Trial Outcomes & Findings for A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children (6-11 Years) With Asthma (NCT NCT00384189)

Last Updated: 2017-02-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1080 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2017-02-01

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Ciclesonide 40 µg 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.	Ciclesonide 80 µg 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.	Ciclesonide 160 µg 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 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 Study STARTED	305	312	313	150
Overall Study Randomized, Not Treated	1	0	2	4
Overall Study Actual Treatment Received	305	312	310	146
Overall Study COMPLETED	255	255	255	110
Overall Study NOT COMPLETED	50	57	58	40

Reasons for withdrawal

Reasons for withdrawal
Measure	Ciclesonide 40 µg 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.	Ciclesonide 80 µg 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.	Ciclesonide 160 µg 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 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 Study Reason Not Specified	50	57	58	40

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ciclesonide 40 µg n=305 Participants 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.	Ciclesonide 80 µg n=312 Participants 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.	Ciclesonide 160 µg n=310 Participants 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 n=146 Participants 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 n=1073 Participants Total of all reporting groups
Age, Continuous	8.4 years STANDARD_DEVIATION 1.7 • n=5 Participants	8.4 years STANDARD_DEVIATION 1.6 • n=7 Participants	8.7 years STANDARD_DEVIATION 1.6 • n=5 Participants	8.4 years STANDARD_DEVIATION 1.7 • n=4 Participants	8.4 years STANDARD_DEVIATION 1.6 • n=21 Participants
Gender Female	95 Participants n=5 Participants	121 Participants n=7 Participants	92 Participants n=5 Participants	54 Participants n=4 Participants	362 Participants n=21 Participants
Gender Male	210 Participants n=5 Participants	191 Participants n=7 Participants	218 Participants n=5 Participants	92 Participants n=4 Participants	711 Participants n=21 Participants
Race/Ethnicity, Customized Caucasian	276 participants n=5 Participants	279 participants n=7 Participants	277 participants n=5 Participants	133 participants n=4 Participants	965 participants n=21 Participants
Race/Ethnicity, Customized non-Caucasian	29 participants n=5 Participants	33 participants n=7 Participants	33 participants n=5 Participants	13 participants n=4 Participants	108 participants n=21 Participants
Region of Enrollment Bulgaria	29 participants n=5 Participants	33 participants n=7 Participants	33 participants n=5 Participants	15 participants n=4 Participants	110 participants n=21 Participants
Region of Enrollment Germany	17 participants n=5 Participants	16 participants n=7 Participants	12 participants n=5 Participants	8 participants n=4 Participants	53 participants n=21 Participants
Region of Enrollment Hungary	42 participants n=5 Participants	45 participants n=7 Participants	43 participants n=5 Participants	22 participants n=4 Participants	152 participants n=21 Participants
Region of Enrollment Poland	49 participants n=5 Participants	48 participants n=7 Participants	49 participants n=5 Participants	23 participants n=4 Participants	169 participants n=21 Participants
Region of Enrollment Romania	15 participants n=5 Participants	16 participants n=7 Participants	21 participants n=5 Participants	8 participants n=4 Participants	60 participants n=21 Participants
Region of Enrollment Russian Federation	54 participants n=5 Participants	52 participants n=7 Participants	55 participants n=5 Participants	27 participants n=4 Participants	188 participants n=21 Participants
Region of Enrollment South Africa	32 participants n=5 Participants	34 participants n=7 Participants	32 participants n=5 Participants	13 participants n=4 Participants	111 participants n=21 Participants
Region of Enrollment Spain	18 participants n=5 Participants	18 participants n=7 Participants	17 participants n=5 Participants	8 participants n=4 Participants	61 participants n=21 Participants
Region of Enrollment Ukraine	49 participants n=5 Participants	50 participants n=7 Participants	48 participants n=5 Participants	22 participants n=4 Participants	169 participants n=21 Participants
Height	134.6 cm STANDARD_DEVIATION 10.8 • n=5 Participants	134.5 cm STANDARD_DEVIATION 11.0 • n=7 Participants	135.9 cm STANDARD_DEVIATION 10.8 • n=5 Participants	134.6 cm STANDARD_DEVIATION 11.1 • n=4 Participants	134.9 cm STANDARD_DEVIATION 10.9 • n=21 Participants
Weight	32.3 kg STANDARD_DEVIATION 9.1 • n=5 Participants	31.9 kg STANDARD_DEVIATION 9.3 • n=7 Participants	33.2 kg STANDARD_DEVIATION 9.5 • n=5 Participants	32.7 kg STANDARD_DEVIATION 9.7 • n=4 Participants	32.5 kg STANDARD_DEVIATION 9.4 • n=21 Participants
Duration of Asthma	44.3 months STANDARD_DEVIATION 27.7 • n=5 Participants	45.5 months STANDARD_DEVIATION 27.8 • n=7 Participants	45.5 months STANDARD_DEVIATION 27.4 • n=5 Participants	47.6 months STANDARD_DEVIATION 28.0 • n=4 Participants	45.5 months STANDARD_DEVIATION 27.7 • n=21 Participants
Inhaled Glucocorticosteroids (ICS) Pretreatment Yes	200 participants n=5 Participants	204 participants n=7 Participants	199 participants n=5 Participants	102 participants n=4 Participants	705 participants n=21 Participants
Inhaled Glucocorticosteroids (ICS) Pretreatment No	105 participants n=5 Participants	108 participants n=7 Participants	111 participants n=5 Participants	44 participants n=4 Participants	368 participants n=21 Participants
ICS Pretreatment Dose	211.9 µg/day STANDARD_DEVIATION 181.9 • n=5 Participants	222.8 µg/day STANDARD_DEVIATION 188.8 • n=7 Participants	205.0 µg/day STANDARD_DEVIATION 177.1 • n=5 Participants	224.6 µg/day STANDARD_DEVIATION 178.8 • n=4 Participants	214.8 µg/day STANDARD_DEVIATION 182.1 • n=21 Participants
Asthma Severity According to Global Initiative for Asthma (GINA) Intermittent	20 participants n=5 Participants	19 participants n=7 Participants	13 participants n=5 Participants	7 participants n=4 Participants	59 participants n=21 Participants
Asthma Severity According to Global Initiative for Asthma (GINA) Mild	25 participants n=5 Participants	22 participants n=7 Participants	29 participants n=5 Participants	10 participants n=4 Participants	86 participants n=21 Participants
Asthma Severity According to Global Initiative for Asthma (GINA) Moderate	112 participants n=5 Participants	110 participants n=7 Participants	104 participants n=5 Participants	50 participants n=4 Participants	376 participants n=21 Participants
Asthma Severity According to Global Initiative for Asthma (GINA) Severe	148 participants n=5 Participants	161 participants n=7 Participants	164 participants n=5 Participants	79 participants n=4 Participants	552 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: 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.

Outcome measures

Outcome measures
Measure	Ciclesonide 40 µg n=304 Participants 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.	Ciclesonide 80 µg n=312 Participants 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.	Ciclesonide 160 µg n=311 Participants 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 n=146 Participants 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.
Change From Baseline in Morning Peak Expiratory Flow (PEF)	15.23 liters/minute Standard Error 2.69	14.79 liters/minute Standard Error 2.60	17.37 liters/minute Standard Error 2.68	5.40 liters/minute Standard Error 3.71

SECONDARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Outcome measures
Measure	Ciclesonide 40 µg n=304 Participants 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.	Ciclesonide 80 µg n=312 Participants 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.	Ciclesonide 160 µg n=311 Participants 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 n=146 Participants 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.
Time to First Event of Lack of Efficacy (LOE) by Week 12	72.8 Percent	74.5 Percent	73.2 Percent	66.9 Percent

SECONDARY outcome

Timeframe: 28 days prior to last visit (Up to 12 Weeks)

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.

Outcome measures

Outcome measures
Measure	Ciclesonide 40 µg n=302 Participants 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.	Ciclesonide 80 µg n=311 Participants 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.	Ciclesonide 160 µg n=309 Participants 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 n=144 Participants 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.
Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication, Morning PEF and PEF Fluctuation	7.14 percentage of days Interval 0.0 to 100.0	10.53 percentage of days Interval 0.0 to 100.0	6.67 percentage of days Interval 0.0 to 100.0	0.0 percentage of days Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Baseline and Week 12

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.

Outcome measures

Outcome measures
Measure	Ciclesonide 40 µg n=270 Participants 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.	Ciclesonide 80 µg n=281 Participants 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.	Ciclesonide 160 µg n=270 Participants 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 n=124 Participants 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.
Change From Baseline in Lung Function Variable Forced Expiratory Volume in One Second (FEV1)	0.123 liters Standard Error 0.015	0.122 liters Standard Error 0.015	0.139 liters Standard Error 0.015	0.039 liters Standard Error 0.022

SECONDARY outcome

Timeframe: Baseline and Week 12

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.

Outcome measures

Outcome measures
Measure	Ciclesonide 40 µg n=270 Participants 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.	Ciclesonide 80 µg n=281 Participants 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.	Ciclesonide 160 µg n=272 Participants 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 n=124 Participants 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.
Change From Baseline in Lung Function Variable PEF by Spirometry	20.68 liters/minute Standard Error 2.61	21.71 liters/minute Standard Error 2.51	22.25 liters/minute Standard Error 2.61	15.13 liters/minute Standard Error 3.69

SECONDARY outcome

Timeframe: Baseline and Weeks 1 thru 12

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.

Outcome measures

Outcome measures
Measure	Ciclesonide 40 µg n=304 Participants 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.	Ciclesonide 80 µg n=312 Participants 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.	Ciclesonide 160 µg n=311 Participants 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 n=146 Participants 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.
Change From Baseline in Morning PEF From Diary Change at Week 7	14.57 liters/minute Standard Error 2.37	15.05 liters/minute Standard Error 2.30	14.14 liters/minute Standard Error 2.36	6.21 liters/minute Standard Error 3.28
Change From Baseline in Morning PEF From Diary Change at Week 1 (n=303,311,310,146)	11.61 liters/minute Standard Error 1.55	9.20 liters/minute Standard Error 1.50	11.54 liters/minute Standard Error 1.54	4.54 liters/minute Standard Error 2.13
Change From Baseline in Morning PEF From Diary Change at Week 2 (n=303,311,310,146)	9.82 liters/minute Standard Error 1.89	11.95 liters/minute Standard Error 1.83	12.26 liters/minute Standard Error 1.89	4.20 liters/minute Standard Error 2.61
Change From Baseline in Morning PEF From Diary Change at Week 3 (n=304,312,310,146)	11.36 liters/minute Standard Error 2.08	11.11 liters/minute Standard Error 2.01	13.15 liters/minute Standard Error 2.07	6.74 liters/minute Standard Error 2.87
Change From Baseline in Morning PEF From Diary Change at Week 4 (n=304,312,310,146)	13.63 liters/minute Standard Error 2.18	13.27 liters/minute Standard Error 2.12	15.60 liters/minute Standard Error 2.18	6.31 liters/minute Standard Error 3.02
Change From Baseline in Morning PEF From Diary Change at Week 5	14.86 liters/minute Standard Error 2.23	13.33 liters/minute Standard Error 2.16	15.39 liters/minute Standard Error 2.22	9.67 liters/minute Standard Error 3.08
Change From Baseline in Morning PEF From Diary Change at Week 6	13.91 liters/minute Standard Error 2.30	13.26 liters/minute Standard Error 2.23	14.71 liters/minute Standard Error 2.29	7.64 liters/minute Standard Error 3.18
Change From Baseline in Morning PEF From Diary Change at Week 8	14.57 liters/minute Standard Error 2.39	15.92 liters/minute Standard Error 2.31	13.63 liters/minute Standard Error 2.38	7.05 liters/minute Standard Error 3.30
Change From Baseline in Morning PEF From Diary Change at Week 9	15.26 liters/minute Standard Error 2.44	16.02 liters/minute Standard Error 2.36	13.23 liters/minute Standard Error 2.43	7.88 liters/minute Standard Error 3.37
Change From Baseline in Morning PEF From Diary Change at Week 10	16.35 liters/minute Standard Error 2.48	16.79 liters/minute Standard Error 2.40	14.59 liters/minute Standard Error 2.47	7.66 liters/minute Standard Error 3.43
Change From Baseline in Morning PEF From Diary Change at Week 11	16.12 liters/minute Standard Error 2.60	15.97 liters/minute Standard Error 2.52	16.24 liters/minute Standard Error 2.59	6.80 liters/minute Standard Error 3.60
Change From Baseline in Morning PEF From Diary Change at Week 12	15.93 liters/minute Standard Error 2.72	15.43 liters/minute Standard Error 2.64	17.59 liters/minute Standard Error 2.71	6.41 liters/minute Standard Error 3.76

SECONDARY outcome

Timeframe: Baseline and Week 12

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.

Outcome measures

Outcome measures
Measure	Ciclesonide 40 µg n=304 Participants 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.	Ciclesonide 80 µg n=312 Participants 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.	Ciclesonide 160 µg n=310 Participants 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 n=146 Participants 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.
Change From Baseline in Evening PEF From Diary	10.16 liters/minute Standard Error 2.54	9.37 liters/minute Standard Error 2.46	12.71 liters/minute Standard Error 2.53	4.02 liters/minute Standard Error 3.52

SECONDARY outcome

Timeframe: Baseline and Week 12

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.

Outcome measures

Outcome measures
Measure	Ciclesonide 40 µg n=303 Participants 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.	Ciclesonide 80 µg n=312 Participants 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.	Ciclesonide 160 µg n=310 Participants 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 n=146 Participants 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.
Change From Baseline in Diurnal PEF Fluctuations	-0.841 percent change Standard Deviation 9.942	-1.209 percent change Standard Deviation 10.686	-1.192 percent change Standard Deviation 11.290	0.214 percent change Standard Deviation 9.453

SECONDARY outcome

Timeframe: Baseline and Week 12

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.

Outcome measures

Outcome measures
Measure	Ciclesonide 40 µg n=304 Participants 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.	Ciclesonide 80 µg n=312 Participants 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.	Ciclesonide 160 µg n=311 Participants 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 n=146 Participants 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.
Change in Asthma Symptom Total Score Asthma Total Symptom Score (n=304,312,310,146)	-0.916 score on a scale Standard Deviation 1.265	-0.983 score on a scale Standard Deviation 1.209	-0.879 score on a scale Standard Deviation 1.270	-0.572 score on a scale Standard Deviation 1.483
Change in Asthma Symptom Total Score Asthma Daytime Symptom Score (n=304,312,310,146)	-0.529 score on a scale Standard Deviation 0.682	-0.553 score on a scale Standard Deviation 0.721	-0.517 score on a scale Standard Deviation 0.662	-0.354 score on a scale Standard Deviation 0.801
Change in Asthma Symptom Total Score Asthma Nighttime Symptom Score	-0.392 score on a scale Standard Deviation 0.775	-0.435 score on a scale Standard Deviation 0.672	-0.350 score on a scale Standard Deviation 0.791	-0.233 score on a scale Standard Deviation 0.858

SECONDARY outcome

Timeframe: Baseline and Week 12

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.

Outcome measures

Outcome measures
Measure	Ciclesonide 40 µg n=304 Participants 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.	Ciclesonide 80 µg n=312 Participants 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.	Ciclesonide 160 µg n=311 Participants 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 n=146 Participants 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.
Change in Use of Rescue Medications	-0.872 puffs/day Standard Deviation 1.634	-0.999 puffs/day Standard Deviation 1.523	-0.886 puffs/day Standard Deviation 1.771	-0.527 puffs/day Standard Deviation 1.931

SECONDARY outcome

Timeframe: 28 days prior to last visit (Up to 12 Weeks)

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.

