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. 2008 Apr 23;2008(2):CD006217. doi: 10.1002/14651858.CD006217.pub2

DFI6153.

Methods STUDY DESIGN: Parallel group 
 LOCATION, NUMBER OF CENTRES: USA, 66 centres 
 DURATION OF STUDY: 6 weeks (2 week run‐in on FP 100mcg) 
 CONCEALMENT OF ALLOCATION: Unclear 
 COCHRANE QUALITY SCORE: B 
 DESCRIBED AS RANDOMISED: Yes 
 DESCRIBED AS DOUBLE BLIND: Yes 
 METHOD OF RANDOMISATION WELL DESCRIBED/APPROPRIATE: Not reported 
 METHOD OF BLINDING WELL DESCRIBED/APPROPRIATE: Not clear 
 DESCRIPTION OF WITHDRAWALS/DROPOUTS: Not clear 
 JADAD SCORE (5‐1): 2 
 TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT 
 COMPLIANCE: Not reported 
 CONFOUNDERS: Not clear
Participants N SCREENED: Not clear 
 N RANDOMISED: 1145 
 N COMPLETED: Not clear 
 M=not clear ; F= not clear 
 MEDIAN AGE (range): Not clear 
 BASELINE DETAILS: Not available 
 INCLUSION CRITERIA: >12 years; history of persistent asthma (>6 months before screening); treatment with ICS for >1 month before screening; FEV1 >40% and <80% predicted. 
 EXCLUSION: Not reported.
Interventions 1. Ciclesonide 100mcg BD 
 2. Ciclesonide 200mcg BD 
 3. Ciclesonide 400mcg BD 
 4. CIcliesonide 400mcg BD 
 5. Ciclesonide 800mcg BD 
 6. Placebo
DELIVERY: CIC: DPI (CIC group 3 given via MDI) 
 TREATMENT PERIOD: 6 weeks 
 RESCUE: Salbutamol MDI 
 CO‐INTERVENTIONS PERMITTED: 
 % on ICS baseline: 100
Outcomes FEV1; am PEF; rescue medication use; symptoms; nocturnal awakenings; safety
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear