Trial Outcomes & Findings for Effect of High Dose Ciclesonide on Asthma Control (NCT NCT01455194)

Last Updated: 2017-02-10

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

520 participants

Primary outcome timeframe

Baseline

Results posted on

2017-02-10

Participant Flow

Participants took part in the study at 5 investigative sites in Argentina, Brazil, Germany, Israel and Russia from 10 November 2011 to 15 August 2014.

Participants with a historical diagnosis of persistent bronchial asthma for at least 6 months,treated with a stable inhaled corticosteroid (ICS)dose for at least 12 weeks were enrolled in a single-blind baseline period receiving 160 microgram(mcg)ciclesonide,then a double-blind treatment period in 1 of 3 treatment arms: ciclesonide 160,320,640 mcg.

Participant milestones

Participant milestones
Measure	Baseline Period: Ciclesonide 160 mcg Ciclesonide 80 mcg, metered dose inhaler (MDI), inhalational, twice daily for up to 3 weeks in the baseline period.	Treatment Period: Ciclesonide 160 mcg Ciclesonide 80 mcg, metered dose inhaler (MDI), inhalational, twice daily for up to 3 weeks in the baseline period. Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 320 mcg Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
Overall Study STARTED	153	120	122	125
Overall Study COMPLETED	0	89	92	97
Overall Study NOT COMPLETED	153	31	30	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Baseline Period: Ciclesonide 160 mcg Ciclesonide 80 mcg, metered dose inhaler (MDI), inhalational, twice daily for up to 3 weeks in the baseline period.	Treatment Period: Ciclesonide 160 mcg Ciclesonide 80 mcg, metered dose inhaler (MDI), inhalational, twice daily for up to 3 weeks in the baseline period. Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 320 mcg Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
Overall Study Screen Failure	20	0	0	0
Overall Study Randomisation Failure	90	0	0	0
Overall Study Deterioration in asthma	12	6	14	9
Overall Study Adverse Event	1	1	1	3
Overall Study Withdrawal by Subject	21	16	12	9
Overall Study Lost to Follow-up	2	0	1	1
Overall Study Pregnancy	0	1	1	0
Overall Study Discontinuation criterion fulfilled	3	2	0	2
Overall Study Miscellaneous	4	5	1	4