Outcome measures

Outcome measures
Measure	Ciclesonide 40 µg n=302 Participants 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.	Ciclesonide 80 µg n=311 Participants 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.	Ciclesonide 160 µg n=309 Participants 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 n=144 Participants 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.
Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication and Morning PEF	8.33 percentage of days Interval 0.0 to 100.0	13.64 percentage of days Interval 0.0 to 100.0	13.04 percentage of days Interval 0.0 to 100.0	0.0 percentage of days Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Baseline and Week 12

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.

Outcome measures

Outcome measures
Measure	Ciclesonide 40 µg n=167 Participants 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.	Ciclesonide 80 µg n=179 Participants 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.	Ciclesonide 160 µg n=171 Participants 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 n=76 Participants 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.
Change From Baseline in Pediatric Asthma Quality of Life Questionnaire Standard [PAQLQ(S)] Overall Score	0.78 score on a scale Standard Error 0.07	0.71 score on a scale Standard Error 0.07	0.72 score on a scale Standard Error 0.07	0.43 score on a scale Standard Error 0.10

SECONDARY outcome

Timeframe: Baseline and Week 12

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.

Outcome measures

Outcome measures
Measure	Ciclesonide 40 µg n=169 Participants 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.	Ciclesonide 80 µg n=177 Participants 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.	Ciclesonide 160 µg n=172 Participants 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 n=74 Participants 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.
Change From Baseline in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) Overall	0.82 score on a scale Standard Error 0.08	0.88 score on a scale Standard Error 0.08	0.84 score on a scale Standard Error 0.08	0.71 score on a scale Standard Error 0.12

Adverse Events

Ciclesonide 40 µg

Serious events: 4 serious events

Other events: 49 other events

Deaths: 0 deaths

Ciclesonide 80 µg

Serious events: 5 serious events

Other events: 45 other events

Deaths: 0 deaths

Ciclesonide 160 µg

Serious events: 2 serious events

Other events: 45 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ciclesonide 40 µg n=305 participants at risk 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.	Ciclesonide 80 µg n=312 participants at risk 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.	Ciclesonide 160 µg n=310 participants at risk 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 n=146 participants at risk 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.
Cardiac disorders Tachycardia	0.00% 0/305 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/312 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/310 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.68% 1/146 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.
Infections and infestations Adenovirus infection	0.33% 1/305 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/312 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/310 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/146 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.
Infections and infestations Appendicitis	0.00% 0/305 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.32% 1/312 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/310 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/146 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.
Infections and infestations Lower respiratory tract infection	0.00% 0/305 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/312 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.32% 1/310 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/146 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.
Infections and infestations Otitis media	0.00% 0/305 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.32% 1/312 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/310 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/146 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.
Infections and infestations Pneumonia	0.33% 1/305 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.32% 1/312 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/310 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/146 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.
Infections and infestations Sinusitis	0.33% 1/305 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.32% 1/312 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/310 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/146 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.
Infections and infestations Tonsillitis streptococcal	0.33% 1/305 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/312 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/310 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/146 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.
Injury, poisoning and procedural complications Open wound	0.00% 0/305 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.32% 1/312 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/310 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/146 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.
Nervous system disorders Tremor	0.00% 0/305 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/312 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/310 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.68% 1/146 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.
Respiratory, thoracic and mediastinal disorders Asthma	0.33% 1/305 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.64% 2/312 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.32% 1/310 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	0.00% 0/146 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.

Other adverse events

Other adverse events
Measure	Ciclesonide 40 µg n=305 participants at risk 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.	Ciclesonide 80 µg n=312 participants at risk 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.	Ciclesonide 160 µg n=310 participants at risk 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 n=146 participants at risk 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.
Infections and infestations Nasopharyngitis	6.2% 19/305 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	3.2% 10/312 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	4.2% 13/310 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	2.1% 3/146 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.
Infections and infestations Pharyngitis	4.6% 14/305 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	5.8% 18/312 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	5.2% 16/310 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	4.8% 7/146 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.
Infections and infestations Upper respiratory tract infection	5.9% 18/305 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	6.4% 20/312 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	5.2% 16/310 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.	3.4% 5/146 • First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks) 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.

Additional Information

AstraZeneca Clinical Study Information Center

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER