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A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children (6-11 Years) With Asthma (RAINBOW)

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ClinicalTrials.gov Identifier: NCT00384189
Recruitment Status : Completed
First Posted : October 5, 2006
Results First Posted : August 16, 2016
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
Nycomed GmbH
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Ciclesonide
Drug: Placebo
Drug: Salbutamol
Enrollment 1080
Recruitment Details Participants took part in the study at 110 investigative sites in Bulgaria, Germany, Hungary, Poland, Romania, Russia, South Africa, Spain, and Ukraine from 29 September 2006 to 17 August 2007.
Pre-assignment Details Children with a diagnosis of asthma were enrolled equally in 1 of 4 treatment groups, once a day placebo, 40 µg, 80 µg or 160 µg ciclesonide.
Arm/Group Title Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
Hide Arm/Group Description Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Period Title: Overall Study
Started 305 312 313 150
Randomized, Not Treated 1 0 2 4
Actual Treatment Received 305 [1] 312 310 [2] 146
Completed 255 255 255 110
Not Completed 50 57 58 40
Reason Not Completed
Reason Not Specified             50             57             58             40
[1]
1 participant randomized to 160 μg who actually received 40 μg is included.
[2]
1 participants in the 160 μg arm actually received 40 μg and is moved to that arm.
Arm/Group Title Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo Total
Hide Arm/Group Description Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. Total of all reporting groups
Overall Number of Baseline Participants 305 312 310 146 1073
Hide Baseline Analysis Population Description
Full Analysis Set includes all randomized participants who received at least one dose of study drug, as treated.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 305 participants 312 participants 310 participants 146 participants 1073 participants
8.4  (1.7) 8.4  (1.6) 8.7  (1.6) 8.4  (1.7) 8.4  (1.6)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 305 participants 312 participants 310 participants 146 participants 1073 participants
Female
95
  31.1%
121
  38.8%
92
  29.7%
54
  37.0%
362
  33.7%
Male
210
  68.9%
191
  61.2%
218
  70.3%
92
  63.0%
711
  66.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 305 participants 312 participants 310 participants 146 participants 1073 participants
Caucasian 276 279 277 133 965
non-Caucasian 29 33 33 13 108
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 305 participants 312 participants 310 participants 146 participants 1073 participants
Bulgaria 29 33 33 15 110
Germany 17 16 12 8 53
Hungary 42 45 43 22 152
Poland 49 48 49 23 169
Romania 15 16 21 8 60
Russian Federation 54 52 55 27 188
South Africa 32 34 32 13 111
Spain 18 18 17 8 61
Ukraine 49 50 48 22 169
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 305 participants 312 participants 310 participants 146 participants 1073 participants
134.6  (10.8) 134.5  (11.0) 135.9  (10.8) 134.6  (11.1) 134.9  (10.9)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 305 participants 312 participants 310 participants 146 participants 1073 participants
32.3  (9.1) 31.9  (9.3) 33.2  (9.5) 32.7  (9.7) 32.5  (9.4)
Duration of Asthma  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 305 participants 312 participants 310 participants 146 participants 1073 participants
44.3  (27.7) 45.5  (27.8) 45.5  (27.4) 47.6  (28.0) 45.5  (27.7)
Inhaled Glucocorticosteroids (ICS) Pretreatment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 305 participants 312 participants 310 participants 146 participants 1073 participants
Yes 200 204 199 102 705
No 105 108 111 44 368
ICS Pretreatment Dose   [1] 
Mean (Standard Deviation)
Unit of measure:  µg/day
Number Analyzed 305 participants 312 participants 310 participants 146 participants 1073 participants
211.9  (181.9) 222.8  (188.8) 205.0  (177.1) 224.6  (178.8) 214.8  (182.1)
[1]
Measure Description: The number of participants with ICS pretreatment dose data is 200, 204, 199 and 102 in each treatment arm, respectively.
Asthma Severity According to Global Initiative for Asthma (GINA)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 305 participants 312 participants 310 participants 146 participants 1073 participants
Intermittent 20 19 13 7 59
Mild 25 22 29 10 86
Moderate 112 110 104 50 376
Severe 148 161 164 79 552
1.Primary Outcome
Title Change From Baseline in Morning Peak Expiratory Flow (PEF)
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.
Arm/Group Title Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
Hide Arm/Group Description:
Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Overall Number of Participants Analyzed 304 312 311 146
Least Squares Mean (Standard Error)
Unit of Measure: liters/minute
15.23  (2.69) 14.79  (2.60) 17.37  (2.68) 5.40  (3.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ciclesonide 40 µg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0116
Comments [Not Specified]
Method ANCOVA
Comments Baseline value and age as covariates. One-sided p-value, significance level 2.5%.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 9.8
Confidence Interval (2-Sided) 95%
1.4 to 18.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ciclesonide 80 µg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0148
Comments [Not Specified]
Method ANCOVA
Comments Baseline value and age as covariates. One-sided p-value, significance level 2.5%.
Method of Estimation Estimation Parameter Least Square Means Difference
Estimated Value 9.4
Confidence Interval (2-Sided) 95%
0.9 to 17.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ciclesonide 160 µg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0028
Comments [Not Specified]
Method ANCOVA
Comments Baseline value and age as covariates. One-sided p-value, significance level 2.5%.
Method of Estimation Estimation Parameter Least Squares Means Difference
Estimated Value 12.0
Confidence Interval (2-Sided) 95%
3.5 to 20.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to First Event of Lack of Efficacy (LOE) by Week 12
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.
Arm/Group Title Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
Hide Arm/Group Description:
Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Overall Number of Participants Analyzed 304 312 311 146
Measure Type: Number
Unit of Measure: Percent
72.8 74.5 73.2 66.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ciclesonide 40 µg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1362
Comments Two-sided p-value, significance level 5%.
Method Log Rank
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ciclesonide 80 µg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0891
Comments Two-sided p-value, significance level 5%.
Method Log Rank
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ciclesonide 160 µg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1574
Comments Two-sided p-value, significance level 5%.
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication, Morning PEF and PEF Fluctuation
Hide Description 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.
Time Frame 28 days prior to last visit (Up to 12 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.
Arm/Group Title Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
Hide Arm/Group Description:
Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Overall Number of Participants Analyzed 302 311 309 144
Median (Full Range)
Unit of Measure: percentage of days
7.14
(0.0 to 100.0)
10.53
(0.0 to 100.0)
6.67
(0.0 to 100.0)
0.0
(0.0 to 100.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ciclesonide 40 µg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments One-sided p-value for superiority, significance level 2.5%.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ciclesonide 80 µg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments One-sided p-value for superiority, significance level 2.5%.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ciclesonide 160 µg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments One-sided p-value for superiority, significance level 2.5%.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Lung Function Variable Forced Expiratory Volume in One Second (FEV1)
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.
Arm/Group Title Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
Hide Arm/Group Description:
Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Overall Number of Participants Analyzed 270 281 270 124
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.123  (0.015) 0.122  (0.015) 0.139  (0.015) 0.039  (0.022)
5.Secondary Outcome
Title Change From Baseline in Lung Function Variable PEF by Spirometry
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last Observation carried forward.
Arm/Group Title Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
Hide Arm/Group Description:
Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Overall Number of Participants Analyzed 270 281 272 124
Least Squares Mean (Standard Error)
Unit of Measure: liters/minute
20.68  (2.61) 21.71  (2.51) 22.25  (2.61) 15.13  (3.69)
6.Secondary Outcome
Title Change From Baseline in Morning PEF From Diary
Hide Description 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.
Time Frame Baseline and Weeks 1 thru 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.
Arm/Group Title Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
Hide Arm/Group Description:
Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Overall Number of Participants Analyzed 304 312 311 146
Least Squares Mean (Standard Error)
Unit of Measure: liters/minute
Change at Week 1 (n=303,311,310,146) 11.61  (1.55) 9.20  (1.50) 11.54  (1.54) 4.54  (2.13)
Change at Week 2 (n=303,311,310,146) 9.82  (1.89) 11.95  (1.83) 12.26  (1.89) 4.20  (2.61)
Change at Week 3 (n=304,312,310,146) 11.36  (2.08) 11.11  (2.01) 13.15  (2.07) 6.74  (2.87)
Change at Week 4 (n=304,312,310,146) 13.63  (2.18) 13.27  (2.12) 15.60  (2.18) 6.31  (3.02)
Change at Week 5 14.86  (2.23) 13.33  (2.16) 15.39  (2.22) 9.67  (3.08)
Change at Week 6 13.91  (2.30) 13.26  (2.23) 14.71  (2.29) 7.64  (3.18)
Change at Week 7 14.57  (2.37) 15.05  (2.30) 14.14  (2.36) 6.21  (3.28)
Change at Week 8 14.57  (2.39) 15.92  (2.31) 13.63  (2.38) 7.05  (3.30)
Change at Week 9 15.26  (2.44) 16.02  (2.36) 13.23  (2.43) 7.88  (3.37)
Change at Week 10 16.35  (2.48) 16.79  (2.40) 14.59  (2.47) 7.66  (3.43)
Change at Week 11 16.12  (2.60) 15.97  (2.52) 16.24  (2.59) 6.80  (3.60)
Change at Week 12 15.93  (2.72) 15.43  (2.64) 17.59  (2.71) 6.41  (3.76)
7.Secondary Outcome
Title Change From Baseline in Evening PEF From Diary
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last observation carried forward.
Arm/Group Title Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
Hide Arm/Group Description:
Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Overall Number of Participants Analyzed 304 312 310 146
Least Squares Mean (Standard Error)
Unit of Measure: liters/minute
10.16  (2.54) 9.37  (2.46) 12.71  (2.53) 4.02  (3.52)
8.Secondary Outcome
Title Change From Baseline in Diurnal PEF Fluctuations
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.
Arm/Group Title Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
Hide Arm/Group Description:
Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Overall Number of Participants Analyzed 303 312 310 146
Mean (Standard Deviation)
Unit of Measure: percent change
-0.841  (9.942) -1.209  (10.686) -1.192  (11.290) 0.214  (9.453)
9.Secondary Outcome
Title Change in Asthma Symptom Total Score
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last observation carried forward.
