Trial Outcomes & Findings for Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101) (NCT NCT00163293)

NCT ID: NCT00163293

Last Updated: 2017-04-26

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 240 participants
• Primary outcome timeframe: Up to 12 months
• Results posted on: 2017-04-26

Participant Flow

Participants took part in the study at 30 investigative sites in Canada, Hungary and South Africa from 24 January 2005 to 25 June 2009.

Children who experienced symptoms consistent with mild asthma for at least 12 months were enrolled in 1 of 3 treatment groups: once a day placebo, 100 µg or 200 µg ciclesonide.

Participant milestones

Measure	Ciclesonide 100 µg Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Overall Study STARTED	79	76	85
Overall Study COMPLETED	66	69	66
Overall Study NOT COMPLETED	13	7	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)

Baseline characteristics by cohort

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Total n=239 Participants Total of all reporting groups
Age, Continuous	7.9 years STANDARD_DEVIATION 2.06 • n=5 Participants	7.7 years STANDARD_DEVIATION 1.84 • n=7 Participants	8.1 years STANDARD_DEVIATION 2.19 • n=5 Participants	7.9 years STANDARD_DEVIATION 2.04 • n=4 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	31 Participants n=7 Participants	34 Participants n=5 Participants	98 Participants n=4 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	45 Participants n=7 Participants	50 Participants n=5 Participants	141 Participants n=4 Participants
Race/Ethnicity, Customized Asian	6 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	18 participants n=4 Participants
Race/Ethnicity, Customized Black	4 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants	11 participants n=4 Participants
Race/Ethnicity, Customized Caucasian	55 participants n=5 Participants	53 participants n=7 Participants	59 participants n=5 Participants	167 participants n=4 Participants
Race/Ethnicity, Customized Other	14 participants n=5 Participants	15 participants n=7 Participants	14 participants n=5 Participants	43 participants n=4 Participants
Weight	29.90 kg STANDARD_DEVIATION 9.701 • n=5 Participants	30.01 kg STANDARD_DEVIATION 9.247 • n=7 Participants	33.13 kg STANDARD_DEVIATION 11.640 • n=5 Participants	31.08 kg STANDARD_DEVIATION 10.365 • n=4 Participants
Body Mass Index (BMI)	17.30 kg/m^2 STANDARD_DEVIATION 3.107 • n=5 Participants	17.69 kg/m^2 STANDARD_DEVIATION 2.977 • n=7 Participants	18.68 kg/m^2 STANDARD_DEVIATION 4.069 • n=5 Participants	17.91 kg/m^2 STANDARD_DEVIATION 3.478 • n=4 Participants
Smoking Classification (Non-smoker)	79 participants n=5 Participants	76 participants n=7 Participants	84 participants n=5 Participants	239 participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: Intention to Treat (ITT) analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.

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

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Time to First Asthma Exacerbation	225.1 days Standard Error 14.73	249.5 days Standard Error 14.79	227.2 days Standard Error 15.20

PRIMARY outcome

Timeframe: Up to 12 months

Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.

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

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Exacerbations (Post-hoc Analysis of Annual Rates)	0.9343 number of events per year Standard Error 0.2909	0.8794 number of events per year Standard Error 0.2747	1.2621 number of events per year Standard Error 0.2768

SECONDARY outcome

Timeframe: Up to 12 months

Population: Safety analysis set included all randomized participants who received at least 1 dose of trial medication.

Standing height measured in millimeters (mm) with a wall-mounted stadiometer.

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Growth Velocity as Assessed by Stadiometric Height Measurement	55.32 mm/year Standard Deviation 25.81	64.60 mm/year Standard Deviation 27.31	54.91 mm/year Standard Deviation 21.78

SECONDARY outcome

Timeframe: Up to 12 months

Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.

Rate of asthma exacerbations per year is equal to total number of asthma exacerbations during treatment/time on treatment (year).

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Mean Rate of Asthma Exacerbations Per Year	0.88 number of exacerbations per year Standard Deviation 1.366	0.85 number of exacerbations per year Standard Deviation 1.310	3.28 number of exacerbations per year Standard Deviation 19.874

SECONDARY outcome

Timeframe: Up to 12 months

Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.

