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

EFC6163a.

Methods STUDY DESIGN: Parallel group 
 LOCATION, NUMBER OF CENTRES: USA, 38 centres 
 DURATION OF STUDY: 6 weeks (1 week run‐in on FP <440mcg) 
 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: identical devices 
 DESCRIPTION OF WITHDRAWALS/DROPOUTS: Not clear 
 JADAD SCORE (5‐1): 3 
 TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT 
 COMPLIANCE: Not reported 
 CONFOUNDERS: Not clear
Participants N SCREENED: Not clear 
 N RANDOMISED: 456 
 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); ICS monotherapy for >1 month or use of ICS/LABA combination therapy for >1 month; FEV1 60‐90% predicted (ICS monotherapy)/FEV1 70‐95% (ICS/LABA combination therapy); </=440mcg/d FP or equivalent or </=200/100 FP/SAL equivalent. 
 EXCLUSION: Not reported.
Interventions 1. Ciclesonide 100mcg BD 
 2. Ciclesonide 200mcg OD 
 3. Placebo
DELIVERY: CIC: MDI 
 TREATMENT PERIOD: weeks 
 RESCUE: Not reported 
 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