Page last updated: 2024-12-11

ciclesonide

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Description

ciclesonide: nasal spray approved for seasonal and perennial allergic rhinitis [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID6918155
CHEMBL ID2040682
CHEBI ID31397
SCHEMBL ID3688
MeSH IDM0332803

Synonyms (96)

Synonym
AC-1330
alvesco hfa
osonide
tbn-15
omnaris
omnaris hfa
byk-20426
by-9010
btr-15k
ciclesonide
alvesco
b-9207-015
osonase
btr-15
omnair
zetonna
DB01410
zetonna (tn)
alvesco (tn)
D01703
126544-47-6
ciclesonide (jan/usan/inn)
omnaris (tn)
rpr 251526
(r)-11beta,16alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with cyclohexanecarboxaldehyde, 21-isobutyrate
pregna-1,4-diene-3,20-dione, 16,17-(((r)-cyclohexylmethylene)bis(oxy))-11-hydroxy-21-(2-methyl-1-oxopropoxy)-, (11beta,16alpha)-
ciclesonide [inn]
pregna-1,4-diene-3,20-dione, 16,17-((cyclohexylmethylene)bis(oxy))-11-hydroxy-21-(2-methyl-1-oxopropoxy)-, (11beta,16alpha(r))-
NCGC00167484-01
NCGC00167972-01
141845-82-1
rpr251526
unii-s59502j185
s59502j185 ,
2h-naphth (2',1':4,5) indeno (1,2-d) (1,3) dioxole, pregna-1,4-diene-3,20-dione deriv.
ciclesonide [usan:inn]
tox21_112486
dtxsid9046659 ,
dtxcid7026659
cas-141845-82-1
S4646
AKOS015994702
(11beta,16alpha)-16,17-[[(r)-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)pregna-1,4-diene-3,20-dione
ciclesonide [who-dd]
ciclesonide [vandf]
ciclesonide [ep monograph]
pregna-1,4-diene-3,20-dione, 16,17-(((r)-cyclohexylmethylene)bis(oxy))-11-hydroxy-21-(2-methyl-1-oxopropoxy)-, (11.beta.,16.alpha.)
ciclesonide [orange book]
ciclesonide [mi]
ciclesonide [jan]
ciclesonide [mart.]
ciclesonide [usan]
rpr-251526
bi54903
CHEMBL2040682
HY-B0625
SCHEMBL3688
alvesco, ciclesonide
gtpl7469
KS-1165 ,
LUKZNWIVRBCLON-GXOBDPJESA-N
[2-[(1s,2s,4r,6r,8s,9s,11s,12s,13r)-6-cyclohexyl-11-hydroxy-9,13-dimethyl-16-oxo-5,7-dioxapentacyclo[10.8.0.02,9.04,8.013,18]icosa-14,17-dien-8-yl]-2-oxoethyl] 2-methylpropanoate
SR-01000942227-1
sr-01000942227
CHEBI:31397
el-87-6
HMS3714N07
ciclesonide, >=98% (hplc)
ciclesonide, european pharmacopoeia (ep) reference standard
alvesco 80
alvesco 160
bdbm50247997
Q5119448
(11?,16?)-16,17-[[(r)-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)pregna-1,4-diene-3,20-dione
CCG-269962
C72110
EX-A4195
[2-[(1s,2s,4r,8s,9s,11s,12s,13r)-6-cyclohexyl-11-hydroxy-9,13-dimethyl-16-oxo-5,7-dioxapentacyclo[10.8.0.02,9.04,8.013,18]icosa-14,17-dien-8-yl]-2-oxoethyl] 2-methylpropanoate
ciclesonide 100 microg/ml in acetonitrile
A899067
2-((6ar,6bs,7s,8as,8bs,10r,11ar,12as,12bs)-10-cyclohexyl-7-hydroxy-6a,8a-dimethyl-4-oxo-1,2,4,6a,6b,7,8,8a,11a,12,12a,12b-dodecahydro-8bh-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8b-yl)-2-oxoethyl isobutyrate
EN300-19766990
2-[(1s,2s,4r,6r,8s,9s,11s,12s,13r)-6-cyclohexyl-11-hydroxy-9,13-dimethyl-16-oxo-5,7-dioxapentacyclo[10.8.0.0^{2,9}.0^{4,8}.0^{13,18}]icosa-14,17-dien-8-yl]-2-oxoethyl 2-methylpropanoate
r01ad13
ciclesonidum
ciclesonida
ciclesonide (mart.)
aservo equihaler
ciclesonide (ep monograph)
r03ba08
pregna-1,4-diene-3,20-dione, 16,17-(((r)-cyclohexylmethylene)bis(oxy))-11-hydroxy-21-(2-methyl-1-oxopropoxy)-, (11beta,16alpha)
16alpha,17-((1r)-cyclohexylmethylidenedioxy)-11beta,21-dihydroxypregna-1,4-diene-3,20-dione 21-(2-methylpropionate)
C3701
ciclesonide (standard)
CS-0694790
HY-B0625R

Research Excerpts

Overview

Ciclesonide is an inhaled corticosteroid used to treat asthma and is currently undergoing clinical trials for treatment of coronavirus disease 2019 (COVID-19) It is an FDA-approved glucocorticoid (GC) used to treats asthma and allergic rhinitis.

ExcerptReferenceRelevance
"Ciclesonide is a novel, inhaled corticosteroid under development for the treatment of asthma. "( Preclinical profile of ciclesonide, a novel corticosteroid for the treatment of asthma.
Battram, CH; Belvisi, MG; Bundschuh, DS; Foster, ML; Haddad, el-B; Stoeck, M; Underwood, S; Webber, SE; Wicks, S, 2005
)
2.08
"Ciclesonide is an inhaled corticosteroid used to treat asthma and is currently undergoing clinical trials for treatment of coronavirus disease 2019 (COVID-19). "( Development of ciclesonide analogues that block SARS-CoV-2 RNA replication.
Asakura, H; Demizu, Y; Inoue, T; Ito, T; Ohoka, N; Tsuji, G; Uema, M; Yanase, Y; Yonemitsu, K, 2021
)
2.42
"Ciclesonide is an FDA-approved glucocorticoid (GC) used to treat asthma and allergic rhinitis. "( The FDA-Approved Anti-Asthma Medicine Ciclesonide Inhibits Lung Cancer Stem Cells through Hedgehog Signaling-Mediated SOX2 Regulation.
Choi, HS; Kim, JH; Kim, SL; Lee, DS, 2020
)
2.27
"Ciclesonide is an FDA-approved glucocorticoid used to treat asthma and allergic rhinitis. "( The Antiasthma Medication Ciclesonide Suppresses Breast Cancer Stem Cells through Inhibition of the Glucocorticoid Receptor Signaling-Dependent YAP Pathway.
Choi, HS; Kim, JH; Kim, SL; Lee, DS, 2020
)
2.3
"Ciclesonide is a glucocorticoid prodrug, already registered for human use. "( Inhaled ciclesonide is efficacious and well tolerated in the treatment of severe equine asthma in a large prospective European clinical trial.
Albrecht, B; Engel, O; Mueller, HW; Pirie, RS; von Salis-Soglio, M, 2021
)
2.5
"Ciclesonide (CIC) is a sGC prodrug approved for asthma treatment that exhibits limited systemic side effects."( Ciclesonide activates glucocorticoid signaling in neonatal rat lung but does not trigger adverse effects in the cortex and cerebellum.
Bargerstock, EM; Cole, TJ; DeFranco, DB; Franks, AL; Ghersi, A; Jaumotte, JD; Kisanga, EP; Menden, HL; Monaghan-Nichols, AP; Omar, M; Rudine, A; Sampath, V; Short, KL; Silswal, N; Wang, L, 2021
)
2.79
"Ciclesonide (CIC) is a corticosteroid for the treatment of asthma with biochemical properties that improve topical potency."( Ciclesonide Impacts Clinicopathological Features of Eosinophilic Esophagitis.
Atkins, D; Burger, C; Furuta, GT; Menard-Katcher, C; Miyazawa, H; Nguyen, N; Nistel, M, 2021
)
2.79
"Ciclesonide (CIC) is an ICS with on-site lung activation for potent anti-inflammatory activity."( Comparison of the efficacy of ciclesonide with that of budesonide in mild to moderate asthma patients after step-down therapy: a randomised parallel-group study.
Chiu, KC; Chou, CL; Chou, PC; Chou, YL; Hsu, JY; Kuo, HP; Lin, CH; Lin, MS; Wang, CH, 2014
)
1.41
"Ciclesonide (CIC) is an effective inhaled corticosteroid for treating asthmatic children. "( Effect of once-daily generic ciclesonide on exhaled nitric oxide in atopic children with persistent asthma.
Aguirre, V; Córdova, P; Cortez, E; Galindo, A; Gallardo, A; Mallol, J; Martínez, M; Riquelme, C; Sánchez, C,
)
1.87
"Ciclesonide is a good option for asthma treatment that allows for adrenal recovery."( Inhaled corticosteroid related adrenal suppression detected by poor growth and reversed with ciclesonide.
Hsu, DP; Liddell, BS; Oberlin, JM, 2017
)
1.4
"Ciclesonide is an intranasal corticosteroid approved for the treatment of allergic rhinitis. "( Onset of action of ciclesonide once daily in the treatment of seasonal allergic rhinitis.
Hall, N; Kunjibettu, S; Patel, D; Patel, P; Wingertzahn, MA, 2008
)
2.12
"Ciclesonide (Alvesco) is an inhaled corticosteroid used in the preventative treatment of persistent bronchial asthma in adults, adolescents and, in some countries, children. "( Ciclesonide: a review of its use in the management of asthma.
Deeks, ED; Perry, CM, 2008
)
3.23
"Ciclesonide is a new inhaled corticosteroid (ICS). "( Efficacy and safety of ciclesonide once daily and fluticasone propionate twice daily in children with asthma.
Barkai, L; Emeryk, A; Engelstätter, R; Hirsch, S; Pedersen, S; Vermeulen, J; Weber, H; Weber, HJ, 2009
)
2.11
"Ciclesonide is an intranasal corticosteroid approved for the treatment of allergic rhinitis (AR)."( Onset of action of ciclesonide once daily in the treatment of seasonal allergic rhinitis.
Couroux, P; Hall, N; Kunjibettu, S; Wingertzahn, MA, 2009
)
2.12
"Ciclesonide (CIC) is a new ICS with a unique pharmacologic profile that may confer a favorable safety profile."( The safety profile of ciclesonide in the treatment of persistent asthma.
Craig, T,
)
1.17
"Ciclesonide is a novel ICS, which is administered as an aerosol solution in a metered-dose inhaler, using hydrofluoroalkane-134a as a propellant."( Clinical pharmacokinetic and pharmacodynamic profile of inhaled ciclesonide.
Nave, R, 2009
)
1.31
"Ciclesonide is an inhaled corticosteroid, administered as a prodrug via a metered-dose inhaler. "( Deposition and metabolism of inhaled ciclesonide in the human lung.
Boss, H; Hoffmann, H; Magnussen, H; Nave, R; Watz, H, 2010
)
2.08
"Ciclesonide (Alvesco(®)) is an inhaled corticosteroid administered as a solution via a metered-dose inhaler, using hydrofluoroalkane HFA-134a as a propellant. "( Determination of lung deposition following inhalation of ciclesonide using different bioanalytical procedures.
Nave, R, 2010
)
2.05
"Ciclesonide (CIC) is a novel inhaled corticosteroid (ICS) approved by US Food and Drug Administration for the treatment of persistent asthma, available as a pressurized metered-dose inhaler in two strengths, 80 mcg/activation and 160 mcg/activation. "( Ciclesonide--a novel corticosteroid for the management of asthma.
Bhandari, B; Chopra, D; Wardhan, N, 2012
)
3.26
"Ciclesonide (CIC) is a highly safe, inhaled corticosteroid (ICS) that is converted into a pharmacologically active metabolite (des-isobutyryl-ciclesonide); this metabolite, in turn, exerts a local anti-inflammatory effect on lung tissue. "( Repeated-dose pharmacokinetics of inhaled ciclesonide (CIC-HFA) in Japanese children with bronchial asthma: a phase I study.
Azuma, J; Fukao, T; Kaneko, H; Kato, Z; Kondo, N; Matsui, E; Nishima, S; Ohnishi, H; Sakai, K; Teramoto, T; Yonezawa, H, 2012
)
2.09
"Ciclesonide is a novel glucocorticoid that is converted into ciclesonide--active principle (CIC-AP) in the lung. "( Population pharmacokinetics and pharmacodynamics of ciclesonide.
Arya, V; Barrett, JS; Hochhaus, G; Jensen, BK; Nave, R; Rohatagi, S; Zech, K, 2003
)
2.01
"Ciclesonide is an inhaled corticosteroid (delivered via a hydrofluoroalkane metered-dose inhaler) that is converted to an active metabolite, desisobutyryl-ciclesonide, in the lung, thereby minimising effects on endogenous cortisol. "( Ciclesonide.
Reynolds, NA; Scott, LJ, 2004
)
3.21
"Ciclesonide is a novel inhaled corticosteroid developed for the treatment of asthma."( Pharmacokinetics of [14C]ciclesonide after oral and intravenous administration to healthy subjects.
Bethke, TD; Nave, R; van Marle, SP; Zech, K, 2004
)
2.07
"Ciclesonide is a novel ICS, which promises to provide airway anti-inflammatory efficacy that is comparable with that of the available ICS in addition to reducing the risk for local and systemic adverse events."( Ciclesonide: a novel inhaled corticosteroid.
Humbert, M, 2004
)
2.49
"Ciclesonide is a parent compound that is converted locally in airways by esterases to produce the active metabolite, desisobutyryl-ciclesonide (des-CIC)."( Ciclesonide: a novel inhaled corticosteroid for asthma.
Christie, P, 2004
)
2.49
"Ciclesonide is a novel inhaled corticosteroid that is converted in the lungs to its active metabolite, desisobutyryl-ciclesonide (des-CIC). "( Comparison of the oropharyngeal deposition of inhaled ciclesonide and fluticasone propionate in patients with asthma.
Biberger, C; Kanniess, F; Magnussen, H; Nave, R; Richter, K, 2005
)
2.02
"Ciclesonide is a novel and effective inhaled corticosteroid for the treatment of asthma that is converted into the active metabolite C21-desisobutyryl-ciclesonide (des-CIC) in the lung. "( Model-based covariate pharmacokinetic analysis and lack of cortisol suppression by the new inhaled corticosteroid ciclesonide using a novel cortisol release model.
Krishnaswami, S; Pfister, M; Rohatagi, S; Sahasranaman, S,
)
1.78
"Ciclesonide is a novel inhaled corticosteroid delivered as inactive prodrug via a hydrofluoroalkane metered-dose inhaler with a deposition rate of 50 - 60 %. "( [Ciclesonide -- a new inhaled corticosteroid].
Ukena, D, 2005
)
2.68
"Ciclesonide is an inhaled corticosteroid with on-site lung activation that provides potent anti-inflammatory activity and has been shown to have a good safety profile, even at high doses."( Comparable efficacy of ciclesonide once daily versus fluticasone propionate twice daily in asthma.
Buhl, R; Engelstätter, R; Escher, A; Györi, Z; Magyar, P; Middle, MV; Rybacki, C; Vinkler, I, 2006
)
1.37
"Ciclesonide is a new generation ICS with demonstrable safety and efficacy in the treatment of asthma."( Systemic side effects of inhaled corticosteroids in patients with asthma.
Dahl, R, 2006
)
1.06
"Ciclesonide is a novel, lung-activated, inhaled corticosteroid with once-daily efficacy and potent anti-inflammatory activity. "( Effect of ciclesonide and fluticasone on exhaled nitric oxide in patients with mild allergic asthma.
Bodzenta-Lukaszyk, A; Skiepko, R; Szymanski, W; Tomasiak, MM; Zietkowski, Z, 2006
)
2.18
"Ciclesonide is a new steroid characterized by clinical efficacy comparable to that of fluticasone and a lower risk of side effects."( [Ciclesonide in the treatment of patients with bronchial asthma].
Grabowska, P; Płusa, T; Targowski, T, 2005
)
1.96
"Ciclesonide is an intranasal corticosteroid in development for the treatment of allergic rhinitis. "( Safety, tolerability, and exposure of ciclesonide nasal spray in healthy and asymptomatic subjects with seasonal allergic rhinitis.
Brookman, S; Kaida, S; Matsunaga, T; Nave, R; Wingertzahn, MA, 2006
)
2.05
"Ciclesonide is a new-generation inhaled corticosteroid developed to treat the inflammation associated with persistent asthma. "( In Vitro metabolism of ciclesonide in human lung and liver precision-cut tissue slices.
Fisher, R; Nave, R; Zech, K, 2006
)
2.09
"Ciclesonide is a new inhaled corticosteroids licensed for the prophylactic treatment of persistent asthma in adults. "( Inhaled ciclesonide versus inhaled budesonide or inhaled beclomethasone or inhaled fluticasone for chronic asthma in adults: a systematic review.
Dyer, MJ; Halpin, DM; Stein, K, 2006
)
2.21
"Ciclesonide is a nonhalogenated, inhaled corticosteroid under investigation for the treatment of asthma."( Two-dimensional and three-dimensional imaging show ciclesonide has high lung deposition and peripheral distribution: a nonrandomized study in healthy volunteers.
Bethke, TD; Boudreau, RJ; Davidson, P; Drollmann, A; Hasselquist, BE; Leach, CL; Wurst, W, 2006
)
1.31
"Ciclesonide is an inhaled corticosteroid that provides safe and effective control of persistent asthma. "( Equivalent pharmacokinetics of the active metabolite of ciclesonide with and without use of the AeroChamber Plus spacer for inhalation.
Baumgärtner, E; Bethke, TD; Drollmann, A; Nave, R; Steinijans, VW, 2006
)
2.02
"Ciclesonide is a new lung-activated inhaled corticosteroid (ICS) that has shown efficacy in previous placebo-controlled and comparative studies in patients with persistent asthma. "( A multinational, 12-week, randomized study comparing the efficacy and tolerability of ciclesonide and budesonide in patients with asthma.
Barnes, PJ; Benezet, O; Cheung, D; Engelstätter, R; Hansel, TT; Kafé, H; Ponitz, HH, 2006
)
2
"Ciclesonide (CIC) is an inhaled corticosteroid (ICS) with high anti-inflammatory activity and low incidence of local and systemic adverse effects. "( A comparative study of inhaled ciclesonide 160 microg/day and fluticasone propionate 176 microg/day in children with asthma.
Engelstätter, R; Garcia Garcia, ML; Manjra, A; Pedersen, S; Theron, I, 2006
)
2.06
"Ciclesonide is a lung-activated inhaled corticosteroid that provides effective control of persistent asthma. "( Ciclesonide is more effective than budesonide in the treatment of persistent asthma.
Beck, E; Biberger, C; Linnhoff, A; Malek, R; Steinijans, V; Ukena, D; von Behren, V; Weber, HH, 2007
)
3.23
"Ciclesonide nasal spray is a corticosteroid being developed as a hypotonic formulation for AR."( Efficacy and safety of ciclesonide nasal spray for the treatment of seasonal allergic rhinitis.
Darken, PF; Hampel, F; Ratner, PH; Shah, T; van Bavel, JH; Wingertzahn, MA, 2006
)
1.37
"Ciclesonide is an investigational corticosteroid under development for treatment of allergic rhinitis. "( Effectiveness of ciclesonide nasal spray in the treatment of seasonal allergic rhinitis.
Brookman, S; Darken, PF; Hampel, F; Hellbardt, S; Ratner, PH; Shah, T; van Bavel, JH; Wingertzahn, MA, 2006
)
2.12
"Ciclesonide is an intranasal corticosteroid approved for the treatment of allergic rhinitis (AR)."( Efficacy and safety of ciclesonide, 200 microg once daily, for the treatment of perennial allergic rhinitis.
Berger, W; Hall, N; Kunjibettu, S; LaForce, C; Meltzer, EO; Murcia, C; Wingertzahn, MA, 2007
)
2.09
"Ciclesonide (CIC) is an inhaled glucocorticosteroid. "( The role of esterases in the metabolism of ciclesonide to desisobutyryl-ciclesonide in human tissue.
McCracken, N; Mutch, E; Nave, R; Williams, FM; Zech, K, 2007
)
2.05
"Ciclesonide is a novel inhaled corticosteroid that possesses a unique pharmacokinetic and pharmacodynamic profile."( Pharmacokinetic and pharmacodynamic properties of inhaled ciclesonide.
Derendorf, H, 2007
)
1.31
"Ciclesonide is an onsite-activated inhaled corticosteroid (ICS) for the treatment of asthma. "( Comparison of the efficacy and safety of ciclesonide 160 microg once daily vs. budesonide 400 microg once daily in children with asthma.
Bethke, TD; Engelstätter, R; Garcia Garcia, ML; Hellbardt, S; Latoś, T; Leichtl, S; Minic, P; Sréckovic, M; Vermeulen, JH; von Berg, A, 2007
)
2.05
"Ciclesonide is a corticosteroid in development for allergic rhinitis that has been shown to be safe and effective in seasonal allergic rhinitis and perennial allergic rhinitis (PAR) trials of up to 6 weeks in duration. "( Long-term safety and efficacy of intranasal ciclesonide in adult and adolescent patients with perennial allergic rhinitis.
Chervinsky, P; Hall, N; Kunjibettu, S; Miller, DL; Prenner, BM; Raphael, G; Shah, T, 2007
)
2.04
"Ciclesonide is a novel inhaled corticosteroid for the treatment of airway inflammation. "( Ciclesonide uptake and metabolism in human alveolar type II epithelial cells (A549).
Katsuura, Y; Kawashimo, A; McCracken, N; Nave, R; Nonaka, T, 2007
)
3.23
"Ciclesonide is a modern inhaled corticosteroid registered for asthma treatment. "( [Role of ciclesonide in asthma therapy].
Kuna, P; Kupryś-Lipińska, I, 2008
)
2.21
"Ciclesonide is a novel inhaled corticosteroid for the treatment of asthma, and it is important to measure the onset of effect of this therapy on airway hyperresponsiveness (AHR), exhaled nitric oxide (NO), and levels of eosinophils in induced sputum."( Rapid effect of inhaled ciclesonide in asthma: a randomized, placebo-controlled study.
Barnes, PJ; Engelstätter, R; Erin, EM; Hansel, TT; Hellwig, M; Kon, OM; Neighbour, H; Nicholson, GC; Tan, AJ; Zacharasiewicz, AS, 2008
)
2.1
"Ciclesonide is a novel steroid that has efficient distribution and release properties that mean it can be taken once daily, making it potentially useful in ongoing asthma management."( Ciclesonide versus placebo for chronic asthma in adults and children.
Gibson, PG; Lasserson, TJ; Manning, P, 2008
)
2.51
"Ciclesonide is a novel steroid that is metabolised to its active component in the lung, making it a potentially useful for reducing local side effects."( Ciclesonide versus other inhaled steroids for chronic asthma in children and adults.
Gibson, PG; Lasserson, TJ; Manning, P, 2008
)
2.51

Effects

ExcerptReferenceRelevance
"Ciclesonide has been formulated as an aerosol solution in a metered dose inhaler with hydrofluoralkane which characterizes a high deposition rate over 50%."( [Role of ciclesonide in asthma therapy].
Kuna, P; Kupryś-Lipińska, I, 2008
)
1.48

Actions

ExcerptReferenceRelevance
"Ciclesonide did not suppress biochemical markers of adrenal function in 52-week studies."( Ciclesonide.
Reynolds, NA; Scott, LJ, 2004
)
2.49

Treatment

Ciclesonide treatment inhibits T cell migration and cytokine production upon allergen inhalation, which is regulated independently from reducing CCL17 release. Treatment with cicles onide 640 micro g/day or beclomethasone dipropionate 640 microg/day for 1 year has a minimal impact on lenticular opacities development.

ExcerptReferenceRelevance
"Ciclesonide treatment inhibits T cell migration and cytokine production upon allergen inhalation, which is regulated independently from reducing CCL17 release, but may contribute to beneficial effects of ciclesonide on Th2-mediated airway inflammation."( Effect of ciclesonide treatment on allergen-induced changes in T cell regulation in asthma.
de Monchy, JG; Heijink, IH; Kauffman, HF; Postma, DS; Vellenga, E; Veltman-Starkenburg, CA, 2008
)
1.47
"Both ciclesonide treatments were noninferior to placebo with respect to growth velocity."( Assessment of the long-term safety of inhaled ciclesonide on growth in children with asthma.
Banerji, D; Maspero, J; Skoner, DP, 2008
)
1.06
"Treatment with ciclesonide may prevent the development of severe COVID-19."( The peripheral lymphocyte count as a predictor of severe COVID-19 and the effect of treatment with ciclesonide.
Fujii, S; Fujitani, S; Hagiwara, Y; Handa, H; Ikeda, H; Ishibashi, Y; Kunishima, H; Morikawa, D; Morisawa, K; Naitou, Y; Nakamura, Y; Nishine, H; Ooka, S; Sakurada, T; Takemura, H; Takita, M; Tsuchida, T; Yamasaki, Y; Yoshida, H, 2020
)
1.11
"Treatment with ciclesonide 640 micro g/day or beclomethasone dipropionate 640 micro g/day for 1 year has a minimal impact on lenticular opacities development and/or progression."( A randomized, controlled trial to investigate the effect of ciclesonide and beclomethasone dipropionate on eye lens opacity.
Chylack, LT; Gross, GN; Pedinoff, A, 2008
)
0.93

Toxicity

Ciclesonide is a corticosteroid in development for allergic rhinitis. It has been shown to be safe and effective in seasonal allergic Rhinitis (SAR) trials of up to 6 weeks.

ExcerptReferenceRelevance
"Poor adherence to medications and other aspects of the treatment plan are described in patients with asthma, especially with adverse events concerning the upper respiratory and digestive tracts."( [Safety and efficacy of inhaled ciclesonide in asthma].
Buczyłko, K, 2003
)
0.6
"Freely circulating, protein unbound, active inhaled corticosteroid (ICS) can cause systemic adverse effects."( Protein binding and its potential for eliciting minimal systemic side effects with a novel inhaled corticosteroid, ciclesonide.
Chen, K; David, M; Guo, Z; Huang, Y; King, SP; Luo, Y; Nave, R; Rohatagi, S; Schemm, C; Shen, L,
)
0.34
" The incidence of adverse events was comparable in all treatment groups and no cortisol suppression was observed."( Once-daily ciclesonide 80 or 320 microg for 12 weeks is safe and effective in patients with persistent asthma.
Adler, M; Alexander, M; Drollmann, A; Langdon, CG; Mehra, S, 2005
)
0.72
" Therefore, cortisol may be a relevant surrogate marker to identify the potential for adverse effects from ICS therapy."( Systemic side effects of inhaled corticosteroids in patients with asthma.
Dahl, R, 2006
)
0.33
" Adverse events were monitored throughout the study."( Efficacy and safety of ciclesonide nasal spray for the treatment of seasonal allergic rhinitis.
Darken, PF; Hampel, F; Ratner, PH; Shah, T; van Bavel, JH; Wingertzahn, MA, 2006
)
0.64
"In a clinical setting ciclesonide was shown to be safe and effective in the treatment of SAR in adolescent and adult patients."( Efficacy and safety of ciclesonide nasal spray for the treatment of seasonal allergic rhinitis.
Darken, PF; Hampel, F; Ratner, PH; Shah, T; van Bavel, JH; Wingertzahn, MA, 2006
)
0.96
" Treatment guidelines, review articles, controlled trials, meta-analyses, and systematic reviews evaluating the efficacy and the adverse events of treatment with ICS were selected."( Inhaled corticosteroids in the treatment of respiratory allergy: safety vs. efficacy.
Rizzo, MC; Solé, D, 2006
)
0.33
" The most documented adverse effect is transitory decrease of growth rate."( Inhaled corticosteroids in the treatment of respiratory allergy: safety vs. efficacy.
Rizzo, MC; Solé, D, 2006
)
0.33
" When administered in low doses, they seem to be safe and effective."( Inhaled corticosteroids in the treatment of respiratory allergy: safety vs. efficacy.
Rizzo, MC; Solé, D, 2006
)
0.33
" The frequency of adverse events was similar between treatment groups."( Efficacy and safety of ciclesonide, 200 microg once daily, for the treatment of perennial allergic rhinitis.
Berger, W; Hall, N; Kunjibettu, S; LaForce, C; Meltzer, EO; Murcia, C; Wingertzahn, MA, 2007
)
0.65
" There was no difference in adverse events between the groups."( Efficacy and safety of inhaled ciclesonide compared with chlorofluorocarbon beclomethasone dipropionate in adults with moderate to severe persistent asthma.
Adachi, M; Inoue, H; Ishihara, K; Kato, R; Kudo, K; Masuda, K; Miyamoto, T; Morita, Y; Sakai, T; Takahashi, K, 2007
)
0.63
" Ciclesonide at doses of 400 microg/day and 800 microg/day was safe and well tolerated."( Efficacy and safety of inhaled ciclesonide compared with chlorofluorocarbon beclomethasone dipropionate in adults with moderate to severe persistent asthma.
Adachi, M; Inoue, H; Ishihara, K; Kato, R; Kudo, K; Masuda, K; Miyamoto, T; Morita, Y; Sakai, T; Takahashi, K, 2007
)
1.54
" Safety assessments included adverse events (AEs) and 24-h urine cortisol."( Randomized comparison of the efficacy and safety of ciclesonide and budesonide in adolescents with severe asthma.
Engelstätter, R; Gyurkovits, K; Rauer, H; Vermeulen, JH, 2007
)
0.59
" Additional measurements included change in daily peak expiratory flow (PEF), change in asthma symptom score sum, change in use of rescue medication, paediatric and caregiver asthma QOL questionnaire [PAQLQ(S) and PACQLQ, respectively] scores, change in body height assessed by stadiometry, change in 24-h urinary cortisol adjusted for creatinine and adverse events."( Comparison of the efficacy and safety of ciclesonide 160 microg once daily vs. budesonide 400 microg once daily in children with asthma.
Bethke, TD; Engelstätter, R; Garcia Garcia, ML; Hellbardt, S; Latoś, T; Leichtl, S; Minic, P; Sréckovic, M; Vermeulen, JH; von Berg, A, 2007
)
0.61
"Ciclesonide is a corticosteroid in development for allergic rhinitis that has been shown to be safe and effective in seasonal allergic rhinitis and perennial allergic rhinitis (PAR) trials of up to 6 weeks in duration."( Long-term safety and efficacy of intranasal ciclesonide in adult and adolescent patients with perennial allergic rhinitis.
Chervinsky, P; Hall, N; Kunjibettu, S; Miller, DL; Prenner, BM; Raphael, G; Shah, T, 2007
)
2.04
" Spontaneous and elicited adverse events were monitored throughout the study."( Long-term safety and efficacy of intranasal ciclesonide in adult and adolescent patients with perennial allergic rhinitis.
Chervinsky, P; Hall, N; Kunjibettu, S; Miller, DL; Prenner, BM; Raphael, G; Shah, T, 2007
)
0.6
"No clinically relevant differences were observed between the ciclesonide and placebo groups in adverse events, ear, nose, and throat examinations, or 24-hour urinary free or morning plasma cortisol levels."( Long-term safety and efficacy of intranasal ciclesonide in adult and adolescent patients with perennial allergic rhinitis.
Chervinsky, P; Hall, N; Kunjibettu, S; Miller, DL; Prenner, BM; Raphael, G; Shah, T, 2007
)
0.84
"In this study, intranasal ciclesonide, 200 microg once daily, was safe and effective for the long-term treatment of PAR, with no evidence of tachyphylaxis."( Long-term safety and efficacy of intranasal ciclesonide in adult and adolescent patients with perennial allergic rhinitis.
Chervinsky, P; Hall, N; Kunjibettu, S; Miller, DL; Prenner, BM; Raphael, G; Shah, T, 2007
)
0.9
" Adverse events and 10-hour overnight and 24-hour urinary free cortisol levels were also assessed."( Assessment of the long-term safety of inhaled ciclesonide on growth in children with asthma.
Banerji, D; Maspero, J; Skoner, DP, 2008
)
0.6
" The overall incidence of adverse events was comparable between groups, and no significant changes in 10-hour overnight or 24-hour urinary free cortisol levels were noted between groups during the double-blind treatment period."( Assessment of the long-term safety of inhaled ciclesonide on growth in children with asthma.
Banerji, D; Maspero, J; Skoner, DP, 2008
)
0.6
"Ciclesonide demonstrated no detectable effect on childhood growth velocity, even at the highest dosage, which may ease concerns about systemic adverse events."( Assessment of the long-term safety of inhaled ciclesonide on growth in children with asthma.
Banerji, D; Maspero, J; Skoner, DP, 2008
)
2.05
" Prolonged exposure to high-dose ICS can cause systemic and oropharyngeal adverse events."( Ciclesonide: a closer look at its systemic and oropharyngeal safety profile.
Berger, WE, 2006
)
1.78
" The incidences of adverse events were comparable across treatments."( Efficacy and safety of ciclesonide once daily and fluticasone propionate twice daily in children with asthma.
Barkai, L; Emeryk, A; Engelstätter, R; Hirsch, S; Pedersen, S; Vermeulen, J; Weber, H; Weber, HJ, 2009
)
0.66
" The treatment must have been withdrawn after a year, because of a whole range of adverse effects, even though there was a severe recurrence of symptoms during the therapy."( Treatment of Churg-Strauss syndrome with an inhaled corticosteroid after oral steroids discontinuation due to side effects.
Doboszynska, A; Swietlik, E, 2008
)
0.35
"Inhaled corticosteroids (ICSs) are considered the most effective therapy currently available for persistent asthma and is the guideline-recommended first-line treatment for all patients requiring controller medication; however, the potential for oropharyngeal and systemic adverse events can be a barrier to their use."( The safety profile of ciclesonide in the treatment of persistent asthma.
Craig, T,
)
0.45
" Incidence of adverse events was similar among treatment groups (range, 52."( Efficacy and safety evaluation of ciclesonide in mild-to-moderate persistent asthma previously treated with inhaled corticosteroids.
Karafilidis, J; Korenblat, PE; Meltzer, EO; Noonan, M; Weinstein, SF,
)
0.41
" The incidence of adverse events was similar among treatment groups (range, 53-58%)."( Efficacy and safety evaluation of ciclesonide in subjects with mild-to-moderate asthma not currently using inhaled corticosteroids.
Bensch, G; Berger, WE; Bernstein, DI; Karafilidis, J; Kerwin, E; Pedinoff, A,
)
0.41
" Patients rated the side effect questions of the 15 domain ICQ on a 7-point Likert scale (0 = not at all, 6 = a very great deal) during scheduled visits."( Difference between patient-reported side effects of ciclesonide versus fluticasone propionate.
Caeser, M; Foster, JM; Müller, T; Postma, DS; van der Molen, T, 2010
)
0.61
"The majority of side effect scores remained similar with ciclesonide but worsened statistically significantly with fluticasone propionate from baseline to the end of the study in within-treatment analyses."( Difference between patient-reported side effects of ciclesonide versus fluticasone propionate.
Caeser, M; Foster, JM; Müller, T; Postma, DS; van der Molen, T, 2010
)
0.86
" Safety assessments included: adverse events (AEs), urinary cortisol excretion and body height."( Efficacy and safety of three ciclesonide doses vs placebo in children with asthma: the RAINBOW study.
Bosheva, M; Dachev, S; Dunkel, J; Engelstätter, R; Kaczmarek, J; Pedersen, S; Potter, P; Springer, E, 2010
)
0.65
" In both groups, the incidence of adverse effects (AEs) was low and mean cortisol levels in serum and urine were not suppressed during the EP."( Efficacy and safety of ciclesonide in patients with severe asthma: a 12-week, double-blind, randomized, parallel-group study with long-term (1-year) follow-up.
Ayres, JG; Blagden, MD; Cheung, D; Engelstätter, R; Kafé, H; Kilfeather, S; O'Connor, BJ; Schlösser, N; Weber, HJ, 2010
)
0.67
" FEV(1), PEF, NO, asthma episodes, use of rescue medication and adverse drug reactions (ADR) were recorded."( Efficacy and safety of ciclesonide in the treatment of 24,037 asthmatic patients in routine medical care.
Bethke, TD; Hering, T; Lewin, T; Sander, P; Vogelmeier, CF, 2011
)
0.68
" Treatment-emergent adverse events were monitored throughout the study."( Evaluation of the efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol, 80 or 160 μg once daily, for the treatment of seasonal allergic rhinitis.
Desai, SY; Hinkle, J; Huang, H; Jacobs, R; Mohar, D; Ratner, P, 2010
)
0.63
" The overall incidence of treatment-emergent adverse events was low and comparable between the CIC-HFA and placebo groups."( Evaluation of the efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol, 80 or 160 μg once daily, for the treatment of seasonal allergic rhinitis.
Desai, SY; Hinkle, J; Huang, H; Jacobs, R; Mohar, D; Ratner, P, 2010
)
0.63
" Serum cortisol (AUC(0-24h)) and adverse events (AE) were also evaluated."( An investigation of the pharmacokinetics, pharmacodynamics, safety, and tolerability of ciclesonide hydrofluoroalkane nasal aerosol in healthy subjects and subjects with perennial allergic rhinitis.
Desai, SY; Herzog, R; Huang, H; Maier, G; Nave, R; Ratner, P; Wingertzahn, MA, 2011
)
0.59
" Recent studies, which evaluated topical and systemic adverse events associated with ciclesonide (CIC), fluticasone furoate (FF), mometasone furoate (MF), triamcinolone acetonide, fluticasone propionate, budesonide, and beclomethasone dipropionate were summarized."( Safety update regarding intranasal corticosteroids for the treatment of allergic rhinitis.
Blaiss, MS,
)
0.36
" Adverse events (AEs) were monitored throughout the study."( A study of the efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol in patients with seasonal allergic rhinitis from mountain cedar pollen.
Andrews, C; Bode, F; Desai, SY; Hinkle, J; Howland, W; Huang, H; Martin, B; Ratner, PH,
)
0.4
" However, there is a concomitant risk of increasing local and systemic adverse events, which may impact patient adherence and physician prescribing practices."( Efficacy and safety of high-dose ciclesonide for the treatment of severe asthma.
Bateman, ED, 2013
)
0.67
" However, their long-term use is associated with various oropharyngeal and systemic side and adverse effects."( Ciclesonide: A Pro-Soft Drug Approach for Mitigation of Side Effects of Inhaled Corticosteroids.
Derendorf, H; Mukker, JK; Singh, RSP, 2016
)
1.88
"Ciclesonide can improve perennial allergic rhinitis without increasing adverse events."( The efficacy and safety of ciclesonide for the treatment of perennial allergic rhinitis: a systematic review and meta-analysis.
Dong, Y; He, L; Li, B; Wang, F; Wu, W; Xiang, N; Xie, D; Yang, Q,
)
1.87
"Synthetic glucocorticoids (sGCs) such as dexamethasone (DEX), while used to mitigate inflammation and disease progression in premature infants with severe bronchopulmonary dysplasia (BPD), are also associated with significant adverse neurologic effects such as reductions in myelination and abnormalities in neuroanatomical development."( Ciclesonide activates glucocorticoid signaling in neonatal rat lung but does not trigger adverse effects in the cortex and cerebellum.
Bargerstock, EM; Cole, TJ; DeFranco, DB; Franks, AL; Ghersi, A; Jaumotte, JD; Kisanga, EP; Menden, HL; Monaghan-Nichols, AP; Omar, M; Rudine, A; Sampath, V; Short, KL; Silswal, N; Wang, L, 2021
)
2.06

Pharmacokinetics

The primary pharmacokinetic parameters were AUC(0-infinity) and C(max) of desisobutyryl ciclesonide. The method was fully validated and successfully applied to determine CIC and des-CIC simultaneously in human plasma.

ExcerptReferenceRelevance
" The study objectives were to identify a structural model for population pharmacokinetic (PK) analysis of CIC-AP using nonlinear mixed-effects modeling, assess the influence of select covariates on PK and/or pharmacodynamic (PD) parameters, and investigate the effects of CIC-AP on endogenous cortisol."( Population pharmacokinetics and pharmacodynamics of ciclesonide.
Arya, V; Barrett, JS; Hochhaus, G; Jensen, BK; Nave, R; Rohatagi, S; Zech, K, 2003
)
0.57
" The mean terminal half-life (t1/2) for des-CIC was also similar in patients with asthma (3."( Pharmacokinetic disposition of inhaled ciclesonide and its metabolite desisobutyryl-ciclesonide in healthy subjects and patients with asthma are similar.
Bethke, TD; Gunawardena, KA; Nave, R; Zech, K, 2006
)
0.6
"After administration of a single dose of ciclesonide, the pharmacokinetic parameter estimates for des-CIC were equivalent between patients with mild-to-moderate asthma and healthy subjects, suggesting that there is comparable lung deposition and activation of ciclesonide in the 2 populations."( Pharmacokinetic disposition of inhaled ciclesonide and its metabolite desisobutyryl-ciclesonide in healthy subjects and patients with asthma are similar.
Bethke, TD; Gunawardena, KA; Nave, R; Zech, K, 2006
)
0.87
"A randomised, open-label, 2-period crossover, single-center pharmacokinetic study was conducted in 30 patients with asthma (forced expiratory volume in 1 second > or = 70% predicted)."( Equivalent pharmacokinetics of the active metabolite of ciclesonide with and without use of the AeroChamber Plus spacer for inhalation.
Baumgärtner, E; Bethke, TD; Drollmann, A; Nave, R; Steinijans, VW, 2006
)
0.58
"The pharmacokinetic properties of the active metabolite, des-CIC, were equivalent after inhalation of ciclesonide with and without the AeroChamber Plus spacer."( Equivalent pharmacokinetics of the active metabolite of ciclesonide with and without use of the AeroChamber Plus spacer for inhalation.
Baumgärtner, E; Bethke, TD; Drollmann, A; Nave, R; Steinijans, VW, 2006
)
0.8
"The pharmacokinetic and pharmacodynamic effects of inhaled corticosteroids (ICS) have shaped the efficacy and safety of these agents in the treatment of asthma."( Relevance of pharmacokinetics and pharmacodynamics of inhaled corticosteroids to asthma.
Cerasoli, F; Derendorf, H; Drollmann, A; Nave, R; Wurst, W, 2006
)
0.33
" Ciclesonide is a novel inhaled corticosteroid that possesses a unique pharmacokinetic and pharmacodynamic profile."( Pharmacokinetic and pharmacodynamic properties of inhaled ciclesonide.
Derendorf, H, 2007
)
1.49
" This pharmacokinetic drug-drug interaction study was conducted to confirm this major metabolic pathway in vivo by using the strong CYP3A4 inhibitor ketoconazole, and to assess the effect of ketoconazole on the pharmacokinetics of ciclesonide and des-CIC."( Effect of coadministered ketoconazole, a strong cytochrome P450 3A4 enzyme inhibitor, on the pharmacokinetics of ciclesonide and its active metabolite desisobutyryl-ciclesonide.
Böhmer, GM; Drollmann, A; Gleiter, CH; Nave, R, 2008
)
0.74
"Fourteen healthy adults participated in this open-label, nonrandomized, fixed sequence, two-period, repeated-dose pharmacokinetic study."( Effect of coadministered ketoconazole, a strong cytochrome P450 3A4 enzyme inhibitor, on the pharmacokinetics of ciclesonide and its active metabolite desisobutyryl-ciclesonide.
Böhmer, GM; Drollmann, A; Gleiter, CH; Nave, R, 2008
)
0.56
"For the parent compound, ciclesonide, no changes in the pharmacokinetic parameter estimates--the area under the serum concentration-time curve during the dosage interval (AUC(tau)), maximum serum concentration (C(max)) and time to reach the C(max)--were observed."( Effect of coadministered ketoconazole, a strong cytochrome P450 3A4 enzyme inhibitor, on the pharmacokinetics of ciclesonide and its active metabolite desisobutyryl-ciclesonide.
Böhmer, GM; Drollmann, A; Gleiter, CH; Nave, R, 2008
)
0.86
" The availability of pharmacokinetic parameters (clearance [CL/F]; volume of distribution [Vd/F]; elimination half-life [T(½)]; and elimination rate constant [Kel]) in mice, rats, rabbits, and dogs enabled the prediction of human parameter values for des-ciclesonide using the well-accepted tool of allometry after intravenous administration of ciclesonide."( Allometric modeling of ciclesonide, a nonhalogenated glucocorticoid, and its active metabolite, desisobutyrylciclesonide, using animal-derived pharmacokinetic parameters.
Ahlawat, P; Shaik, JB; Srinivas, NR,
)
0.62
" The unique pharmacokinetic and pharmacodynamic profile of ciclesonide offers a rationale that supports the favourable risk-benefit profile observed in clinical trials in patients with persistent asthma."( Clinical pharmacokinetic and pharmacodynamic profile of inhaled ciclesonide.
Nave, R, 2009
)
0.83
" The primary pharmacokinetic parameters were AUC(0-infinity) and C(max) of desisobutyryl ciclesonide."( Pharmacokinetics of ciclesonide and desisobutyryl ciclesonide after administration via aqueous nasal spray or hydrofluoroalkane nasal aerosol compared with orally inhaled ciclesonide: an open-label, single-dose, three-period crossover study in healthy vol
Herzog, R; Laurent, A; Nave, R; Wingertzahn, MA, 2009
)
0.9
" The method was fully validated and successfully applied to determine CIC and des-CIC simultaneously in human plasma and proved to be suitable for phase I clinical pharmacokinetic study of inhaled ciclesonide in healthy Chinese volunteers."( Simultaneous determination of ciclesonide and its active metabolite desisobutyryl-ciclesonide in human plasma by LC-APCI-MS/MS: application to pharmacokinetic study in healthy Chinese volunteers.
Hang, TJ; Song, M; Su, MX; Wang, YQ; Zhuang, Y, 2011
)
0.85
"The pharmacokinetic parameters (AUC from time zero to last observed concentration [AUC(t)], AUC over the dosage interval τ at steady state [AUC(ss)], maximum concentration [C(max)], and terminal elimination half-life [T(1/2)]) and the temporal changes in the serum levels of des-isobutyryl-ciclesonide after repeated administration of CIC-HFA (200 μg/day) in Japanese children with bronchial asthma differed only slightly from those in Caucasian children with bronchial asthma."( Repeated-dose pharmacokinetics of inhaled ciclesonide (CIC-HFA) in Japanese children with bronchial asthma: a phase I study.
Azuma, J; Fukao, T; Kaneko, H; Kato, Z; Kondo, N; Matsui, E; Nishima, S; Ohnishi, H; Sakai, K; Teramoto, T; Yonezawa, H, 2012
)
0.82

Bioavailability

Ciclesonide and its active metabolite have low systemic bioavailability and therefore have a low potential to produce systemic adverse events. The pharmacokinetics of ciclesonides in all animal species were characterized by a low oral bioavailability (approximately 6% or less), a high clearance, and a large volume of distribution.

ExcerptReferenceRelevance
"To investigate the extent of oral absorption and bioavailability of ciclesonide referenced to an intravenous infusion."( Pharmacokinetics of [14C]ciclesonide after oral and intravenous administration to healthy subjects.
Bethke, TD; Nave, R; van Marle, SP; Zech, K, 2004
)
0.86
" Thus, systemic bioavailability for des-CIC is <1% and the absolute bioavailability of ciclesonide is even less than this."( Pharmacokinetics of [14C]ciclesonide after oral and intravenous administration to healthy subjects.
Bethke, TD; Nave, R; van Marle, SP; Zech, K, 2004
)
0.85
" In addition, other favourable pharmacokinetic and pharmacodynamic characteristics such as high protein binding, low oral bioavailability and rapid clearance contribute to the efficacy and improved systemic safety profile of ciclesonide."( Ciclesonide: a novel inhaled corticosteroid.
Humbert, M, 2004
)
1.95
" The pharmacokinetics of ciclesonide in all animal species were characterized by a low oral bioavailability (approximately 6% or less), a high clearance, and a large volume of distribution."( Ciclesonide disposition and metabolism: pharmacokinetics, metabolism, and excretion in the mouse, rat, rabbit, and dog.
Cai, L; Chen, K; Gu, Z; Guo, Z; Howell, SR; Rohatagi, S; Stuhler, J; Wu, J,
)
1.88
" The bioavailability of these products is essential in order to determine the incidence of side effects."( Inhaled corticosteroids in the treatment of respiratory allergy: safety vs. efficacy.
Rizzo, MC; Solé, D, 2006
)
0.33
" Ciclesonide and its active metabolite have low systemic bioavailability and therefore have a low potential to produce systemic adverse events."( Ciclesonide: a review of its use in the management of asthma.
Deeks, ED; Perry, CM, 2008
)
2.7
" In conclusion, the data suggested that allometry tool may be amenable for the prediction of the pharmacokinetic parameters of des-ciclesonide despite differences in the conversion rates and bioavailability of the active metabolite in various animal species."( Allometric modeling of ciclesonide, a nonhalogenated glucocorticoid, and its active metabolite, desisobutyrylciclesonide, using animal-derived pharmacokinetic parameters.
Ahlawat, P; Shaik, JB; Srinivas, NR,
)
0.65
" Due to the negligible oral bioavailability the pharmacokinetic parameters following inhalation are a surrogate for lung deposition."( Determination of lung deposition following inhalation of ciclesonide using different bioanalytical procedures.
Nave, R, 2010
)
0.61
" Ciclesonide is a corticosteroid with unique pharmacological profile including a high degree of serum protein binding, a low oral bioavailability and rapid systemic elimination."( Ciclesonide--a novel corticosteroid for the management of asthma.
Bhandari, B; Chopra, D; Wardhan, N, 2012
)
2.73
" Pharmacokinetic studies have revealed no drug-drug interactions but a discrete increase in bioavailability of fluticasone propionate which was considered clinically unimportant."( New patents of fixed combinations of nasal antihistamines and corticosteroids in allergic rhinitis.
Wolthers, OD, 2013
)
0.39
"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

Dosage Studied

Ciclesonide is delivered in solution form via a hydrofluoroalkane metered-dose inhaler (MDI) with a once-daily dosing schedule, which facilitates patient compliance. The presence of des-CIC fatty acid conjugates at >24 h after dosing suggests that cicles onide is appropriate for once- daily dosing. A significant dose-response occurred between low and higher doses of ciclesonides for exacerbations and asthma control definitions.

ExcerptRelevanceReference
" We have previously demonstrated that inhaled budesonide reduced airway responsiveness to the mast cell stimulus adenosine-5'-monophosphate (AMP) to a threefold greater extent than to methacholine and sodium metabisulfite, suggesting that AMP responsiveness may be a more sensitive marker of airway inflammation and steroid action in order to assess a dose-response relationship."( A dose-dependent effect of the novel inhaled corticosteroid ciclesonide on airway responsiveness to adenosine-5'-monophosphate in asthmatic patients.
Barnes, PJ; Engelstätter, R; Jensen, MW; Kanabar, V; O'Connor, BJ; Steinijans, VW; Taylor, DA, 1999
)
0.55
" Regarding morning PEF, the improvements after evening dosing were more prominent and equivalence of morning and evening administration could not be demonstrated."( Treatment of asthma by the inhaled corticosteroid ciclesonide given either in the morning or evening.
Aumann, J; Kafé, H; Martinat, Y; Postma, DS; Schlösser, N; Sevette, C, 2001
)
0.56
" Therefore, a placebo-controlled, randomized, double-blind, four-period, change-over equivalence study in 12 healthy male volunteers (age 21-28 yr, body weight 62-90 kg) was conducted to assess the influence of three dosage regimens (800 microg in the morning, 800 microg in the evening, 400 microg twice daily for 7 d, metered inhalers) on the circadian time serum cortisol rhythm."( Circadian rhythm of serum cortisol after repeated inhalation of the new topical steroid ciclesonide.
Bethke, T; Drollmann, A; Engel, G; Hüneke, D; Kaatz, HJ; Siegmund, W; Steinijans, VW; Timmer, W; Weinbrenner, A; Wurst, W; Zschiesche, M, 2002
)
0.54
" The compound is formulated for once-daily dosing and demonstrated good efficacy without corticosteroid-associated systemic side effects [409257]."( Ciclesonide ( Byk Gulden).
Dent, G, 2002
)
1.76
" However, a range of unwanted side effects and the often complex dosing schedules associated with these drugs frequently result in poor patient compliance."( Soft steroids: a new approach to the treatment of inflammatory airways diseases.
Belvisi, MG; Hele, DJ, 2003
)
0.32
" Ciclesonide is delivered in solution form via a hydrofluoroalkane metered-dose inhaler (MDI) with a once-daily dosing schedule, which facilitates patient compliance."( Ciclesonide: a novel inhaled corticosteroid for asthma.
Christie, P, 2004
)
2.68
" There was no statistically significant dose-response effect."( Short-term lower-leg growth rate and urine cortisol excretion in children treated with ciclesonide.
Agertoft, L; Pedersen, S, 2005
)
0.55
" PC20 more than doubled with each active treatment, but no statistically significant dose-response effect could be established."( Effects of inhaled ciclesonide and fluticasone propionate on cortisol secretion and airway responsiveness to adenosine 5'monophosphate in asthmatic patients.
Derom, E; Engelstätter, R; Marissens, S; Pauwels, R; Van De Velde, V; Vincken, W, 2005
)
0.66
" A 1-compartment model with first-order absorption, an endogenous "predose" cortisol concentration at dose interval and a lag time based on a fixed, hypothetical cortisol dosing time of 10:00 PM could adequately characterize the circadian rhythm of endogenous cortisol release."( Model-based covariate pharmacokinetic analysis and lack of cortisol suppression by the new inhaled corticosteroid ciclesonide using a novel cortisol release model.
Krishnaswami, S; Pfister, M; Rohatagi, S; Sahasranaman, S,
)
0.34
" The presence of des-CIC fatty acid conjugates at >24 h after dosing suggests that ciclesonide is appropriate for once-daily dosing."( Formation of fatty acid conjugates of ciclesonide active metabolite in the rat lung after 4-week inhalation of ciclesonide.
Fuhst, R; Meyer, W; Nave, R; Zech, K, 2005
)
0.82
" In addition to concerns about ICS safety, dosing regimens that are difficult to follow may further reduce a patient's ability to comply with treatment."( Safety of inhaled corticosteroids: room for improvement.
Cazzola, M; Cerasoli, F; Rossi, GA, 2007
)
0.34
"Demonstrating clinical benefit of higher doses of inhaled corticosteroids in asthma is frequently problematic owing to their relatively flat dose-response curve in this condition."( Randomized comparison of ciclesonide 160 and 640 microg/day in severe asthma.
Bateman, ED; Cheung, D; Engelstätter, R; Göhring, UM; Lapa e Silva, J; Schäfer, M, 2008
)
0.65
"05); however, no dose-response effect was seen and the difference between groups was not significant (p=0."( Randomized comparison of ciclesonide 160 and 640 microg/day in severe asthma.
Bateman, ED; Cheung, D; Engelstätter, R; Göhring, UM; Lapa e Silva, J; Schäfer, M, 2008
)
0.65
"For the parent compound, ciclesonide, no changes in the pharmacokinetic parameter estimates--the area under the serum concentration-time curve during the dosage interval (AUC(tau)), maximum serum concentration (C(max)) and time to reach the C(max)--were observed."( Effect of coadministered ketoconazole, a strong cytochrome P450 3A4 enzyme inhibitor, on the pharmacokinetics of ciclesonide and its active metabolite desisobutyryl-ciclesonide.
Böhmer, GM; Drollmann, A; Gleiter, CH; Nave, R, 2008
)
0.86
" A significant dose-response occurred between low and higher doses of ciclesonide for exacerbations and asthma control definitions."( Efficacy and safety of ciclesonide once daily and fluticasone propionate twice daily in children with asthma.
Barkai, L; Emeryk, A; Engelstätter, R; Hirsch, S; Pedersen, S; Vermeulen, J; Weber, H; Weber, HJ, 2009
)
0.9
" All of the inhaled corticosteroids demonstrate efficacy with once-daily dosing, and all are more effective when dosed twice daily."( Comparison of inhaled corticosteroids: an update.
Kelly, HW, 2009
)
0.35
" The CIC showed the least serum cortisol suppression of the tested dosing regimens."( Population pharmacokinetics and pharmacodynamics of inhaled ciclesonide and fluticasone propionate in patients with persistent asthma.
Derendorf, H; Derom, E; Lahu, G; Nave, R; Xu, J, 2010
)
0.6
" In addition, clinical dosing strategies for ICSs including as-needed use will be explored."( Updates on the use of inhaled corticosteroids in asthma.
Kelly, HW; Stoloff, SW, 2011
)
0.37
"The pharmacokinetic parameters (AUC from time zero to last observed concentration [AUC(t)], AUC over the dosage interval τ at steady state [AUC(ss)], maximum concentration [C(max)], and terminal elimination half-life [T(1/2)]) and the temporal changes in the serum levels of des-isobutyryl-ciclesonide after repeated administration of CIC-HFA (200 μg/day) in Japanese children with bronchial asthma differed only slightly from those in Caucasian children with bronchial asthma."( Repeated-dose pharmacokinetics of inhaled ciclesonide (CIC-HFA) in Japanese children with bronchial asthma: a phase I study.
Azuma, J; Fukao, T; Kaneko, H; Kato, Z; Kondo, N; Matsui, E; Nishima, S; Ohnishi, H; Sakai, K; Teramoto, T; Yonezawa, H, 2012
)
0.82
" The primary assessments were TPS and regimen attributes composite satisfaction score composed of two of nine satisfaction subscales: sensory impact (including medication running out of the nose, medication running down the throat, and impact on smell and taste) and regimen management (comprised of issues relating to dosing and ability to remember to take medication)."( A patient preference and satisfaction study of ciclesonide nasal aerosol and mometasone furoate aqueous nasal spray in patients with perennial allergic rhinitis.
Berger, WE; Meltzer, EO; Prenner, B; Turner, R,
)
0.39
" The practical advantage of once-daily dosing with ciclesonide seems minor."( Ciclesonide: long-term treatment of persistent asthma--no clear progress.
, 2013
)
2.08
" The present results demonstrated that ciclesonide suspension has the potential to achieve once-daily dosing for nebulization therapy and the in vitro dissolution profile has limited usefulness in predicting in vitro-in vivo correlation."( Ciclesonide and budesonide suspensions for nebulization delivery: An in vivo inhalation biopharmaceutics investigation.
Fu, TT; Liao, YH; Liu, CY; Wen, H; Yang, FF; Zhao, Y, 2018
)
2.19
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
organic molecular entityAny molecular entity that contains carbon.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (17)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
PPM1D proteinHomo sapiens (human)Potency0.16540.00529.466132.9993AID1347411
AR proteinHomo sapiens (human)Potency2.68070.000221.22318,912.5098AID743040; AID743042; AID743053; AID743054
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency0.12590.01237.983543.2770AID1346984
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency0.03550.000214.376460.0339AID720691; AID720692; AID720719
pregnane X nuclear receptorHomo sapiens (human)Potency0.63100.005428.02631,258.9301AID1346985
estrogen nuclear receptor alphaHomo sapiens (human)Potency15.80420.000229.305416,493.5996AID743069; AID743075; AID743078; AID743079; AID743080
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_aHomo sapiens (human)Potency0.05310.001723.839378.1014AID743083
nuclear receptor subfamily 1, group I, member 2Rattus norvegicus (Norway rat)Potency7.94330.10009.191631.6228AID1346983
potassium voltage-gated channel subfamily H member 2 isoform dHomo sapiens (human)Potency3.98110.01789.637444.6684AID588834
thyroid hormone receptor beta isoform 2Rattus norvegicus (Norway rat)Potency11.71110.000323.4451159.6830AID743065; AID743067
Interferon betaHomo sapiens (human)Potency0.16540.00339.158239.8107AID1347411
Cellular tumor antigen p53Homo sapiens (human)Potency8.41270.002319.595674.0614AID651631
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Bile salt export pumpHomo sapiens (human)IC50 (µMol)133.00000.11007.190310.0000AID1473738
Replicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2IC50 (µMol)4.33000.00022.45859.9600AID1804171
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (194)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell activation involved in immune responseInterferon betaHomo sapiens (human)
cell surface receptor signaling pathwayInterferon betaHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to virusInterferon betaHomo sapiens (human)
positive regulation of autophagyInterferon betaHomo sapiens (human)
cytokine-mediated signaling pathwayInterferon betaHomo sapiens (human)
natural killer cell activationInterferon betaHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT proteinInterferon betaHomo sapiens (human)
cellular response to interferon-betaInterferon betaHomo sapiens (human)
B cell proliferationInterferon betaHomo sapiens (human)
negative regulation of viral genome replicationInterferon betaHomo sapiens (human)
innate immune responseInterferon betaHomo sapiens (human)
positive regulation of innate immune responseInterferon betaHomo sapiens (human)
regulation of MHC class I biosynthetic processInterferon betaHomo sapiens (human)
negative regulation of T cell differentiationInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIInterferon betaHomo sapiens (human)
defense response to virusInterferon betaHomo sapiens (human)
type I interferon-mediated signaling pathwayInterferon betaHomo sapiens (human)
neuron cellular homeostasisInterferon betaHomo sapiens (human)
cellular response to exogenous dsRNAInterferon betaHomo sapiens (human)
cellular response to virusInterferon betaHomo sapiens (human)
negative regulation of Lewy body formationInterferon betaHomo sapiens (human)
negative regulation of T-helper 2 cell cytokine productionInterferon betaHomo sapiens (human)
positive regulation of apoptotic signaling pathwayInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell differentiationInterferon betaHomo sapiens (human)
natural killer cell activation involved in immune responseInterferon betaHomo sapiens (human)
adaptive immune responseInterferon betaHomo sapiens (human)
T cell activation involved in immune responseInterferon betaHomo sapiens (human)
humoral immune responseInterferon betaHomo sapiens (human)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycle G2/M phase transitionCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
ER overload responseCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
mitophagyCellular tumor antigen p53Homo sapiens (human)
in utero embryonic developmentCellular tumor antigen p53Homo sapiens (human)
somitogenesisCellular tumor antigen p53Homo sapiens (human)
release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
hematopoietic progenitor cell differentiationCellular tumor antigen p53Homo sapiens (human)
T cell proliferation involved in immune responseCellular tumor antigen p53Homo sapiens (human)
B cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
T cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
response to ischemiaCellular tumor antigen p53Homo sapiens (human)
nucleotide-excision repairCellular tumor antigen p53Homo sapiens (human)
double-strand break repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
protein import into nucleusCellular tumor antigen p53Homo sapiens (human)
autophagyCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in cell cycle arrestCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in transcription of p21 class mediatorCellular tumor antigen p53Homo sapiens (human)
transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
Ras protein signal transductionCellular tumor antigen p53Homo sapiens (human)
gastrulationCellular tumor antigen p53Homo sapiens (human)
neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
protein localizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA replicationCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
determination of adult lifespanCellular tumor antigen p53Homo sapiens (human)
mRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
rRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
response to salt stressCellular tumor antigen p53Homo sapiens (human)
response to inorganic substanceCellular tumor antigen p53Homo sapiens (human)
response to X-rayCellular tumor antigen p53Homo sapiens (human)
response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
positive regulation of gene expressionCellular tumor antigen p53Homo sapiens (human)
cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
viral processCellular tumor antigen p53Homo sapiens (human)
glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
cerebellum developmentCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell growthCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
negative regulation of transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
mitotic G1 DNA damage checkpoint signalingCellular tumor antigen p53Homo sapiens (human)
negative regulation of telomere maintenance via telomeraseCellular tumor antigen p53Homo sapiens (human)
T cell differentiation in thymusCellular tumor antigen p53Homo sapiens (human)
tumor necrosis factor-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
regulation of tissue remodelingCellular tumor antigen p53Homo sapiens (human)
cellular response to UVCellular tumor antigen p53Homo sapiens (human)
multicellular organism growthCellular tumor antigen p53Homo sapiens (human)
positive regulation of mitochondrial membrane permeabilityCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
entrainment of circadian clock by photoperiodCellular tumor antigen p53Homo sapiens (human)
mitochondrial DNA repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
transcription initiation-coupled chromatin remodelingCellular tumor antigen p53Homo sapiens (human)
negative regulation of proteolysisCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of RNA polymerase II transcription preinitiation complex assemblyCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
response to antibioticCellular tumor antigen p53Homo sapiens (human)
fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
circadian behaviorCellular tumor antigen p53Homo sapiens (human)
bone marrow developmentCellular tumor antigen p53Homo sapiens (human)
embryonic organ developmentCellular tumor antigen p53Homo sapiens (human)
positive regulation of peptidyl-tyrosine phosphorylationCellular tumor antigen p53Homo sapiens (human)
protein stabilizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of helicase activityCellular tumor antigen p53Homo sapiens (human)
protein tetramerizationCellular tumor antigen p53Homo sapiens (human)
chromosome organizationCellular tumor antigen p53Homo sapiens (human)
neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
hematopoietic stem cell differentiationCellular tumor antigen p53Homo sapiens (human)
negative regulation of glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
type II interferon-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
cardiac septum morphogenesisCellular tumor antigen p53Homo sapiens (human)
positive regulation of programmed necrotic cell deathCellular tumor antigen p53Homo sapiens (human)
protein-containing complex assemblyCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to endoplasmic reticulum stressCellular tumor antigen p53Homo sapiens (human)
thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
necroptotic processCellular tumor antigen p53Homo sapiens (human)
cellular response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
cellular response to xenobiotic stimulusCellular tumor antigen p53Homo sapiens (human)
cellular response to ionizing radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to UV-CCellular tumor antigen p53Homo sapiens (human)
stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
cellular response to actinomycin DCellular tumor antigen p53Homo sapiens (human)
positive regulation of release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
cellular senescenceCellular tumor antigen p53Homo sapiens (human)
replicative senescenceCellular tumor antigen p53Homo sapiens (human)
oxidative stress-induced premature senescenceCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
oligodendrocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of execution phase of apoptosisCellular tumor antigen p53Homo sapiens (human)
negative regulation of mitophagyCellular tumor antigen p53Homo sapiens (human)
regulation of mitochondrial membrane permeability involved in apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of G1 to G0 transitionCellular tumor antigen p53Homo sapiens (human)
negative regulation of miRNA processingCellular tumor antigen p53Homo sapiens (human)
negative regulation of glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
negative regulation of pentose-phosphate shuntCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
regulation of fibroblast apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
positive regulation of cellular senescenceCellular tumor antigen p53Homo sapiens (human)
positive regulation of intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (71)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
cytokine activityInterferon betaHomo sapiens (human)
cytokine receptor bindingInterferon betaHomo sapiens (human)
type I interferon receptor bindingInterferon betaHomo sapiens (human)
protein bindingInterferon betaHomo sapiens (human)
chloramphenicol O-acetyltransferase activityInterferon betaHomo sapiens (human)
transcription cis-regulatory region bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
core promoter sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
TFIID-class transcription factor complex bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
protease bindingCellular tumor antigen p53Homo sapiens (human)
p53 bindingCellular tumor antigen p53Homo sapiens (human)
DNA bindingCellular tumor antigen p53Homo sapiens (human)
chromatin bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activityCellular tumor antigen p53Homo sapiens (human)
mRNA 3'-UTR bindingCellular tumor antigen p53Homo sapiens (human)
copper ion bindingCellular tumor antigen p53Homo sapiens (human)
protein bindingCellular tumor antigen p53Homo sapiens (human)
zinc ion bindingCellular tumor antigen p53Homo sapiens (human)
enzyme bindingCellular tumor antigen p53Homo sapiens (human)
receptor tyrosine kinase bindingCellular tumor antigen p53Homo sapiens (human)
ubiquitin protein ligase bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase regulator activityCellular tumor antigen p53Homo sapiens (human)
ATP-dependent DNA/DNA annealing activityCellular tumor antigen p53Homo sapiens (human)
identical protein bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase bindingCellular tumor antigen p53Homo sapiens (human)
protein heterodimerization activityCellular tumor antigen p53Homo sapiens (human)
protein-folding chaperone bindingCellular tumor antigen p53Homo sapiens (human)
protein phosphatase 2A bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II-specific DNA-binding transcription factor bindingCellular tumor antigen p53Homo sapiens (human)
14-3-3 protein bindingCellular tumor antigen p53Homo sapiens (human)
MDM2/MDM4 family protein bindingCellular tumor antigen p53Homo sapiens (human)
disordered domain specific bindingCellular tumor antigen p53Homo sapiens (human)
general transcription initiation factor bindingCellular tumor antigen p53Homo sapiens (human)
molecular function activator activityCellular tumor antigen p53Homo sapiens (human)
promoter-specific chromatin bindingCellular tumor antigen p53Homo sapiens (human)
3'-5'-RNA exonuclease activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
RNA-dependent RNA polymerase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
cysteine-type endopeptidase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
mRNA 5'-cap (guanine-N7-)-methyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
mRNA (nucleoside-2'-O-)-methyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
mRNA guanylyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
RNA endonuclease activity, producing 3'-phosphomonoestersReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
ISG15-specific peptidase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
5'-3' RNA helicase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
protein guanylyltransferase activityReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (38)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
nuclear bodyCellular tumor antigen p53Homo sapiens (human)
nucleusCellular tumor antigen p53Homo sapiens (human)
nucleoplasmCellular tumor antigen p53Homo sapiens (human)
replication forkCellular tumor antigen p53Homo sapiens (human)
nucleolusCellular tumor antigen p53Homo sapiens (human)
cytoplasmCellular tumor antigen p53Homo sapiens (human)
mitochondrionCellular tumor antigen p53Homo sapiens (human)
mitochondrial matrixCellular tumor antigen p53Homo sapiens (human)
endoplasmic reticulumCellular tumor antigen p53Homo sapiens (human)
centrosomeCellular tumor antigen p53Homo sapiens (human)
cytosolCellular tumor antigen p53Homo sapiens (human)
nuclear matrixCellular tumor antigen p53Homo sapiens (human)
PML bodyCellular tumor antigen p53Homo sapiens (human)
transcription repressor complexCellular tumor antigen p53Homo sapiens (human)
site of double-strand breakCellular tumor antigen p53Homo sapiens (human)
germ cell nucleusCellular tumor antigen p53Homo sapiens (human)
chromatinCellular tumor antigen p53Homo sapiens (human)
transcription regulator complexCellular tumor antigen p53Homo sapiens (human)
protein-containing complexCellular tumor antigen p53Homo sapiens (human)
double membrane vesicle viral factory outer membraneReplicase polyprotein 1abSevere acute respiratory syndrome coronavirus 2
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (27)

Assay IDTitleYearJournalArticle
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1763053Antiviral activity against SARS-CoV-2 JPN/TY/WK-251 infected in African green monkey Vero E6 cells expressing TMPRSS2 assessed as reduction in viral RNA replication by measuring replication copies assessed per well at 10 uM incubated for 18 hrs by qRT-PCR2021Bioorganic & medicinal chemistry letters, 07-01, Volume: 43Development of ciclesonide analogues that block SARS-CoV-2 RNA replication.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1763050Cytotoxicity against African green monkey Vero E6 cells expressing TMPRSS2 assessed as reduction in cell viability upto 40 uM incubated for 18 hrs by LDH assay2021Bioorganic & medicinal chemistry letters, 07-01, Volume: 43Development of ciclesonide analogues that block SARS-CoV-2 RNA replication.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1763054Antiviral activity against SARS-CoV-2 JPN/TY/WK-251 infected in African Green monkey Vero E6 cells expressing TMPRSS2 assessed as reduction in viral plaques incubated for 18 hrs by plaque reduction assay2021Bioorganic & medicinal chemistry letters, 07-01, Volume: 43Development of ciclesonide analogues that block SARS-CoV-2 RNA replication.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346849Human Glucocorticoid receptor (3C. 3-Ketosteroid receptors)2005The Journal of pharmacology and experimental therapeutics, Aug, Volume: 314, Issue:2
Preclinical profile of ciclesonide, a novel corticosteroid for the treatment of asthma.
AID1804171DRC analysis by immunofluorescence from Article 10.1128/AAC.00819-20: \\Identification of Antiviral Drug Candidates against SARS-CoV-2 from FDA-Approved Drugs.\\2020Antimicrobial agents and chemotherapy, 06-23, Volume: 64, Issue:7
Identification of Antiviral Drug Candidates against SARS-CoV-2 from FDA-Approved Drugs.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (254)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's2 (0.79)18.2507
2000's139 (54.72)29.6817
2010's70 (27.56)24.3611
2020's43 (16.93)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 77.19

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

MetricThis Compound (vs All)
Research Demand Index77.19 (24.57)
Research Supply Index5.97 (2.92)
Research Growth Index6.91 (4.65)
Search Engine Demand Index131.24 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (77.19)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials108 (38.03%)5.53%
Reviews53 (18.66%)6.00%
Case Studies14 (4.93%)4.05%
Observational1 (0.35%)0.25%
Other108 (38.03%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (77)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Alvesco for the Therapy of Persistent Asthma With or Without Allergic Component [NCT01147224]400 participants (Anticipated)Observational2010-03-31Completed
Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection: A Multi-Arm Multi-Stage Randomized Trial (MAMS) to Evaluate the Effectiveness of Several Specific Treatments in Reducing the Risk of Clinical Worsening or Death in Sub-Saharan [NCT04920838]Phase 2/Phase 3600 participants (Anticipated)Interventional2021-04-12Recruiting
Small Particle Inhaled Steroids in Refractory Steroid-responsive Asthma [NCT01171365]Phase 430 participants (Actual)Interventional2010-01-31Completed
Randomized Trial to Evaluate the Safety and Efficacy of Outpatient Treatments to Reduce the Risk of Worsening in Individuals With COVID-19 With Risk Factors (COVERAGE France) [NCT04356495]Phase 2/Phase 3412 participants (Actual)Interventional2020-07-29Completed
A 6-Month Open-Label, Long-Term Safety Extension Study of Once Daily Ciclesonide HFA Nasal Aerosol (160 μg) in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older [NCT01067105]Phase 3824 participants (Actual)Interventional2010-02-28Completed
A Randomised, Phase II, Double-Blind, Double-Dummy, Four-period Crossover Efficacy and Safety Comparison of 4-Week Treatment Periods of Blinded Fluticasone (500 mcg Bid, MDI), Ciclesonide (400 mcg qd, MDI), Ciclesonide (800 mcg qd, MDI) or Placebo in Free [NCT00535366]Phase 2103 participants (Actual)Interventional2007-10-31Completed
Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19) [NCT04381364]Phase 298 participants (Actual)Interventional2020-05-29Active, not recruiting
Phase 4 Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma in a Hospital in Bogotá [NCT01333800]Phase 494 participants (Actual)Interventional2010-07-31Completed
A 6-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety and Efficacy Study of the Potential Inhibitory Effects on the Hypothalamic-Pituitary-Adrenal Axis of Ciclesonide HFA Nasal Aerosol and Ciclesonide Aqueous Nasal Spray in Subject [NCT01033825]Phase 3310 participants (Actual)Interventional2010-01-31Completed
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol (160 μg Once Daily and 80 μg Once Daily) for the Treatment of Seasonal Allergic Rhinitis [NCT01010971]Phase 3671 participants (Actual)Interventional2009-12-31Completed
Ciclesonide for the Treatment of Airway Hyperresponsiveness. The Mannitol-Asthma-Ciclesonide Study (MACS). A Double-blind, Randomized, Parallel Group Study. [NCT00826969]Phase 464 participants (Actual)Interventional2008-09-30Completed
Safety, Tolerability and Pharmacokinetics of Multiple Rising Inhalative Doses of Butylated Hydroxytoluene Via Respimat Soft MistTM Inhaler B (Sub-study 1) and Safety, Tolerability and Pharmacokinetics of Multiple Rising Inhalative Doses of BI 54903 XX Via [NCT02221375]Phase 156 participants (Actual)Interventional2008-06-30Completed
A 6-Month Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of Once Daily Ciclesonide HFA Nasal Aerosol (80 and 160 μg) in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older [NCT00953147]Phase 31,110 participants (Actual)Interventional2009-08-31Completed
A Double-blind, Randomized, Placebo-controlled, Parallel Group, Multicenter, Dose-ranging Study to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol in Adult and Adolescent Patients 12 Years and Older With Seasonal Allergic Rhinitis (SAR) [NCT00807053]Phase 2480 participants (Actual)Interventional2007-04-30Completed
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 3 Clinical Trial to Assess the Safety and Efficacy of Ciclesonide, Applied as a Nasal Spray (200µg Once Daily) in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 12 Years [NCT00659841]Phase 3302 participants (Actual)Interventional2003-12-31Completed
Ciclesonide vs Fluticasone Propionate Nasal Sprays in Patients With Nasal Poplyposis; a Randomized Clinical Trial [NCT02665806]Phase 332 participants (Anticipated)Interventional2016-01-31Not yet recruiting
An Open-Label Randomized, Multicenter Study in Patients With Asthma to Evaluate the Effectiveness of Alvesco® (Ciclesonide) Compared to Asthma Usual Care in a Primary Practice Setting [NCT00404547]Phase 41,121 participants (Actual)Interventional2006-11-30Completed
A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children With Asthma [NCT00384189]Phase 31,080 participants (Actual)Interventional2006-09-30Completed
A Pilot Investigation of the Nasal Mucosal Absorption, Retention, and Metabolism of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray When Each Formulation Is Administered to Currently Symptomatic Patie [NCT00793858]Phase 40 participants (Actual)Interventional2009-02-28Withdrawn(stopped due to Cost prohibitive and company withdrew support.)
A Randomized, Multicenter, Double Blind, Placebo Controlled, Parallel Group, Phase III Clinical Trial to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol (160 μg Once Daily and 80 μg Once Daily) for the Treatment of Seasonal Allergic Rhinit [NCT00790023]Phase 3707 participants (Actual)Interventional2008-11-30Completed
Ciclesonide for the Therapy of Asthma During the Cold Season. [NCT00608218]2,100 participants (Anticipated)Observational2008-01-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Using the Environmental Exposure Unit (EEU) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray (200 mg, Once Daily), in the Treatment of Seasonal Allergic Rhinitis (S [NCT00659503]Phase 3420 participants (Actual)Interventional2005-02-28Completed
Effect of Ciclesonide on Exercise Induced Bronchoconstriction [NCT00525772]Phase 326 participants (Actual)Interventional2001-11-30Completed
A Multinational,Multicenter,Randomized,Double-Blind,Placebo-Controlled,Parallel-Group Study to Assess the Efficacy of Ciclesonide Metered-Dose Inhaler at a Daily Dose of 160 μg Administered Either in a Once-Daily in the Morning Regimen (160 μg qd AM) for [NCT00174720]Phase 3708 participants (Actual)Interventional2005-09-30Completed
A 3-period Double-blind, Cross-over Study on the Onset of Action of Inhaled Ciclesonide (7 Days of 400 mcg Sid Versus 800 mcg Bid Versus Placebo) on Airway Responsiveness to Adenosine Monophosphate (AMP), Sputum Eosinophiles and Exhaled Breath Nitric Oxid [NCT00546520]Phase 321 participants (Actual)Interventional2002-04-30Completed
A Multicenter, Multi-national, Randomized, Double-blind, Placebo-controlled, Study to Assess the Efficacy and Safety of Ciclesonide Metered-dose Inhaler (MDI) at 80 μg BID or 40 μg BID for 12 Weeks in Patients Aged 4 to <12 Years With Persistent Asthma. [NCT00392288]Phase 3528 participants (Actual)Interventional2006-09-30Completed
Ciclesonide Clinical Trial for COVID-19 Treatment [NCT04435795]Phase 2/Phase 3215 participants (Actual)Interventional2020-09-15Terminated(stopped due to could not meet target enrolment)
Effect of Ciclesonide (320 mcg/Day) vs Fluticasone Propionate (375 mcg/Day) vs. Placebo on Short-term Linear Growth Rate and HPA-axis Function in Prepubertal Children With Mild Asthma [NCT00163371]Phase 328 participants Interventional2005-09-30Completed
Investigation of the Efficacy and Safety of Concomitant Administration of Ciclesonide Nasal Spray and Azelastine Nasal Spray in Patients (18 Years or Older) With Perennial Allergic Rhinitis (PAR) Not Adequately Controlled on an Intranasal Corticosteroid o [NCT00806754]Phase 4340 participants (Actual)Interventional2006-11-30Completed
Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Beclomethasone Dipropionate (HFA-BDP) in Patients (18-60 Years) With Perennial Allergic Rhinitis (PAR) [NCT00659048]Phase 3106 participants (Actual)Interventional2004-12-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Using the Environmental Exposure Chamber (EEC) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray (200 mg, Once Daily), in the Treatment of Seasonal Allergic Rhinitis [NCT00659594]Phase 3500 participants (Actual)Interventional2004-11-30Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial to Assess the Safety and Efficacy of Ciclesonide, Applied as a Nasal Spray (200 mg Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 12 Year [NCT00659750]Phase 3418 participants (Actual)Interventional2003-12-31Completed
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Clinical Trial Designed to Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, 200µg, 100µg or 25µg Once Daily for Six Weeks, in the Treatment of Perennial Allerg [NCT00658918]Phase 3120 participants (Actual)Interventional2004-09-30Completed
Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma [NCT01248065]Phase 3408 participants (Actual)Interventional2011-04-30Completed
PROphylaxis for paTiEnts at Risk of COVID-19 infecTion [NCT04870333]Phase 2/Phase 35,000 participants (Anticipated)Interventional2021-02-19Recruiting
Comparison of Inhaled Ciclesonide (640 mcg/Day) and Fluticasone Propionate (1000 mcg/Day) in Patients With Moderate and Severe Persistent Asthma [NCT00163319]Phase 3500 participants Interventional2004-11-30Completed
Comparison of the Efficacy and Safety of 160 mcg Ciclesonide Administered Once Daily in the Evening With or Without Different Spacer Types in Patients With Asthma [NCT00163436]Phase 3450 participants Interventional2005-09-30Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial Designed to Assess the Efficacy and Safety of Ciclesonide Applied as a Nasal Spray at Three Dose Levels (200 Mcg, 100 Mcg, or 25 Mcg, Once Daily) in the Treatment of Pe [NCT00163514]Phase 3636 participants Interventional2004-05-31Completed
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 4349 participants (Actual)Interventional2011-01-31Completed
Ciclesonide for the Treatment of Airway Hyperresponsiveness: The Mannitol-Asthma-Ciclesonide-Study [NCT03839433]Phase 472 participants (Actual)Interventional2007-06-30Completed
Control of Moderate or Severe Asthma With 160, 320 and 640 mcg Ciclesonide/Day. A One-year Randomised, Double-blind, Multicenter Trial. [NCT01455194]Phase 3520 participants (Actual)Interventional2011-11-30Completed
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study Comparing the Bioquivalence of Ciclesonide Nasal Spray(Apotex Inc.) to That of Omnaris ™Nasal Spray (Sepracor, Inc.) in the Treatment of Seasonal Allergic Rhinitis [NCT02273817]Phase 3580 participants (Actual)Interventional2011-03-31Completed
Psychometric Evaluation of a Novel Questionnaire Designed to Assess Patient Satisfaction With and Preference of Intranasal Corticosteroids Administered Via HFA Aerosol or Aqueous Suspension Used for the Treatment of Allergic Rhinitis [NCT01287364]Phase 3185 participants (Actual)Interventional2011-02-28Completed
A Multi-Center, Multinational, Randomized, Double-Blind, Parallel Group Study of the Effects of Ciclesonide Hfa-Mdi 640 μg/Day and Beclomethasone Hfa-Mdi 640 μg/Day on Lens Opacification in Adult Subjects With Moderate to Severe Persistent Asthma [NCT00254956]Phase 31,568 participants (Actual)Interventional2004-01-31Completed
A Pilot Study on the Impact of Two Different Doses of Ciclesonide (160 mcg/Day and 320 mcg/Day) Administered in the Evening on Quality of Life in Patients With Moderate Persistent Asthma. [NCT00305461]Phase 3101 participants (Actual)Interventional2006-02-28Completed
ADVICE: A Dose Range Finding Study of Formoterol Administered Once Daily in the Evening in Combination With Ciclesonide Using the Ultrahaler™ Versus Monotherapy of Each Drug in Asthmatic Patients [NCT00314509]Phase 2240 participants Interventional2005-07-31Completed
Comparison of Inhaled Ciclesonide (160 mcg b.i.d. or 320 mcg b.i.d.) and Fluticasone Propionate (250 mcg b.i.d. or 500 mcg b.i.d.) in Pretreated Patients With Mild to Moderate Asthma [NCT00163332]Phase 330 participants Interventional2003-03-31Completed
A Comparative Study of Inhaled Ciclesonide 200 mcg/Day vs Fluticasone Propionate 200 mcg/Day in Children With Asthma [NCT00163410]Phase 3500 participants Interventional2003-04-30Completed
BALLOON: Efficacy and Safety - Study by ALTANA on Ciclesonide in Pre-school Asthma Patients [NCT00163449]Phase 31,000 participants (Anticipated)Interventional2005-11-30Completed
Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Fluticasone Propionate/Salmeterol (FP/SAL) in Patients (18-60 Years) With Perennial Allergic Rhinitis (PAR) [NCT00163488]Phase 3106 participants Interventional2005-01-31Completed
A Phase 1, Open Label, Two Period, Randomized, Cross Over Scintigraphy Study Assessing Nasal Deposition of a Single Dose of a Ciclesonide Radiolabeled Solution Following Nasal Inhalation of a Novel Nasal Metered Dose Inhaler (MDI) and of a Mometasone Furo [NCT01371786]Phase 114 participants (Actual)Interventional2011-06-30Completed
Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-term Asthma Control [NCT00163358]Phase 3630 participants Interventional2003-09-30Completed
A Comparative Study of Inhaled Ciclesonide 160 mcg/Day vs Budesonide 400 mcg/Day in Patients With Asthma [NCT00163397]Phase 3120 participants Interventional2004-01-31Completed
Evaluation of Parameters of the Small Airways and Their Changes Under Treatment With Ciclesonide (320 mcg Once Daily) Versus Placebo in Patients With Asthma [NCT00163345]Phase 320 participants Interventional2003-09-30Completed
A Comparative Study of Inhaled Ciclesonide 160 mcg/Day vs Budesonide 400 mcg/Day in Patients With Asthma [NCT00163384]Phase 3240 participants Interventional2004-01-31Completed
Comparison of Ciclesonide (80 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily) in Patients With Mild to Moderate Asthma [NCT00163423]Phase 3480 participants Interventional2004-11-30Completed
Comparison of Ciclesonide (80 mcg or 160 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily in the Morning and Evening) in Pediatric Asthma Patients [NCT00163462]Phase 3750 participants Interventional2004-10-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial to Assess the Long Term Safety of Ciclesonide, Applied as a Nasal Spray (200 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 12 Years [NCT00163501]Phase 3600 participants Interventional2003-12-31Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy of Ciclesonide Metered-Dose Inhaler at a Daily Dose of 160 μg Administered for Twelve Weeks Either in a Once-Daily Regimen in the Morning (160 μg qd A [NCT00174733]Phase 3456 participants (Actual)Interventional2005-07-31Completed
Nebulizer Trial: Evaluation of the Influence of Particle Size of Aerosolized AMP on Bronchial Responsiveness in Patients With Asthma and the Effects of Treatment With Ciclesonide Versus Fluticasone. [NCT00306163]Phase 337 participants (Actual)Interventional2006-05-31Completed
A Study Evaluating the Effect of Omnaris Nasal Spray 200 mcg QD & Alvesco Inhalation Aerosol 80 BID vs Beconase AQ Nasal Spray 168 mcg BID & QVAR Inhalation Aerosol 40 mcg BID vs Placebo Nasal Spray QD & Placebo Inhalation Aerosol BID on Short Term Growth [NCT01550471]Phase 422 participants (Actual)Interventional2012-03-31Completed
A Phase III, Multicenter, Double-Blind, Placebo Controlled, Non-Inferiority Study Assessing the Effects of Ciclesonide Metered Dose Inhaler 50 Mg/Day and 200 Mg/Day (Ex-Valve) Administered Once Daily on Growth in Children With Mild Persistent Asthma [NCT00270348]Phase 3450 participants Interventional2000-12-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Tolerability of Ciclesonide (200 mcg Once Daily), Applied as a Nasal Spray for Twelve Weeks, in the Treatment of Perennial Allergic Rhinitis ( [NCT00261287]Phase 3102 participants Interventional2005-11-30Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Efficacy of Ciclesonide (200mcg and 100mcg, Once Daily) Applied as a Nasal Spray for Two Weeks in the Treatment of Seasonal Allergic Rhinitis [NCT00305487]Phase 3660 participants Interventional2006-03-31Completed
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Ciclesonide Metered-Dose Inhaler in Non-hospitalized Patients 12 Years of Age and Older With Symptomatic COVID-19 Infection [NCT04377711]Phase 3400 participants (Actual)Interventional2020-06-08Completed
A Randomized Cross-Over Design Study Evaluating a Traditional Paper Symptom Diary vs. the VOCEL Mobile Diary in Subjects 12 Years and Older With Mild to Moderate Persistent Asthma Receiving Ciclesonide MDI (Alvesco) 80 ug BID [NCT00367263]12 participants (Actual)Interventional2006-10-31Completed
A 6 Month Randomized, Open Label, Parallel Group, Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis [NCT01654536]Phase 4737 participants (Actual)Interventional2012-09-30Completed
A Trial of Ciclesonide to Assess The Antiviral Effect for Adults With Mild-to-moderate COVID-19 [NCT04330586]Phase 268 participants (Actual)Interventional2020-04-01Completed
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study Using the Environmental Exposure Chamber (EEC) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray (200 mcg, Once Daily), in the Treatment of Seasonal Allergic Rhiniti [NCT00384475]Phase 3500 participants Interventional2006-10-31Completed
A 2-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6 to 11 Years With Seasonal Allergic Rhinitis [NCT01458275]Phase 3847 participants (Actual)Interventional2011-11-30Completed
A Randomized, Open-label, Single-dose, 3-period Crossover, Pharmacokinetic Study Designed to Compare the Systemic Des-ciclesonide Exposure of OMNARIS™ (Ciclesonide) Nasal Spray, Ciclesonide HFA Nasal Aerosol, and Orally Inhaled Ciclesonide [NCT00458835]Phase 430 participants (Actual)Interventional2007-04-30Completed
Periostin-guided Withdrawal of Inhaled Corticosteroids in Patients With Non-eosinophilic Asthma [NCT03141424]Phase 4110 participants (Anticipated)Interventional2022-06-01Recruiting
A 12-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis [NCT01451541]Phase 3848 participants (Actual)Interventional2011-10-31Completed
A Randomized Two Period Two-Way Crossover Study To Evaluate Patient Preference, Satisfaction And Efficacy Of A Nasal Aerosol Versus An Aqueous Nasal Spray Used For The Treatment Of Allergic Rhinitis [NCT01401465]Phase 3327 participants (Actual)Interventional2011-07-31Completed
A Multi-Center, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group, Phase III (Registration) Study to Assess the Efficacy and Safety of Ciclesonide Nasal Spray (Omnaris®) 200 mcg Once Daily in the Treatment of the Patients With Seasonal Allergic Rh [NCT02155881]Phase 380 participants (Actual)Interventional2014-08-31Completed
A 6-Week Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA) Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis ( [NCT01378429]Phase 389 participants (Actual)Interventional2011-07-31Completed
Effect of Low Dose Continuous Treatment With Ciclesonide Over One Year on the Time to First Exacerbation in Children With Mild Asthma Versus Intermittent Treatment for Exacerbations [NCT00163293]Phase 3240 participants (Actual)Interventional2005-01-01Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00163293 (23) [back to overview]Percentage of Asthma Symptom Free Days
NCT00163293 (23) [back to overview]Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value)
NCT00163293 (23) [back to overview]Change From Baseline in Diurnal PEF Fluctuation
NCT00163293 (23) [back to overview]Time to First Asthma Exacerbation
NCT00163293 (23) [back to overview]Percentage of Participants Who Dropped-out Due to Asthma Exacerbation
NCT00163293 (23) [back to overview]Number of Participants With Clinically Significant Vital Signs Findings
NCT00163293 (23) [back to overview]Number of Participants With Clinically Significant Physical Examination Findings
NCT00163293 (23) [back to overview]Number of Participants With Clinically Significant Laboratory Values
NCT00163293 (23) [back to overview]Number of Exacerbations Per Participant
NCT00163293 (23) [back to overview]Exacerbations (Post-hoc Analysis of Annual Rates)
NCT00163293 (23) [back to overview]Mean Rate of Asthma Exacerbations Per Year
NCT00163293 (23) [back to overview]Growth Velocity as Assessed by Stadiometric Height Measurement
NCT00163293 (23) [back to overview]Total Asthma Symptom Score by Diary Entries
NCT00163293 (23) [back to overview]Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S])
NCT00163293 (23) [back to overview]Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
NCT00163293 (23) [back to overview]Percentage of Rescue Medication Free Days
NCT00163293 (23) [back to overview]Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms
NCT00163293 (23) [back to overview]Duration of Exacerbations
NCT00163293 (23) [back to overview]Number of Participants With Adverse Events and Serious Adverse Events
NCT00163293 (23) [back to overview]Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries
NCT00163293 (23) [back to overview]Rescue Medication Use Per Day
NCT00163293 (23) [back to overview]Change From Baseline in PEF by Diary Entries
NCT00163293 (23) [back to overview]Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted)
NCT00306163 (1) [back to overview]PC20 AMP (Post-treatment Compared to Baseline)
NCT00384189 (13) [back to overview]Time to First Event of Lack of Efficacy (LOE) by Week 12
NCT00384189 (13) [back to overview]Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication, Morning PEF and PEF Fluctuation
NCT00384189 (13) [back to overview]Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication and Morning PEF
NCT00384189 (13) [back to overview]Change in Use of Rescue Medications
NCT00384189 (13) [back to overview]Change From Baseline in Pediatric Asthma Quality of Life Questionnaire Standard [PAQLQ(S)] Overall Score
NCT00384189 (13) [back to overview]Change From Baseline in Morning Peak Expiratory Flow (PEF)
NCT00384189 (13) [back to overview]Change From Baseline in Lung Function Variable PEF by Spirometry
NCT00384189 (13) [back to overview]Change From Baseline in Lung Function Variable Forced Expiratory Volume in One Second (FEV1)
NCT00384189 (13) [back to overview]Change From Baseline in Diurnal PEF Fluctuations
NCT00384189 (13) [back to overview]Change in Asthma Symptom Total Score
NCT00384189 (13) [back to overview]Change From Baseline in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) Overall
NCT00384189 (13) [back to overview]Change From Baseline in Evening PEF From Diary
NCT00384189 (13) [back to overview]Change From Baseline in Morning PEF From Diary
NCT00392288 (3) [back to overview]Change From Baseline in Use of Albuterol/Salbutamol at Week 12.
NCT00392288 (3) [back to overview]Change From Baseline in Total Daily Asthma Symptom Score at Week 12.
NCT00392288 (3) [back to overview]Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12.
NCT00404547 (2) [back to overview]Change in Patient Assessment of Asthma Control
NCT00404547 (2) [back to overview]Change in Mean of Total Score of Asthma Control Questionnaire (ACQ)
NCT00458835 (2) [back to overview]Comparison of Systemic Exposure Measured by Cmax, pg/mL, (Highest Concentration of Drug in the Blood) of Des-ciclesonide With Ciclesonide Nasal Spray, and Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide.
NCT00458835 (2) [back to overview]Comparison of Systemic Exposure Measured by AUC, ng*hr/L, (Area Under the Serum Concentration) of Des-ciclesonide With Ciclesonide Nasal Spray, and Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide.
NCT00790023 (28) [back to overview]Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS)
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period
NCT00790023 (28) [back to overview]Time to Maximal Effect as Measured by Change From Baseline in the Average AM and PM Reflective Total Nasal Symptoms Scores (rTNSS)
NCT00790023 (28) [back to overview]Change From Baseline in Overall Score of the Rhinoconjunctivitis Quality of Life Questionnaire With Standard Activities (RQLQ(S)) in Participants With a Baseline Overall Score >= 3.0
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported PM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the Two Week Treatment Period
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the Two Week Treatment Period
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the Two Week Treatment Period
NCT00790023 (28) [back to overview]Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported AM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the Two Week Treatment Period
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported AM and PM rTOSS Averaged Over the Two-week Treatment Period in Participants With a Baseline rTOSS >= 5.0
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Averaged Over the Two-week Treatment Period.
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported AM and PM iTNSS Averaged Over the Two-week Treatment Period.
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject Reported AM and PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0
NCT00790023 (28) [back to overview]Change From Baseline in Daily Subject-reported AM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0
NCT00953147 (14) [back to overview]Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment
NCT00953147 (14) [back to overview]Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
NCT00953147 (14) [back to overview]Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
NCT00953147 (14) [back to overview]Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
NCT00953147 (14) [back to overview]Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
NCT00953147 (14) [back to overview]Change From Baseline to Month 6 (Week 26) in RQLQ(S) Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0.
NCT00953147 (14) [back to overview]Change From Baseline to Week 6 in Rhinoconjunctivitis Quality of Life Questionnaire With Standardized [RQLQ(S)] Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0
NCT00953147 (14) [back to overview]Change From Baseline in Daily Subject-reported AM & PM rNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period.
NCT00953147 (14) [back to overview]Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period
NCT00953147 (14) [back to overview]Change From Baseline in Daily Subject-reported AM iNSS Averaged the First 6 Weeks of the Double-blind Treatment
NCT00953147 (14) [back to overview]Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment
NCT00953147 (14) [back to overview]Change From Baseline in Daily Subject-reported PM iNSS Averaged the First 6 Weeks of the Double-blind Treatment
NCT00953147 (14) [back to overview]Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment
NCT00953147 (14) [back to overview]Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 2-week Treatment Period
NCT01010971 (27) [back to overview]Time to Maximal Effect Over the 2-week of Double-blind Treatment Period.
NCT01010971 (27) [back to overview]Change From Baseline in the RQLQ(S) Overall Score at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 2 Week Treatment Period.
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported AM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported AM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 2-week Treatment Period.
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 2-week Treatment Period.
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported AM and PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over the Two-week Treatment Period.
NCT01010971 (27) [back to overview]Change From Baseline in the RQLQ(S) Domains at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported Individual PM Reflective OSS in Subjects With Baseline TOSS ≥5.0
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 2-week Treatment Period.
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported Individual PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 2-week Treatment Period
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported Individual AM Reflective OSS in Subjects With Baseline TOSS ≥5.0
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported Individual AM Reflective Nasal Symptom Scores (NSS) Averaged Over the 2-week Treatment Period.
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported AM and PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported Individual AM Instantaneous OSS in Subjects With Baseline TOSS≥5.0
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported Individual AM and PM Reflective OSS in Subjects With Baseline TOSS ≥5.0
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 2-week Treatment Period.
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0
NCT01010971 (27) [back to overview]Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 2-week Treatment Period
NCT01033825 (44) [back to overview]Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment
NCT01033825 (44) [back to overview]Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment
NCT01033825 (44) [back to overview]Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment
NCT01033825 (44) [back to overview]Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment
NCT01033825 (44) [back to overview]Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment
NCT01033825 (44) [back to overview]Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment
NCT01033825 (44) [back to overview]Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment
NCT01033825 (44) [back to overview]Baseline Daily Subject-reported PM Reflective TNSS
NCT01033825 (44) [back to overview]Baseline Daily Subject-reported PM Instantaneous TNSS
NCT01033825 (44) [back to overview]Baseline Daily Subject-reported AM Reflective TNSS
NCT01033825 (44) [back to overview]Baseline Daily Subject-reported AM Instantaneous TNSS
NCT01033825 (44) [back to overview]Baseline Daily Subject-reported AM and PM Reflective TNSS
NCT01033825 (44) [back to overview]Baseline Daily Subject-reported AM and PM Instantaneous TNSS
NCT01033825 (44) [back to overview]Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances.
NCT01033825 (44) [back to overview]Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period
NCT01033825 (44) [back to overview]Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment
NCT01033825 (44) [back to overview]Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period
NCT01033825 (44) [back to overview]Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment
NCT01033825 (44) [back to overview]Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period
NCT01033825 (44) [back to overview]Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment
NCT01033825 (44) [back to overview]Baseline Daily Subject-reported Individual PM Reflective NSS
NCT01033825 (44) [back to overview]Baseline Daily Subject-reported Individual PM Instantaneous NSS
NCT01033825 (44) [back to overview]Baseline Daily Subject-reported Individual AM Reflective NSS
NCT01033825 (44) [back to overview]Baseline Daily Subject-reported Individual AM Instantaneous NSS
NCT01033825 (44) [back to overview]Baseline Daily Subject-reported Individual AM and PM Reflective NSS
NCT01033825 (44) [back to overview]Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS
NCT01033825 (44) [back to overview]Time to Maximal Effect Over 6 Weeks of Double-blind Treatment.
NCT01033825 (44) [back to overview]The Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) From Baseline to Week 6 of the Double Blind Treatment Period
NCT01033825 (44) [back to overview]Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline
NCT01033825 (44) [back to overview]Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline
NCT01033825 (44) [back to overview]Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline
NCT01033825 (44) [back to overview]Percentage of Subjects Who Discontinue Due to AEs
NCT01033825 (44) [back to overview]Percentage of Subjects Experiencing Serious Adverse Events (SAEs).
NCT01033825 (44) [back to overview]Percentage of Subjects Experiencing Local Nasal AEs
NCT01033825 (44) [back to overview]Percentage of Subjects Experiencing Adverse Events (AEs)
NCT01033825 (44) [back to overview]Percentage of Devices With Major Discrepancies
NCT01033825 (44) [back to overview]Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over Each Week, and Averaged Over the 6 Weeks of Double-blind Treatment
NCT01033825 (44) [back to overview]Percentage of Devices With Actuation Consistency
NCT01033825 (44) [back to overview]Number of Subjects Who Discontinue Due to AEs
NCT01033825 (44) [back to overview]Number of Subjects Experiencing Serious Adverse Events (SAEs).
NCT01033825 (44) [back to overview]Number of Subjects Experiencing Local Nasal AEs
NCT01033825 (44) [back to overview]Number of Subjects Experiencing Adverse Events (AEs)
NCT01033825 (44) [back to overview]Number of Devices With Major Discrepancies
NCT01033825 (44) [back to overview]Number of Devices With Actuation Consistency
NCT01067105 (14) [back to overview]Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period.
NCT01067105 (14) [back to overview]Percentage of Subjects Experiencing Adverse Events (AEs)
NCT01067105 (14) [back to overview]Percentage of Subjects Experiencing Local Nasal AEs
NCT01067105 (14) [back to overview]Percentage of Subjects Experiencing Serious Adverse Events (SAEs)
NCT01067105 (14) [back to overview]Percentage of Subjects Who Discontinue Due to AEs.
NCT01067105 (14) [back to overview]Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period.
NCT01067105 (14) [back to overview]Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period.
NCT01067105 (14) [back to overview]Number of Devices With Actuation Consistency
NCT01067105 (14) [back to overview]Number of Devices With Major Discrepancies
NCT01067105 (14) [back to overview]Percentage of Devices With Actuation Consistency
NCT01067105 (14) [back to overview]Percentage of Devices With Major Discrepancies
NCT01067105 (14) [back to overview]Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey
NCT01067105 (14) [back to overview]Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period.
NCT01067105 (14) [back to overview]Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances
NCT01248065 (3) [back to overview]Exacerbations
NCT01248065 (3) [back to overview]Lung Function Change From Baseline
NCT01248065 (3) [back to overview]Treatment Failure
NCT01287364 (6) [back to overview]Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES)
NCT01287364 (6) [back to overview]Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics
NCT01287364 (6) [back to overview]Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change)
NCT01287364 (6) [back to overview]Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change)
NCT01287364 (6) [back to overview]Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales
NCT01287364 (6) [back to overview]Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High)
NCT01371786 (5) [back to overview]Deposition of Radioactivity Within on Nasal Wipes Over 10 Minutes as a Percent of Delivered Dose
NCT01371786 (5) [back to overview]Deposition of Radioactivity Within the Nasal Cavity Over 10 Minutes as a Percent of Delivered Dose
NCT01371786 (5) [back to overview]Initial Deposition of Radioactivity on Nasal Wipes as a Percent of Delivered Dose
NCT01371786 (5) [back to overview]Initial Deposition of Radioactivity Within the Nasal Cavity as a Percent of Delivered Dose
NCT01371786 (5) [back to overview]Initial Deposition of Radioactivity Within the Nasopharynx as a Percent of Delivered Dose
NCT01378429 (17) [back to overview]Apparent Volume of Distribution (Vz/F)
NCT01378429 (17) [back to overview]Apparent Clearance of the Drug (CL/F)
NCT01378429 (17) [back to overview]Change From Baseline in Averaged Daily Subject-reported AM and PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment
NCT01378429 (17) [back to overview]The Change in Serum Cortisol Area Under the Curve (AUC) From Time 0 to 24 Hours (0-24), Calculated Using a Trapezoidal Rule, From Baseline to the End of the 6 Week Treatment Period
NCT01378429 (17) [back to overview]Ratio (Percentage) of the Number of Correct Advances of the Dose Indicator to the Number of Expected Advances Based on Subject Self-report of Study Medication Administration Plus Extra Non-nasal Actuations
NCT01378429 (17) [back to overview]Percentage of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration
NCT01378429 (17) [back to overview]Number of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration
NCT01378429 (17) [back to overview]Change From Baseline in Urinary Free Cortisol-Uncorrected for Urine Creatinine
NCT01378429 (17) [back to overview]Change From Baseline in Urinary Free Cortisol-Corrected for Urine Creatinine
NCT01378429 (17) [back to overview]Time to the Occurrence of Cmax
NCT01378429 (17) [back to overview]Terminal Half Life (t1/2)
NCT01378429 (17) [back to overview]Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
NCT01378429 (17) [back to overview]Percentage of Subjects Experiencing AEs
NCT01378429 (17) [back to overview]Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
NCT01378429 (17) [back to overview]Number of Subjects Experiencing AEs
NCT01378429 (17) [back to overview]Maximum Observed Concentration
NCT01378429 (17) [back to overview]AUC(0-24h)
NCT01401465 (31) [back to overview]Change From Baseline in Regimen Attributes Composite Score
NCT01401465 (31) [back to overview]Change From Baseline in Subject-reported AM and PM rTNSS Averaged Over Each 2-week Treatment Period.
NCT01401465 (31) [back to overview]Change From Baseline in the Treatment Functional Impact Composite Score
NCT01401465 (31) [back to overview]Change From Baseline in the Treatment Satisfaction Rating Scale: Burden
NCT01401465 (31) [back to overview]Change From Baseline in the Treatment Satisfaction Rating Scale: Hassle
NCT01401465 (31) [back to overview]Change From Baseline in the Treatment Satisfaction Rating Scale: Interference
NCT01401465 (31) [back to overview]Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Adaptation
NCT01401465 (31) [back to overview]Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Difficulties
NCT01401465 (31) [back to overview]Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Management
NCT01401465 (31) [back to overview]Change From Baseline in the Regimen Acceptance Composite Score
NCT01401465 (31) [back to overview]Treatment Process Composite Preference Score
NCT01401465 (31) [back to overview]Change From Baseline in the Treatment Satisfaction Rating Scale: Sensory Impact
NCT01401465 (31) [back to overview]The Change From Baseline in Health-Related Quality of Life: Allergic-Rhinitis Specific Symptom Interference Scale
NCT01401465 (31) [back to overview]The Change From Baseline in Health-Related Quality of Life: General Health Perceptions Scale
NCT01401465 (31) [back to overview]The Change From Baseline in Health-Related Quality of Life: General Symptom Interference Scale
NCT01401465 (31) [back to overview]The Change From Baseline in Health-Related Quality of Life: Mental and Emotional Health Scale
NCT01401465 (31) [back to overview]The Change From Baseline in Health-Related Quality of Life: Perceived Health (Global Analogue Scale)
NCT01401465 (31) [back to overview]The Change From Baseline in Health-Related Quality of Life: Symptoms and Side-Effects Distress Scale
NCT01401465 (31) [back to overview]The Change From Baseline in Health-Related Quality of Life: Work Well Being Questionnaire Scale
NCT01401465 (31) [back to overview]The Change From Baseline in Overall Quality of Life Composite Score
NCT01401465 (31) [back to overview]The Change From Baseline in the Treatment Satisfaction Rating Scale: Perceived Relief
NCT01401465 (31) [back to overview]The Number of Subjects Experiencing AEs
NCT01401465 (31) [back to overview]The Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NCT01401465 (31) [back to overview]The Percentage of Subjects Experiencing AEs
NCT01401465 (31) [back to overview]The Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NCT01401465 (31) [back to overview]Total Preference Composite Score Assessed at the End of the Study. The Total Preference Score is the Standardized Sum of 17 Individual Preference Items
NCT01401465 (31) [back to overview]Treatment Outcome Composite Score Assessed at the End of the Study
NCT01401465 (31) [back to overview]Work/Disability Days: Bed Days
NCT01401465 (31) [back to overview]Work/Disability Days: Missed Work
NCT01401465 (31) [back to overview]Work/Disability Days: Reduced Activity Days
NCT01401465 (31) [back to overview]Change From Baseline in the Treatment Satisfaction Rating Scale: Role Limitation
NCT01451541 (12) [back to overview]The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the Double-blind Treatment.
NCT01451541 (12) [back to overview]Time to Maximal Effect [Time to >= 90% Maximum Difference From Placebo in LS Means (Days)]
NCT01451541 (12) [back to overview]Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
NCT01451541 (12) [back to overview]Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NCT01451541 (12) [back to overview]Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
NCT01451541 (12) [back to overview]Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly Over the First 6 Weeks of Double-blind Treatment
NCT01451541 (12) [back to overview]Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment
NCT01451541 (12) [back to overview]Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NCT01451541 (12) [back to overview]Change From Baseline in Daily Average Subject-reported AM and PM rTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period
NCT01451541 (12) [back to overview]Change From Baseline in Daily Average Subject-reported AM and PM iTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period
NCT01451541 (12) [back to overview]Change From Baseline in Daily Average Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment
NCT01451541 (12) [back to overview]Change From Baseline in Daily PRQLQ Overall Score at the End of the 12-week Double-blind Treatment Period
NCT01455194 (14) [back to overview]Asthma Control Questionnaire (ACQ) Score at Baseline
NCT01455194 (14) [back to overview]Number of Participants Reporting Asthma Exacerbations Rates
NCT01455194 (14) [back to overview]Number of Participants Reporting Clinically Significant Change From Baseline in Physical Examination Findings
NCT01455194 (14) [back to overview]Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs
NCT01455194 (14) [back to overview]Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
NCT01455194 (14) [back to overview]Number of Participants Reporting Time to First Asthma Exacerbation
NCT01455194 (14) [back to overview]Number of Participants With Markedly Abnormal Laboratory Values
NCT01455194 (14) [back to overview]Number of Participants With Markedly High Benefits
NCT01455194 (14) [back to overview]Time Course of ACQ
NCT01455194 (14) [back to overview]Number of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement
NCT01455194 (14) [back to overview]Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point
NCT01455194 (14) [back to overview]Number of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study
NCT01455194 (14) [back to overview]Change From Baseline in ACQ Score to Tlast
NCT01455194 (14) [back to overview]Number of Weeks With Well-controlled Asthma Over the Course of the Study
NCT01458275 (12) [back to overview]Percentage of Subjects Experiencing Treatment-emergent AEs
NCT01458275 (12) [back to overview]Number of Subjects Experiencing Treatment-emergent AEs
NCT01458275 (12) [back to overview]Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NCT01458275 (12) [back to overview]Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Ocular Symptom Scores (rTOSS) Over the 2-week Double-blind Treatment Period.
NCT01458275 (12) [back to overview]Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
NCT01458275 (12) [back to overview]Treatment-emergent AEs Causing Study Medication Discontinuation
NCT01458275 (12) [back to overview]Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period
NCT01458275 (12) [back to overview]Change From Baseline in Average Daily Subject Reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period
NCT01458275 (12) [back to overview]Change From Baseline in Average Daily Subject Reported AM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period
NCT01458275 (12) [back to overview]Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Ocular Symptom Scores (iTOSS) Over the 2-week Double-blind Treatment Period.
NCT01458275 (12) [back to overview]Time to Maximal Effect in the AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period
NCT01458275 (12) [back to overview]Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the Double-blind Treatment Period.
NCT01550471 (2) [back to overview]The Effect of Omnaris Nasal Spray & Alvesco Inhalation Aerosol vs Beconase AQ Nasal Spray & QVAR Inhalation Aerosol on Short-term Lower Leg Growth Velocity as Measured by Knemometry in Pediatric Subjects w/ Mild Asthma & Allergic Rhinitis.
NCT01550471 (2) [back to overview]The Effects of Omnaris Nasal Spray & Alvesco Inhalation Aerosol vs Placebo Nasal Spray & Placebo Inhalation Aerosol on Short-term Lower Leg Growth Velocity as Measured by Knemometry in Pediatric Subjects w/ Mild Asthma & Allergic Rhinitis.
NCT01654536 (16) [back to overview]Number of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye
NCT01654536 (16) [back to overview]Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity.
NCT01654536 (16) [back to overview]Percentage of Subjects With Development of or Worsening in Lens Opacities.
NCT01654536 (16) [back to overview]The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)
NCT01654536 (16) [back to overview]The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
NCT01654536 (16) [back to overview]The Number of Subjects Experiencing Treatment Emergent AEs.
NCT01654536 (16) [back to overview]The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
NCT01654536 (16) [back to overview]The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)
NCT01654536 (16) [back to overview]The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
NCT01654536 (16) [back to overview]The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
NCT01654536 (16) [back to overview]The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
NCT01654536 (16) [back to overview]Number of Subjects With Development of or Worsening in Lens Opacities.
NCT01654536 (16) [back to overview]The Percentage of Subjects Experiencing Treatment Emergent AEs.
NCT01654536 (16) [back to overview]The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
NCT01654536 (16) [back to overview]Number of Subjects With Change From Baseline in Best Corrected Visual Acuity.
NCT01654536 (16) [back to overview]Percentage of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye
NCT02155881 (8) [back to overview]Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score
NCT02155881 (8) [back to overview]Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score
NCT02155881 (8) [back to overview]Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Ocular Symptom Scores (TOSS)
NCT02155881 (8) [back to overview]Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Nasal Symptom Scores (TNSS)
NCT02155881 (8) [back to overview]Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Nasal Symptom Scores
NCT02155881 (8) [back to overview]Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score
NCT02155881 (8) [back to overview]Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score
NCT02155881 (8) [back to overview]Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Ocular Symptom Scores
NCT04377711 (6) [back to overview]Time to Alleviation of COVID-19-related Symptoms by Day 30
NCT04377711 (6) [back to overview]Percentage of Patients With Subsequent Emergency Department Visit or Hospital Admission for Reasons Attributable to COVID-19 by Day 30
NCT04377711 (6) [back to overview]Percentage of Patients With Alleviation of COVID-19-related Symptoms Defined as Symptom-free for a Continuous Period of More Than 24 Hours (ie, Later Than 3 AM/PM Assessments) by Day 7, by Day 14, and by Day 30
NCT04377711 (6) [back to overview]COVID-19-related Mortality by Day 30
NCT04377711 (6) [back to overview]All-cause Mortality by Day 30
NCT04377711 (6) [back to overview]Percentage of Patients With Hospital Admission or Death by Day 30
NCT04435795 (8) [back to overview]Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at Day 7
NCT04435795 (8) [back to overview]"Overall Feeling: Proportion Who Are Reporting That They Are Very Much Improved or Much Improved at Day 7"
NCT04435795 (8) [back to overview]"Overall Feeling: Proportion Who Are Reporting That They Are Very Much Improved or Much Improved at Day 14"
NCT04435795 (8) [back to overview]Mortality
NCT04435795 (8) [back to overview]Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea
NCT04435795 (8) [back to overview]Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea
NCT04435795 (8) [back to overview]Improvement in Dyspnea: Resolution of Dyspnea at Day 7
NCT04435795 (8) [back to overview]Proportion of Participants Hospitalized for SARS-CoV-2

Percentage of Asthma Symptom Free Days

Days without Asthma Symptom documented in the participant's diary were reported. (NCT00163293)
Timeframe: Months 1, 2, 4, 6, 8, 10 and 12

,,
Interventionpercentage of days (Mean)
Month 1 (n=62, 60, 60)Month 2 (n=61, 50, 56)Month 4 (n=54,55, 59)Month 6 (n=53, 50, 51)Month 8 (n=46, 46, 46)Month 10 (n=43, 47, 44)Month 12 (n=42, 44, 45)
Ciclesonide 100 µg37.3238.4742.5741.7538.8641.0043.20
Ciclesonide 200 µg36.9541.1638.8339.8743.9041.6542.03
Placebo35.0033.5635.7840.0940.0339.8344.61

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Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value)

FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement. (NCT00163293)
Timeframe: Baseline and Months 1, 2, 4, 6, 8, 10 and 12

,,
Interventionliters (Mean)
Change at Month 1 (n=78, 76, 81)Change at Month 2 (n=76, 73, 77)Change at Month 4 (n=68, 72, 75)Change at Month 6 (n=67, 72, 72)Change at Month 8 (n=66, 71, 68)Change at Month 10 (n=66, 69, 67)Change at Month 12 (n=65, 69, 65)
Ciclesonide 100 µg0.0190.0240.0650.0910.0750.1430.161
Ciclesonide 200 µg0.0180.0600.0830.1250.1260.1680.185
Placebo0.0120.0050.0760.0780.1200.1460.178

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Change From Baseline in Diurnal PEF Fluctuation

Diurnal PEF Fluctuation is equal to [(Higher PEF - Lower PEF)/0.5*(Higher PEF + Lower PEF)] * 100%. A positive change from Baseline indicates improvement. (NCT00163293)
Timeframe: Baseline and Months 1, 2, 4, 6, 8, 10 and 12

,,
Interventionpercent fluctuation (Mean)
Change at Month 1 (n=78, 76, 80)Change at Month 2 (n=76, 71, 77)Change at Month 4 (n=68, 71, 75)Change at Month 6 (n=67, 72, 73)Change at Month 8 (n=66, 70, 69)Change at Month 10 (n=64, 70, 68)Change at Month 12 (n=68, 70, 70)
Ciclesonide 100 µg-0.59-0.13-0.65-1.01-1.12-1.46-1.81
Ciclesonide 200 µg0.06-0.16-1.01-0.22-1.21-0.70-0.62
Placebo0.000.15-0.55-0.47-1.11-1.14-1.26

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Time to First Asthma Exacerbation

Time to first asthma exacerbation is defined as the time in days until the first asthma exacerbation, or to the end of treatment visit. In the absence of an exacerbation, an early treatment discontinuation is treated as a censored observation on the day following the last use of study drug. (NCT00163293)
Timeframe: Up to 12 months

Interventiondays (Mean)
Ciclesonide 100 µg225.1
Ciclesonide 200 µg249.5
Placebo227.2

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Percentage of Participants Who Dropped-out Due to Asthma Exacerbation

(NCT00163293)
Timeframe: Up to 12 months

Interventionpercentage of participants (Number)
Ciclesonide 100 µg1.3
Ciclesonide 200 µg1.3
Placebo4.8

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Number of Participants With Clinically Significant Vital Signs Findings

Vital signs included body temperature, systolic and diastolic blood pressure and heart rate in beats per minute (bpm). The investigator determined if the result was clinically significant based on the following criteria: Systolic Blood Pressure >130 mmHg or <80 mmHg or a >20 mmHg difference from Baseline; Diastolic Blood Pressure > 85 mmHg; and Resting Heart Rate >140 bpm or <60 bpm or a >30 bpm difference from Baseline. (NCT00163293)
Timeframe: Up to 12 months

Interventionparticipants (Number)
Ciclesonide 100 µg0
Ciclesonide 200 µg0
Placebo0

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Number of Participants With Clinically Significant Physical Examination Findings

A thorough physical examination was performed consisting of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) lungs/thorax; (4) heart/cardiovascular system; (5) abdomen; (6) skin and mucosae; (7) nervous system; (8) lymph nodes; (9) musculo-skeletal system; (10) physical examinations other than body systems described in (1) to (9). The investigator determined if any of the findings were clinically significant. (NCT00163293)
Timeframe: Up to 12 months

Interventionparticipants (Number)
Ciclesonide 100 µg0
Ciclesonide 200 µg0
Placebo0

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Number of Participants With Clinically Significant Laboratory Values

Clinically significant laboratory values were hematology and chemistry tests determined by the investigator to be clinically significant based on the following criteria: Hemoglobin <9.5 g/dL; Erythrocytes <3.0 x 10^6/μL or >6.5 x 10^6/μL; White Blood Count <3000/mm^3 or >20000/mm^3; serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyl transpeptidase (GGT), Total Bilirubin and Glucose >2 times Upper limit of Normal Range (ULNR); Alkaline Phosphatase and Creatine Kinase >3 times ULNR; Creatinine >1.5 times ULN; Potassium >5.0 mmol/L or <3.0 mmol/L; and Sodium >150 mmol/L or 130 mmol/L. (NCT00163293)
Timeframe: Up to 12 months

Interventionparticipants (Number)
Ciclesonide 100 µg0
Ciclesonide 200 µg0
Placebo0

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Number of Exacerbations Per Participant

The mean number of asthma exacerbations per participant is reported. (NCT00163293)
Timeframe: Up to 12 months

Interventionexacerbations (Mean)
Ciclesonide 100 µg0.72
Ciclesonide 200 µg0.78
Placebo0.95

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Exacerbations (Post-hoc Analysis of Annual Rates)

A model-based analysis of asthma exacerbation was performed to adjust to important covariables. The distribution of the data suggested a Poisson regression modeling (zero inflated) strategy. After a variable selection process considering also variable-by-treatment interactions, the variables centre, age [years] and race were identified to be important beside treatment. The parameters centre and age [years] were allocated to zero-model part and the variables treatment and race to the Poisson model part. The estimates of the per-treatment rates are based on a negative-binomial distribution. (NCT00163293)
Timeframe: Up to 12 months

Interventionnumber of events per year (Least Squares Mean)
Ciclesonide 100 µg0.9343
Ciclesonide 200 µg0.8794
Placebo1.2621

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Mean Rate of Asthma Exacerbations Per Year

Rate of asthma exacerbations per year is equal to total number of asthma exacerbations during treatment/time on treatment (year). (NCT00163293)
Timeframe: Up to 12 months

Interventionnumber of exacerbations per year (Mean)
Ciclesonide 100 µg0.88
Ciclesonide 200 µg0.85
Placebo3.28

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Growth Velocity as Assessed by Stadiometric Height Measurement

Standing height measured in millimeters (mm) with a wall-mounted stadiometer. (NCT00163293)
Timeframe: Up to 12 months

Interventionmm/year (Mean)
Ciclesonide 100 µg55.32
Ciclesonide 200 µg64.60
Placebo54.91

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Total Asthma Symptom Score by Diary Entries

Total Asthma Score = daytime asthma score + night-time asthma score, where higher score indicates worsening of disease. Night-time asthma score is assessed on a 5 point scale where 0=No symptoms, slept through the night, 1=Slept well but some complaints in the morning, 2=Woke up once because of asthma (including early wakening), 3=Woke up several times because of asthma (including early wakening) and 4=Bad night, awake most of the night because of asthma. Day-time asthma score is assessed on a 5 point scale where 0= Very well, no symptoms, 1= One episode of wheezing, cough or breathlessness, 2= More than one episode of wheezing, cough or breathlessness without interfering with normal activities, 3= Wheezing, cough or shortness of breath most of the day which interfered to some extent with normal activities and 4= Asthma very bad. Unable to carry out daily activities as usual. (NCT00163293)
Timeframe: Months 1, 2, 4, 6, 8, 10 and 12

,,
Interventionscore on a scale (Mean)
Month 1 (n=77, 75, 79)Month 2 (n=76, 70, 77)Month 4 (n=68, 72, 75)Month 6 (n=67, 72, 73)Month 8 (n=66, 69, 69)Month 10 (n=64, 70, 68)Month 12 (n=68, 69, 70)
Ciclesonide 100 µg0.370.260.180.160.170.120.11
Ciclesonide 200 µg0.220.140.120.170.130.110.08
Placebo0.320.280.240.180.230.240.15

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Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S])

"The PAQLQ(S) consists of 23 items divided into three domains: Activity limitations (items 1-3, 19, 22); Symptoms (items 4, 6, 8, 10, 12, 14, 16, 18, 20, 23) and Emotional function (items 5, 7, 9, 11, 13, 15, 17, 21). Participants were asked to answer each question using a seven-point scale (where 1 indicated maximum impairment and 7 indicated no impairment) and recall their experience during the previous week. Overall PAQLQ score is equal to the mean of all 23 items for a total possible score 1 (worst) to 7 (best)." (NCT00163293)
Timeframe: Months 2, 6 and 12

,,
Interventionscore on a scale (Mean)
Month 2 (n=70, 73, 75)Month 6 (n=65, 72, 72)Month 12 (n=64, 69, 65)
Ciclesonide 100 µg6.216.336.42
Ciclesonide 200 µg6.276.266.34
Placebo6.086.306.36

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Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)

"The PACQLQ consists of 13 items divided into two domains: Activity limitations (items 2, 4, 6, 8) and Emotional function (items 1, 3, 5, 7, 9, 10, 11, 12, 13). Caregivers answered each question using a seven-point scale (whereby 1 indicated maximum impairment and 7 indicated no impairment) and recalled their experiences during the previous week. Overall PACQLQ score is equal to the mean of all 13 items for a total possible score of 1 (worst) to 7 (best)." (NCT00163293)
Timeframe: Months 2, 6 and 12