Duration of exacerbation was defined as the time in days when the criteria for an exacerbation were met to the time when peak flow measurements returned to baseline.

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Duration of Exacerbations	9.17 days Standard Deviation 6.198	9.31 days Standard Deviation 7.650	7.92 days Standard Deviation 4.061

SECONDARY outcome

Timeframe: Up to 12 months

Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.

The mean number of asthma exacerbations per participant is reported.

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Number of Exacerbations Per Participant	0.72 exacerbations Standard Deviation 1.025	0.78 exacerbations Standard Deviation 1.028	0.95 exacerbations Standard Deviation 1.316

SECONDARY outcome

Timeframe: Up to 12 months

Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Percentage of Participants Who Dropped-out Due to Asthma Exacerbation	1.3 percentage of participants	1.3 percentage of participants	4.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.

FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement.

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) Change at Month 1 (n=78, 76, 81)	0.019 liters Standard Deviation 0.1715	0.018 liters Standard Deviation 0.1639	0.012 liters Standard Deviation 0.1627
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) Change at Month 2 (n=76, 73, 77)	0.024 liters Standard Deviation 0.1416	0.060 liters Standard Deviation 0.1582	0.005 liters Standard Deviation 0.1416
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) Change at Month 4 (n=68, 72, 75)	0.065 liters Standard Deviation 0.1483	0.083 liters Standard Deviation 0.1486	0.076 liters Standard Deviation 0.1725
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) Change at Month 6 (n=67, 72, 72)	0.091 liters Standard Deviation 0.1714	0.125 liters Standard Deviation 0.1975	0.078 liters Standard Deviation 0.1855
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) Change at Month 8 (n=66, 71, 68)	0.075 liters Standard Deviation 0.2144	0.126 liters Standard Deviation 0.2089	0.120 liters Standard Deviation 0.1855
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) Change at Month 10 (n=66, 69, 67)	0.143 liters Standard Deviation 0.1458	0.168 liters Standard Deviation 0.1910	0.146 liters Standard Deviation 0.1609
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Absolute Value) Change at Month 12 (n=65, 69, 65)	0.161 liters Standard Deviation 0.2022	0.185 liters Standard Deviation 0.2024	0.178 liters Standard Deviation 0.1593

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.

FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement.

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) Change at Month 1 (n=78, 76, 81)	1.0 percent predicted FEV1 Standard Deviation 10.96	0.6 percent predicted FEV1 Standard Deviation 9.67	1.0 percent predicted FEV1 Standard Deviation 9.06
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) Change at Month 2 (n=76, 73, 77)	1.4 percent predicted FEV1 Standard Deviation 8.50	3.4 percent predicted FEV1 Standard Deviation 9.60	0.3 percent predicted FEV1 Standard Deviation 8.05
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) Change at Month 4 (n=68, 72, 75)	4.0 percent predicted FEV1 Standard Deviation 8.69	4.6 percent predicted FEV1 Standard Deviation 9.31	5.1 percent predicted FEV1 Standard Deviation 9.83
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) Change at Month 6 (n=67, 72, 72)	5.5 percent predicted FEV1 Standard Deviation 10.00	7.2 percent predicted FEV1 Standard Deviation 11.35	4.9 percent predicted FEV1 Standard Deviation 10.93
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) Change at Month 8 (n=66, 71, 68)	4.4 percent predicted FEV1 Standard Deviation 12.44	6.5 percent predicted FEV1 Standard Deviation 12.25	7.1 percent predicted FEV1 Standard Deviation 10.24
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) Change at Month 10 (n=66, 69, 67)	8.6 percent predicted FEV1 Standard Deviation 9.41	9.1 percent predicted FEV1 Standard Deviation 10.48	8.7 percent predicted FEV1 Standard Deviation 9.22
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent Predicted) Change at Month 12 (n=65, 69, 65)	9.5 percent predicted FEV1 Standard Deviation 10.96	10.1 percent predicted FEV1 Standard Deviation 11.29	10.4 percent predicted FEV1 Standard Deviation 9.89

SECONDARY outcome

Timeframe: Months 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.

PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF.

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries Month 1, Evening PEF (n=78, 76, 80)	235.72 liters/second Standard Deviation 63.882	238.16 liters/second Standard Deviation 52.565	241.89 liters/second Standard Deviation 70.619
Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries Month 1, Morning PEF (n=78, 76, 81)	232.09 liters/second Standard Deviation 64.933	234.41 liters/second Standard Deviation 52.908	233.81 liters/second Standard Deviation 66.039
Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries Month 2, Evening PEF (n=76, 71, 77)	241.07 liters/second Standard Deviation 58.604	241.16 liters/second Standard Deviation 50.422	244.67 liters/second Standard Deviation 67.846
Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries Month 2, Morning PEF (n=76, 72, 77)	236.92 liters/second Standard Deviation 61.243	236.42 liters/second Standard Deviation 52.323	239.07 liters/second Standard Deviation 70.132
Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries Month 4, Evening PEF (n=68, 72, 75)	249.75 liters/second Standard Deviation 58.528	243.52 liters/second Standard Deviation 49.076	245.91 liters/second Standard Deviation 65.802
Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries Month 4, Morning PEF (n=68, 71, 76)	242.93 liters/second Standard Deviation 56.658	241.91 liters/second Standard Deviation 48.498	240.16 liters/second Standard Deviation 65.211
Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries Month 6, Evening PEF (n=67, 72, 73)	251.88 liters/second Standard Deviation 60.255	249.36 liters/second Standard Deviation 59.294	246.44 liters/second Standard Deviation 63.946
Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries Month 6, Morning PEF (n=67, 72, 73)	246.44 liters/second Standard Deviation 59.781	246.75 liters/second Standard Deviation 60.020	238.81 liters/second Standard Deviation 63.419
Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries Month 8, Evening PEF (n=66, 70, 69)	253.49 liters/second Standard Deviation 59.666	250.92 liters/second Standard Deviation 51.376	245.72 liters/second Standard Deviation 61.399
Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries Month 8, Morning PEF (n=66, 71, 69)	247.24 liters/second Standard Deviation 59.806	246.97 liters/second Standard Deviation 51.592	239.73 liters/second Standard Deviation 61.733
Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries Month 10, Evening PEF (n=65, 70, 68)	254.21 liters/second Standard Deviation 56.815	256.44 liters/second Standard Deviation 56.469	251.69 liters/second Standard Deviation 60.704
Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries Month 10, Morning PEF (n=66, 70, 68)	247.94 liters/second Standard Deviation 60.418	254.04 liters/second Standard Deviation 56.719	246.23 liters/second Standard Deviation 62.805
Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries Month 12, Evening PEF (n=68, 71, 70)	255.97 liters/second Standard Deviation 57.291	263.87 liters/second Standard Deviation 58.469	261.88 liters/second Standard Deviation 61.383
Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries Month 12, Morning PEF (n=75, 73, 78)	245.84 liters/second Standard Deviation 59.834	258.62 liters/second Standard Deviation 57.009	250.55 liters/second Standard Deviation 63.204

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.

PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF. A positive change from Baseline indicates improvement.

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Change From Baseline in PEF by Diary Entries Change at Month 1, Evening PEF (n=78, 76, 80)	8.46 liters/second Standard Deviation 17.952	8.54 liters/second Standard Deviation 19.474	6.06 liters/second Standard Deviation 39.183
Change From Baseline in PEF by Diary Entries Change at Month 1, Morning PEF (n=78, 76, 81)	11.69 liters/second Standard Deviation 21.268	10.82 liters/second Standard Deviation 20.372	7.54 liters/second Standard Deviation 25.697
Change From Baseline in PEF by Diary Entries Change at Month 2, Evening PEF (n=76, 71, 77)	13.66 liters/second Standard Deviation 28.491	13.04 liters/second Standard Deviation 20.890	10.83 liters/second Standard Deviation 40.563
Change From Baseline in PEF by Diary Entries Change at Month 2, Morning PEF (n=76, 72, 77)	17.12 liters/second Standard Deviation 32.068	14.30 liters/second Standard Deviation 22.649	14.29 liters/second Standard Deviation 37.228
Change From Baseline in PEF by Diary Entries Change at Month 4, Evening PEF (n=68, 72, 75)	20.41 liters/second Standard Deviation 22.058	16.01 liters/second Standard Deviation 21.547	13.62 liters/second Standard Deviation 37.990
Change From Baseline in PEF by Diary Entries Change at Month 4, Morning PEF (n=68, 71, 76)	21.33 liters/second Standard Deviation 26.603	18.24 liters/second Standard Deviation 22.808	16.28 liters/second Standard Deviation 34.841
Change From Baseline in PEF by Diary Entries Change at Month 6, Evening PEF (n=67, 72, 73)	22.44 liters/second Standard Deviation 28.236	21.86 liters/second Standard Deviation 38.280	13.14 liters/second Standard Deviation 33.321
Change From Baseline in PEF by Diary Entries Change at Month 6, Morning PEF (n=67, 72, 73)	24.82 liters/second Standard Deviation 30.613	24.68 liters/second Standard Deviation 40.981	14.44 liters/second Standard Deviation 29.950
Change From Baseline in PEF by Diary Entries Change at Month 8, Evening PEF (n=66, 70, 69)	25.47 liters/second Standard Deviation 27.430	21.38 liters/second Standard Deviation 28.648	13.30 liters/second Standard Deviation 37.061
Change From Baseline in PEF by Diary Entries Change at Month 8, Morning PEF (n=66, 71, 69)	27.16 liters/second Standard Deviation 32.530	23.76 liters/second Standard Deviation 29.089	16.03 liters/second Standard Deviation 34.017
Change From Baseline in PEF by Diary Entries Change at Month 10, Evening PEF (n=65, 70, 68)	25.68 liters/second Standard Deviation 30.945	26.78 liters/second Standard Deviation 34.255	18.04 liters/second Standard Deviation 38.209
Change From Baseline in PEF by Diary Entries Change at Month 10, Morning PEF (n=66, 70, 68)	27.86 liters/second Standard Deviation 38.406	29.84 liters/second Standard Deviation 36.390	21.25 liters/second Standard Deviation 34.940
Change From Baseline in PEF by Diary Entries Change at Month 12, Evening PEF (n=68, 71, 70)	28.24 liters/second Standard Deviation 28.811	33.35 liters/second Standard Deviation 38.772	25.38 liters/second Standard Deviation 43.284
Change From Baseline in PEF by Diary Entries Change at Month 12, Morning PEF (n=75, 73, 78)	26.84 liters/second Standard Deviation 32.932	34.31 liters/second Standard Deviation 41.166	24.37 liters/second Standard Deviation 39.312

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.

Diurnal PEF Fluctuation is equal to [(Higher PEF - Lower PEF)/0.5*(Higher PEF + Lower PEF)] * 100%. A positive change from Baseline indicates improvement.

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Change From Baseline in Diurnal PEF Fluctuation Change at Month 8 (n=66, 70, 69)	-1.12 percent fluctuation Standard Deviation 4.830	-1.21 percent fluctuation Standard Deviation 3.757	-1.11 percent fluctuation Standard Deviation 4.048
Change From Baseline in Diurnal PEF Fluctuation Change at Month 1 (n=78, 76, 80)	-0.59 percent fluctuation Standard Deviation 3.970	0.06 percent fluctuation Standard Deviation 3.772	0.00 percent fluctuation Standard Deviation 3.867
Change From Baseline in Diurnal PEF Fluctuation Change at Month 2 (n=76, 71, 77)	-0.13 percent fluctuation Standard Deviation 5.009	-0.16 percent fluctuation Standard Deviation 4.131	0.15 percent fluctuation Standard Deviation 5.084
Change From Baseline in Diurnal PEF Fluctuation Change at Month 4 (n=68, 71, 75)	-0.65 percent fluctuation Standard Deviation 5.251	-1.01 percent fluctuation Standard Deviation 3.784	-0.55 percent fluctuation Standard Deviation 4.421
Change From Baseline in Diurnal PEF Fluctuation Change at Month 6 (n=67, 72, 73)	-1.01 percent fluctuation Standard Deviation 4.351	-0.22 percent fluctuation Standard Deviation 5.860	-0.47 percent fluctuation Standard Deviation 4.280
Change From Baseline in Diurnal PEF Fluctuation Change at Month 10 (n=64, 70, 68)	-1.46 percent fluctuation Standard Deviation 5.221	-0.70 percent fluctuation Standard Deviation 4.319	-1.14 percent fluctuation Standard Deviation 4.059
Change From Baseline in Diurnal PEF Fluctuation Change at Month 12 (n=68, 70, 70)	-1.81 percent fluctuation Standard Deviation 4.913	-0.62 percent fluctuation Standard Deviation 4.440	-1.26 percent fluctuation Standard Deviation 4.187

SECONDARY outcome

Timeframe: Months 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.

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

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Total Asthma Symptom Score by Diary Entries Month 1 (n=77, 75, 79)	0.37 score on a scale Standard Deviation 0.489	0.22 score on a scale Standard Deviation 0.329	0.32 score on a scale Standard Deviation 0.535
Total Asthma Symptom Score by Diary Entries Month 2 (n=76, 70, 77)	0.26 score on a scale Standard Deviation 0.424	0.14 score on a scale Standard Deviation 0.246	0.28 score on a scale Standard Deviation 0.484
Total Asthma Symptom Score by Diary Entries Month 4 (n=68, 72, 75)	0.18 score on a scale Standard Deviation 0.342	0.12 score on a scale Standard Deviation 0.178	0.24 score on a scale Standard Deviation 0.359
Total Asthma Symptom Score by Diary Entries Month 6 (n=67, 72, 73)	0.16 score on a scale Standard Deviation 0.289	0.17 score on a scale Standard Deviation 0.294	0.18 score on a scale Standard Deviation 0.289
Total Asthma Symptom Score by Diary Entries Month 8 (n=66, 69, 69)	0.17 score on a scale Standard Deviation 0.283	0.13 score on a scale Standard Deviation 0.243	0.23 score on a scale Standard Deviation 0.414
Total Asthma Symptom Score by Diary Entries Month 10 (n=64, 70, 68)	0.12 score on a scale Standard Deviation 0.253	0.11 score on a scale Standard Deviation 0.227	0.24 score on a scale Standard Deviation 0.490
Total Asthma Symptom Score by Diary Entries Month 12 (n=68, 69, 70)	0.11 score on a scale Standard Deviation 0.240	0.08 score on a scale Standard Deviation 0.129	0.15 score on a scale Standard Deviation 0.338

SECONDARY outcome

Timeframe: Months 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.

Nocturnal awakenings due to asthma symptoms were recorded in the participant's diary.

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms Month 1 (n=78, 75, 80)	2.40 percentage of nights Standard Deviation 6.159	1.64 percentage of nights Standard Deviation 4.256	1.85 percentage of nights Standard Deviation 4.223
Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms Month 2 (n=76, 73, 77)	1.96 percentage of nights Standard Deviation 5.877	0.62 percentage of nights Standard Deviation 2.364	1.73 percentage of nights Standard Deviation 4.662
Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms Month 4 (n=68, 72, 75)	1.33 percentage of nights Standard Deviation 4.017	0.86 percentage of nights Standard Deviation 2.139	1.54 percentage of nights Standard Deviation 4.106
Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms Month 6 (n=67, 72, 73)	0.87 percentage of nights Standard Deviation 2.527	1.51 percentage of nights Standard Deviation 3.288	1.26 percentage of nights Standard Deviation 3.235
Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms Month 8 (n=66, 70, 69)	1.62 percentage of nights Standard Deviation 4.129	1.05 percentage of nights Standard Deviation 2.823	1.82 percentage of nights Standard Deviation 5.024
Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms Month 10 (n=66, 70, 68)	1.93 percentage of nights Standard Deviation 7.106	0.59 percentage of nights Standard Deviation 2.220	1.88 percentage of nights Standard Deviation 5.468
Percentage of Nights With Nocturnal Awakenings Due to Asthma Symptoms Month 12 (n=74, 73, 78)	0.41 percentage of nights Standard Deviation 1.554	1.84 percentage of nights Standard Deviation 11.769	0.53 percentage of nights Standard Deviation 1.853

SECONDARY outcome

Timeframe: Months 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.

