10 item questionnaire broken down into 6 domains; symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment with a total score ranging from 0-30 (no effect on subject's life for 0, extremely large effect on subject's life for 30) (NCT00884325)
Timeframe: Baseline - Week 2 - Week 4

Intervention	units on a scale (Median)
	DLQI - Baseline	DLQI - Week 2	DLQI - Week 4
Subjects Receiving Placebo	8.00	5.5	4.00
Subjects Receiving Xyzal	7.5	3.5	2.00

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Pruritus VAS Scores at Baseline, Week 2 and Week 4

Consented subjects who met inclusion/exclusion criteria were assigned either 5mg levocetirizine dihydrochloride (Xyzal) or placebo to be taken daily each evening for 28 days. Subjects were asked to complete a Visual Analog Scale to measure itch at Baseline, Week 2 and Week 4. The scale is an eleven point scale ranging from 0-10 with 0 indicating no itch to 10 indicating itch that frequently interferes with daily activities. (NCT00884325)
Timeframe: Baseline - Week 2-Week 4

Intervention	units on a scale (Median)
	Baseline	Week 2	Week 4
Subjects Receiving Placebo	7.5	5.9	6.4
Subjects Receiving Xyzal	7.8	6.10	4.15

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Characterize Contribution of Histamine in Children With Asthma

The investigators will compare the response to histamine via histamine iontophoresis with laser doppler monitoring (measured in flux units on a continuous scale)between subjects with allergic asthma compared to subjects with non-allergic asthma. (NCT01392859)
Timeframe: one year

Intervention	flux units on a continuous scale (Mean)
	Hyper-Reactive-	Normo-Reactive	Hypo-Reactive
Overall Study	11253.24	6464.20	3539.67

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Cmax and Cmin of Levocetirizine in Plasma

Cmax is defined as the peak plasma concentration of a drug after administration. Cmin is defined as the lowest (trough) concentration that a drug reaches before the next dose is administered. For both age cohorts, blood samples were collected 1.5-2.5 hours after the last drug administration for assessment of Cmax at either Week 1 or 2/EW. For participants in the >=6 months and <12 months cohort, blood samples were collected 22.5-25.5 hours after the last drug administration for Cmin at a different visit from Cmax sampling. For participants in the >=12 months and <24 months cohort, blood samples were collected 10.5-13.5 hours after the final drug administration for Cmin at a different visit from Cmax sampling. For all participants, if Cmin sampling occurred at Week 1, then Cmax sampling occurred at Week 2/EW, and vice versa. (NCT01563081)
Timeframe: Weeks 1 and 2/Early Withdrawal

Intervention	nanograms per milliliter (Median)
	Cmax	Cmin
Levocetirizine: >=12 Months and <24 Months Old	213.440	48.330
Levocetirizine: >=6 Months and <12 Months Old	206.780	17.710

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Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal

The investigator comprehensively assessed the pariticipant's severity of pruritus on the first day of treatment (FDOT), at Week 1, and at Week 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) by using the following scale: 4, severe; 3, moderate; 2, mild; 1, slight; 0, none. (NCT01563081)
Timeframe: First day of treatment; Weeks 1 and 2/Early Withdrawal

Intervention	participants (Number)
	FDOT, none	FDOT, slight	FDOT, mild	FDOT, moderate	FDOT, severe	Week 1, none	Week 1, slight	Week 1, mild	Week 1, moderate	Week 1, severe	Week 2/EW, none	Week 2/EW, slight	Week 2/EW, mild	Week 2/EW, moderate	Week 2/EW, severe
Levocetrizine: Total Population	0	7	17	11	5	6	14	11	7	2	13	8	11	8	0

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Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs)

A non-serious AE is defined as any untoward medical occurrence in a participant/clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is a possible drug-induced liver injury. For a list of all SAEs/non-serious AEs occurring at a frequency of >=5%, please see the SAE/non-serious AE module of this record. (NCT01563081)
Timeframe: up to Week 2/Early Withdrawal (EW)

Intervention	participants (Number)
	Any Adverse Event	Any Serious Adverse Event
Levocetirizine: >=12 Months and <24 Months Old	17	0
Levocetirizine: >=6 Months and <12 Months Old	15	0
Levocetirizine: Total Population	32	0

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Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression

"The investigator or sub-investigator made an overall assessment of nasal symptoms (allergic rhinitis [AR]) and pruritus associated with skin diseases (PAWSD) at Weeks 1 and 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) by asking the participants' legal representatives to provide feedback using the following scale: 1, significantly improved; 2, moderately improved; 3, mildly improved; 4, no change; 5, mildly worse; 6, moderately worse; 7, significantly worse. Only those participants with AR and PAWSD at Baseline were assessed for improvement in the conditions at Weeks 1 and 2. The ns in the category titles reflect the number of participants in the Full Analysis Set (FAS) who had AR and PAWSD at Baseline." (NCT01563081)
Timeframe: First day of treatment; Weeks 1 and 2/Early Withdrawal

Intervention	participants (Number)
	AR, Week 1, significantly improved, n=20	AR, Week 2/EW, significantly improved, n=20	AR, Week 1, moderately improved, n=20	AR, Week 2/EW, moderately improved, n=20	AR, Week 1, mildly improved, n=20	AR, Week 2/EW, mildly improved, n=20	AR, Week 1, no change, n=20	AR, Week 2/EW, no change, n=20	AR, Week 1, mildly worse, n=20	AR, Week 2/EW, mildly worse, n=20	AR, Week 1, moderately worse, n=20	AR, Week 2/EW, moderately worse, n=20	AR, Week 1, significantly worse, n=20	AR, Week 2/EW, significantly worse, n=20	PAWSD, Week 1, significantly improved, n=40	PAWSD, Week 2/EW, significantly improved, n=40	PAWSD, Week 1, moderately improved, n=40	PAWSD, Week 2/EW, moderately improved, n=40	PAWSD, Week 1, mildly improved, n=40	PAWSD, Week 2/EW, mildly improved, n=40	PAWSD, Week 1, no change, n=40	PAWSD, Week 2/EW, no change, n=40	PAWSD, Week 1, mildly worse, n=40	PAWSD, Week 2/EW, mildly worse, n=40	PAWSD, Week 1, moderately worse, n=40	PAWSD, Week 2/EW, moderately worse, n=40	PAWSD, Week 1, significantly worse, n=40	PAWSD, Week 2/EW, significantly worse, n=40
Levocetirizine: Total Population	4	8	5	5	4	5	7	1	0	0	0	1	0	0	4	6	11	16	13	14	12	4	0	0	0	0	0	0

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Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator

The investigator or sub-investigator comprehensively assessed the participants' improvement in nasal symptoms (allergic rhinitis [AR]) and pruritus associated with skin diseases (PAWSD) at Weeks 1 and 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) compared to the first day of treatment by using the following scale: 1, markedly improved; 2, moderately improved; 3, slightly improved; 4, no change; 5, worsened. (NCT01563081)
Timeframe: First day of treatment; Weeks 1 and 2/Early Withdrawal

Intervention	participants (Number)
	AR, Week 1, markedly improved, n=20	AR, Week 2/EW, markedly improved, n=20	AR, Week moderately improved, n=20	AR, Week 2/EW, moderately improved, n=20	AR, Week 1, slightly improved, n=20	AR, Week 2/EW, slightly improved, n=20	AR, Week 1, no change, n=20	AR, Week 2/EW, no change, n=20	AR, Week 1, worsened, n=20	AR, Week 2/EW, worsened, n=20	PAWSD, Week 1, markedly improved, n=40	PAWSD, Week 2/EW, markedly improved, n=40	PAWSD, Week 1, moderately improved, n=40	PAWSD, Week 2/EW, moderately improved, n=40	PAWSD, Week 1, slightly improved, n=40	PAWSD, Week 2/EW, slightly improved, n=40	PAWSD, Week 1, no change, n=40	PAWSD, Week 2/EW, no change, n=40	PAWSD, Week 1, worsened, n=40	PAWSD, Week 2/EW, worsened, n=40
Levocetrizine: Total Population	7	12	4	3	3	4	6	1	0	0	6	10	15	19	12	8	7	3	0	0

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Flaire Diameter (mm)

Flaire diameter was measured with a transparent ruler as the mean of the largest diameter and the diameter at right angles to this. (NCT01586091)
Timeframe: 24 hours per treatment

Intervention	mm (Mean)
Placebo	69.4
Levocetirizin	20.4
Fexofenadine	39.9

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Pruritus as Assessed by the VAS Score

"We measured drug concentrations and various aspects of skin provocation testing such as itch intensity and wheal size. Measurements made at each time point were as followed: Pruritus was assessed every 30 s for 10 min after SPT using a visual analogue scale (VAS) score with a 0 and 100 at the two ex- tremes of an unmarked 100 mm line with higher values indicating greater puritus. The mean VAS for each 10 min was calculated and used as a primary end Point." (NCT01586091)
Timeframe: up to 10 minutes after skin prick test performed 24 hours after drug administration

Intervention	mm (Mean)
Levocetirizin	11.5
Fexofenadine	25.4
Placebo	46.0

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Wheal Volume (cm3)

Wheal volume was measured by a non-contact three dimensional measurement system (PRIMOS contact, GFM Messtechnik GmbH, Teltow, Germany). (NCT01586091)
Timeframe: 24 hours per treatment

Intervention	cm3 (Mean)
Placebo	174.6
Levocetirizin	35.2
Fexofenadine	106.3

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Progression Free Survival (Arm A)

"Time from start of treatment to the time of progression or death, whichever occurs first~Progressive disease (target lesions): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Progressive disease (non-target lesions): appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase." (NCT01722162)
Timeframe: Until progressive disease (PD) (estimated to be 92 days)

Intervention	proportion of patients with PFS (Number)
	PFS Days = 29	PFS Days = 36	PFS Days = 43	PFS Days = 46	PFS Days = 50	PFS Days = 92
Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)	0.946	0.892	0.739	0.685	0.630	0.575

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Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events

NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (NCT01722162)
Timeframe: Up to 6 months

Intervention	participants (Number)
	Small intestinal obstruction	Fatigue	Urinary tract infection	Blood bilirubin increased	Peripheral motor neuropathy	Peripheral sensory neuropathy	Dyspnea	Hypertension	Thromboembolic event	Anemia	Heart failure	Colonic fistula	Colonic perforation	Gram-negative bacilli infection	Clostridium bloodstream infection	Alanine aminotransferase increased	Anorexia	Bone pain	Generalized muscle weakness	Muscle weakness lower limbs	Urinary retention	Respiratory failure
Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)	1	1	1	2	1	1	1	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)	0	1	0	0	0	0	2	2	0	1	1	1	1	1	1	1	1	1	1	1	1	1

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Progression Free Survival (Arm B)

Intervention	proportion of patients with PFS (Number)
	PFS Days = 29	PFS Days = 33	PFS Days = 44	PFS Days = 50	PFS Days = 54	PFS Days = 60
Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)	0.946	0.892	0.838	0.686	0.631	0.576

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Part 2: Number of Participants With AEs and 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. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. (NCT03555890)
Timeframe: Up to 18 days

Intervention	Participants (Count of Participants)
	AEs	SAEs
Part 2: Levocetirizine IRT 5 mg	0	0
Part 2: Levocetirizine ODT 5 mg	6	0

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Part 2: Change From Baseline in SBP and DBP

Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose

Intervention	mmHg (Mean)
	SBP, 1 hour	SBP, 24 hour	SBP, 48 hour	DBP, 1 hour	DBP, 24 hour	DBP, 48 hour
Part 2: Levocetirizine IRT 5 mg	-0.9	-1.2	0.3	-2.6	-1.2	-0.2
Part 2: Levocetirizine ODT 5 mg	0.2	-1.9	0.7	-2.6	-2.3	-0.6

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Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval

Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose

Intervention	Millisecond (Mean)
	PR interval, 1 hour	PR interval, 48 hour	QRS duration, 1 hour	QRS duration, 48 hour	QT interval, 1 hour	QT interval, 48 hour	QTcF interval, 1 hour	QTcF interval, 48 hour
Part 2: Levocetirizine IRT 5 mg	-2.8	0.6	-1.9	-0.4	3.1	-11.4	-0.9	-7.6
Part 2: Levocetirizine ODT 5 mg	-3.2	1.2	-1.4	0.3	3.8	-12.1	1.4	-8.5

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Part 2: Change From Baseline in Platelet Count and White Blood Cell Count

Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose

Intervention	GI/L (Mean)
	Platelet count	White blood cell count
Part 2: Levocetirizine IRT 5 mg	-2.9	-1.06
Part 2: Levocetirizine ODT 5 mg	-2.5	-1.14

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Part 2: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration

Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose

Intervention	G/L (Mean)
	Hemoglobin	Mean corpuscle hemoglobin concentration
Part 2: Levocetirizine IRT 5 mg	0.9	0.5
Part 2: Levocetirizine ODT 5 mg	0.9	0.2

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Part 2: Change From Baseline in Heart Rate (ECG)

Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose

Intervention	Beats per minute (Mean)
	1 hour	48 hour
Part 2: Levocetirizine IRT 5 mg	-1.7	1.9
Part 2: Levocetirizine ODT 5 mg	-1.0	1.7

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Part 2: Change From Baseline in Heart Rate

Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose

Intervention	Beats per minute (Mean)
	1 hour	24 hour	48 hour
Part 2: Levocetirizine IRT 5 mg	-0.6	0.6	3.0
Part 2: Levocetirizine ODT 5 mg	-1.5	-1.9	1.5

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Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels

Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose

Intervention	UMOL/L (Mean)
	Direct bilirubin	Total bilirubin	Creatinine	Uric acid
Part 2: Levocetirizine IRT 5 mg	0.036	-0.619	-3.8746	13.6677
Part 2: Levocetirizine ODT 5 mg	-0.071	-0.748	-3.5913	14.0026

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Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels

Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/BUN levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose

Intervention	MMOL/L (Mean)
	Calcium	Cholesterol	Chloride	Glucose	High density lipids cholesterol	Potassium	Low density lipids cholesterol	Sodium	Phosphorus inorganic	Triglycerides	Urea/BUN
Part 2: Levocetirizine IRT 5 mg	0.015926	0.064925	-0.5	0.059053	-0.047869	0.08	0.084733	-0.6	-0.239770	0.03606	-0.45802
Part 2: Levocetirizine ODT 5 mg	0.015594	0.083506	-0.6	-0.049728	-0.049565	-0.03	0.123374	-1.1	-0.203831	-0.02707	-0.12272

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Part 2: Change From Baseline in Body Temperature

Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose

Intervention	Degree Celsius (Mean)
	1 hour	24 hour	48 hour
Part 2: Levocetirizine IRT 5 mg	0.09	0.08	0.03
Part 2: Levocetirizine ODT 5 mg	0.19	0.13	0.03

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Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count

Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose

Intervention	Percentage (Mean)
	Basophils	Eosinophils	Lymphocytes	Monocytes	Total neutrophils levels
Part 2: Levocetirizine IRT 5 mg	0.04	-0.74	-8.07	-0.48	9.25
Part 2: Levocetirizine ODT 5 mg	0.08	-0.92	-8.45	-0.49	9.78

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Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels

Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose

Intervention	IU/L (Mean)
	Alkaline phosphatase	Alanine amino transferase	Aspartate amino transferase	Creatine kinase	Gamma glutamyl transferase	Lactate dehydrogenase
Part 2: Levocetirizine IRT 5 mg	-2.3	-0.7	-0.1	-16.3	-0.1	-3.7
Part 2: Levocetirizine ODT 5 mg	-1.1	-0.5	0.1	-12.4	-0.1	-3.5

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Part 2: Change From Baseline in Albumin and Total Protein Levels

Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose

Intervention	g/L (Mean)
	Albumin	Total protein
Part 2: Levocetirizine IRT 5 mg	1.4	1.9
Part 2: Levocetirizine ODT 5 mg	1.2	1.8

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Part 1: Urine Specific Gravity

Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030. (NCT03555890)
Timeframe: Pre-dose (Day 1) and 48 hours post-dose

Intervention	Ratio (Mean)
	Pre-dose	48 hours
Part 1: Levocetirizine IRT 5 mg	1.0144	1.0163
Part 1: Levocetirizine ODT 5 mg	1.0158	1.0178

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Part 1: Urine Potential of Hydrogen (pH)

Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). (NCT03555890)
Timeframe: Pre-dose (Day 1) and 48 hours post-dose

Intervention	pH (Mean)
	Pre-dose	48 hours
Part 1: Levocetirizine IRT 5 mg	6.06	6.02
Part 1: Levocetirizine ODT 5 mg	6.04	6.10

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Part 1: Number of Participants With Urinalysis Results by Dipstick Method

Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented. (NCT03555890)
Timeframe: Pre-dose (Day 1) and 48 hours post-dose

Intervention	Participants (Count of Participants)
	Bilirubin, Pre-dose, negative	Bilirubin, 48 hours, negative	Occult blood, Pre-dose, negative	Occult blood, Pre-dose, trace	Occult blood, 48 hours, negative	Occult blood, 48 hours, trace	Glucose, Pre-dose, negative	Glucose, 48 hours, negative	Ketones, Pre-dose, negative	Ketones, Pre-dose, positive (1+)	Ketones, 48 hours, negative	Protein, Pre-dose, negative	Protein, 48 hours, negative	Urobilinogen, Pre-dose, trace	Urobilinogen, 48 hours, trace
Part 1: Levocetirizine IRT 5 mg	24	24	24	0	24	0	24	24	23	1	24	24	24	24	24
Part 1: Levocetirizine ODT 5 mg	24	24	23	1	23	1	24	24	24	0	24	24	24	24	24

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Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Intervention	Participants (Count of Participants)
	AEs	SAEs
Part 1: Levocetirizine IRT 5 mg	0	0
Part 1: Levocetirizine ODT 5 mg	0	0

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Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Intervention	Millimeters of mercury (mmHg) (Mean)
	SBP, 1 hour	SBP, 24 hour	SBP, 48 hour	DBP, 1 hour	DBP, 24 hour	DBP, 48 hour
Part 1: Levocetirizine IRT 5 mg	0.4	0.6	1.3	-2.2	0.0	1.1
Part 1: Levocetirizine ODT 5 mg	-2.0	0.0	-1.2	-1.8	0.3	0.6

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Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval

Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose

Intervention	Millisecond (Mean)
	PR interval, 1 hour	PR interval, 48 hour	QRS duration, 1 hour	QRS duration, 48 hour	QT interval, 1 hour	QT interval, 48 hour	QTcF interval, 1 hour	QTcF interval, 48 hour
Part 1: Levocetirizine IRT 5 mg	-6.3	-1.9	-0.8	-0.6	-6.4	-10.7	-4.3	-4.8
Part 1: Levocetirizine ODT 5 mg	-7.3	-5.5	-0.5	1.7	-9.3	-14.3	-6.1	-9.3

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Part 1: Change From Baseline in Platelet Count and White Blood Cell Count

Intervention	Giga per liter (GI/L) (Mean)
	Platelet count	White blood cell count
Part 1: Levocetirizine IRT 5 mg	-11.4	-1.26
Part 1: Levocetirizine ODT 5 mg	-6.4	-0.94

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Part 1: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration

Intervention	Grams per liter (G/L) (Mean)
	Hemoglobin	Mean corpuscle hemoglobin concentration
Part 1: Levocetirizine IRT 5 mg	2.3	1.8
Part 1: Levocetirizine ODT 5 mg	2.2	2.3

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Part 1: Change From Baseline in Heart Rate (12-Lead Electrocardiogram [ECG])

Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval with Fridericia's correction (QTcF). Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose

Intervention	Beats per minute (Mean)
	1 hour	48 hour
Part 1: Levocetirizine IRT 5 mg	1.0	2.5
Part 1: Levocetirizine ODT 5 mg	1.6	2.1

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Part 1: Change From Baseline in Heart Rate

Intervention	Beats per minute (Mean)
	1 hour	24 hour	48 hour
Part 1: Levocetirizine IRT 5 mg	-0.9	-0.1	2.5
Part 1: Levocetirizine ODT 5 mg	-2.3	-0.8	0.8

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Part 1: Apparent Terminal Phase Half-life (t1/2) of Levocetirizine

Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Intervention	Hours (Geometric Mean)
Part 1: Levocetirizine ODT 5 mg	8.784
Part 1: Levocetirizine IRT 5 mg	8.544

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Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels

Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/blood urea nitrogen (BUN) levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose

Intervention	Millimoles per liter (MMOL/L) (Mean)
	Calcium	Cholesterol	Chloride	Glucose	High density lipids cholesterol	Potassium	Low density lipids cholesterol	Sodium	Phosphorus inorganic	Triglycerides	Urea/BUN
Part 1: Levocetirizine IRT 5 mg	0.018713	0.054953	-1.0	-0.050884	-0.063573	0.10	0.038790	-0.7	-0.182977	-0.00047	0.08033
Part 1: Levocetirizine ODT 5 mg	0.032227	0.117448	-0.9	-0.067075	-0.032325	0.13	0.059263	-0.6	-0.193740	0.04520	0.01934

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Part 1: Change From Baseline in Body Temperature

Intervention	Degree Celsius (Mean)
	1 hour	24 hour	48 hour
Part 1: Levocetirizine IRT 5 mg	0.02	0.09	0.01
Part 1: Levocetirizine ODT 5 mg	0.20	-0.01	0.06