,,
Interventionscore on a scale (Mean)
Month 2 (n=73, 73, 76)Month 6 (n=67, 72, 73)Month 12 (n=66, 69, 66)
Ciclesonide 100 µg5.876.156.32
Ciclesonide 200 µg6.166.166.25
Placebo6.086.316.31

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Percentage of Rescue Medication Free Days

Days without use of rescue medication documented in the participant's diary were reported. (NCT00163293)
Timeframe: Months 1, 2, 4, 6, 8, 10 and 12

,,
Interventionpercentage of days (Mean)
Month 1 (n=55, 53, 54)Month 2 (n=52, 41, 48)Month 4 (n=49, 48, 52)Month 6 (n=47, 44, 45)Month 8 (n=39, 42, 44)Month 10 (n=40, 40, 37)Month 12 (n=35, 41, 40)
Ciclesonide 100 µg47.9448.7849.9149.6347.9346.2253.58
Ciclesonide 200 µg47.3454.4646.5148.1450.5049.7853.63
Placebo44.3745.3145.9149.4245.2252.7058.03

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Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms

Nocturnal awakenings due to asthma symptoms were recorded in the participant's diary. (NCT00163293)
Timeframe: Months 1, 2, 4, 6, 8, 10 and 12

,,
Interventionpercentage of nights (Mean)
Month 1 (n=78, 75, 80)Month 2 (n=76, 73, 77)Month 4 (n=68, 72, 75)Month 6 (n=67, 72, 73)Month 8 (n=66, 70, 69)Month 10 (n=66, 70, 68)Month 12 (n=74, 73, 78)
Ciclesonide 100 µg2.401.961.330.871.621.930.41
Ciclesonide 200 µg1.640.620.861.511.050.591.84
Placebo1.851.731.541.261.821.880.53

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Duration of Exacerbations

Duration of exacerbation was defined as the time in days when the criteria for an exacerbation were met to the time when peak flow measurements returned to baseline. (NCT00163293)
Timeframe: Up to 12 months

Interventiondays (Mean)
Ciclesonide 100 µg9.17
Ciclesonide 200 µg9.31
Placebo7.92

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Number of Participants With Adverse Events and Serious Adverse Events

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect or any other important medical condition considered serious based on medical and scientific judgement. (NCT00163293)
Timeframe: Up to 12 months

,,
Interventionparticipants (Number)
Adverse EventsSerious Adverse Events
Ciclesonide 100 µg612
Ciclesonide 200 µg642
Placebo632

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Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries

PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF. (NCT00163293)
Timeframe: Months 1, 2, 4, 6, 8, 10 and 12

,,
Interventionliters/second (Mean)
Month 1, Evening PEF (n=78, 76, 80)Month 1, Morning PEF (n=78, 76, 81)Month 2, Evening PEF (n=76, 71, 77)Month 2, Morning PEF (n=76, 72, 77)Month 4, Evening PEF (n=68, 72, 75)Month 4, Morning PEF (n=68, 71, 76)Month 6, Evening PEF (n=67, 72, 73)Month 6, Morning PEF (n=67, 72, 73)Month 8, Evening PEF (n=66, 70, 69)Month 8, Morning PEF (n=66, 71, 69)Month 10, Evening PEF (n=65, 70, 68)Month 10, Morning PEF (n=66, 70, 68)Month 12, Evening PEF (n=68, 71, 70)Month 12, Morning PEF (n=75, 73, 78)
Ciclesonide 100 µg235.72232.09241.07236.92249.75242.93251.88246.44253.49247.24254.21247.94255.97245.84
Ciclesonide 200 µg238.16234.41241.16236.42243.52241.91249.36246.75250.92246.97256.44254.04263.87258.62
Placebo241.89233.81244.67239.07245.91240.16246.44238.81245.72239.73251.69246.23261.88250.55

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Rescue Medication Use Per Day

Salbutamol (100 μg/puff) was used as rescue medication according to the individual needs of the participant. Each use was documented in the participant's diary. (NCT00163293)
Timeframe: Months 1, 2, 4, 6, 8, 10 and 12

,,
Interventionpuffs/day (Mean)
Month 1 (n=57, 51, 54)Month 2 (n=53, 40, 46)Month 4 (n=48, 47, 51)Month 6 (n=45, 43, 44)Month 8 (n=38, 42, 45)Month 10 (n=38, 41, 39)Month 12 (n=36, 40, 40)
Ciclesonide 100 µg1.000.990.880.791.010.930.71
Ciclesonide 200 µg0.830.531.181.071.130.951.01
Placebo0.870.971.270.920.970.830.75

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Change From Baseline in PEF by Diary Entries

PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF. A positive change from Baseline indicates improvement. (NCT00163293)
Timeframe: Baseline and Months 1, 2, 4, 6, 8, 10 and 12

,,
Interventionliters/second (Mean)
Change at Month 1, Evening PEF (n=78, 76, 80)Change at Month 1, Morning PEF (n=78, 76, 81)Change at Month 2, Evening PEF (n=76, 71, 77)Change at Month 2, Morning PEF (n=76, 72, 77)Change at Month 4, Evening PEF (n=68, 72, 75)Change at Month 4, Morning PEF (n=68, 71, 76)Change at Month 6, Evening PEF (n=67, 72, 73)Change at Month 6, Morning PEF (n=67, 72, 73)Change at Month 8, Evening PEF (n=66, 70, 69)Change at Month 8, Morning PEF (n=66, 71, 69)Change at Month 10, Evening PEF (n=65, 70, 68)Change at Month 10, Morning PEF (n=66, 70, 68)Change at Month 12, Evening PEF (n=68, 71, 70)Change at Month 12, Morning PEF (n=75, 73, 78)
Ciclesonide 100 µg8.4611.6913.6617.1220.4121.3322.4424.8225.4727.1625.6827.8628.2426.84
Ciclesonide 200 µg8.5410.8213.0414.3016.0118.2421.8624.6821.3823.7626.7829.8433.3534.31
Placebo6.067.5410.8314.2913.6216.2813.1414.4413.3016.0318.0421.2525.3824.37

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Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted)

FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement. (NCT00163293)
Timeframe: Baseline and Months 1, 2, 4, 6, 8, 10 and 12

,,
Interventionpercent predicted FEV1 (Mean)
Change at Month 1 (n=78, 76, 81)Change at Month 2 (n=76, 73, 77)Change at Month 4 (n=68, 72, 75)Change at Month 6 (n=67, 72, 72)Change at Month 8 (n=66, 71, 68)Change at Month 10 (n=66, 69, 67)Change at Month 12 (n=65, 69, 65)
Ciclesonide 100 µg1.01.44.05.54.48.69.5
Ciclesonide 200 µg0.63.44.67.26.59.110.1
Placebo1.00.35.14.97.18.710.4

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PC20 AMP (Post-treatment Compared to Baseline)

Mean change of Provocative concentration of Adenosine-5'-monophosphate (PC20 AMP) leading to a 20 percent decrease in Forced expiratory volume in one second (FEV1) between post-treatment and baseline using two different particle sizes. - Small particles = Mass mean aerodynamic diameter (MMAD) of approximately 1.04-1.08 micron - Large particles = MMAD of approximately 9.9-10.6 micron (NCT00306163)
Timeframe: Baseline and 5 weeks

,
InterventionLogarithm (mg/mL) (Mean)
Baseline PC20 small-particle AMPBaseline PC20 large-particle AMPPost-Treatment PC20 small-particle AMPPost-Treatment PC20 large-particle AMP
Ciclesonide4.93.76.64.5
Fluticasone5.23.06.04.3

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Time to First Event of Lack of Efficacy (LOE) by Week 12

Kaplan Meier Estimates of the probability of not experiencing LOE by Week 12 was measured. LOE was reached if any of the following criteria occurred during the treatment period: • asthma exacerbation (a worsening of asthma symptoms requiring a change in medication; • nocturnal awakenings due to asthma on any 4 or more nights during any 7-consecutive-day period; • use of more than 8 puffs/day of salbutamol on any 4 or more days during any 7-consecutive-day period; • decrease in morning PEF to <80% of randomization value on any 4 consecutive days during the treatment period. (NCT00384189)
Timeframe: 12 weeks

InterventionPercent (Number)
Ciclesonide 40 µg72.8
Ciclesonide 80 µg74.5
Ciclesonide 160 µg73.2
Placebo66.9

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Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication, Morning PEF and PEF Fluctuation

Control of asthma was evaluated on a daily basis (24 hours) using the following variables: asthma symptoms, use of rescue medication, morning (am) PEF and PEF fluctuation. The median percentage of days with asthma control is presented. (NCT00384189)
Timeframe: 28 days prior to last visit (Up to 12 Weeks)

Interventionpercentage of days (Median)
Ciclesonide 40 µg7.14
Ciclesonide 80 µg10.53
Ciclesonide 160 µg6.67
Placebo0.0

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Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication and Morning PEF

Control of asthma was evaluated on a daily basis (24 hours) using the following variables: asthma symptoms, use of rescue medication, and morning (am) PEF. The median percentage of days with asthma control is presented. (NCT00384189)
Timeframe: 28 days prior to last visit (Up to 12 Weeks)

Interventionpercentage of days (Median)
Ciclesonide 40 µg8.33
Ciclesonide 80 µg13.64
Ciclesonide 160 µg13.04
Placebo0.0

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Change in Use of Rescue Medications

The daily use of rescue medication (salbutamol) was recorded in the electronic diary in the morning and the evening. A negative change from Baseline indicates improvement. (NCT00384189)
Timeframe: Baseline and Week 12

Interventionpuffs/day (Mean)
Ciclesonide 40 µg-0.872
Ciclesonide 80 µg-0.999
Ciclesonide 160 µg-0.886
Placebo-0.527

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Change From Baseline in Pediatric Asthma Quality of Life Questionnaire Standard [PAQLQ(S)] Overall Score

PAQLQS is a disease specific instrument to assess the impact of asthma on the patient's quality of life. The PAQLQS consists of 23 items in 3 domains evaluating activity limitations, symptoms and emotional function. Patients answered each question using a 7-point scale from 1= maximum impairment to 7=no impairment) about their experience during the previous week. Total possible score ranging from 23 (worst) to 161(best). Higher change from Baseline scores are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis. (NCT00384189)
Timeframe: Baseline and Week 12

Interventionscore on a scale (Least Squares Mean)
Ciclesonide 40 µg0.78
Ciclesonide 80 µg0.71
Ciclesonide 160 µg0.72
Placebo0.43

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Change From Baseline in Morning Peak Expiratory Flow (PEF)

PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis. Last observation carried forward. (NCT00384189)
Timeframe: Baseline and Week 12

Interventionliters/minute (Least Squares Mean)
Ciclesonide 40 µg15.23
Ciclesonide 80 µg14.79
Ciclesonide 160 µg17.37
Placebo5.40

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Change From Baseline in Lung Function Variable PEF by Spirometry

Spirometry was performed according to local standards. PEF is the maximum speed of expiration. Analysis was ANCOVA with factors value at Baseline, treatment, age, sex, center pool, ICS pretreatment, spacer use and asthma severity. Higher change numbers indicate better lung function. (NCT00384189)
Timeframe: Baseline and Week 12

Interventionliters/minute (Least Squares Mean)
Ciclesonide 40 µg20.68
Ciclesonide 80 µg21.71
Ciclesonide 160 µg22.25
Placebo15.13

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Change From Baseline in Lung Function Variable Forced Expiratory Volume in One Second (FEV1)

Spirometry was performed according to local standards. FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Higher change numbers indicate better lung function. (NCT00384189)
Timeframe: Baseline and Week 12

Interventionliters (Least Squares Mean)
Ciclesonide 40 µg0.123
Ciclesonide 80 µg0.122
Ciclesonide 160 µg0.139
Placebo0.039

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Change From Baseline in Diurnal PEF Fluctuations

PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. A negative change from Baseline indicates improvement. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis. (NCT00384189)
Timeframe: Baseline and Week 12

Interventionpercent change (Mean)
Ciclesonide 40 µg-0.841
Ciclesonide 80 µg-1.209
Ciclesonide 160 µg-1.192
Placebo0.214

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Change in Asthma Symptom Total Score

Measurements of both nighttime and daytime asthma symptoms were assessed on a daily basis by the patient in the electronic diary, according to the following scales: Nighttime Asthma Score using a 5 point scale: 0=no asthma symptoms, slept through the night to 4=bad night, awake most of the night because of asthma. Daytime Asthma Score using a 5 point scale: 0=very well, no asthma symptoms to 4=asthma very bad, unable to carry out daily activities as usual. Total possible overall daily score range from 0(best) to 4 (worst). A negative change from Baseline indicated improvement. (NCT00384189)
Timeframe: Baseline and Week 12

,,,
Interventionscore on a scale (Mean)
Asthma Total Symptom Score (n=304,312,310,146)Asthma Daytime Symptom Score (n=304,312,310,146)Asthma Nighttime Symptom Score
Ciclesonide 160 µg-0.879-0.517-0.350
Ciclesonide 40 µg-0.916-0.529-0.392
Ciclesonide 80 µg-0.983-0.553-0.435
Placebo-0.572-0.354-0.233

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Change From Baseline in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) Overall

PACQLQ assesses the impact of the child's asthma on the quality of life of the caregiver. The PACQLQ consists of 13 items in 2 domains evaluating activity limitations and emotional function. Caregivers answered each question using a 7-point scale from 1= maximum impairment to 7=no impairment about their experience during the previous week. Total possible score ranging from 13 (worst) to 91(best). Higher change from Baseline scores are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis. (NCT00384189)
Timeframe: Baseline and Week 12

Interventionscore on a scale (Least Squares Mean)
Ciclesonide 40 µg0.82
Ciclesonide 80 µg0.88
Ciclesonide 160 µg0.84
Placebo0.71

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Change From Baseline in Evening PEF From Diary

PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis. (NCT00384189)
Timeframe: Baseline and Week 12

Interventionliters/minute (Least Squares Mean)
Ciclesonide 40 µg10.16
Ciclesonide 80 µg9.37
Ciclesonide 160 µg12.71
Placebo4.02

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Change From Baseline in Morning PEF From Diary

PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis. (NCT00384189)
Timeframe: Baseline and Weeks 1 thru 12

,,,
Interventionliters/minute (Least Squares Mean)
Change at Week 1 (n=303,311,310,146)Change at Week 2 (n=303,311,310,146)Change at Week 3 (n=304,312,310,146)Change at Week 4 (n=304,312,310,146)Change at Week 5Change at Week 6Change at Week 7Change at Week 8Change at Week 9Change at Week 10Change at Week 11Change at Week 12
Ciclesonide 160 µg11.5412.2613.1515.6015.3914.7114.1413.6313.2314.5916.2417.59
Ciclesonide 40 µg11.619.8211.3613.6314.8613.9114.5714.5715.2616.3516.1215.93
Ciclesonide 80 µg9.2011.9511.1113.2713.3313.2615.0515.9216.0216.7915.9715.43
Placebo4.544.206.746.319.677.646.217.057.887.666.806.41

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Change From Baseline in Use of Albuterol/Salbutamol at Week 12.

Change in albuterol/salbutamol use from baseline to week 12 (NCT00392288)
Timeframe: Baseline and Week 12

InterventionPuffs per day (Least Squares Mean)
Placebo Metered Dose Inhaler (MDI)-0.59
Ciclesonide MDI 40 µg BID-0.87
Ciclesonide MDI 80 µg BID-0.93

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Change From Baseline in Total Daily Asthma Symptom Score at Week 12.

Change in total daily asthma symptom score from baseline to week 12. 5-Point, ordinal scale specifying patient's experience of symptoms during day and night from 0 (no symptoms) to 4 (symptoms that prevent the patient from engaging in daily activities or sleep) (NCT00392288)
Timeframe: Baseline and Week 12

InterventionScores on a scale (Least Squares Mean)
Placebo Metered Dose Inhaler (MDI)-0.96
Ciclesonide MDI 40 µg BID-1.13
Ciclesonide MDI 80 µg BID-0.99

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Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12.

Change in FEV1 (Percent of predicted) from baseline to week 12. FEV1 was measured only in children between 6 to <12 years only. Least Squares Mean were adjusted for Baseline FEV1, age [yrs], pooled center, previous corticosteroid therapy and holding chamber. (NCT00392288)
Timeframe: Baseline and Week 12

InterventionPercent of predicted FEV1 (Least Squares Mean)
Placebo Metered Dose Inhaler (MDI)5.2
Ciclesonide MDI 40 µg BID5.3
Ciclesonide MDI 80 µg BID7.7

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Change in Patient Assessment of Asthma Control

"Patient assessment of asthma control was assessed at baseline and at week 12 using the question How would you rate the control of your asthma symptoms?. The change in this assessment was categorized in Improvement and Non-Improvement." (NCT00404547)
Timeframe: At baseline and at week 12

,
Interventionparticipants (Number)
ImprovementNon-ImprovementNot reported
Alvesco4222846
Usual Asthma Care and Dosage1322094

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Change in Mean of Total Score of Asthma Control Questionnaire (ACQ)

The score of the change from baseline ranges from -6 (=best possible outcome) to 6 (=worst possible outcome). (NCT00404547)
Timeframe: At the middle and end of the 12 week treatment period

Interventionpoints on a scale (Mean)
Alvesco-0.76
Usual Asthma Care and Dosage-0.37

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Comparison of Systemic Exposure Measured by Cmax, pg/mL, (Highest Concentration of Drug in the Blood) of Des-ciclesonide With Ciclesonide Nasal Spray, and Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide.

The primary pharmacokinetics comparisons between treatments will be that of 300 mcg OMNARIS™ [ciclesonide] nasal spray and 300 mcg ciclesonide nasal HFA aerosol vs. 320 mcg orally inhaled ciclesonide as a reference. At prespecified timepoints, blood samples were obtained from subjects. The Cmax may be available only for a limited number of subjects. Thus the focus of statistical PK analysis will be on descriptive statistics. In particular, mean and median for Cmax will be calculated using data from subjects with Cmax above LLOQ (Lower Limit of Quantitation) and from all subjects with Cmax below LLOQ imputed by 0. (NCT00458835)
Timeframe: 5min, 15min, 30min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h following drug administration.

Interventionpg/mL (Median)
Ciclesonide Nasal Spray20.05
Ciclesonide Nasal Aerosol59.0
Ciclesonide HFA MDI602.0

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Comparison of Systemic Exposure Measured by AUC, ng*hr/L, (Area Under the Serum Concentration) of Des-ciclesonide With Ciclesonide Nasal Spray, and Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide.

The primary pharmacokinetics comparisons between treatments will be that of 300 mcg OMNARIS™ [ciclesonide] nasal spray and 300 mcg ciclesonide nasal HFA aerosol vs. 320 mcg orally inhaled ciclesonide as a reference. At prespecified timepoints, blood samples were obtained from subjects. It was anticipated that only a limited number of des-ciclesonide concentrations would exceed the lower limit of quantification (LLOQ) of 10 pg/mL for ciclesonide aqueous nasal spray. AUC for the aqueous nasal spray could not be determined due to the fact that there were too few analysis samples that produced values above the LLOQ. (NCT00458835)
Timeframe: 5min, 15min, 30min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h following drug administration.

Interventionng*hr/L (Median)
Ciclesonide Nasal SprayNA
Ciclesonide Nasal Aerosol403.7
Ciclesonide HFA MDI2762

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Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS)

"Onset of nasal improvement was defined as the first assessment at which iTNSS for active treatment demonstrated an improvement over placebo from baseline.~TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and 12 reflecting more severe symptoms). Instaneous measures these symptoms over the previous 10 minute time interval." (NCT00790023)
Timeframe: Baseline and up to 36 hours

,,
InterventionUnits on a scale (Least Squares Mean)
Day 1, 4 Hours Postdose (n=237, 233, 233)Day 1, 6 Hours Postdose (n=235, 234, 231)Day 1, 8 Hours Postdose (n=236, 233, 233)Day 1, 10 Hours Postdose (n=237,232,231)Day 1, 12 Hours Postdose (n=236, 233, 233)Day 2, Predose (n=237,234,233)Day 2, 6 Hours Postdose (n=237,233,231)Day 2, 12 Hours Postdose (n=235,233,232)
160 mcg Ciclesonide-0.79-1.36-1.35-1.19-1.15-0.81-1.59-1.59
80 mcg Ciclesonide-0.77-1.19-1.31-1.34-1.14-0.57-1.56-1.35
Placebo-0.84-1.19-1.14-0.90-0.87-0.45-1.16-0.77

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Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0

"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

,,
InterventionUnits on a scale (Least Squares Mean)
Itching EyesRedness of EyesTearing Eyes
160 mcg Ciclesonide-0.35-0.34-0.42
80 mcg Ciclesonide-0.34-0.35-0.39
Placebo-0.14-0.16-0.16

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Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

,,
InterventionUnits on a scale (Least Squares Mean)
SneezingRunny NoseNasal ItchingNasal Congestion
160 mcg Ciclesonide-0.46-0.37-0.44-0.35
80 mcg Ciclesonide-0.41-0.32-0.38-0.35
Placebo-0.13-0.10-0.17-0.11

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Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0

"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

,,
InterventionUnits on a scale (Least Squares Mean)
Itching EyesRedness of EyesTearing Eyes
160 mcg Ciclesonide-0.36-0.38-0.42
80 mcg Ciclesonide-0.34-0.36-0.36
Placebo-0.13-0.13-0.10

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Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

,,
InterventionUnits on a scale (Least Squares Mean)
SneezingRunny NoseNasal ItchingNasal Congestion
160 mcg Ciclesonide-0.43-0.35-0.44-0.33
80 mcg Ciclesonide-0.37-0.30-0.35-0.33
Placebo-0.14-0.11-0.14-0.09

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Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0

"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

,,
InterventionUnits on a scale (Least Squares Mean)
Itching EyesRedness of EyesTearing Eyes
160 mcg Ciclesonide-0.34-0.32-0.38
80 mcg Ciclesonide-0.35-0.33-0.38
Placebo-0.14-0.14-0.16

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Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0

"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

,,
InterventionUnits on a scale (Least Squares Mean)
Itching EyesRedness of EyesTearing Eyes
160 mcg Ciclesonide-0.33-0.31-0.35
80 mcg Ciclesonide-0.36-0.32-0.36
Placebo-0.14-0.12-0.16

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Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

,,
InterventionUnits on a scale (Least Squares Mean)
SneezingRunny NoseNasal ItchingNasal Congestion
160 mcg Ciclesonide-0.43-0.35-0.43-0.36
80 mcg Ciclesonide-0.39-0.32-0.38-0.35
Placebo-0.12-0.13-0.17-0.12

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Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0

"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

,,
InterventionUnits on a scale (Least Squares Mean)
Itching EyesRedness of EyesTearing Eyes
160 mcg Ciclesonide-0.32-0.32-0.35
80 mcg Ciclesonide-0.33-0.33-0.31
Placebo-0.17-0.10-0.13

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Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

,,
InterventionUnits on a scale (Least Squares Mean)
SneezingRunny NoseNasal ItchingNasal Congestion
160 mcg Ciclesonide-0.33-0.29-0.42-0.33
80 mcg Ciclesonide-0.33-0.30-0.38-0.31
Placebo-0.10-0.09-0.16-0.11

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Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0

"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

,,
InterventionUnits on a scale (Least Squares Mean)
Itching EyesRedness of EyesTearing Eyes
160 mcg Ciclesonide-0.34-0.35-0.38
80 mcg Ciclesonide-0.34-0.34-0.33
Placebo-0.15-0.12-0.12

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Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

,,
InterventionUnits on a scale (Least Squares Mean)
SneezingRunny NoseNasal ItchingNasal Congestion
160 mcg Ciclesonide-0.38-0.33-0.43-0.33
80 mcg Ciclesonide-0.35-0.30-0.37-0.32
Placebo-0.12-0.10-0.15-0.33

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Time to Maximal Effect as Measured by Change From Baseline in the Average AM and PM Reflective Total Nasal Symptoms Scores (rTNSS)

The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between Ciclesonide HFA and placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. (NCT00790023)
Timeframe: Week 0-2

Interventiondays (Least Squares Mean)
80 mcg Ciclesonide13
160 mcg Ciclesonide8

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Change From Baseline in Overall Score of the Rhinoconjunctivitis Quality of Life Questionnaire With Standard Activities (RQLQ(S)) in Participants With a Baseline Overall Score >= 3.0

The RQLQ(S) in impaired subjects (baseline RQLQ[S] score ≥3.0) at baseline and end of week 2. It consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores. (NCT00790023)
Timeframe: Week 0-2

Interventionunits on a scale (Least Squares Mean)
80 mcg Ciclesonide-1.05
160 mcg Ciclesonide-1.07
Placebo-0.42

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Change From Baseline in Daily Subject-reported PM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0

"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

InterventionUnits on a scale (Least Squares Mean)
80 mcg Ciclesonide-1.09
160 mcg Ciclesonide-1.11
Placebo-0.47

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Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the Two Week Treatment Period

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

InterventionUnits on a scale (Least Squares Mean)
80 mcg Ciclesonide-1.46
160 mcg Ciclesonide-1.60
Placebo-0.51

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Change From Baseline in Daily Subject-reported PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0

"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

InterventionUnits on a scale (Least Squares Mean)
80 mcg Ciclesonide-1.06
160 mcg Ciclesonide-1.16
Placebo-0.36

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Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the Two Week Treatment Period

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

InterventionUnits on a scale (Least Squares Mean)
80 mcg Ciclesonide-1.36
160 mcg Ciclesonide-1.55
Placebo-0.49

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Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

,,
InterventionUnits on a scale (Least Squares Mean)
SneezingRunny NoseNasal ItchingNasal Congestion
160 mcg Ciclesonide-0.44-0.36-0.43-0.36
80 mcg Ciclesonide-0.40-0.32-0.38-0.35
Placebo-0.12-0.11-0.16-0.11

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Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the Two Week Treatment Period

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

InterventionUnits on a scale (Least Squares Mean)
80 mcg Ciclesonide-1.45
160 mcg Ciclesonide-1.56
Placebo-0.53

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Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0

"Onset of improvement iTOSS was defined as the first assessment at which iTOSSS for active treatment demonstrated an improvement over placebo from baseline. TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval." (NCT00790023)
Timeframe: Baseline and up to 48 hours

,,
InterventionUnits on a scale (Least Squares Mean)
Day 1, 4 Hours Postdose (n=149, 150, 132)Day 1, 6 Hours Postdose (n=149, 150, 132)Day 1, 8 Hours Postdose (n=148, 150, 132)Day 1, 10 Hours Postdose (n=149, 150, 132)Day 1, 12 Hours Postdose (n=149, 148, 132)Day 2, Predose (n=149, 149, 132)Day 2, 6 Hours Postdose (n=149, 150, 131)Day 2, 12 Hours Postdose (n=149, 149, 132)
160 mcg Ciclesonide-0.57-0.83-0.97-0.79-0.83-0.37-1.15-1.26
80 mcg Ciclesonide-0.69-0.93-0.97-1.02-0.80-0.29-1.11-1.09
Placebo-0.53-0.75-0.72-0.69-0.49-0.09-0.71-0.47

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Change From Baseline in Daily Subject-reported AM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0

"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

InterventionUnits on a scale (Least Squares Mean)
80 mcg Ciclesonide-0.96
160 mcg Ciclesonide-0.99
Placebo-0.42

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Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the Two Week Treatment Period

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

InterventionUnits on a scale (Least Squares Mean)
80 mcg Ciclesonide-1.32
160 mcg Ciclesonide-1.37
Placebo-0.46

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Change From Baseline in Daily Subject-reported AM and PM rTOSS Averaged Over the Two-week Treatment Period in Participants With a Baseline rTOSS >= 5.0

"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

Interventionunits on a scale (Least Squares Mean)
80 mcg Ciclesonide-1.06
160 mcg Ciclesonide-1.05
Placebo-0.44

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Change From Baseline in Daily Subject-reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Averaged Over the Two-week Treatment Period.

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

Interventionunits on a scale (Least Squares Mean)
80 mcg Ciclesonide-1.45
160 mcg Ciclesonide-1.59
Placebo-0.51

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Change From Baseline in Daily Subject-reported AM and PM iTNSS Averaged Over the Two-week Treatment Period.

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

Interventionunits on a scale (Least Squares Mean)
80 mcg Ciclesonide-1.34
160 mcg Ciclesonide-1.47
Placebo-0.47

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Change From Baseline in Daily Subject Reported AM and PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0

"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

InterventionUnits on a scale (Least Squares Mean)
80 mcg Ciclesonide-1.00
160 mcg Ciclesonide-1.07
Placebo-0.40

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Change From Baseline in Daily Subject-reported AM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0

"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00790023)
Timeframe: Week 0-2

InterventionUnits on a scale (Least Squares Mean)
80 mcg Ciclesonide-1.03
160 mcg Ciclesonide-0.98
Placebo-0.41

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Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00953147)
Timeframe: Weeks 0-6

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA 80 Mcg Once Daily-1.97
Ciclesonide HFA 160 Mcg Once Daily-1.82
Placebo Once Daily-1.28

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Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00953147)
Timeframe: Weeks 0-6

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA 80 Mcg Once Daily-1.78
Ciclesonide HFA 160 Mcg Once Daily-1.67
Placebo Once Daily-1.23

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Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00953147)
Timeframe: Weeks 0-6

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA 80 Mcg Once Daily-1.94
Ciclesonide HFA 160 Mcg Once Daily-1.78
Placebo Once Daily-1.25

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Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00953147)
Timeframe: Weeks 0-6

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA 80 Mcg Once Daily-1.76
Ciclesonide HFA 160 Mcg Once Daily-1.55
Placebo Once Daily-1.15

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Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00953147)
Timeframe: Weeks 0-6

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA 80 Mcg Once Daily-2.01
Ciclesonide HFA 160 Mcg Once Daily-1.88
Placebo Once Daily-1.32

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Change From Baseline to Month 6 (Week 26) in RQLQ(S) Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0.

RQLQ(S) scores in impaired subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S)consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores. (NCT00953147)
Timeframe: Baseline and Week 26

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA 80 Mcg Once Daily-1.67
Ciclesonide HFA 160 Mcg Once Daily-1.62
Placebo Once Daily-1.40

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Change From Baseline to Week 6 in Rhinoconjunctivitis Quality of Life Questionnaire With Standardized [RQLQ(S)] Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0

RQLQ(S) scores in subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores. (NCT00953147)
Timeframe: Baseline and Week 6

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA 80 Mcg Once Daily-1.55
Ciclesonide HFA 160 Mcg Once Daily-1.27
Placebo Once Daily-0.96

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Change From Baseline in Daily Subject-reported AM & PM rNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period.

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00953147)
Timeframe: Weeks 0-6

,,
Interventionunits on a scale (Least Squares Mean)
SneezingRunny NoseNasal ItchingNasal Congestion
Ciclesonide HFA 160 Mcg Once Daily-0.49-0.45-0.49-0.39
Ciclesonide HFA 80 Mcg Once Daily-0.52-0.50-0.53-0.42
Placebo Once Daily-0.33-0.31-0.39-0.26

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Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00953147)
Timeframe: Weeks 0-6

,,
Interventionunits on a scale (Least Squares Mean)
SneezingRunny NoseNasal ItchingNasal Congestion
Ciclesonide HFA 160 Mcg Once Daily-0.41-0.41-0.46-0.32
Ciclesonide HFA 80 Mcg Once Daily-0.44-0.47-0.50-0.36
Placebo Once Daily-0.32-0.30-0.35-0.22

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Change From Baseline in Daily Subject-reported AM iNSS Averaged the First 6 Weeks of the Double-blind Treatment

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00953147)
Timeframe: Weeks 0-6

,,
Interventionunits on a scale (Least Squares Mean)
SneezingRunny NoseNasal ItchingNasal Congestion
Ciclesonide HFA 160 Mcg Once Daily-0.44-0.43-0.47-0.33
Ciclesonide HFA 80 Mcg Once Daily-0.45-0.47-0.51-0.36
Placebo Once Daily-0.34-0.30-0.37-0.22

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Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00953147)
Timeframe: Weeks 0 - 6

,,
Interventionunits on a scale (Least Squares Mean)
SneezingRunny NoseNasal ItchingNasal Congestion
Ciclesonide HFA 160 Mcg Once Daily-0.47-0.44-0.48-0.38
Ciclesonide HFA 80 Mcg Once Daily-0.51-0.49-0.52-0.42
Placebo Once Daily-0.31-0.31-0.38-0.25

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Change From Baseline in Daily Subject-reported PM iNSS Averaged the First 6 Weeks of the Double-blind Treatment

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00953147)
Timeframe: Weeks 0-6

,,
Interventionunits on a scale (Least Squares Mean)
SneezingRunny NoseNasal ItchingNasal Congestion
Ciclesonide HFA 160 Mcg Once Daily-0.39-0.40-0.45-0.31
Ciclesonide HFA 80 Mcg Once Daily-0.44-0.47-0.49-0.37
Placebo Once Daily-0.31-0.29-0.33-0.22

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Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00953147)
Timeframe: Weeks 0-6

,,
Interventionunits on a scale (Least Squares Mean)
SneezingRunny NoseNasal ItchingNasal Congestion
Ciclesonide HFA 160 Mcg Once Daily-0.52-0.47-0.51-0.39
Ciclesonide HFA 80 Mcg Once Daily-0.53-0.51-0.54-0.43
Placebo Once Daily-0.35-0.31-0.39-0.26

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Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT00953147)
Timeframe: Weeks 0-6

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA 80 Mcg Once Daily-1.77
Ciclesonide HFA 160 Mcg Once Daily-1.60
Placebo Once Daily-1.18

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Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 2-week Treatment Period

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

,,
Interventionunits on a scale (Least Squares Mean)
SneezingRunny NoseNasal ItchingNasal Congestion
Ciclesonide HFA Nasal Aerosol 160 μg-0.36-0.40-0.45-0.35
Ciclesonide HFA Nasal Aerosol 80 μg-0.40-0.45-0.39-0.37
Placebo-0.14-0.18-0.21-0.18

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Time to Maximal Effect Over the 2-week of Double-blind Treatment Period.

The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between Ciclesonide HFA and placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo. (NCT01010971)
Timeframe: Week 0-2

InterventionDays (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 160 μg7
Ciclesonide HFA Nasal Aerosol 80 μg8

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Change From Baseline in the RQLQ(S) Overall Score at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0

RQLQ(S) in impaired subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores. (NCT01010971)
Timeframe: Week 0-2

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 160 μg-1.41
Ciclesonide HFA Nasal Aerosol 80 μg-1.44
Placebo-0.79

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Change From Baseline in Daily Subject-reported PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0

"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 160 μg-1.21
Ciclesonide HFA Nasal Aerosol 80 μg-1.39
Placebo-0.88

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Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 2 Week Treatment Period.

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 160 μg-1.70
Ciclesonide HFA Nasal Aerosol 80 μg-1.67
Placebo-0.66

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Change From Baseline in Daily Subject-reported PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.

"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 160 μg-1.14
Ciclesonide HFA Nasal Aerosol 80 μg-1.20
Placebo-0.74

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Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 160 μg-1.46
Ciclesonide HFA Nasal Aerosol 80 μg-1.56
Placebo-0.64

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Change From Baseline in Daily Subject-reported AM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0

"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 160 μg-1.24
Ciclesonide HFA Nasal Aerosol 80 μg-1.41
Placebo-0.88

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Change From Baseline in Daily Subject-reported AM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.

"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 160 μg-1.12
Ciclesonide HFA Nasal Aerosol 80 μg-1.24
Placebo-0.72

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Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 2-week Treatment Period.

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week0-2

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 160 μg-1.56
Ciclesonide HFA Nasal Aerosol 80 μg-1.60
Placebo-0.71

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Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 2-week Treatment Period.

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 160 μg-1.77
Ciclesonide HFA Nasal Aerosol 80 μg-1.84
Placebo-0.77

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Change From Baseline in Daily Subject-reported AM and PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0

"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 160 μg-1.21
Ciclesonide HFA Nasal Aerosol 80 μg-1.40
Placebo-0.88

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Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over the Two-week Treatment Period.

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

InterventionUnits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 160 μg-1.74
Ciclesonide HFA Nasal Aerosol 80 μg-1.75
Placebo-0.72

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Change From Baseline in the RQLQ(S) Domains at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0

RQLQ(S) in subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores. (NCT01010971)
Timeframe: Week 0-2

,,
Interventionunits on a scale (Least Squares Mean)
Overall ScoreDomain 1: ActivitiesDomain 2: SleepDomain 3: Non-Nose/Eye SymptomsDomain 4: Practical ProblemsDomain 5: Nasal SymptomsDomain 6: Eye SymptomsDomain 7: Emotional
Ciclesonide HFA Nasal Aerosol 160 μg-1.41-1.39-1.49-1.33-1.62-1.52-1.25-1.36
Ciclesonide HFA Nasal Aerosol 80 μg-1.44-1.34-1.60-1.21-1.64-1.61-1.25-1.36
Placebo-0.79-0.70-0.83-0.67-0.91-0.83-0.81-0.82

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Change From Baseline in Daily Subject-reported Individual PM Reflective OSS in Subjects With Baseline TOSS ≥5.0

"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

,,
Interventionparticipants (Least Squares Mean)
itching eyesredness of eyestearing eyes
Ciclesonide HFA Nasal Aerosol 160 μg-0.42-0.39-0.40
Ciclesonide HFA Nasal Aerosol 80 μg-0.43-0.42-0.54
Placebo-0.28-0.28-0.32

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Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 2-week Treatment Period.

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

,,
Interventionunits on a scale (Least Squares Mean)
SneezingRunny NoseNasal ItchingNasal Congestion
Ciclesonide HFA Nasal Aerosol 160 μg-0.43-0.43-0.45-0.39
Ciclesonide HFA Nasal Aerosol 80 μg-0.43-0.45-0.39-0.40
Placebo-0.14-0.16-0.16-0.20

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Change From Baseline in Daily Subject-reported Individual PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0

"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

,,
Interventionunits on a scale (Least Squares Mean)
itching eyesredness of eyestearing eyes
Ciclesonide HFA Nasal Aerosol 160 μg-0.38-0.39-0.38
Ciclesonide HFA Nasal Aerosol 80 μg-0.37-0.37-0.45
Placebo-0.25-0.27-0.22

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Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 2-week Treatment Period

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

,,
Interventionunits on a scale (Least Squares Mean)
SneezingRunny NoseNasal ItchingNasal Congestion
Ciclesonide HFA Nasal Aerosol 160 μg-0.35-0.36-0.39-0.36
Ciclesonide HFA Nasal Aerosol 80 μg-0.40-0.42-0.37-0.36
Placebo-0.14-0.16-0.16-0.18

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Change From Baseline in Daily Subject-reported Individual AM Reflective OSS in Subjects With Baseline TOSS ≥5.0

"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

,,
Interventionparticipants (Least Squares Mean)
itching eyesredness of eyestearing eyes
Ciclesonide HFA Nasal Aerosol 160 μg-0.41-0.41-0.42
Ciclesonide HFA Nasal Aerosol 80 μg-0.45-0.42-0.53
Placebo-0.31-0.25-0.33

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Change From Baseline in Daily Subject-reported Individual AM Reflective Nasal Symptom Scores (NSS) Averaged Over the 2-week Treatment Period.

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

,,
Interventionunits on a scale (Least Squares Mean)
sneezingrunny nosenasal itchingnasal congestion
Ciclesonide HFA Nasal Aerosol 160 μg-0.47-0.44-0.47-0.40
Ciclesonide HFA Nasal Aerosol 80 μg-0.51-0.51-0.43-0.38
Placebo-0.18-0.21-0.20-0.18

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Change From Baseline in Daily Subject-reported AM and PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.

"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 160 μg-1.13
Ciclesonide HFA Nasal Aerosol 80 μg-1.21
Placebo-0.72

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Change From Baseline in Daily Subject-reported Individual AM Instantaneous OSS in Subjects With Baseline TOSS≥5.0

"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

,,
Interventionunits on a scale (Least Squares Mean)
itching eyesredness of eyestearing eyes
Ciclesonide HFA Nasal Aerosol 160 μg-0.37-0.38-0.37
Ciclesonide HFA Nasal Aerosol 80 μg-0.39-0.38-0.47
Placebo-0.24-0.21-0.27

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Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 160 μg-0.36
Ciclesonide HFA Nasal Aerosol 80 μg-0.36
Placebo-0.18

[back to top]

Change From Baseline in Daily Subject-reported Individual AM and PM Reflective OSS in Subjects With Baseline TOSS ≥5.0

"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

,,
Interventionunits on a scale (Least Squares Mean)
itching eyesredness of eyestearing eyes
Ciclesonide HFA Nasal Aerosol 160 μg-0.42-0.39-0.41
Ciclesonide HFA Nasal Aerosol 80 μg-0.44-0.42-0.53
Placebo-0.29-0.27-0.32

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Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 2-week Treatment Period.

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

,,
Interventionunits on a scale (Least Squares Mean)
SneezingRunny NoseNasal ItchingNasal Congestion
Ciclesonide HFA Nasal Aerosol 160 μg-0.45-0.44-0.44-0.39
Ciclesonide HFA Nasal Aerosol 80 μg-0.47-0.41-0.41-0.39
Placebo-0.16-0.18-0.18-0.19

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Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0

"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

,,
Interventionunits on a scale (Least Squares Mean)
itching eyesredness of eyestearing eyes
Ciclesonide HFA Nasal Aerosol 160 μg-0.37-0.39-0.37
Ciclesonide HFA Nasal Aerosol 80 μg-0.38-0.38-0.46
Placebo-0.24-0.24-0.24

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Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 2-week Treatment Period

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01010971)
Timeframe: Week 0-2

,,
Interventionunits on a scale (Least Squares Mean)
SneezingRunny NoseNasal ItchingNasal Congestion
Ciclesonide HFA Nasal Aerosol 160 μg-0.35-0.38-0.42-0.36
Ciclesonide HFA Nasal Aerosol 80 μg-0.40-0.43-0.38-0.36
Placebo-0.14-0.17-0.19-0.18

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Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment

(NCT01033825)
Timeframe: Weeks 0-6

Interventionmcg•h/dL (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 320 Mcg-3.9
Ciclesonide HFA Nasal Aerosol 160 Mcg-2.0
HFA Nasal Aerosol Placebo-5.9
Ciclesonide Aqueous Nasal Spray 200 Mcg-6.1
AQ Nasal Spray Placebo2.2

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Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment

(NCT01033825)
Timeframe: Weeks 0-6

Interventionmcg•h/dL (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 320 Mcg-1.0
Ciclesonide HFA Nasal Aerosol 160 Mcg-1.3
HFA Nasal Aerosol Placebo0.5
Ciclesonide Aqueous Nasal Spray 200 Mcg-5.8
AQ Nasal Spray Placebo-2.9

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Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 320 Mcg-1.77
Ciclesonide HFA Nasal Aerosol 160 Mcg-1.88
HFA Nasal Aerosol Placebo-0.31
Ciclesonide Aqueous Nasal Spray 200 Mcg-1.14
AQ Nasal Spray Placebo-1.19

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Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 320 Mcg-1.39
Ciclesonide HFA Nasal Aerosol 160 Mcg-1.67
HFA Nasal Aerosol Placebo-0.10
Ciclesonide Aqueous Nasal Spray 200 Mcg-1.09
AQ Nasal Spray Placebo-0.88

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Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 320 Mcg-1.80
Ciclesonide HFA Nasal Aerosol 160 Mcg-1.75
HFA Nasal Aerosol Placebo-0.35
Ciclesonide Aqueous Nasal Spray 200 Mcg-1.18
AQ Nasal Spray Placebo-0.91

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Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 320 Mcg-1.52
Ciclesonide HFA Nasal Aerosol 160 Mcg-1.62
HFA Nasal Aerosol Placebo-0.26
Ciclesonide Aqueous Nasal Spray 200 Mcg-1.23
AQ Nasal Spray Placebo-0.60

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Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 320 Mcg-1.45
Ciclesonide HFA Nasal Aerosol 160 Mcg-1.67
HFA Nasal Aerosol Placebo-0.19
Ciclesonide Aqueous Nasal Spray 200 Mcg-1.15
AQ Nasal Spray Placebo-0.75

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Baseline Daily Subject-reported PM Reflective TNSS

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Ciclesonide HFA Nasal Aerosol 320 Mcg7.82
Ciclesonide HFA Nasal Aerosol 160 Mcg8.39
HFA Nasal Aerosol Placebo7.83
Ciclesonide Aqueous Nasal Spray 200 Mcg8.13
AQ Nasal Spray Placebo8.16

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Baseline Daily Subject-reported PM Instantaneous TNSS

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Ciclesonide HFA Nasal Aerosol 320 Mcg6.84
Ciclesonide HFA Nasal Aerosol 160 Mcg7.60
HFA Nasal Aerosol Placebo7.13
Ciclesonide Aqueous Nasal Spray 200 Mcg7.38
AQ Nasal Spray Placebo7.44

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Baseline Daily Subject-reported AM Reflective TNSS

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Ciclesonide HFA Nasal Aerosol 320 Mcg7.55
Ciclesonide HFA Nasal Aerosol 160 Mcg8.03
HFA Nasal Aerosol Placebo7.81
Ciclesonide Aqueous Nasal Spray 200 Mcg7.91
AQ Nasal Spray Placebo7.84

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Baseline Daily Subject-reported AM Instantaneous TNSS

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Ciclesonide HFA Nasal Aerosol 320 Mcg6.91
Ciclesonide HFA Nasal Aerosol 160 Mcg7.63
HFA Nasal Aerosol Placebo7.37
Ciclesonide Aqueous Nasal Spray 200 Mcg7.24
AQ Nasal Spray Placebo7.19

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Baseline Daily Subject-reported AM and PM Reflective TNSS

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Ciclesonide HFA Nasal Aerosol 320 Mcg7.68
Ciclesonide HFA Nasal Aerosol 160 Mcg8.20
HFA Nasal Aerosol Placebo7.82
Ciclesonide Aqueous Nasal Spray 200 Mcg8.01
AQ Nasal Spray Placebo8.01

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Baseline Daily Subject-reported AM and PM Instantaneous TNSS

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Ciclesonide HFA Nasal Aerosol 320 Mcg6.87
Ciclesonide HFA Nasal Aerosol 160 Mcg7.62
HFA Nasal Aerosol Placebo7.26
Ciclesonide Aqueous Nasal Spray 200 Mcg7.30
AQ Nasal Spray Placebo7.33

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Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances.

Ratio of correct advance is defined as the (number of doses actuated/number of dose reported). (NCT01033825)
Timeframe: Weeks 1-2, 2-4

,,
Interventionpercentage of correct advances (Mean)
Weeks 1-2 (n=49,58,75)Weeks 2-4 (n=46,52,71)
Ciclesonide HFA Nasal Aerosol 160 Mcg106.2105.9
Ciclesonide HFA Nasal Aerosol 320 Mcg106.3105.6
HFA Nasal Aerosol Placebo105.3105.8

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Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6

,,,,
Interventionunits on a scale (Least Squares Mean)
Nasal SneezingRunny NoseNasal ItchingNasal Congestion
AQ Nasal Spray Placebo-0.27-0.37-0.34-0.21
Ciclesonide Aqueous Nasal Spray 200 Mcg-0.23-0.37-0.32-0.20
Ciclesonide HFA Nasal Aerosol 160 Mcg-0.48-0.48-0.46-0.44
Ciclesonide HFA Nasal Aerosol 320 Mcg-0.45-0.49-0.38-0.44
HFA Nasal Aerosol Placebo-0.13-0.09-0.05-0.04

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Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6

,,,,
Interventionunits on a scale (Least Squares Mean)
Nasal SneezingRunny NoseNasal ItchingNasal Congestion
AQ Nasal Spray Placebo-0.22-0.30-0.25-0.12
Ciclesonide Aqueous Nasal Spray 200 Mcg-0.24-0.33-0.35-0.15
Ciclesonide HFA Nasal Aerosol 160 Mcg-0.37-0.45-0.44-0.39
Ciclesonide HFA Nasal Aerosol 320 Mcg-0.33-0.41-0.32-0.34
HFA Nasal Aerosol Placebo-0.07-0.080.020.02

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Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6

,,,,
Interventionunits on a scale (Least Squares Mean)
Nasal SneezingRunny NoseNasal ItchingNasal Congestion
AQ Nasal Spray Placebo-0.25-0.29-0.25-0.13
Ciclesonide Aqueous Nasal Spray 200 Mcg-0.28-0.36-0.33-0.20
Ciclesonide HFA Nasal Aerosol 160 Mcg-0.41-0.50-0.40-0.42
Ciclesonide HFA Nasal Aerosol 320 Mcg-0.41-0.50-0.40-0.49
HFA Nasal Aerosol Placebo-0.09-0.17-0.05-0.05

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Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6

,,,,
Interventionunits on a scale (Least Squares Mean)
Nasal SneezingRunny NoseNasal ItchingNasal Congestion
AQ Nasal Spray Placebo-0.17-0.23-0.14-0.06
Ciclesonide Aqueous Nasal Spray 200 Mcg-0.24-0.36-0.40-0.20
Ciclesonide HFA Nasal Aerosol 160 Mcg-0.37-0.47-0.40-0.37
Ciclesonide HFA Nasal Aerosol 320 Mcg-0.32-0.43-0.38-0.41
HFA Nasal Aerosol Placebo-0.06-0.12-0.03-0.05

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Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6

,,,,
Interventionunits on a scale (Least Squares Mean)
Nasal SneezingRunny NoseNasal ItchingNasal Congestion
AQ Nasal Spray Placebo-0.26-0.33-0.30-0.17
Ciclesonide Aqueous Nasal Spray 200 Mcg-0.25-0.37-0.32-0.20
Ciclesonide HFA Nasal Aerosol 160 Mcg-0.45-0.50-0.43-0.43
Ciclesonide HFA Nasal Aerosol 320 Mcg-0.43-0.50-0.39-0.47
HFA Nasal Aerosol Placebo-0.11-0.13-0.05-0.04

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Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6

,,,,
Interventionunits on a scale (Least Squares Mean)
Nasal SneezingRunny NoseNasal ItchingNasal Congestion
AQ Nasal Spray Placebo-0.20-0.27-0.20-0.09
Ciclesonide Aqueous Nasal Spray 200 Mcg-0.23-0.35-0.37-0.17
Ciclesonide HFA Nasal Aerosol 160 Mcg-0.37-0.47-0.42-0.39
Ciclesonide HFA Nasal Aerosol 320 Mcg-0.32-0.42-0.35-0.37
HFA Nasal Aerosol Placebo-0.06-0.10-0.01-0.01

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Baseline Daily Subject-reported Individual PM Reflective NSS

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline

,,,,
Interventionunits on a scale (Mean)
Baseline Nasal SneezingBaseline Runny NoseBaseline Nasal ItchingBaseline Nasal Congestion
AQ Nasal Spray Placebo1.742.162.002.25
Ciclesonide Aqueous Nasal Spray 200 Mcg1.592.301.932.31
Ciclesonide HFA Nasal Aerosol 160 Mcg1.872.202.022.30
Ciclesonide HFA Nasal Aerosol 320 Mcg1.822.031.752.23
HFA Nasal Aerosol Placebo1.692.111.802.23

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Baseline Daily Subject-reported Individual PM Instantaneous NSS

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline

,,,,
Interventionunits on a scale (Mean)
Baseline Nasal SneezingBaseline Runny NoseBaseline Nasal ItchingBaseline Nasal Congestion
AQ Nasal Spray Placebo1.472.011.842.12
Ciclesonide Aqueous Nasal Spray 200 Mcg1.302.131.792.16
Ciclesonide HFA Nasal Aerosol 160 Mcg1.512.031.882.19
Ciclesonide HFA Nasal Aerosol 320 Mcg1.421.801.602.02
HFA Nasal Aerosol Placebo1.401.981.642.11

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Baseline Daily Subject-reported Individual AM Reflective NSS

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline

,,,,
Interventionunits on a scale (Mean)
Baseline Nasal SneezingBaseline Runny NoseBaseline Nasal ItchingBaseline Nasal Congestion
AQ Nasal Spray Placebo1.572.061.922.29
Ciclesonide Aqueous Nasal Spray 200 Mcg1.422.271.852.36
Ciclesonide HFA Nasal Aerosol 160 Mcg1.652.161.892.32
Ciclesonide HFA Nasal Aerosol 320 Mcg1.561.991.712.30
HFA Nasal Aerosol Placebo1.542.151.832.29

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Baseline Daily Subject-reported Individual AM Instantaneous NSS

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline

,,,,
Interventionunits on a scale (Mean)
Baseline Nasal SneezingBaseline Runny NoseBaseline Nasal ItchingBaseline Nasal Congestion
AQ Nasal Spray Placebo1.301.931.762.20
Ciclesonide Aqueous Nasal Spray 200 Mcg1.152.081.762.25
Ciclesonide HFA Nasal Aerosol 160 Mcg1.432.081.852.27
Ciclesonide HFA Nasal Aerosol 320 Mcg1.241.831.612.24
HFA Nasal Aerosol Placebo1.342.011.762.27

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Baseline Daily Subject-reported Individual AM and PM Reflective NSS

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline

,,,,
Interventionunits on a scale (Mean)
Baseline Nasal SneezingBaseline Runny NoseBaseline Nasal ItchingBaseline Nasal Congestion
AQ Nasal Spray Placebo1.662.111.962.27
Ciclesonide Aqueous Nasal Spray 200 Mcg1.512.291.892.33
Ciclesonide HFA Nasal Aerosol 160 Mcg1.762.181.952.31
Ciclesonide HFA Nasal Aerosol 320 Mcg1.692.011.732.26
HFA Nasal Aerosol Placebo1.622.131.822.26

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Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS

"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline

,,,,
Interventionunits on a scale (Mean)
Baseline Nasal SneezingBaseline Runny NoseBaseline Nasal ItchingBaseline Nasal Congestion
AQ Nasal Spray Placebo1.381.981.802.16
Ciclesonide Aqueous Nasal Spray 200 Mcg1.222.101.782.20
Ciclesonide HFA Nasal Aerosol 160 Mcg1.472.051.872.23
Ciclesonide HFA Nasal Aerosol 320 Mcg1.331.811.612.13
HFA Nasal Aerosol Placebo1.372.001.702.19

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Time to Maximal Effect Over 6 Weeks of Double-blind Treatment.

The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between each active treatment group and corresponding placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo. Difference is calculated as placebo - ciclesonide. Analysis of HFA data and AQ data were conducted separately. (NCT01033825)
Timeframe: Weeks 0-6

InterventionNumber of days (Number)
Ciclesonide HFA Nasal Aerosol 320 Mcg15
Ciclesonide HFA Nasal Aerosol 160 Mcg29
Ciclesonide Aqueous Nasal Spray 200 Mcg7

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The Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) From Baseline to Week 6 of the Double Blind Treatment Period

Change is calculated as week 6 minus baseline. AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE). (NCT01033825)
Timeframe: week 6

Interventionmcg•h/dL (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 320 Mcg-4.6
Ciclesonide HFA Nasal Aerosol 160 Mcg-2.6
HFA Nasal Aerosol Placebo-5.0
Ciclesonide Aqueous Nasal Spray 200 Mcg-11.4
Placebo Aqueous Nasal Spray-1.0

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Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline

(NCT01033825)
Timeframe: Baseline

Interventionmcg•h/dL (Mean)
Ciclesonide HFA Nasal Aerosol 320 Mcg83.4
Ciclesonide HFA Nasal Aerosol 160 Mcg76.2
HFA Nasal Aerosol Placebo81.1
Ciclesonide Aqueous Nasal Spray 200 Mcg80.9
AQ Nasal Spray Placebo81.8

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Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline

AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE). (NCT01033825)
Timeframe: Baseline

Interventionmcg•h/dL (Mean)
Ciclesonide HFA Nasal Aerosol 320 Mcg183.2
Ciclesonide HFA Nasal Aerosol 160 Mcg171.7
HFA Nasal Aerosol Placebo173.1
Ciclesonide Aqueous Nasal Spray 200 Mcg172.8
Placebo Aqueous Nasal Spray179.0

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Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline

(NCT01033825)
Timeframe: Baseline

Interventionmcg•h/dL (Mean)
Ciclesonide HFA Nasal Aerosol 320 Mcg99.8
Ciclesonide HFA Nasal Aerosol 160 Mcg95.1
HFA Nasal Aerosol Placebo92.0
Ciclesonide Aqueous Nasal Spray 200 Mcg91.9
AQ Nasal Spray Placebo97.2

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Percentage of Subjects Who Discontinue Due to AEs

(NCT01033825)
Timeframe: Weeks 0-6

Interventionpercentage of subjects (Number)
Ciclesonide HFA Nasal Aerosol 320 Mcg0
Ciclesonide HFA Nasal Aerosol 160 Mcg0
HFA Nasal Aerosol Placebo0
Ciclesonide Aqueous Nasal Spray 200 Mcg2.1
AQ Nasal Spray Placebo0

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Percentage of Subjects Experiencing Serious Adverse Events (SAEs).

(NCT01033825)
Timeframe: Weeks 0-6

Interventionpercentage of subjects (Number)
Ciclesonide HFA Nasal Aerosol 320 Mcg0
Ciclesonide HFA Nasal Aerosol 160 Mcg0
HFA Nasal Aerosol Placebo0
Ciclesonide Aqueous Nasal Spray 200 Mcg0
AQ Nasal Spray Placebo0

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Percentage of Subjects Experiencing Local Nasal AEs

Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions. (NCT01033825)
Timeframe: Weeks 0-6

Interventionpercentage of subjects (Number)
Ciclesonide HFA Nasal Aerosol 320 Mcg41.2
Ciclesonide HFA Nasal Aerosol 160 Mcg18.3
HFA Nasal Aerosol Placebo14.0
Ciclesonide Aqueous Nasal Spray 200 Mcg33.3
AQ Nasal Spray Placebo19.0
Placebo HFA Plus 6 mg Dexamethasone27.8
Placebo AQ Plus 6 mg Dexamethasone5.6

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Percentage of Subjects Experiencing Adverse Events (AEs)

(NCT01033825)
Timeframe: Weeks 0-6

Interventionpercentage of subjects (Number)
Ciclesonide HFA Nasal Aerosol 320 Mcg45.1
Ciclesonide HFA Nasal Aerosol 160 Mcg28.3
HFA Nasal Aerosol Placebo30.7
Ciclesonide Aqueous Nasal Spray 200 Mcg39.6
AQ Nasal Spray Placebo38.2

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Percentage of Devices With Major Discrepancies

A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration. (NCT01033825)
Timeframe: Week 6

Interventionpercentage of devices (Number)
Ciclesonide HFA Nasal Aerosol 320 Mcg0
Ciclesonide HFA Nasal Aerosol 160 Mcg3.8
HFA Nasal Aerosol Placebo1.4

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Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over Each Week, and Averaged Over the 6 Weeks of Double-blind Treatment

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6

Interventionunits on a scale (Least Squares Mean)
Ciclesonide HFA Nasal Aerosol 320 Mcg-1.78
Ciclesonide HFA Nasal Aerosol 160 Mcg-1.82
HFA Nasal Aerosol Placebo-0.33
Ciclesonide Aqueous Nasal Spray 200 Mcg-1.16
AQ Nasal Spray Placebo-1.06

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Percentage of Devices With Actuation Consistency

Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration. (NCT01033825)
Timeframe: Weeks 1-4

Interventionpercentage of devices (Number)
Ciclesonide HFA Nasal Aerosol 320 Mcg91.3
Ciclesonide HFA Nasal Aerosol 160 Mcg92.3
HFA Nasal Aerosol Placebo95.8

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Number of Subjects Who Discontinue Due to AEs

(NCT01033825)
Timeframe: Weeks 0-6

Interventionparticipants (Number)
Ciclesonide HFA Nasal Aerosol 320 Mcg0
Ciclesonide HFA Nasal Aerosol 160 Mcg0
HFA Nasal Aerosol Placebo0
Ciclesonide Aqueous Nasal Spray 200 Mcg1
AQ Nasal Spray Placebo0

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Number of Subjects Experiencing Serious Adverse Events (SAEs).

(NCT01033825)
Timeframe: Weeks 0-6

Interventionparticipants (Number)
Ciclesonide HFA Nasal Aerosol 320 Mcg0
Ciclesonide HFA Nasal Aerosol 160 Mcg0
HFA Nasal Aerosol Placebo0
Ciclesonide Aqueous Nasal Spray 200 Mcg0
AQ Nasal Spray Placebo0

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Number of Subjects Experiencing Local Nasal AEs

Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions. (NCT01033825)
Timeframe: Weeks 0-6

Interventionparticipants (Number)
Ciclesonide HFA Nasal Aerosol 320 Mcg21
Ciclesonide HFA Nasal Aerosol 160 Mcg11
HFA Nasal Aerosol Placebo8
Ciclesonide Aqueous Nasal Spray 200 Mcg16
AQ Nasal Spray Placebo11
Placebo HFA Plus 6 mg Dexamethasone5
Placebo AQ Plus 6 mg Dexamethasone1

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Number of Subjects Experiencing Adverse Events (AEs)

(NCT01033825)
Timeframe: Weeks 0-6

Interventionparticipants (Number)
Ciclesonide HFA Nasal Aerosol 320 Mcg23
Ciclesonide HFA Nasal Aerosol 160 Mcg17
HFA Nasal Aerosol Placebo23
Ciclesonide Aqueous Nasal Spray 200 Mcg19
Placebo Aqueous Nasal Spray29

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Number of Devices With Major Discrepancies

A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration. (NCT01033825)
Timeframe: Week 6

InterventionDevices (Number)
Ciclesonide HFA Nasal Aerosol 320 Mcg0
Ciclesonide HFA Nasal Aerosol 160 Mcg2
Ciclesonide Aqueous Nasal Spray 200 Mcg1

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Number of Devices With Actuation Consistency

Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration. (NCT01033825)
Timeframe: Weeks 1-4

InterventionDevices (Number)
Ciclesonide HFA Nasal Aerosol 320 Mcg42
Ciclesonide HFA Nasal Aerosol 160 Mcg48
Ciclesonide Aqueous Nasal Spray 200 Mcg68

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Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period.

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the 6-month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01067105)
Timeframe: Baseline and Weeks 1-26

Interventionunits on a scale (Mean)
Ciclesonide-0.50

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Percentage of Subjects Experiencing Adverse Events (AEs)

(NCT01067105)
Timeframe: Weeks 1-26

Interventionpercentage of participants (Number)
Ciclesonide51.5

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Percentage of Subjects Experiencing Local Nasal AEs

Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions. (NCT01067105)
Timeframe: Weeks 1-26

Interventionpercentage of participants (Number)
Ciclesonide29.4

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Percentage of Subjects Experiencing Serious Adverse Events (SAEs)

(NCT01067105)
Timeframe: Weeks 1-26

Interventionpercentage of participants (Number)
Ciclesonide1.8

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Percentage of Subjects Who Discontinue Due to AEs.

(NCT01067105)
Timeframe: Weeks 1-26

Interventionpercentage of participants (Number)
Ciclesonide1.7

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Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period.

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01067105)
Timeframe: Baseline and Months 1, 2, 3, 4, 5, 6

Interventionunits on a scale (Mean)
Month 1 (n=823)Month 2 (n=806)Month 3 (n=768)Month 4 (n=743)Month 5 (n=716)Month 6 (n=697)
Ciclesonide-0.26-0.55-0.66-0.70-0.67-0.57

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Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period.

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01067105)
Timeframe: Baseline and Months 1, 2, 3, 4, 5, and 6

Interventionunits on a scale (Mean)
Month 1 (n=823)Month 2 (n=806)Month 3 (n=768)Month 4 (n=743)Month 5 (n=716)Month 6 (n=697)
Ciclesonide-0.18-0.48-0.64-0.69-0.64-0.54

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Number of Devices With Actuation Consistency

Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration (NCT01067105)
Timeframe: Weeks 0-6 and 6-12

Interventiondevices (Number)
Week 0-6Week 6-12
Ciclesonide556531

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Number of Devices With Major Discrepancies

A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration (NCT01067105)
Timeframe: Weeks 0-6 and 6-12

Interventiondevices (Number)
Week 0-6Week 6-12
Ciclesonide144117

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Percentage of Devices With Actuation Consistency

Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration (NCT01067105)
Timeframe: Weeks 0-6 and 6-12

Interventionpercentage of devices (Number)
Week 0-6Week 6-12
Ciclesonide71.572.5

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Percentage of Devices With Major Discrepancies

A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration (NCT01067105)
Timeframe: Weeks 0-6 and 6-12

Interventionpercentage of devices (Number)
Week 0-6Week 6-12
Ciclesonide18.516.0

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Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey

Participants responding to a survey that consisted of 7 questions assessing subject satisfaction with the dose indicator. (NCT01067105)
Timeframe: Weeks 6 and 12

Interventionparticipants (Number)
Week 6Week 12
Ciclesonide794744

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Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period.

"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01067105)
Timeframe: Baseline and Weeks 1-26

Interventionunits on a scale (Mean)
Ciclesonide-0.54

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Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances

Ratio of correct advance is defined as the (number of doses actuated/number of doses reported) * 100% and therefore reported as a percentage. (NCT01067105)
Timeframe: Weeks 0-12

Interventionpercentage of correct advances (Mean)
Week 0-6 (n=778)Week 6-12 (n=732)
Ciclesonide112.29112.23

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Exacerbations

Outcome defined as number of exacerbations per person-year. (NCT01248065)
Timeframe: Overall exacerbation rate during 28-week trial

InterventionExacerbations/person-year (Number)
Ciclesonide + Placebo0.40
Ciclesonide + Vitamin D0.26

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Lung Function Change From Baseline

FEV1 (liters) and methacholine PC20 will be evaluated. Changes are measured as 28 weeks minus baseline. (NCT01248065)
Timeframe: Change is measured as value at 28 weeks minus baseline value.

InterventionLiters (Least Squares Mean)
Ciclesonide + Placebo-0.04
Ciclesonide + Vitamin D-0.07

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Treatment Failure

Treatment failure is a well-defined asthma outcome reflecting overall asthma control that has been used previously in multiple clinical trials. Treatment failure as defined in the current proposal and prior trials is consistent with the American Thoracic Society (ATS)/European Respiratory Society(ERS) definition of a moderate exacerbation - a deterioration in symptoms and/or lung function with increased rescue bronchodilator use that lasts 2 days or more. The percentages of participants experiencing a treatment failure are Kaplan-Meier estimates of failure rate. (NCT01248065)
Timeframe: Twenty-eight week intervention period from randomization until end of trial.

InterventionPercentage of participants (Number)
Ciclesonide + Placebo29
Ciclesonide + Vitamin D28

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Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES)

"Within-and between-responder group standardized effect sizes (SES) were calculated. The generally accepted guidelines for clinically important standard effect sizes are small(0.2), medium (0.5), and large (0.8).~Between group SES indicates the magnitude of treatment differences. In this case, the groups were responders according to the baseline rTNSS scores. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction)." (NCT01287364)
Timeframe: Day 1 (Pre-treatment) through Day 29

,,
Interventionstandard effect sizes (Number)
InterferenceRegimen AdaptationRole LimitationRegimen DifficultySensory ImpactHassleBurdenRegimen ManagementPerceived Relief
High Minus Low Response Group0.4740.5530.1980.1570.3260.5970.0640.0760.591
High Response Group0.8930.5340.9200.0980.8430.9260.7610.7280.439
Low Response Group0.5510.0570.722-0.0570.7200.4660.8980.656-0.114

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Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics

Reliability for the nine treatment satisfaction subscales was established through internal consistency statistical analyses [Cronbach's alpha (raw and standardized) coefficients were calculated]. The correlation coefficients for these analyses ranged from 0.0 to 1.0, with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability. (NCT01287364)
Timeframe: Day 1 (Pre-treatment) through Day 7 Treatment Period 2

,
Interventionratio of variance (Number)
InterferenceRegimen AdaptationRole LimitationsSensory ImpactRegimen DifficultiesHassleBurdenRegimen ManagementPerceived Relief
Average Cronbach's Alpha (Raw) Coefficients0.9710.9320.9390.8890.7220.9180.9370.7500.864
Average Cronbach's Alpha (Standardized) Coefficients0.9720.9320.9440.8950.7310.9280.9380.8040.871

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Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change)

"Analysis was conducted with one-sample t-tests on the treatment satisfaction subscale change scores for Treatment Period 2 against the test criterion of no change (ie, change score = 0)TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. TNSS values range from 0-12 (0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction)." (NCT01287364)
Timeframe: Day 1 (pre-treatment) through Day 7 Treatment Period 2

,,
Interventionscores on a scale (Mean)
InterferenceRegimen AdaptationRole LimitationRegimen DifficultySensory ImpactHassleBurdenRegimen ManagementPerceived ReliefOverall Satisfaction
High Change6.6124.2424.688.3093.20010.2734.6021.5248.4244.875
Low Change.8838-8.4621.075-7.620-3.407-0.6481.8520.2521-6.512-2.510
Medium Change7.914-3.7616.079-3.751-0.5008.0368.1471.265-2.3812.337

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Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change)

"Analysis was conducted with one-sample t-tests on the treatment satisfaction subscale change scores for Treatment Period 1 against the test criterion of no change (ie, change score = 0)TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. TNSS values range from 0-12 (0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction)." (NCT01287364)
Timeframe: Day 1 (pre-treatment) through Day 7 Treatment Period 1

,,
Interventionscores on a scale (Mean)
InterferenceRegimen AdaptationRole LimitationRegimen DifficultySensory ImpactHassleBurdenRegimen ManagementPerceived ReliefOverall Satisfaction
High Change20.38013.33312.4402.08319.47526.47516.7019.02712.70514.735
Low Change10.4921.1219.764-1.08312.66711.25015.4698.042-2.9177.201
Medium Change15.83612.12110.5123.76013.22617.74216.3319.3488.28011.906

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Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales

"Principal components analysis was conducted with varimax rotation that revealed two factors. These two factors are the principal components of the preference scale: Treatment Process and Treatment Outcomes. Loadings represent the degree each of the variables correlates with each of the factors. The loadings range from -1 to 1. An inspection of the factor loadings, reveals the extent to which each of the variables contributes to the meaning of each of the factors. High loading number provide meaning and interpretation of factors." (NCT01287364)
Timeframe: Day 1 (Pre-treatment) through Day 29

,
Interventionfactor loadings (Number)
for conveniencefor ease of usefor use in publicfor tastefewer problems with medicaton running out nosefor number of sprays per dosefor flexibility in daily activitiesfor smellfewer problems w/ medication dripping down throatfor longer relieffor symptom relieffor faster reliefif both were the same pricefor better feeling about your appearancefor fewer problems with irritation to your nosefor how is makes your nose feel
Treatment Outcomes0.4330.4500.2700.1420.3240.3310.5600.3600.2340.8760.8750.8020.7730.6780.5870.571
Treatment Process0.7660.7640.7620.7560.7220.7130.7120.7060.6660.2300.2430.2830.4330.5390.5090.501

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Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High)

Discriminant validity tests whether the subscales differentiate among groups of respondents that differ on a pre-specified criterion, baseline rTNSS. Patients were assigned to baseline rTNSS categories of Low Symptoms(3.00 - 7.17; n = 62), Medium Symptoms (7.25 - 9.25; n = 61), or High Symptoms (9.33 - 12.00; n = 62). Reflective TNSS group served as the independent variable and the nine treatment satisfaction subscales were evaluated as dependent variables by analysis of variance models. Contrasts were tested between the Low and Medium Symptoms and the High and Low Symptom categories. Reflective TNSS group served as the independent variable and the nine treatment satisfaction subscales were evaluated as dependent variables by analysis of variance models. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction). (NCT01287364)
Timeframe: Day 1 (Pre-treatment) through Day 7 Treatment Period 1

,,
Interventionscores on a scale (Mean)
InterferenceRegimen AdaptationRole LimitationRegimen DifficultySensory ImpactHassleBurdenRegimen ManagementPerceived ReliefOverall Satisfaction
High Symptoms59.01853.45573.26971.67653.74240.72660.53472.19250.05459.407
Low Symptoms78.72660.76487.14185.94067.93463.36177.81880.94956.06673.189
Medium Symptoms70.93159.49183.52878.89061.45249.83976.10981.77155.45768.607

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Deposition of Radioactivity Within on Nasal Wipes Over 10 Minutes as a Percent of Delivered Dose

The scintigraphic measure of radioactivity deposited on nasal wipes, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), over 10 minutes (at approximately 2 minute intervals post-dose) following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray. (NCT01371786)
Timeframe: Average of 2, 4, 6, 8, and 10 minutes post dose

Interventionpercentage of radiolabeled (Mean)
Ciclesonide Nasal Aerosol0.98
Mometasone13.15

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Deposition of Radioactivity Within the Nasal Cavity Over 10 Minutes as a Percent of Delivered Dose

The scintigraphic measure of radioactivity deposited within the nasal cavity, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), over 10 minutes (at approximately 2 minute intervals post-dose) following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray. (NCT01371786)
Timeframe: Average of 2, 4, 6, 8 and 10 minutes post dose

Interventionpercentage of of radiolabled (Mean)
Ciclesonide Nasal Aerosol89.61
Mometasone69.15

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Initial Deposition of Radioactivity on Nasal Wipes as a Percent of Delivered Dose

The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) on nasal wipes, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray. (NCT01371786)
Timeframe: Day 1 at 2 minutes post-dose

Interventionpercentage of radiolabeled (Mean)
Ciclesonide Nasal Aerosol0.49
Mometasone12.15

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Initial Deposition of Radioactivity Within the Nasal Cavity as a Percent of Delivered Dose

The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) within the nasal cavity, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray. (NCT01371786)
Timeframe: Day 1 at 2 minutes post dose

Interventionpercentage of radiolabeled (Mean)
Ciclesonide Nasal Aerosol99.48
Mometasone86.28

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Initial Deposition of Radioactivity Within the Nasopharynx as a Percent of Delivered Dose

The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) within the nasopharynx, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray. (NCT01371786)
Timeframe: Day 1 at 2 minutes post-dose

Interventionpercentage of radiolabeled (Mean)
Ciclesonide Nasal Aerosol0.03
Mometasone1.58

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Apparent Volume of Distribution (Vz/F)

Vz/F Liters (L) is the apparent volume of distribution (NCT01378429)
Timeframe: Week 6

InterventionL (Mean)
Ciclesonide serum concentrationDes-ciclesonide serum concentration
Ciclesonide Nasal Aerosol34831.46151.3

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Apparent Clearance of the Drug (CL/F)

CL/F liter per hour (L/hour) is the apparent clearance of the drug (NCT01378429)
Timeframe: Week 6

InterventionL/hour (Mean)
Ciclesonide serum concentrationDes-ciclesonide serum concentration
Ciclesonide Nasal Aerosol1222.4317.8

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Change From Baseline in Averaged Daily Subject-reported AM and PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement (NCT01378429)
Timeframe: weeks 0-6

Interventionunits on a scale (Mean)
Placebo-0.7
Ciclesonide Nasal Aerosol-1.5

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The Change in Serum Cortisol Area Under the Curve (AUC) From Time 0 to 24 Hours (0-24), Calculated Using a Trapezoidal Rule, From Baseline to the End of the 6 Week Treatment Period

Area under the concentration-time curve from time 0 to 24 hours [AUC(0-24h)]. Timepoints at which data were collected: 0, 2, 4, 8, 12, 16, and 24 at week 0 and 6. (NCT01378429)
Timeframe: Week 0 and 6

Interventionmcg•hour/dL (Least Squares Mean)
Placebo5.9
Ciclesonide Nasal Aerosol-1.7

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Ratio (Percentage) of the Number of Correct Advances of the Dose Indicator to the Number of Expected Advances Based on Subject Self-report of Study Medication Administration Plus Extra Non-nasal Actuations

(NCT01378429)
Timeframe: weeks 0-6

Interventionpercentage of number of correct advances (Mean)
Placebo101.75
Ciclesonide Nasal Aerosol100.73

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Percentage of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration

(NCT01378429)
Timeframe: weeks 0-6

Interventionpercentage of devices (Number)
Placebo91.1
Ciclesonide Nasal Aerosol89.4

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Number of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration

(NCT01378429)
Timeframe: weeks 0-6

InterventionDevices (Number)
Placebo112
Ciclesonide Nasal Aerosol126

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Change From Baseline in Urinary Free Cortisol-Uncorrected for Urine Creatinine

(NCT01378429)
Timeframe: weeks 0-6

Interventionmcg/g (Least Squares Mean)
Placebo0.5
Ciclesonide Nasal Aerosol1.2

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Change From Baseline in Urinary Free Cortisol-Corrected for Urine Creatinine

(NCT01378429)
Timeframe: weeks 0-6

Interventionmcg/g (Least Squares Mean)
Placebo1.4
Ciclesonide Nasal Aerosol3.3

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Time to the Occurrence of Cmax

tmax (hour) (PK Population) (NCT01378429)
Timeframe: Week 6

InterventionHour (Mean)
Ciclesonide serum concentrationDes-ciclesonide serum concentration
Ciclesonide Nasal Aerosol1.1462.200

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Terminal Half Life (t1/2)

Terminal half-life (t1/2) (hour) (NCT01378429)
Timeframe: Weeks 6

InterventionHour (Mean)
Ciclesonide serum concentrationDes-ciclesonide serum concentration
Ciclesonide Nasal Aerosol8.19411.727

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Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.

Local Treatment-Emergent Adverse Events (ITT Population) (NCT01378429)
Timeframe: weeks 0-6

,
Interventionpercentage of participants (Number)
OverallEpistaxisMucosal erosionNasal discomfortPostnasal dripRhinitisRhinorrheaTraumatic hemorrhageUpper respiratory tract infectionViral upper respiratory tract infection
Ciclesonide Nasal Aerosol10.62.102.12.102.102.10
Placebo14.34.82.42.402.402.404.8

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Percentage of Subjects Experiencing AEs

(NCT01378429)
Timeframe: weeks 0-6

,
Interventionpercentage of participants (Number)
Any AEPotentially related AENasal (local) AEsDiscontinued study drug due to an AESevere AESerious AEDeath
Ciclesonide Nasal Aerosol42.68.510.60000
Placebo45.214.314.302.400

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Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.

Local Treatment-Emergent Adverse Events (ITT Population) (NCT01378429)
Timeframe: weeks 0-6

,
Interventionparticipants (Number)
OverallEpistaxisMucosal erosionNasal discomfortPostnasal dripRhinitisRhinorrheaTraumatic hemorrhageUpper respiratory tract infectionViral upper respiratory tract infection
Ciclesonide Nasal Aerosol5101101010
Placebo6211010102

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Number of Subjects Experiencing AEs

(NCT01378429)
Timeframe: weeks 0-6

,
Interventionparticipants (Number)
Any AEPotentially related AENasal (local) AEsDiscontinued study drug due to an AESevere AESerious AEDeath
Ciclesonide Nasal Aerosol20450000
Placebo19660100

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Maximum Observed Concentration

Cmax (ng/mL) (PK Population) (NCT01378429)
Timeframe: Week 6

Interventionng/mL (Mean)
Ciclesonide serum concentrationDes-ciclesonide serum concentration
Ciclesonide Nasal Aerosol0.0120.029

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AUC(0-24h)

Area under the concentration-time curve from time 0 to 24 hours. Collected at 0, 30 min, 60 min, 90 min, 2 hours (h), 4 h, 8 h, 12 h, 16 h, and 24h after dosing. (NCT01378429)
Timeframe: Week 6

Interventionng*hr/mL (Mean)
Ciclesonide serum concentrationDes-ciclesonide serum concentration
Ciclesonide Nasal Aerosol0.0720.261

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Change From Baseline in Regimen Attributes Composite Score

The Regimen Attributes Composite Score is a composite of the Sensory Impact and Regimen Management Scales of the Allergic Rhinitis Treatment Satisfaction and Preference Scales. The Regimen Management Scale assess patient satisfaction with issues relating to dosing, ability to remember to use the spray, the ease/difficulty of the spray, and convenience of the treatment. The Sensory Impact Scale assess patient satisfaction with issues relating to sensory attributes, including medication running out of the nose, medication running down the throat, impact on smell/taste, etc. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Interventionscores on a scale (Least Squares Mean)
Ciclesonide13.90
Mometasone4.88

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Change From Baseline in Subject-reported AM and PM rTNSS Averaged Over Each 2-week Treatment Period.

The reflective Total Nasal Symptom Score (rTNSS) is the sum of 4 Nasal Symptoms: Runny Nose, Sneezing, Itchy Nose, and Nasal Congestion. These symptoms were assessed each morning and evening, and their totals averaged to obtain a daily average rTNSS. These daily averages were averaged over the 6 days prior to treatment to obtain the baseline value, and over the 14 days of each two-week period to obtain the on-treatment averages. The baseline values were then subtracted from the on-treatment averages to obtain the change from baseline scores. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent, 1 = mild ,2 = moderate ,3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. (NCT01401465)
Timeframe: Averages over each two week treatment period

Interventionunits on a scale (Least Squares Mean)
Ciclesonide-2.4
Mometasone-2.3

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Change From Baseline in the Treatment Functional Impact Composite Score

A combination of the Interference Scale, the Role Limitation Scale, and the Burden Scale. The composite score and the subscales all range from 0 (lower satisfaction) to 100 (higher satisfaction). This is an unweighted average of the combined scales. (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Interventionscores on scale (Least Squares Mean)
Ciclesonide12.36
Mometasone9.70

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Change From Baseline in the Treatment Satisfaction Rating Scale: Burden

This subscale evaluates the patient's assessment of the level of degree of burden that treatment for allergic rhinitis imposes on a number of areas, including adherence to the treatment regimen, exercise, performing daily activities, social activities, and enjoying life. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Interventionunits on a scale (Least Squares Mean)
Ciclesonide10.45
Mometasone8.23

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Change From Baseline in the Treatment Satisfaction Rating Scale: Hassle

This subscale focuses specifically on the patient's assessment of the amount of bother and hassle of the treatment regimen, including coordinating activities, dosing, carrying supplies, rubbing nose or eyes, blowing nose repeatedly, or facial puffiness. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Interventionunits on a scale (Least Squares Mean)
Ciclesonide24.7
Mometasone17.4

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Change From Baseline in the Treatment Satisfaction Rating Scale: Interference

This subscale evaluates the patient's assessment of the degree to which allergy symptoms or side effects of the nasal spray interfered with daily routine, meals, recreation, family life, sleep schedules, energy levels, making plans, traveling, having fun and overall quality of life. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Interventionunits on a scale (Least Squares Mean)
Ciclesonide17.31
Mometasone14.36

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Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Adaptation

This subscale evaluates the patient's assessment of the convenience of the treatment, whether the treatment was one the subject would recommend to other persons with the same condition, and the level of satisfaction with the current treatment. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Interventionunits on a scale (Least Squares Mean)
Ciclesonide6.65
Mometasone2.19

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Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Difficulties

This subscale evaluates the patient's degree of pain, discomfort and side effects perceived to be associated with treatment, and the extent to which pain and discomfort were bothersome. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Interventionunits on a scale (Least Squares Mean)
Ciclesonide-7.58
Mometasone-0.13

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Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Management

This subscale evaluates the patient's assessment of issues relating to dosing (number of times and the time required to dose), ability to remember to use the spray, the ease/difficulty of the spray and several questions further pertaining to the convenience of the treatment. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Interventionunits on a scale (Least Squares Mean)
Ciclesonide6.41
Mometasone5.38

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Change From Baseline in the Regimen Acceptance Composite Score

A combination of the Perceived Relief Scale and the Regimen Adaptation Scale. The composite score and all subscales range from 0 (lower satisfaction) to 100 (higher satisfaction). This is an unweighted average of the combined scales. (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Interventionscores on a scale (Least Squares Mean)
Ciclesonide7.34
Mometasone2.99

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Treatment Process Composite Preference Score

"The Treatment Process Composite Preference Score is a standardized sum of 9 individual preference items (Ease of use, Convenience, Flexibility Daily Activity, Taste, Use in public, Smell. Less Run out of nose, Less Run down of throat, Number Sprays Dose). For each of these 9 individual items, patients were forced to choose their preference between ciclesonide nasal aerosol 74 mcg and mometasone AQ 200 mcg. Larger values greater than 50 indicated greater preference for ciclesonide, while smaller values less than 50 indicated greater preference for mometasone." (NCT01401465)
Timeframe: End of Study - Day 43

Interventionscores on a scale (Mean)
Ciclesonide74.087

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Change From Baseline in the Treatment Satisfaction Rating Scale: Sensory Impact

This subscale evaluates the patient's assessment of the sensory attributes including medication running out of the nose, medication running down the throat, and impact on smell and taste. Issues regarding skipping the medication because of the way the nose feels and wanting to try other medications to find a better one are also included. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Interventionunits on a scale (Least Squares Mean)
Ciclesonide21.37
Mometasone4.41

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The Change From Baseline in Overall Quality of Life Composite Score

Mean of all items in the Mental and Emotional Health and General Health Perceptions scales. Scores range from 100 (lower satisfaction) to 500 (higher satisfaction) (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Interventionscores on a scale (Least Squares Mean)
Ciclesonide6.64
Mometasone6.31

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The Change From Baseline in the Treatment Satisfaction Rating Scale: Perceived Relief

The patient's perceived level of relief along with the degree of satisfaction associated with that amount of relief was evaluated within this scale. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Interventionunits on a scale (Least Squares Mean)
Ciclesonide8.05
Mometasone3.77

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The Number of Subjects Experiencing AEs

(NCT01401465)
Timeframe: Over both two-week treatment periods combined

Interventionparticipants (Number)
Ciclesonide90
Mometasone67

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The Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation

(NCT01401465)
Timeframe: Over both two-week treatment periods combined

Interventionparticipants (Number)
Ciclesonide6
Mometasone4

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The Percentage of Subjects Experiencing AEs

(NCT01401465)
Timeframe: Over both two-week treatment periods combined

Interventionpercentage of participants (Number)
Ciclesonide28.9
Mometasone21.5

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The Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation

(NCT01401465)
Timeframe: Over both two-week treatment periods combined

Interventionpercentage of participants (Number)
Ciclesonide1.9
Mometasone1.3

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Total Preference Composite Score Assessed at the End of the Study. The Total Preference Score is the Standardized Sum of 17 Individual Preference Items

"For the 17 individual items, patients were forced to choose their preference between ciclesonide and mometasone (item choices: 1 = prefer ciclesonide; 0 = prefer mometasone). The items for the Total Preference Score assessed 16 treatment attributes and one overall treatment preference: Ease of use, Convenience, Flexibility in daily activities, Taste, Use in public, Smell, Less run out of nose, Longer relief, Less run down of throat, Symptom relief, If both were the same price, Better appearance, Less nasal irritation, Faster relief, Number of sprays per dose, Makes nose feel, and Overall - the one preferred. The score is based on the proportion of items (x 100) preferred for ciclesonide and a score of 50 indicates no preference and scores over 50 indicate preference for ciclesonide. This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide." (NCT01401465)
Timeframe: End of Study - Day 43

Interventionscores on a scale (Mean)
Ciclesonide Versus Mometasone68.3

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Treatment Outcome Composite Score Assessed at the End of the Study

Reflects preference on items concerned with perceived drug effectiveness (longer relief; symptom relief; prefer if both were the same price; for feeling better about your appearance; for few problems with irritation to nose; faster relief; how it makes your nose feel). The score is based on the proportion of items (x 100) preferred for ciclesonide and a score of 50 indicates an equal number of items preferred in the two groups. Larger values than 50 indicated greater than 50 percent of the subjects indicated preference for ciclesonide, while smaller values than 50 indicated greater than 50 percent preference for mometasone. Data is presented as the mean treatment outcome composite score. This analysis presents the comparison of ciclesonide versus mometasone in relation to preference for ciclesonide. (NCT01401465)
Timeframe: End of Study - Day 43

InterventionScores on a scale (Mean)
Ciclesonide61.598

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Work/Disability Days: Bed Days

Assessed at the end of each two-week treatment period (NCT01401465)
Timeframe: Period 1 (days 0-14), Period 2 (days 29-43)

,
InterventionIncidence Rate (#events/person-days) (Number)
Period 1Period 2
Ciclesonide0.0180.009
Mometasone0.0130.018

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Work/Disability Days: Missed Work

Assessed at the end of each two-week treatment period (NCT01401465)
Timeframe: Period 1 (days 0-14), Period 2 (days 29-43)

,
InterventionIncidence Rate (#events/person-days) (Number)
Period 1Period 2
Ciclesonide0.0020.004
Mometasone0.0050.004

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Work/Disability Days: Reduced Activity Days

Assessed at the end of each two-week treatment period (NCT01401465)
Timeframe: Period 1 (days 0-14), Period 2 (days 29-43)

,
InterventionIncidence Rate (#events/person-days) (Number)
Period 1Period 2
Ciclesonide0.0390.017
Mometasone0.0670.039

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Change From Baseline in the Treatment Satisfaction Rating Scale: Role Limitation

This subscale evaluates the patient's assessment of the degree of interference with social interactions with family, friends, travel, having fun, problems in performing work or social roles and how flexible the treatment was with scheduling life activities. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42

Interventionunits on a scale (Least Squares Mean)
Ciclesonide9.35
Mometasone6.62

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The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the Double-blind Treatment.

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. (NCT01451541)
Timeframe: Weeks 0-6

Interventionunits on a scale (Least Squares Mean)
Placebo-1.51
Ciclesonide Nasal Aerosol 37mcg-2.10
Ciclesonide Nasal Aerosol 74 mcg-1.98

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Time to Maximal Effect [Time to >= 90% Maximum Difference From Placebo in LS Means (Days)]

The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between active ciclesonide nasal aerosol and placebo is at least 90% of the largest estimated difference.This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The time to achieve at least 90% of these estimated differences was calculated. (NCT01451541)
Timeframe: Weeks 0 -6

InterventionNumber of Days (Number)
Ciclesonide Nasal Aerosol 37mcg39
Ciclesonide Nasal Aerosol 74 mcg10

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Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs

(NCT01451541)
Timeframe: Weeks 0 -12

,,
Interventionparticipants (Number)
Any TEAEAny TEAE during first 6 weeks of double-blindPotentially related AELocal AEDiscontinued study drug due to an AESevere AESerious AE
Ciclesonide Nasal Aerosol 37mcg1429939453141
Ciclesonide Nasal Aerosol 74 mcg14310246466172
Placebo15411446494121

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Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation

(NCT01451541)
Timeframe: Weeks 0 -12

,,
Interventionparticipants (Number)
ACUTE SINUSITISAPPLICATION SITE PAINEPISTAXISFACE INJURYINCREASED UPPER AIRWAY SECRETIONMUCOSAL DISCOLOURATIONMUCOSAL EXCORIATIONMUCOSAL HAEMORRHAGENASAL CONGESTIONNASAL DISCOMFORTNASAL DRYNESSNASAL MUCOSAL DISCOLOURATIONNASAL MUCOSAL DISORDERNASAL OEDEMANASAL SEPTUM DISORDERNASAL SEPTUM ULCERATIONNASAL TURBINATE ABNORMALITYNASAL ULCERPOSTNASAL DRIPRHINALGIARHINITIS PERENNIALRHINORRHOEASCABSCRATCHSINUS HEADACHESINUSITISSNEEZING
Ciclesonide Nasal Aerosol 37mcg2320100103401031010100100161
Ciclesonide Nasal Aerosol 74 mcg1126400011810231121111120140
Placebo1326211000600440110004211057

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Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs

(NCT01451541)
Timeframe: Weeks 0 -12

,,
Interventionpercentage of subjects (Number)
Any TEAEAny TEAE during first 6 weeks of double-blindPotentially related AELocal AEDiscontinued study drug due to an AESevere AESerious AE
Ciclesonide Nasal Aerosol 37mcg50.435.113.816.035.00.4
Ciclesonide Nasal Aerosol 74 mcg50.936.316.416.466.00.7
Placebo54.440.316.317.344.20.4

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Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly Over the First 6 Weeks of Double-blind Treatment

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. (NCT01451541)
Timeframe: Weeks 0 -6

Interventionunits on a scale (Least Squares Mean)
Placebo-1.29
Ciclesonide Nasal Aerosol 37mcg-1.77
Ciclesonide Nasal Aerosol 74 mcg-1.72

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Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment

PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses. (NCT01451541)
Timeframe: Weeks 0 -6

Interventionunits on a scale (Least Squares Mean)
Placebo-0.39
Ciclesonide Nasal Aerosol 37mcg-0.51
Ciclesonide Nasal Aerosol 74 mcg-0.30

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Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation

(NCT01451541)
Timeframe: Weeks 0 -12

,,
Interventionpercentage of subjects (Number)
ACUTE SINUSITISAPPLICATION SITE PAINEPISTAXISFACE INJURYINCREASED UPPER AIRWAY SECRETIONMUCOSAL DISCOLOURATIONMUCOSAL EXCORIATIONMUCOSAL HAEMORRHAGENASAL CONGESTIONNASAL DISCOMFORTNASAL DRYNESSNASAL MUCOSAL DISCOLOURATIONNASAL MUCOSAL DISORDERNASAL OEDEMANASAL SEPTUM DISORDERNASAL SEPTUM ULCERATIONNASAL TURBINATE ABNORMALITYNASAL ULCERPOSTNASAL DRIPRHINALGIARHINITIS PERENNIALRHINORRHOEASCABSCRATCHSINUS HEADACHESINUSITISSNEEZING
Ciclesonide Nasal Aerosol 37mcg0.71.17.10.4000.401.11.400.401.10.400.400.4000.4000.42.10.4
Ciclesonide Nasal Aerosol 74 mcg0.40.49.31.40000.40.42.80.400.71.10.40.40.70.40.40.40.40.40.700.41.40
Placebo0.41.19.20.70.40.40002.1001.41.400.40.40001.40.70.40.401.82.5

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Change From Baseline in Daily Average Subject-reported AM and PM rTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement (NCT01451541)
Timeframe: Weeks 0 -12

Interventionunits on a scale (Least Squares Mean)
Placebo-1.92
Ciclesonide Nasal Aerosol 37mcg-2.60
Ciclesonide Nasal Aerosol 74 mcg-2.47