Salbutamol (100 μg/puff) was used as rescue medication according to the individual needs of the participant. Each use was documented in the participant's diary.

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Rescue Medication Use Per Day Month 1 (n=57, 51, 54)	1.00 puffs/day Standard Deviation 1.345	0.83 puffs/day Standard Deviation 1.148	0.87 puffs/day Standard Deviation 0.910
Rescue Medication Use Per Day Month 2 (n=53, 40, 46)	0.99 puffs/day Standard Deviation 1.296	0.53 puffs/day Standard Deviation 0.728	0.97 puffs/day Standard Deviation 1.298
Rescue Medication Use Per Day Month 4 (n=48, 47, 51)	0.88 puffs/day Standard Deviation 1.300	1.18 puffs/day Standard Deviation 1.595	1.27 puffs/day Standard Deviation 1.984
Rescue Medication Use Per Day Month 6 (n=45, 43, 44)	0.79 puffs/day Standard Deviation 1.084	1.07 puffs/day Standard Deviation 1.329	0.92 puffs/day Standard Deviation 1.583
Rescue Medication Use Per Day Month 8 (n=38, 42, 45)	1.01 puffs/day Standard Deviation 1.530	1.13 puffs/day Standard Deviation 1.950	0.97 puffs/day Standard Deviation 1.219
Rescue Medication Use Per Day Month 10 (n=38, 41, 39)	0.93 puffs/day Standard Deviation 1.423	0.95 puffs/day Standard Deviation 1.243	0.83 puffs/day Standard Deviation 1.113
Rescue Medication Use Per Day Month 12 (n=36, 40, 40)	0.71 puffs/day Standard Deviation 0.897	1.01 puffs/day Standard Deviation 1.360	0.75 puffs/day Standard Deviation 1.152

SECONDARY outcome

Timeframe: Months 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.

Days without use of rescue medication documented in the participant's diary were reported.

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Percentage of Rescue Medication Free Days Month 2 (n=52, 41, 48)	48.78 percentage of days Standard Deviation 46.442	54.46 percentage of days Standard Deviation 46.668	45.31 percentage of days Standard Deviation 47.761
Percentage of Rescue Medication Free Days Month 4 (n=49, 48, 52)	49.91 percentage of days Standard Deviation 48.274	46.51 percentage of days Standard Deviation 45.209	45.91 percentage of days Standard Deviation 46.328
Percentage of Rescue Medication Free Days Month 6 (n=47, 44, 45)	49.63 percentage of days Standard Deviation 48.084	48.14 percentage of days Standard Deviation 45.321	49.42 percentage of days Standard Deviation 47.515
Percentage of Rescue Medication Free Days Month 8 (n=39, 42, 44)	47.93 percentage of days Standard Deviation 45.170	50.50 percentage of days Standard Deviation 46.100	45.22 percentage of days Standard Deviation 45.002
Percentage of Rescue Medication Free Days Month 10 (n=40, 40, 37)	46.22 percentage of days Standard Deviation 47.901	49.78 percentage of days Standard Deviation 48.521	52.70 percentage of days Standard Deviation 46.015
Percentage of Rescue Medication Free Days Month 12 (n=35, 41, 40)	53.58 percentage of days Standard Deviation 47.785	53.63 percentage of days Standard Deviation 48.358	58.03 percentage of days Standard Deviation 46.264
Percentage of Rescue Medication Free Days Month 1 (n=55, 53, 54)	47.94 percentage of days Standard Deviation 44.405	47.34 percentage of days Standard Deviation 44.984	44.37 percentage of days Standard Deviation 45.367

SECONDARY outcome

Timeframe: Months 1, 2, 4, 6, 8, 10 and 12

Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.

Days without Asthma Symptom documented in the participant's diary were reported.

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Percentage of Asthma Symptom Free Days Month 1 (n=62, 60, 60)	37.32 percentage of days Standard Deviation 40.983	36.95 percentage of days Standard Deviation 42.207	35.00 percentage of days Standard Deviation 43.032
Percentage of Asthma Symptom Free Days Month 2 (n=61, 50, 56)	38.47 percentage of days Standard Deviation 44.743	41.16 percentage of days Standard Deviation 44.738	33.56 percentage of days Standard Deviation 44.161
Percentage of Asthma Symptom Free Days Month 4 (n=54,55, 59)	42.57 percentage of days Standard Deviation 46.573	38.83 percentage of days Standard Deviation 44.042	35.78 percentage of days Standard Deviation 43.538
Percentage of Asthma Symptom Free Days Month 6 (n=53, 50, 51)	41.75 percentage of days Standard Deviation 46.474	39.87 percentage of days Standard Deviation 43.744	40.09 percentage of days Standard Deviation 45.274
Percentage of Asthma Symptom Free Days Month 8 (n=46, 46, 46)	38.86 percentage of days Standard Deviation 43.312	43.90 percentage of days Standard Deviation 45.377	40.03 percentage of days Standard Deviation 43.369
Percentage of Asthma Symptom Free Days Month 10 (n=43, 47, 44)	41.00 percentage of days Standard Deviation 46.575	41.65 percentage of days Standard Deviation 47.435	39.83 percentage of days Standard Deviation 44.332
Percentage of Asthma Symptom Free Days Month 12 (n=42, 44, 45)	43.20 percentage of days Standard Deviation 46.787	42.03 percentage of days Standard Deviation 47.093	44.61 percentage of days Standard Deviation 46.120

SECONDARY outcome

Timeframe: Months 2, 6 and 12

Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.

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

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S]) Month 2 (n=70, 73, 75)	6.21 score on a scale Standard Deviation 0.979	6.27 score on a scale Standard Deviation 0.878	6.08 score on a scale Standard Deviation 1.031
Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S]) Month 6 (n=65, 72, 72)	6.33 score on a scale Standard Deviation 0.874	6.26 score on a scale Standard Deviation 0.982	6.30 score on a scale Standard Deviation 0.933
Quality of Life Assessments as Per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S]) Month 12 (n=64, 69, 65)	6.42 score on a scale Standard Deviation 0.786	6.34 score on a scale Standard Deviation 0.946	6.36 score on a scale Standard Deviation 0.824

SECONDARY outcome

Timeframe: Months 2, 6 and 12

Population: ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.

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

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) Month 2 (n=73, 73, 76)	5.87 score on a scale Standard Deviation 1.196	6.16 score on a scale Standard Deviation 1.033	6.08 score on a scale Standard Deviation 1.078
Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) Month 6 (n=67, 72, 73)	6.15 score on a scale Standard Deviation 1.005	6.16 score on a scale Standard Deviation 1.115	6.31 score on a scale Standard Deviation 0.927
Quality of Life Assessments as Per Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) Month 12 (n=66, 69, 66)	6.32 score on a scale Standard Deviation 0.849	6.25 score on a scale Standard Deviation 0.712	6.31 score on a scale Standard Deviation 0.899

SECONDARY outcome

Timeframe: Up to 12 months

Population: Safety analysis set included all randomized participants who received at least 1 dose of trial medication.

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

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Number of Participants With Clinically Significant Vital Signs Findings	0 participants 0	0 participants 0	0 participants 0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Safety analysis set included all randomized participants who received at least 1 dose of trial medication.

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

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Number of Participants With Clinically Significant Physical Examination Findings	0 participants 0	0 participants 0	0 participants 0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Safety analysis set included all randomized participants who received at least 1 dose of trial medication.

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

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Number of Participants With Clinically Significant Laboratory Values	0 participants 0	0 participants 0	0 participants 0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Safety analysis set included all randomized participants who received at least 1 dose of trial medication.