Baseline Characteristics

Effect of High Dose Ciclesonide on Asthma Control

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Period: Ciclesonide 160 mcg n=120 Participants Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 320 mcg n=122 Participants Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg n=125 Participants Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Total n=367 Participants Total of all reporting groups
Age, Continuous	43.2 years STANDARD_DEVIATION 14.86 • n=5 Participants	44.7 years STANDARD_DEVIATION 15.60 • n=7 Participants	45.3 years STANDARD_DEVIATION 16.22 • n=5 Participants	44.4 years STANDARD_DEVIATION 15.57 • n=4 Participants
Gender Female	72 Participants n=5 Participants	77 Participants n=7 Participants	81 Participants n=5 Participants	230 Participants n=4 Participants
Gender Male	48 Participants n=5 Participants	45 Participants n=7 Participants	44 Participants n=5 Participants	137 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	6 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	15 participants n=4 Participants
Race/Ethnicity, Customized White	113 participants n=5 Participants	115 participants n=7 Participants	114 participants n=5 Participants	342 participants n=4 Participants
History of exacerbations Unknown	29 participants n=5 Participants	30 participants n=7 Participants	37 participants n=5 Participants	96 participants n=4 Participants
Race/Ethnicity, Customized Unknown or Not Reported	1 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants	10 participants n=4 Participants
Height	1.65 meter (m) STANDARD_DEVIATION 0.093 • n=5 Participants	1.66 meter (m) STANDARD_DEVIATION 0.101 • n=7 Participants	1.65 meter (m) STANDARD_DEVIATION 0.104 • n=5 Participants	1.65 meter (m) STANDARD_DEVIATION 0.099 • n=4 Participants
Weight	74.59 kilograms (kg) STANDARD_DEVIATION 16.371 • n=5 Participants	77.98 kilograms (kg) STANDARD_DEVIATION 18.993 • n=7 Participants	73.72 kilograms (kg) STANDARD_DEVIATION 14.660 • n=5 Participants	75.42 kilograms (kg) STANDARD_DEVIATION 16.811 • n=4 Participants
Body Mass Index	27.34 kilogram per meter square (kg/m^2) STANDARD_DEVIATION 5.217 • n=5 Participants	28.42 kilogram per meter square (kg/m^2) STANDARD_DEVIATION 6.346 • n=7 Participants	27.12 kilogram per meter square (kg/m^2) STANDARD_DEVIATION 5.373 • n=5 Participants	27.62 kilogram per meter square (kg/m^2) STANDARD_DEVIATION 5.681 • n=4 Participants
History of exacerbations 0	70 participants n=5 Participants	70 participants n=7 Participants	63 participants n=5 Participants	203 participants n=4 Participants
History of exacerbations 1	17 participants n=5 Participants	19 participants n=7 Participants	21 participants n=5 Participants	57 participants n=4 Participants
History of exacerbations 2-3	4 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	11 participants n=4 Participants
History of exacerbations 4+	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Smoking Status Never	109 participants n=5 Participants	102 participants n=7 Participants	109 participants n=5 Participants	320 participants n=4 Participants
Smoking Status Current	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants
Smoking Status Former	10 participants n=5 Participants	19 participants n=7 Participants	15 participants n=5 Participants	44 participants n=4 Participants
Prestudy ICS dose <200(mcg/day) fluticasone propionate(FP)equivalent	3 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	8 participants n=4 Participants
Prestudy ICS dose Low:>=200 mcg/day(=<)250 mcg/day FP equivalent	40 participants n=5 Participants	37 participants n=7 Participants	42 participants n=5 Participants	119 participants n=4 Participants
Prestudy ICS dose Medium:>250 mcg/dayto=<500 mcg/day FP equivalent	72 participants n=5 Participants	75 participants n=7 Participants	70 participants n=5 Participants	217 participants n=4 Participants
Prestudy ICS dose High:>500 mcg/dayto=<1000 mcg/day FP equivalent	5 participants n=5 Participants	7 participants n=7 Participants	11 participants n=5 Participants	23 participants n=4 Participants
Baseline asthma control questionnaire (ACQ)	2.24 units on scale STANDARD_DEVIATION 0.304 • n=5 Participants	2.16 units on scale STANDARD_DEVIATION 0.384 • n=7 Participants	2.20 units on scale STANDARD_DEVIATION 0.361 • n=5 Participants	2.20 units on scale STANDARD_DEVIATION 0.363 • n=4 Participants
Pre-forced expiratory volume in 1 second (FEV1)	2.20 liter (L) STANDARD_DEVIATION 0.792 • n=5 Participants	2.35 liter (L) STANDARD_DEVIATION 0.798 • n=7 Participants	2.23 liter (L) STANDARD_DEVIATION 0.801 • n=5 Participants	2.26 liter (L) STANDARD_DEVIATION 0.797 • n=4 Participants
Post-FEV1	2.71 L STANDARD_DEVIATION 0.915 • n=5 Participants	2.84 L STANDARD_DEVIATION 0.883 • n=7 Participants	2.76 L STANDARD_DEVIATION 0.906 • n=5 Participants	2.77 L STANDARD_DEVIATION 0.900 • n=4 Participants
FEV1 reversibility	25.5 percent reversibility STANDARD_DEVIATION 17.02 • n=5 Participants	23 percent reversibility STANDARD_DEVIATION 17.10 • n=7 Participants	26.5 percent reversibility STANDARD_DEVIATION 20.78 • n=5 Participants	25.0 percent reversibility STANDARD_DEVIATION 18.41 • n=4 Participants
Pre FEV1 predicted	69.095 percent of predicted STANDARD_DEVIATION 18.4683 • n=5 Participants	74.345 percent of predicted STANDARD_DEVIATION 16.7285 • n=7 Participants	71.835 percent of predicted STANDARD_DEVIATION 18.4365 • n=5 Participants	71.773 percent of predicted STANDARD_DEVIATION 17.9737 • n=4 Participants
Post FEV1 predicted	84.893 percent of predicted STANDARD_DEVIATION 19.3038 • n=5 Participants	90.168 percent of predicted STANDARD_DEVIATION 17.7365 • n=7 Participants	88.505 percent of predicted STANDARD_DEVIATION 17.7105 • n=5 Participants	87.875 percent of predicted STANDARD_DEVIATION 18.3373 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline

Population: The intent-to-treat (ITT) analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.

Outcome measures

Outcome measures
Measure	Treatment Period: Ciclesonide 160 mcg n=120 Participants Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 320 mcg n=119 Participants Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg n=122 Participants Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
Asthma Control Questionnaire (ACQ) Score at Baseline	2.24 units on a scale Standard Error 0.031	2.15 units on a scale Standard Error 0.035	2.19 units on a scale Standard Error 0.032	—

PRIMARY outcome

Timeframe: Week 52

Population: The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.

Outcome measures

Outcome measures
Measure	Treatment Period: Ciclesonide 160 mcg n=120 Participants Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 320 mcg n=119 Participants Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg n=122 Participants Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
Change From Baseline in ACQ Score to Tlast	-0.833 units on a scale Standard Error 0.1028	-0.799 units on a scale Standard Error 0.1019	-0.955 units on a scale Standard Error 0.0969	—

SECONDARY outcome

Timeframe: Baseline, Week 52 (Treatment period)

Population: The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.

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

Outcome measures

Outcome measures
Measure	Treatment Period: Ciclesonide 160 mcg n=105 Participants Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 320 mcg n=108 Participants Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg n=115 Participants Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
Time Course of ACQ	1.100 Weeks Interval 0.0 to 4.4	1.000 Weeks Interval 0.0 to 3.9	1.000 Weeks Interval 0.0 to 4.6	—

SECONDARY outcome

Timeframe: Baseline up to Week 52 (treatment period)

Population: The intent-to-treat ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.

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

Outcome measures

Outcome measures
Measure	Treatment Period: Ciclesonide 160 mcg n=5286 weeks Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 320 mcg n=5388 weeks Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg n=5669 weeks Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
Number of Weeks With Well-controlled Asthma Over the Course of the Study	1211 weeks	1514 weeks	1447 weeks	—

SECONDARY outcome

Timeframe: Week 52

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

Outcome measures

Outcome measures
Measure	Treatment Period: Ciclesonide 160 mcg n=120 Participants Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 320 mcg n=122 Participants Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg n=125 Participants Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
Number of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study Well-controlled Asthma	38 participants	45 participants	51 participants	—
Number of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study ACQ Improvement	87 participants	81 participants	85 participants	—

SECONDARY outcome

Timeframe: Baseline up to Week 52 (treatment period)

Population: The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.

Outcome measures

Outcome measures
Measure	Treatment Period: Ciclesonide 160 mcg n=120 Participants Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 320 mcg n=122 Participants Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg n=125 Participants Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
Number of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement Well-controlled Asthma	73 participants	84 participants	81 participants	—
Number of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement ACQ Improvement	112 participants	107 participants	115 participants	—

SECONDARY outcome

Timeframe: Baseline up to Week 52 (treatment period)

Population: The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.

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

Outcome measures

Outcome measures
Measure	Treatment Period: Ciclesonide 160 mcg n=120 Participants Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 320 mcg n=122 Participants Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg n=125 Participants Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point ACQ cut-off at 0.5	56 participants	69 participants	63 participants	—
Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point ACQ cut-off at 1.0	91 participants	95 participants	93 participants	—
Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point ACQ cut-off at 1.25	99 participants	101 participants	101 participants	—
Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point ACQ cut-off at 1.5	103 participants	105 participants	107 participants	—

SECONDARY outcome

Timeframe: Baseline up to Week 52 (treatment period)

Population: The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.

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

Outcome measures

Outcome measures
Measure	Treatment Period: Ciclesonide 160 mcg n=120 Participants Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 320 mcg n=122 Participants Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg n=125 Participants Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
Number of Participants Reporting Time to First Asthma Exacerbation	5 participants	11 participants	10 participants	—

SECONDARY outcome

Timeframe: Baseline up to Week 52 (treatment period)

Population: The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.

Participants with at least 1 asthma exacerbation in the double-blind treatment period have been reported. As predefined in the protocol, the results for participants with missing data for any category were not included.

Outcome measures

Outcome measures
Measure	Treatment Period: Ciclesonide 160 mcg n=120 Participants Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 320 mcg n=122 Participants Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg n=122 Participants Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
Number of Participants Reporting Asthma Exacerbations Rates	5 participants	10 participants	10 participants	—

SECONDARY outcome

Timeframe: Week 1 up to Week 52

Population: Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.

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

Outcome measures

Outcome measures
Measure	Treatment Period: Ciclesonide 160 mcg n=119 Participants Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 320 mcg n=122 Participants Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg n=126 Participants Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
Number of Participants With Markedly High Benefits	0 participants	0 participants	0 participants	—

SECONDARY outcome

Timeframe: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)

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

Outcome measures

Outcome measures
Measure	Treatment Period: Ciclesonide 160 mcg n=520 Participants Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 320 mcg n=119 Participants Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg n=122 Participants Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg n=126 Participants Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)	109 participants	85 participants	86 participants	89 participants

SECONDARY outcome

Timeframe: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)

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

Outcome measures

Outcome measures
Measure	Treatment Period: Ciclesonide 160 mcg n=119 Participants Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 320 mcg n=122 Participants Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg n=126 Participants Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs	0 participants	0 participants	0 participants	—

SECONDARY outcome

Timeframe: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)

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

Outcome measures

Outcome measures
Measure	Treatment Period: Ciclesonide 160 mcg n=119 Participants Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 320 mcg n=122 Participants Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg n=126 Participants Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
Number of Participants Reporting Clinically Significant Change From Baseline in Physical Examination Findings	0 participants	0 participants	0 participants	—

SECONDARY outcome

Timeframe: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)

The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.

Outcome measures

Outcome measures
Measure	Treatment Period: Ciclesonide 160 mcg n=119 Participants Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 320 mcg n=122 Participants Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg n=126 Participants Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
Number of Participants With Markedly Abnormal Laboratory Values	0 participants	0 participants	0 participants	—

Adverse Events

Baseline Period: Ciclesonide 160 mcg

Serious events: 1 serious events

Other events: 64 other events

Deaths: 0 deaths

Treatment Period: Ciclesonide 160 mcg

Serious events: 6 serious events

Other events: 65 other events

Deaths: 0 deaths

Treatment Period: Ciclesonide 320 mcg

Serious events: 9 serious events

Other events: 65 other events

Deaths: 0 deaths

Treatment Period: Ciclesonide 640 mcg

Serious events: 0 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Baseline Period: Ciclesonide 160 mcg n=520 participants at risk Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 3 weeks in the baseline period.	Treatment Period: Ciclesonide 160 mcg n=119 participants at risk Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 320 mcg n=122 participants at risk Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.	Treatment Period: Ciclesonide 640 mcg n=126 participants at risk Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
Infections and infestations Bronchitis	0.19% 1/520 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	15.1% 18/119 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	13.1% 16/122 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	12.7% 16/126 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.
Infections and infestations Influenza	0.00% 0/520 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	5.0% 6/119 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	4.9% 6/122 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	8.7% 11/126 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.
Infections and infestations Nasopharyngitis	1.2% 6/520 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	19.3% 23/119 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	20.5% 25/122 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	17.5% 22/126 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.
Infections and infestations Pharyngitis	0.19% 1/520 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	3.4% 4/119 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	6.6% 8/122 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	3.2% 4/126 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.
Infections and infestations Rhinitis	1.2% 6/520 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	1.7% 2/119 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	6.6% 8/122 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	3.2% 4/126 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.
Infections and infestations Sinusitis	0.19% 1/520 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	5.9% 7/119 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	4.1% 5/122 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	6.3% 8/126 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.
Infections and infestations Upper respiratory tract infection	0.58% 3/520 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	5.9% 7/119 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	0.82% 1/122 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	4.8% 6/126 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.
Musculoskeletal and connective tissue disorders Back pain	0.58% 3/520 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	3.4% 4/119 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	1.6% 2/122 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	6.3% 8/126 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.
Nervous system disorders Headache	8.3% 43/520 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	18.5% 22/119 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	18.9% 23/122 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	12.7% 16/126 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Asthma	0.77% 4/520 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	3.4% 4/119 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	5.7% 7/122 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	3.2% 4/126 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Cough	0.38% 2/520 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	5.0% 6/119 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	5.7% 7/122 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	2.4% 3/126 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.58% 3/520 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	6.7% 8/119 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	2.5% 3/122 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.	4.8% 6/126 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug. Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.

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