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Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count

Intervention	Percentage (Mean)
	Basophils	Eosinophils	Lymphocytes	Monocytes	Total neutrophils levels
Part 1: Levocetirizine IRT 5 mg	0.01	-0.52	-5.96	0.16	6.32
Part 1: Levocetirizine ODT 5 mg	-0.01	-0.53	-5.94	-0.16	6.64

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Part 1: Change From Baseline in Albumin and Total Protein Levels

Intervention	Grams per liter (g/L) (Mean)
	Albumin	Total protein
Part 1: Levocetirizine IRT 5 mg	1.5	2.3
Part 1: Levocetirizine ODT 5 mg	1.6	2.7

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Part 2: Vz/F of Levocetirizine

Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated as by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Intervention	Liters (Geometric Mean)
Part 2: Levocetirizine ODT 5 mg	34.82
Part 2: Levocetirizine IRT 5 mg	33.91

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Part 2: Tmax of Levocetirizine

Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference. (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Intervention	Hours (Median)
Part 2: Levocetirizine ODT 5 mg	1.0000
Part 2: Levocetirizine IRT 5 mg	1.0000

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Part 1: Apparent Clearance Following Oral Dosing (CL/F) of Levocetirizine

Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Intervention	Liters per hour (Geometric Mean)
Part 1: Levocetirizine ODT 5 mg	2.758
Part 1: Levocetirizine IRT 5 mg	2.699

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Part 2: t1/2 of Levocetirizine

Intervention	Hours (Geometric Mean)
Part 2: Levocetirizine ODT 5 mg	9.024
Part 2: Levocetirizine IRT 5 mg	8.933

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Part 2: MRT of Levocetirizine

Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Intervention	Hours (Geometric Mean)
Part 2: Levocetirizine ODT 5 mg	12.573
Part 2: Levocetirizine IRT 5 mg	12.272

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Part 2: Kel (lambda_z) of Levocetirizine

Blood samples were collected at indicated time points for analysis of kel. kel (lambda_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Intervention	Per hour (Geometric Mean)
Part 2: Levocetirizine ODT 5 mg	0.07681
Part 2: Levocetirizine IRT 5 mg	0.07760

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Part 2: Cmax of Levocetirizine

Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data. (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose

Intervention	ng/mL (Geometric Mean)
Part 2: Levocetirizine ODT 5 mg	191.5
Part 2: Levocetirizine IRT 5 mg	223.6

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Part 2: CL/F of Levocetirizine

Intervention	Liters per hour (Geometric Mean)
Part 2: Levocetirizine ODT 5 mg	2.675
Part 2: Levocetirizine IRT 5 mg	2.631

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Part 2: Change From Baseline in Reticulocytes

Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose

Intervention	Percentage of reticulocytes (Mean)
Part 2: Levocetirizine ODT 5 mg	-0.0001
Part 2: Levocetirizine IRT 5 mg	-0.0004

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Part 2: Change From Baseline in Red Blood Cell Count

Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose

Intervention	Trillion cells per liter (Mean)
Part 2: Levocetirizine ODT 5 mg	0.040
Part 2: Levocetirizine IRT 5 mg	0.041

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Part 2: Change From Baseline in Mean Corpuscle Volume

Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose

Intervention	Femtoliters (Mean)
Part 2: Levocetirizine ODT 5 mg	-0.2
Part 2: Levocetirizine IRT 5 mg	-0.3

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Part 2: Change From Baseline in Mean Corpuscle Hemoglobin

Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose

Intervention	Picograms (Mean)
Part 2: Levocetirizine ODT 5 mg	-0.07
Part 2: Levocetirizine IRT 5 mg	-0.07

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Part 2: Change From Baseline in Amylase Levels

Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in amylase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose

Intervention	U/L (Mean)
Part 2: Levocetirizine ODT 5 mg	7.4
Part 2: Levocetirizine IRT 5 mg	7.1

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Part 2: Change Form Baseline in Hematocrit

Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hematocrit was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose

Intervention	Proportion of red blood cells in blood (Mean)
Part 2: Levocetirizine ODT 5 mg	0.0023
Part 2: Levocetirizine IRT 5 mg	0.0019

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Part 2: AUC(0-t) of Levocetirizine

Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose

Intervention	Hr*ng/mL (Geometric Mean)
Part 2: Levocetirizine ODT 5 mg	1809.9
Part 2: Levocetirizine IRT 5 mg	1843.5

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Part 1: Apparent Volume of Distribution Following Oral Dosing (Vz/F) of Levocetirizine

Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Intervention	Liters (Geometric Mean)
Part 1: Levocetirizine ODT 5 mg	34.95
Part 1: Levocetirizine IRT 5 mg	33.27

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Part 2: %AUCex of Levocetirizine

Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Intervention	Percentage AUCex (Geometric Mean)
Part 2: Levocetirizine ODT 5 mg	2.973
Part 2: Levocetirizine IRT 5 mg	2.779

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Part 1: Time to First Occurrence of Cmax (Tmax) of Levocetirizine

Intervention	Hours (Median)
Part 1: Levocetirizine ODT 5 mg	0.5000
Part 1: Levocetirizine IRT 5 mg	0.7500

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Part 1: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) of Levocetirizine

Intervention	Percentage AUCex (Geometric Mean)
Part 1: Levocetirizine ODT 5 mg	2.772
Part 1: Levocetirizine IRT 5 mg	2.500

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Part 1: Mean Residence Time (MRT) of Levocetirizine

Intervention	Hours (Geometric Mean)
Part 1: Levocetirizine ODT 5 mg	11.545
Part 1: Levocetirizine IRT 5 mg	11.417

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Part 1: Maximum Observed Concentration (Cmax) of Levocetirizine

Intervention	Nanogram per milliliter (ng/mL) (Geometric Mean)
Part 1: Levocetirizine ODT 5 mg	219.9
Part 1: Levocetirizine IRT 5 mg	235.4

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Part 1: Elimination Rate Constant (Kel) (lambda_z) of Levocetirizine

Intervention	Per hour (Geometric Mean)
Part 1: Levocetirizine ODT 5 mg	0.07891
Part 1: Levocetirizine IRT 5 mg	0.08113

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Part 1: Change From Baseline in Reticulocytes

Intervention	Percentage of reticulocytes (Mean)
Part 1: Levocetirizine ODT 5 mg	-0.0001
Part 1: Levocetirizine IRT 5 mg	0.0004

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Part 1: Change From Baseline in Red Blood Cell Count

Intervention	Trillion cells per liter (Mean)
Part 1: Levocetirizine ODT 5 mg	0.078
Part 1: Levocetirizine IRT 5 mg	0.080

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Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero Time (Pre-dose) to the Time of Last Quantifiable Concentration (AUC[0-t]) of Levocetirizine

Intervention	Hoursnanogram per milliliter (Hrng/mL) (Geometric Mean)
Part 1: Levocetirizine ODT 5 mg	1758.5
Part 1: Levocetirizine IRT 5 mg	1803.2

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Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels

Intervention	Micromoles per liter (UMOL/L) (Mean)
	Direct bilirubin	Total bilirubin	Creatinine	Uric acid
Part 1: Levocetirizine IRT 5 mg	0.356	-1.710	-1.9890	23.2963
Part 1: Levocetirizine ODT 5 mg	0.214	0.143	-1.9522	21.0658

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Part 1: Area Under the Concentration-time Curve From Zero Time (Pre-dose) Extrapolated to Infinite Time AUC(0-inf) of Levocetirizine

Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf)) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Intervention	Hr*ng/mL (Geometric Mean)
Part 1: Levocetirizine ODT 5 mg	1812.9
Part 1: Levocetirizine IRT 5 mg	1852.5

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Part 1: Change Form Baseline in Hematocrit

Intervention	Proportion of red blood cells in blood (Mean)
Part 1: Levocetirizine ODT 5 mg	0.0036
Part 1: Levocetirizine IRT 5 mg	0.0043

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Part 1: Change From Baseline in Amylase Levels

Blood samples were collected for the assessment of clinical chemistry parameters. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose

Intervention	Units per liter (U/L) (Mean)
Part 1: Levocetirizine ODT 5 mg	6.3
Part 1: Levocetirizine IRT 5 mg	7.2

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Part 1: Change From Baseline in Mean Corpuscle Hemoglobin

Intervention	Picograms (Mean)
Part 1: Levocetirizine ODT 5 mg	-0.04
Part 1: Levocetirizine IRT 5 mg	-0.03

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Part 1: Change From Baseline in Mean Corpuscle Volume

Intervention	Femtoliters (Mean)
Part 1: Levocetirizine ODT 5 mg	-0.6
Part 1: Levocetirizine IRT 5 mg	-0.5

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Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels

Intervention	International units per liter (IU/L) (Mean)
	Alkaline phosphatase	Alanine amino transferase	Aspartate amino transferase	Creatine kinase	Gamma glutamyl transferase	Lactate dehydrogenase
Part 1: Levocetirizine IRT 5 mg	-1.6	1.0	-0.3	-13.2	-0.5	-8.8
Part 1: Levocetirizine ODT 5 mg	-0.8	0.5	-0.1	-10.0	-0.6	-11.0

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Part 2: Urine Specific Gravity

Intervention	Ratio (Mean)
	Pre-dose	48 hours
Part 2: Levocetirizine IRT 5 mg	1.0179	1.0159
Part 2: Levocetirizine ODT 5 mg	1.0156	1.0160

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Part 2: Urine Potential of Hydrogen (pH)

Intervention	pH (Mean)
	Pre-dose	48 hours
Part 2: Levocetirizine IRT 5 mg	6.11	6.00
Part 2: Levocetirizine ODT 5 mg	6.20	6.09

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Part 2: Number of Participants With Urinalysis Results by Dipstick Method

Intervention	Participants (Count of Participants)
	Bilirubin, Pre-dose, negative	Bilirubin, 48 hours, negative	Occult blood, Pre-dose, negative	Occult blood, 48 hours, negative	Occult blood, 48 hours, trace	Glucose, Pre-dose, negative	Glucose, 48 hours, negative	Ketones, Pre-dose, negative	Ketones, Pre-dose, positive (1+)	Ketones, 48 hours, negative	Protein, Pre-dose, negative	Protein, 48 hours, negative	Urobilinogen, Pre-dose, trace	Urobilinogen, 48 hours, trace
Part 2: Levocetirizine IRT 5 mg	47	47	47	47	0	47	47	46	1	47	47	47	47	47
Part 2: Levocetirizine ODT 5 mg	48	48	48	47	1	48	48	48	0	48	48	48	48	48

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Part 2: AUC(0-inf) of Levocetirizine

Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose

Intervention	Hr*ng/mL (Geometric Mean)
Part 2: Levocetirizine ODT 5 mg	1869.5
Part 2: Levocetirizine IRT 5 mg	1900.2

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levocetirizine

Cross-References

Synonyms (80)

Research Excerpts

Overview

Effects

Treatment

Toxicity

Pharmacokinetics

Compound-Compound Interactions

Bioavailability

Dosage Studied

Drug Classes (1)

Pathways (1)

Protein Targets (8)

Potency Measurements

Bioassays (27)

Research

Studies (254)

Market Indicators

Research Demand Index: 127.31

Study Types

Clinical Trials (69)

Trial Overview

Trial Outcomes

Percentage of Days With Symptoms of Nocturnal Cough

Percentage of Subjects Using Medication for Atopic Dermatitis

Number of Episodes of Urticaria Per Subject

Percentage of Days With Symptoms of Either Wheezing or Nocturnal Cough

Percentage of Days With Symptoms of Wheezing

Percentage of Subjects With Urticaria

Time to Onset of Asthma During the Treatment Period

Percentage of Days of Use of Asthma Medication

Percentage of Days of Use of Medication for Atopic Dermatitis

Percentage of Subjects Using Asthma Medication

Mean Weekly Individual Symptoms Scores During the Treatment Period

Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period

Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period

Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period

Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period

Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period

Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period

Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period

Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period

Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period

Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period

Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period

Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period

Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period

Mean Score for Pruritus Duration Over the Four Weeks of Treatment

Mean Pruritus Severity Score Over the Four Weeks of Treatment

Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment

Mean Pruritus Severity Score Over the First Week of Treatment

Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment

Mean Score for Pruritus Duration Over the First Week of Treatment

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

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

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

Change From Baseline in the MSC Score Over Period II

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

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

Change From Baseline in the Individual Symptom Scores Over Period I

Change From Baseline in the Individual Symptom Scores Over Period II

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

Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season

Onset of Action During Period I

Global Satisfaction of the Subjects at the End of Period III

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

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

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

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

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

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

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

Change From Baseline in the Individual Symptom Scores Over Period I

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

Change From Baseline in the MSC Score Over Period III

Change From Baseline in the MSC Score Over Period II

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

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