Arm/Group Title Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
Hide Arm/Group Description:
Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Overall Number of Participants Analyzed 304 312 311 146
Mean (Standard Deviation)
Unit of Measure: score on a scale
Asthma Total Symptom Score (n=304,312,310,146) -0.916  (1.265) -0.983  (1.209) -0.879  (1.270) -0.572  (1.483)
Asthma Daytime Symptom Score (n=304,312,310,146) -0.529  (0.682) -0.553  (0.721) -0.517  (0.662) -0.354  (0.801)
Asthma Nighttime Symptom Score -0.392  (0.775) -0.435  (0.672) -0.350  (0.791) -0.233  (0.858)
10.Secondary Outcome
Title Change in Use of Rescue Medications
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last Observation carried forward.
Arm/Group Title Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
Hide Arm/Group Description:
Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Overall Number of Participants Analyzed 304 312 311 146
Mean (Standard Deviation)
Unit of Measure: puffs/day
-0.872  (1.634) -0.999  (1.523) -0.886  (1.771) -0.527  (1.931)
11.Secondary Outcome
Title Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication and Morning PEF
Hide Description 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.
Time Frame 28 days prior to last visit (Up to 12 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.
Arm/Group Title Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
Hide Arm/Group Description:
Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Overall Number of Participants Analyzed 302 311 309 144
Median (Full Range)
Unit of Measure: percentage of days
8.33
(0.0 to 100.0)
13.64
(0.0 to 100.0)
13.04
(0.0 to 100.0)
0.0
(0.0 to 100.0)
12.Secondary Outcome
Title Change From Baseline in Pediatric Asthma Quality of Life Questionnaire Standard [PAQLQ(S)] Overall Score
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.
Arm/Group Title Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
Hide Arm/Group Description:
Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Overall Number of Participants Analyzed 167 179 171 76
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.78  (0.07) 0.71  (0.07) 0.72  (0.07) 0.43  (0.10)
13.Secondary Outcome
Title Change From Baseline in Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ) Overall
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.
Arm/Group Title Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
Hide Arm/Group Description:
Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
Overall Number of Participants Analyzed 169 177 172 74
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.82  (0.08) 0.88  (0.08) 0.84  (0.08) 0.71  (0.12)
Time Frame First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
Hide Arm/Group Description Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed. Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
All-Cause Mortality
Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/305 (1.31%)   5/312 (1.60%)   2/310 (0.65%)   1/146 (0.68%) 
Cardiac disorders         
Tachycardia  1  0/305 (0.00%)  0/312 (0.00%)  0/310 (0.00%)  1/146 (0.68%) 
Infections and infestations         
Adenovirus infection  1  1/305 (0.33%)  0/312 (0.00%)  0/310 (0.00%)  0/146 (0.00%) 
Appendicitis  1  0/305 (0.00%)  1/312 (0.32%)  0/310 (0.00%)  0/146 (0.00%) 
Lower respiratory tract infection  1  0/305 (0.00%)  0/312 (0.00%)  1/310 (0.32%)  0/146 (0.00%) 
Otitis media  1  0/305 (0.00%)  1/312 (0.32%)  0/310 (0.00%)  0/146 (0.00%) 
Pneumonia  1  1/305 (0.33%)  1/312 (0.32%)  0/310 (0.00%)  0/146 (0.00%) 
Sinusitis  1  1/305 (0.33%)  1/312 (0.32%)  0/310 (0.00%)  0/146 (0.00%) 
Tonsillitis streptococcal  1  1/305 (0.33%)  0/312 (0.00%)  0/310 (0.00%)  0/146 (0.00%) 
Injury, poisoning and procedural complications         
Open wound  1  0/305 (0.00%)  1/312 (0.32%)  0/310 (0.00%)  0/146 (0.00%) 
Nervous system disorders         
Tremor  1  0/305 (0.00%)  0/312 (0.00%)  0/310 (0.00%)  1/146 (0.68%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  1/305 (0.33%)  2/312 (0.64%)  1/310 (0.32%)  0/146 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   49/305 (16.07%)   45/312 (14.42%)   45/310 (14.52%)   14/146 (9.59%) 
Infections and infestations         
Nasopharyngitis  1  19/305 (6.23%)  10/312 (3.21%)  13/310 (4.19%)  3/146 (2.05%) 
Pharyngitis  1  14/305 (4.59%)  18/312 (5.77%)  16/310 (5.16%)  7/146 (4.79%) 
Upper respiratory tract infection  1  18/305 (5.90%)  20/312 (6.41%)  16/310 (5.16%)  5/146 (3.42%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 10.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: AstraZeneca Clinical Study Information Center
Organization: AstraZeneca
Phone: 1-877-240-9479
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00384189     History of Changes
Other Study ID Numbers: BY9010/M1-209
U1111-1172-2297 ( Registry Identifier: WHO )
First Submitted: October 4, 2006
First Posted: October 5, 2006
Results First Submitted: July 6, 2016
Results First Posted: August 16, 2016
Last Update Posted: February 1, 2017