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

Outcome measures

Measure	Ciclesonide 100 µg n=79 Participants Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 Participants Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 Participants Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Number of Participants With Adverse Events and Serious Adverse Events Adverse Events	61 participants	64 participants	63 participants
Number of Participants With Adverse Events and Serious Adverse Events Serious Adverse Events	2 participants	2 participants	2 participants

Adverse Events

Ciclesonide 100 µg

Serious events: 2 serious events

Other events: 56 other events

Deaths: 0 deaths

Ciclesonide 200 µg

Serious events: 2 serious events

Other events: 55 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ciclesonide 100 µg n=79 participants at risk Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 participants at risk Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 participants at risk Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Ear and labyrinth disorders Vertigo	0.00% 0/79 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	0.00% 0/76 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	1.2% 1/84 • Number of events 1 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Infections and infestations Arthritis bacterial	0.00% 0/79 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	0.00% 0/76 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	1.2% 1/84 • Number of events 1 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Infections and infestations Laryngitis	0.00% 0/79 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	1.3% 1/76 • Number of events 1 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	0.00% 0/84 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Infections and infestations Lobar pneumonia	1.3% 1/79 • Number of events 1 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	0.00% 0/76 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	0.00% 0/84 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Nervous system disorders Headache	0.00% 0/79 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	0.00% 0/76 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	1.2% 1/84 • Number of events 1 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Respiratory, thoracic and mediastinal disorders Asthma	1.3% 1/79 • Number of events 1 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	0.00% 0/76 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	0.00% 0/84 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/79 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	1.3% 1/76 • Number of events 1 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	0.00% 0/84 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Surgical and medical procedures Myringoplasty	0.00% 0/79 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	1.3% 1/76 • Number of events 1 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	0.00% 0/84 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.

Other adverse events

Measure	Ciclesonide 100 µg n=79 participants at risk Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Ciclesonide 200 µg n=76 participants at risk Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.	Placebo n=84 participants at risk Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
General disorders Pyrexia	7.6% 6/79 • Number of events 6 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	2.6% 2/76 • Number of events 2 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	4.8% 4/84 • Number of events 5 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Infections and infestations Ear infection	6.3% 5/79 • Number of events 5 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	3.9% 3/76 • Number of events 4 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	2.4% 2/84 • Number of events 2 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Infections and infestations Influenza	3.8% 3/79 • Number of events 3 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	7.9% 6/76 • Number of events 8 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	3.6% 3/84 • Number of events 3 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Infections and infestations Lower respiratory tract infection	1.3% 1/79 • Number of events 1 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	5.3% 4/76 • Number of events 4 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	1.2% 1/84 • Number of events 1 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Infections and infestations Nasopharyngitis	16.5% 13/79 • Number of events 20 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	11.8% 9/76 • Number of events 18 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	16.7% 14/84 • Number of events 30 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Infections and infestations Pharyngitis	6.3% 5/79 • Number of events 5 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	5.3% 4/76 • Number of events 5 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	4.8% 4/84 • Number of events 5 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Infections and infestations Rhinitis	5.1% 4/79 • Number of events 4 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	0.00% 0/76 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	3.6% 3/84 • Number of events 5 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Infections and infestations Sinusitis	1.3% 1/79 • Number of events 2 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	1.3% 1/76 • Number of events 1 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	6.0% 5/84 • Number of events 7 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Infections and infestations Upper respiratory tract infection	22.8% 18/79 • Number of events 28 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	25.0% 19/76 • Number of events 31 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	19.0% 16/84 • Number of events 35 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Nervous system disorders Headache	5.1% 4/79 • Number of events 6 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	9.2% 7/76 • Number of events 10 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	9.5% 8/84 • Number of events 10 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Respiratory, thoracic and mediastinal disorders Asthma	44.3% 35/79 • Number of events 60 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	50.0% 38/76 • Number of events 64 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	46.4% 39/84 • Number of events 82 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Respiratory, thoracic and mediastinal disorders Cough	7.6% 6/79 • Number of events 8 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	5.3% 4/76 • Number of events 10 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	7.1% 6/84 • Number of events 7 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	8.9% 7/79 • Number of events 7 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	5.3% 4/76 • Number of events 4 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.	4.8% 4/84 • Number of events 6 • Up to 12 months At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.

Additional Information

AstraZeneca Clinical Study Information Center

AstraZeneca

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Results disclosure agreements

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

Restriction type: GT60