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Change From Baseline in Daily Average Subject-reported AM and PM iTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. (NCT01451541)
Timeframe: Weeks 0 -12

Interventionunits on a scale (Least Squares Mean)
Placebo-1.69
Ciclesonide Nasal Aerosol 37mcg-2.22
Ciclesonide Nasal Aerosol 74 mcg-2.15

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Change From Baseline in Daily Average Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. (NCT01451541)
Timeframe: Weeks 0 -6

Interventionunits on a scale (Least Squares Mean)
Placebo-1.26
Ciclesonide Nasal Aerosol 37mcg-1.75
Ciclesonide Nasal Aerosol 74 mcg-1.74

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Change From Baseline in Daily PRQLQ Overall Score at the End of the 12-week Double-blind Treatment Period

PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses. (NCT01451541)
Timeframe: Weeks 0 -12

Interventionunits on a scale (Least Squares Mean)
Placebo-0.54
Ciclesonide Nasal Aerosol 37mcg-0.68
Ciclesonide Nasal Aerosol 74 mcg-0.47

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Asthma Control Questionnaire (ACQ) Score at Baseline

The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. (NCT01455194)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Treatment Period: Ciclesonide 160 mcg2.24
Treatment Period: Ciclesonide 320 mcg2.15
Treatment Period: Ciclesonide 640 mcg2.19

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Number of Participants Reporting Asthma Exacerbations Rates

Participants with at least 1 asthma exacerbation in the double-blind treatment period have been reported. As predefined in the protocol, the results for participants with missing data for any category were not included. (NCT01455194)
Timeframe: Baseline up to Week 52 (treatment period)

Interventionparticipants (Number)
Treatment Period: Ciclesonide 160 mcg5
Treatment Period: Ciclesonide 320 mcg10
Treatment Period: Ciclesonide 640 mcg10

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Number of Participants Reporting Clinically Significant Change From Baseline in Physical Examination Findings

Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10). Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication. (NCT01455194)
Timeframe: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)

Interventionparticipants (Number)
Treatment Period: Ciclesonide 160 mcg0
Treatment Period: Ciclesonide 320 mcg0
Treatment Period: Ciclesonide 640 mcg0

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Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs

Vital signs included body temperature, blood pressure (BP) and pulse rate. Normal range for vital signs included: Systolic BP >170 millimeters of mercury (mm Hg) or <85 mm Hg, Diastolic BP >105 mm Hg, resting pulse rate: >120 bpm or <50 bpm, difference in systolic BP at Visit x (increase or decrease) compared with pretreatment >40 mm Hg and difference in pulse rate at Visit x (increase or decrease) compared with pretreatment >30 bpm. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication. (NCT01455194)
Timeframe: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)

Interventionparticipants (Number)
Treatment Period: Ciclesonide 160 mcg0
Treatment Period: Ciclesonide 320 mcg0
Treatment Period: Ciclesonide 640 mcg0

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Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. AEs included both serious AEs and non-serious AEs. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication. (NCT01455194)
Timeframe: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)

Interventionparticipants (Number)
Baseline Period: Ciclesonide 160 mcg109
Treatment Period: Ciclesonide 160 mcg85
Treatment Period: Ciclesonide 320 mcg86
Treatment Period: Ciclesonide 640 mcg89

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Number of Participants Reporting Time to First Asthma Exacerbation

Asthma exacerbations were defined as a worsening of asthma requiring either treatment with oral (or other systemic) glucocorticosteroids for at least 3 days or hospitalisation or a visit to the emergency room because of asthma. Baseline was defined as the average of the ACQ measurements of the last 2 weeks at site prior to first intake of double-blind study medication (NCT01455194)
Timeframe: Baseline up to Week 52 (treatment period)

Interventionparticipants (Number)
Treatment Period: Ciclesonide 160 mcg5
Treatment Period: Ciclesonide 320 mcg11
Treatment Period: Ciclesonide 640 mcg10

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Number of Participants With Markedly Abnormal Laboratory Values

The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication. (NCT01455194)
Timeframe: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)

Interventionparticipants (Number)
Treatment Period: Ciclesonide 160 mcg0
Treatment Period: Ciclesonide 320 mcg0
Treatment Period: Ciclesonide 640 mcg0

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Number of Participants With Markedly High Benefits

The analyses was intended to identify participant's subsets that would benefit from dose escalation. This analysis tested the potential factors, including age, sex, pretrial inhaled corticosteroid (ICS) dose category, history of exacerbations, baseline ACQ score, baseline BMI category and smoking status. ACQ includes 5 questions about symptoms, 1 about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled).Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >=1.5 indicates uncontrolled asthma. As predefined in the protocol, participants with missing data for any category were not included. (NCT01455194)
Timeframe: Week 1 up to Week 52

Interventionparticipants (Number)
Treatment Period: Ciclesonide 160 mcg0
Treatment Period: Ciclesonide 320 mcg0
Treatment Period: Ciclesonide 640 mcg0

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Time Course of ACQ

The time course of the incidence of a 0.5 points improvement of ACQ score was evaluated. Mean ACQ values over time by treatment group for on-treatment site measurements was assessed. The time course of asthma control (ACQ) was done on a weekly base using home-based and site-based ACQ measurements. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. (NCT01455194)
Timeframe: Baseline, Week 52 (Treatment period)

InterventionWeeks (Median)
Treatment Period: Ciclesonide 160 mcg1.100
Treatment Period: Ciclesonide 320 mcg1.000
Treatment Period: Ciclesonide 640 mcg1.000

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Number of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement

Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. (NCT01455194)
Timeframe: Baseline up to Week 52 (treatment period)

,,
Interventionparticipants (Number)
Well-controlled AsthmaACQ Improvement
Treatment Period: Ciclesonide 160 mcg73112
Treatment Period: Ciclesonide 320 mcg84107
Treatment Period: Ciclesonide 640 mcg81115

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Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point

Well-controlled asthma was defined as an ACQ score of equal to or lower than the ACQ cut-off point.The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. (NCT01455194)
Timeframe: Baseline up to Week 52 (treatment period)

,,
Interventionparticipants (Number)
ACQ cut-off at 0.5ACQ cut-off at 1.0ACQ cut-off at 1.25ACQ cut-off at 1.5
Treatment Period: Ciclesonide 160 mcg569199103
Treatment Period: Ciclesonide 320 mcg6995101105
Treatment Period: Ciclesonide 640 mcg6393101107

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Number of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study

Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. (NCT01455194)
Timeframe: Week 52

,,
Interventionparticipants (Number)
Well-controlled AsthmaACQ Improvement
Treatment Period: Ciclesonide 160 mcg3887
Treatment Period: Ciclesonide 320 mcg4581
Treatment Period: Ciclesonide 640 mcg5185

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Change From Baseline in ACQ Score to Tlast

The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. (NCT01455194)
Timeframe: Week 52

Interventionunits on a scale (Mean)
Treatment Period: Ciclesonide 160 mcg-0.833
Treatment Period: Ciclesonide 320 mcg-0.799
Treatment Period: Ciclesonide 640 mcg-0.955

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Number of Weeks With Well-controlled Asthma Over the Course of the Study

The number of weeks with well-controlled asthma is defined as the number of weeks that the participant had an ACQ score of 0.75 or lower over the course of the study. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. (NCT01455194)
Timeframe: Baseline up to Week 52 (treatment period)

Interventionweeks (Number)
Treatment Period: Ciclesonide 160 mcg1211
Treatment Period: Ciclesonide 320 mcg1514
Treatment Period: Ciclesonide 640 mcg1447

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Percentage of Subjects Experiencing Treatment-emergent AEs

Treatment-Emergent Adverse Events Occurring in ≥ 2% of Subjects in Any Treatment Group (ITT Population) (NCT01458275)
Timeframe: Weeks 0 - 3

,,
InterventionPercentage of participants (Number)
PYREXIAHEADACHECOUGHEPISTAXIS
Ciclesonide Nasal Aerosol 37mcg1.85.01.44.3
Ciclesonide Nasal Aerosol 74 mcg2.53.51.42.1
Placebo1.43.22.13.5

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Number of Subjects Experiencing Treatment-emergent AEs

Treatment-Emergent Adverse Events Occurring in ≥ 2% of Subjects in Any Treatment Group (ITT Population) (NCT01458275)
Timeframe: Weeks 0 - 3

,,
Interventionparticipants (Number)
PYREXIAHEADACHECOUGHEPISTAXIS
Ciclesonide Nasal Aerosol 37mcg514412
Ciclesonide Nasal Aerosol 74 mcg71046
Placebo49610

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Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation

(NCT01458275)
Timeframe: Weeks 0 - 3

,,
Interventionparticipants (Number)
Acute sinusitsApplication site burnApplication site painEpistaxisMucosal erosionMucosal excoriationMucosal haemorrhageNasal congestionNasal discomfortNasal drynessNasal mucosal disorderNasal septum ulcerationRhinalgiaRhinitis seasonalScabScratchSinus headacheSinus lesionSneezing
Ciclesonide Nasal Aerosol 37mcg10412101050100110000
Ciclesonide Nasal Aerosol 74 mcg1036000001010000001
Placebo01310010100101101110

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Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Ocular Symptom Scores (rTOSS) Over the 2-week Double-blind Treatment Period.

"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01458275)
Timeframe: Weeks 0 - 2

Interventionunits on a scale (Least Squares Mean)
Placebo-0.84
Ciclesonide Nasal Aerosol 37mcg-0.69
Ciclesonide Nasal Aerosol 74 mcg-0.79

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Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation

(NCT01458275)
Timeframe: Weeks 0 - 3

,,
InterventionPercentage of participants (Number)
Acute sinusitsApplication site burnApplication site painEpistaxisMucosal erosionMucosal excoriationMucosal haemorrhageNasal congestionNasal discomfortNasal drynessNasal mucosal disorderNasal septum ulcerationRhinalgiaRhinitis seasonalScabScratchSinus headacheSinus lesionSneezing
Ciclesonide Nasal Aerosol 37mcg0.401.44.30.400.401.800.4000.40.40000
Ciclesonide Nasal Aerosol 74 mcg0.401.12.1000000.400.40000000.4
Placebo00.41.13.500.400.4000.400.40.400.40.40.40

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Treatment-emergent AEs Causing Study Medication Discontinuation

(NCT01458275)
Timeframe: Weeks 0 - 3

,,
Interventionparticipants (Number)
Application site painHypersensitivityPharyngitis streptococcalAllergic respiratory symptomAsthmaRhinitis seasonal
Ciclesonide Nasal Aerosol 37mcg011020
Ciclesonide Nasal Aerosol 74 mcg100000
Placebo000111

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Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. (NCT01458275)
Timeframe: Weeks 0 - 2

Interventionunits on a scale (Least Squares Mean)
Placebo-1.32
Ciclesonide Nasal Aerosol 37mcg-1.48
Ciclesonide Nasal Aerosol 74 mcg-1.35

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Change From Baseline in Average Daily Subject Reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. (NCT01458275)
Timeframe: Weeks 0 - 2

Interventionunits on a scale (Least Squares Mean)
Placebo-1.63
Ciclesonide Nasal Aerosol 37mcg-1.73
Ciclesonide Nasal Aerosol 74 mcg-1.61

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Change From Baseline in Average Daily Subject Reported AM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions assessed in the AM. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe in the AM. Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. (NCT01458275)
Timeframe: Weeks 0 - 2

Interventionunits on a scale (Least Squares Mean)
Placebo-1.27
Ciclesonide Nasal Aerosol 37mcg-1.48
Ciclesonide Nasal Aerosol 74 mcg-1.34

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Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Ocular Symptom Scores (iTOSS) Over the 2-week Double-blind Treatment Period.

"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement" (NCT01458275)
Timeframe: Weeks 0 - 2

Interventionunits on a scale (Least Squares Mean)
Placebo-0.71
Ciclesonide Nasal Aerosol 37mcg-0.57
Ciclesonide Nasal Aerosol 74 mcg-0.66

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Time to Maximal Effect in the AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period

The time to maximal effect, defined as the number of days until the first treatment day on which the estimated difference between ciclesonide nasal aerosol and placebo was at least 90% of the largest estimated difference, was based on the analyses of change from baseline in the average of AM and PM rTNSS scores for each day. The time to achieve at least 90% of these estimated differences is presented. (NCT01458275)
Timeframe: Weeks 0 - 2

InterventionDays (Number)
Ciclesonide Nasal Aerosol 37mcg2
Ciclesonide Nasal Aerosol 74 mcg13

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Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the Double-blind Treatment Period.

PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains. (NCT01458275)
Timeframe: Weeks 0 - 2

Interventionunits on a scale (Least Squares Mean)
Placebo-0.41
Ciclesonide Nasal Aerosol 37mcg-0.43
Ciclesonide Nasal Aerosol 74 mcg-0.51

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The Effect of Omnaris Nasal Spray & Alvesco Inhalation Aerosol vs Beconase AQ Nasal Spray & QVAR Inhalation Aerosol on Short-term Lower Leg Growth Velocity as Measured by Knemometry in Pediatric Subjects w/ Mild Asthma & Allergic Rhinitis.

To evaulate the effect of Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID versus Beconase AQ Nasal Spray 168 mcg BID and QVAR Inhalation Aerosol 40 mcg BID on- short-term lower leg growth as measured by knemometry in children with mild asthma and allergic rhinitis. (NCT01550471)
Timeframe: 1 yr

Interventionmm/wk (Mean)
Alvesco and Omnaris0.23
Beconase and QVAR0.33

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The Effects of Omnaris Nasal Spray & Alvesco Inhalation Aerosol vs Placebo Nasal Spray & Placebo Inhalation Aerosol on Short-term Lower Leg Growth Velocity as Measured by Knemometry in Pediatric Subjects w/ Mild Asthma & Allergic Rhinitis.

To evaluate growth suppressive effect of Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID as compared to Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID on short-term lower leg growth velocity as measured by knemometry in children with mild asthma and allergic rhinitis. (NCT01550471)
Timeframe: 1 yr

Interventionmm/wk (Mean)
Omnaris & Alvesco0.23
Placebo & Placebo0.51

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Number of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye

(NCT01654536)
Timeframe: 0-6 months

Interventionparticipants (Number)
Ciclesonide Nasal Aerosol9
Ciclesonide Nasal Spray6

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Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity.

(NCT01654536)
Timeframe: 0-6 months

Interventionpercentage of participants (Number)
Ciclesonide Nasal Aerosol0.3
Ciclesonide Nasal Spray0.5

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Percentage of Subjects With Development of or Worsening in Lens Opacities.

(NCT01654536)
Timeframe: 0-6 months

Interventionpercentage of participants (Number)
Ciclesonide Nasal Aerosol13.9
Ciclesonide Nasal Spray14.3

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The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)

(NCT01654536)
Timeframe: 0-6 months

,
Interventionparticipants (Number)
Any Nasal Mucosal Disorder, Septum Disorder, or NaNasal Mucosal DisorderNasal Septum DisorderNasal Septum UlcerationNasal Septum Perforation
Ciclesonide Nasal Aerosol32010
Ciclesonide Nasal Spray40040

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The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.

(NCT01654536)
Timeframe: 0-6 months

,
Interventionparticipants (Number)
OverallCardiac DisordersAngina pectorisCoronary artery diseaseEar and Labyrinth DisordersEar painTinnitusEye DisordersVision blurredInfections and InfestationsBronchitisPelvic inflammatory diseaseUpper respiratory tract infectionInjury, Poisoning and Procedural ComplicationsFacial bones fractureMucosal excoriationInvestigationsBlood pressure increasedIntraocular pressure increasedNervous System DisordersDizzinessHeadacheLacunar infarctionNerve compressionRespiratory, Thoracic and Mediastinal DisordersAsthmaEpistaxisNasal congestionNasal discomfortPulmonary embolismSneezingSkin and Subcutaneous Tissue DisordersUrticariaVascular DisordersHaematoma
Ciclesonide Nasal Aerosol130001101131110001013021172102110000
Ciclesonide Nasal Spray121111010010012111102110051311001111

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The Number of Subjects Experiencing Treatment Emergent AEs.

(NCT01654536)
Timeframe: 0-6 months

,
Interventionparticipants (Number)
OverallGeneral Disorders and Administration Site ConditioApplication site painInfections and InfestationsBronchitisGastroenteritis viralInfluenzaNasopharyngitisSinusitisUpper respiratory tract infectionViral upper respiratory tract infectionInjury, Poisoning and Procedural ComplicationsMuscle strainNervous System DisordersHeadacheRespiratory, Thoracic and Mediastinal DisordersAsthmaCoughEpistaxisNasal congestionNasal discomfortNasal septum ulcerationSneezing
Ciclesonide Nasal Aerosol12175555671210125110944944224616
Ciclesonide Nasal Spray1143046303117851341493712262440

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The Number of Subjects Experiencing Treatment Emergent Nasal AEs.

(NCT01654536)
Timeframe: 0-6 months

,
Interventionparticipants (Number)
OverallGeneral Disorders and Administration Site ConditioApplication site painInfections and InfestationsAcute sinusitisSinusitisInjury, Poisoning and Procedural ComplicationsFacial bones fractureMucosal excoriationScratchNervous System DisordersSinus headacheRespiratory, Thoracic and Mediastinal DisordersEpistaxisNasal congestionNasal discomfortNasal drynessNasal mucosal discolourationNasal mucosal disorderNasal septum ulcerationParanasal sinus hypersecretionRespiratory tract congestionRhinalgiaRhinorrhoeaSinus congestionSneezingSkin and Subcutaneous Tissue DisordersScab
Ciclesonide Nasal Aerosol535511110200200412246102121223600
Ciclesonide Nasal Spray4400817211011342624110410001011

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The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)

(NCT01654536)
Timeframe: 0-6 months

,
Interventionpercentage of participants (Number)
Any Nasal Mucosal Disorder, Septum Disorder, or NaNasal Mucosal DisorderNasal Septum DisorderNasal Septum UlcerationNasal Septum Perforation
Ciclesonide Nasal Aerosol0.80.500.30
Ciclesonide Nasal Spray1.1001.10

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The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.

(NCT01654536)
Timeframe: 0-6 months

,
Interventionpercentage of participants (Number)
OverallCardiac DisordersAngina pectorisCoronary artery diseaseEar and Labyrinth DisordersEar painTinnitusEye DisordersVision blurredInfections and InfestationsBronchitisPelvic inflammatory diseaseUpper respiratory tract infectionInjury, Poisoning and Procedural ComplicationsFacial bones fractureMucosal excoriationInvestigationsBlood pressure increasedIntraocular pressure increasedNervous System DisordersDizzinessHeadacheLacunar infarctionNerve compressionRespiratory, Thoracic and Mediastinal DisordersAsthmaEpistaxisNasal congestionNasal discomfortPulmonary embolismSneezingSkin and Subcutaneous Tissue DisordersUrticariaVascular DisordersHaematoma
Ciclesonide Nasal Aerosol3.50000.30.300.30.30.80.30.30.30000.300.30.800.50.30.31.90.50.300.50.30.30000
Ciclesonide Nasal Spray3.20.30.30.30.300.3000.3000.30.50.30.30.30.300.50.30.3001.40.30.80.30.3000.30.30.30.3

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The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.

(NCT01654536)
Timeframe: 0-6 months

,
Interventionpercentage of participants (Number)
OverallGeneral Disorders and Administration Site ConditioApplication site painInfections and InfestationsAcute sinusitisSinusitisInjury, Poisoning and Procedural ComplicationsFacial bones fractureMucosal excoriationScratchNervous System DisordersSinus headacheRespiratory, Thoracic and Mediastinal DisordersEpistaxisNasal congestionNasal discomfortNasal drynessNasal mucosal discolourationNasal mucosal disorderNasal septum ulcerationParanasal sinus hypersecretionRespiratory tract congestionRhinalgiaRhinorrhoeaSinus congestionSneezingSkin and Subcutaneous Tissue DisordersScab
Ciclesonide Nasal Aerosol14.41.41.43.00.32.70.5000.50011.26.01.11.60.300.50.30.50.30.50.50.81.600
Ciclesonide Nasal Spray11.9002.20.31.90.50.30.300.30.39.27.00.51.10.30.301.10.30000.300.30.3

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The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).

(NCT01654536)
Timeframe: 0-6 months

,
Interventionpercentage of participants (Number)
OverallCardiac DisordersAngina pectorisCoronary artery diseaseHepatobiliary DisordersBile duct stenosisInfections and InfestationsAppendicitisInjury, Poisoning and Procedural ComplicationsFacial bones fractureLimb injuryInvestigationsBlood pressure increasedNervous System DisordersLacunar infarctionMigraineReproductive System and Breast DisordersPostmenopausal haemorrhageRespiratory, Thoracic and Mediastinal DisordersPulmonary embolism
Ciclesonide Nasal Aerosol1.100000000.300.3000.50.30.3000.30.3
Ciclesonide Nasal Spray1.40.30.30.30.30.30.30.30.30.300.30.30000.30.400

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Number of Subjects With Development of or Worsening in Lens Opacities.

(NCT01654536)
Timeframe: 0-6 months

Interventionparticipants (Number)
Ciclesonide Nasal Aerosol51
Ciclesonide Nasal Spray53

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The Percentage of Subjects Experiencing Treatment Emergent AEs.

(NCT01654536)
Timeframe: 0-6 months

,
Interventionpercentage of participants (Number)
OverallGeneral Disorders and Administration Site ConditioApplication site painInfections and InfestationsBronchitisGastroenteritis viralInfluenzaNasopharyngitisSinusitisUpper respiratory tract infectionViral upper respiratory tract infectionInjury, Poisoning and Procedural ComplicationsMuscle strainNervous System DisordersHeadacheRespiratory, Thoracic and Mediastinal DisordersAsthmaCoughEpistaxisNasal congestionNasal discomfortNasal septum ulcerationSneezing
Ciclesonide Nasal Aerosol33.01.91.415.01.41.61.93.32.73.31.43.002.51.113.41.11.16.01.11.60.31.6
Ciclesonide Nasal Spray30.80.8012.40.800.83.01.92.21.43.51.13.82.410.00.30.57.00.51.11.10

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The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).

(NCT01654536)
Timeframe: 0-6 months

,
Interventionparticipants (Number)
OverallCardiac DisordersAngina pectorisCoronary artery diseaseHepatobiliary DisordersBile duct stenosisInfections and InfestationsAppendicitisInjury, Poisoning and Procedural ComplicationsFacial bones fractureLimb injuryInvestigationsBlood pressure increasedNervous System DisordersLacunar infarctionMigraineReproductive System and Breast DisordersPostmenopausal haemorrhageRespiratory, Thoracic and Mediastinal DisordersPulmonary embolism
Ciclesonide Nasal Aerosol40000000101002110011
Ciclesonide Nasal Spray51111111110110001100

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Number of Subjects With Change From Baseline in Best Corrected Visual Acuity.

(NCT01654536)
Timeframe: 0-6 months

Interventionparticipants (Number)
Ciclesonide Nasal Aerosol1
Ciclesonide Nasal Spray2

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Percentage of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye

(NCT01654536)
Timeframe: 0-6 months

Interventionpercentage of partcipants (Number)
Ciclesonide Nasal Aerosol2.5
Ciclesonide Nasal Spray1.6

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Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score

The RQLQ is a 28-item, disease-specific quality of life questionnaire that measures the functional (physical, emotional, and social) problems troublesome to adults with allergies. The RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional). All 28 questions were evaluated by the participant in an assessment diary over 2 weeks of treatment period and was rated on a 7-point severity scale ranging from 0 to 6, where 0 = least severe to 6 = extremely severe. Overall total score was calculated by taking the mean of the response of all individual 28 questions. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score. (NCT02155881)
Timeframe: Baseline and Week 1 up to Week 2 (entire treatment period)

,
Interventionscores on a scale (Mean)
BaselineChange Over 2 Weeks
Ciclesonide 200 mcg3.31-1.40
Placebo3.24-1.09

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Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score

The RQLQ is a 28-item, disease-specific quality of life questionnaire that measures the functional (physical, emotional, and social) problems troublesome to adults with allergies. The RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional). All 28 questions were evaluated by the participant in an assessment diary over 2 weeks of treatment period and was rated on a 7-point severity scale ranging from 0 to 6, where 0 = least severe to 6 = extremely severe. Overall domain scores were calculated by taking the mean of the response of the relevant questions. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score. (NCT02155881)
Timeframe: Baseline and Week 1 up to Week 2 (entire treatment period)

,
Interventionscores on a scale (Mean)
Activities: BaselineActivities: Change Over 2 WeeksSleep: BaselineSleep: Change Over 2 WeeksNon-Nose/Eye Symptoms: BaselineNon-Nose/Eye Symptoms: Change Over 2 WeeksPractical Problems: BaselinePractical Problems: Change Over 2 WeeksNasal Symptoms: BaselineNasal Symptoms: Change Over 2 WeeksEye Symptoms: BaselineEye Symptoms: Change Over 2 WeeksEmotional: BaselineEmotional: Change Over 2 Weeks
Ciclesonide 200 mcg4.07-1.553.22-1.382.74-1.074.01-1.764.05-1.783.01-1.282.82-1.39
Placebo4.05-1.243.15-1.022.85-0.903.50-1.183.90-1.442.91-1.032.89-1.06

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Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Ocular Symptom Scores (TOSS)

The reflective TOSS is defined as the sum of the participant-rated reflective symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Reflective TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score. (NCT02155881)
Timeframe: Baseline and Week 1 up to Week 2 (entire treatment period)

,
Interventionscores on a scale (Mean)
BaselineChange Over 2 Weeks
Ciclesonide 200 mcg4.78-1.68
Placebo4.75-1.68

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Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Nasal Symptom Scores (TNSS)

The reflective TNSS is defined as the sum of the participant-rated reflective symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score. (NCT02155881)
Timeframe: Baseline and Week 1 up to Week 2 (entire treatment period)

,
Interventionscores on a scale (Mean)
BaselineChange Over 2 Weeks
Ciclesonide 200 mcg7.81-2.85
Placebo7.71-2.68

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Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Nasal Symptom Scores

The instantaneous TNSS is defined as the sum of the participant-rated instantaneous symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion at the time of evaluation. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score. (NCT02155881)
Timeframe: Baseline and Week 1 up to Week 2 (entire treatment period)

,
Interventionscores on a scale (Mean)
BaselineChange Over 2 Weeks
Ciclesonide 200 mcg7.81-2.76
Placebo7.64-2.62

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Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score

The reflective TOSS is defined as the sum of the participant-rated reflective symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Reflective TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score. (NCT02155881)
Timeframe: Baseline and Week 1 up to Week 2 (entire treatment period)

,
Interventionscores on a scale (Mean)
Itching/Burning Eyes: BaselineItching/Burning Eyes: Change Over 2 WeeksRedness: BaselineRedness: Change Over 2 WeeksTearing/Watering Eyes: BaselineTearing/Watering Eyes: Change Over 2 Weeks
Ciclesonide 200 mcg1.85-0.631.57-0.591.37-0.45
Placebo1.79-0.731.67-0.521.29-0.43

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Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score

The reflective TNSS is defined as the sum of the participant-rated reflective symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score. (NCT02155881)
Timeframe: Baseline and Week 1 up to Week 2 (entire treatment period)

,
Interventionscores on a scale (Mean)
Nasal Congestion: BaselineNasal Congestion: Change Over 2 WeeksRunny nose: BaselineRunny nose: Change Over 2 WeeksItchy Nose: BaselineItchy Nose: Change Over 2 WeeksSneezing: BaselineSneezing: Change Over 2 Weeks
Ciclesonide 200 mcg2.19-0.702.04-0.791.77-0.641.80-0.71
Placebo2.22-0.622.01-0.771.76-0.641.73-0.64

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Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Ocular Symptom Scores

The instantaneous TOSS is defined as the sum of the participant-rated instantaneous symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes at the time of evaluation. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Instantaneous TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score. (NCT02155881)
Timeframe: Baseline and Week 1 up to Week 2 (entire treatment period)

,
Interventionscores on a scale (Mean)
BaselineChange Over 2 Weeks
Ciclesonide 200 mcg4.74-1.56
Placebo4.69-1.61

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Percentage of Patients With Subsequent Emergency Department Visit or Hospital Admission for Reasons Attributable to COVID-19 by Day 30

Assess whether treatment with ciclesonide MDI plus standard supportive care reduces the incidence of subsequent emergency department visits or hospital admissions for reasons attributable to COVID-19 compared with placebo plus standard supportive care in non-hospitalized patients with symptomatic COVID-19 infection (NCT04377711)
Timeframe: Day 30

Interventionpercentage of patients (Number)
Ciclesonide Arm1.0
Placebo Arm5.4

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All-cause Mortality by Day 30

Assess whether treatment with ciclesonide MDI plus standard supportive care reduces all-cause mortality compared with placebo plus standard supportive care in non-hospitalized patients with symptomatic COVID-19 infection. (NCT04377711)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
Ciclesonide Arm0
Placebo Arm0

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Percentage of Patients With Hospital Admission or Death by Day 30

Assess whether treatment with ciclesonide MDI (Metered Dose Inhaler) plus standard supportive care reduces the incidence of hospital admissions or death compared with placebo plus standard supportive care in non-hospitalized patients with symptomatic COVID-19 infection. (NCT04377711)
Timeframe: Day 30

Interventionpercentage of patients (Number)
Ciclesonide Arm1.5
Placebo Arm3.4

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Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at Day 7

Improvement of wet or dry cough. Analysis limited to patients who reported cough at baseline. Defined as a 2 point decrease, or a decrease to 0 on a visual analogue scale that ranged from 0 for no symptoms to 10 for severe symptoms (NCT04435795)
Timeframe: day 7

InterventionParticipants (Count of Participants)
Ciclesonide Inhaled and Nasal57
Placebo54

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"Overall Feeling: Proportion Who Are Reporting That They Are Very Much Improved or Much Improved at Day 7"

"Proportion who are reporting that they are very much improved or much improved" (NCT04435795)
Timeframe: Day 7

InterventionParticipants (Count of Participants)
Ciclesonide Inhaled and Nasal77
Placebo74

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"Overall Feeling: Proportion Who Are Reporting That They Are Very Much Improved or Much Improved at Day 14"

"Proportion who are reporting that they are very much improved or much improved" (NCT04435795)
Timeframe: Day 14

InterventionParticipants (Count of Participants)
Ciclesonide Inhaled and Nasal95
Placebo91

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Mortality

All cause mortality (NCT04435795)
Timeframe: day 29

InterventionParticipants (Count of Participants)
Ciclesonide Inhaled and Nasal0
Placebo0

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Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea

Proportion of participants with no symptoms of cough, fever or dyspnea at day 7 (NCT04435795)
Timeframe: day 7

InterventionParticipants (Count of Participants)
Ciclesonide Inhaled and Nasal42
Placebo34

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Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea

Proportion of participants with no symptoms of cough, fever or dyspnea at Day 14 (NCT04435795)
Timeframe: Day 14

InterventionParticipants (Count of Participants)
Ciclesonide Inhaled and Nasal95
Placebo91

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Improvement in Dyspnea: Resolution of Dyspnea at Day 7

"Dyspnea was defined as reporting shortness of breath or chest congestion or chest tightness. In those who reported dyspnea at baseline, resolution will be defined as having no symptoms in these three areas." (NCT04435795)
Timeframe: day 7

InterventionParticipants (Count of Participants)
Ciclesonide Inhaled and Nasal38
Placebo27

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Proportion of Participants Hospitalized for SARS-CoV-2

Hospitalization for SARS-CoV-2 related illness (NCT04435795)
Timeframe: day 14

InterventionParticipants (Count of Participants)
Ciclesonide Inhaled and Nasal6
Placebo3

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