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

Adachi 2007a.

Methods STUDY DESIGN: Parallel group 
 LOCATION, NUMBER OF CENTRES: 50 centres in Japan 
 DURATION OF STUDY: 8 weeks (4 week run‐in period reported with BDP 400mcg/d) 
 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 reported 
 DESCRIPTION OF WITHDRAWALS/DROPOUTS: Not stated 
 JADAD SCORE (5‐1): 2 
 TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): Available case (assumed) 
 COMPLIANCE: Not reported 
 CONFOUNDERS: Slight imbalance between groups in terms of PEF% predicted at baseline
Participants N SCREENED: 435 
 N RANDOMISED: 311 
 N COMPLETED: 311 (assumed) 
 M= 171, F= 140 
 MEAN AGE: 51 years 
 BASELINE DETAILS: FEV1 % predicted: 71% 
 INCLUSION CRITERIA: 16‐75 years; mild to moderate asthma according to the Japanese guidelines; treatment with 400‐800 mcg/day BDP/200‐400 mcg/d FP >4 weeks; mean morning PEF during the last week of run‐in 60% to 90% predicted PEF. 
 EXCLUSION: Significant coexisting respiratory disease; hospitalisation, 
 emergency room care for asthma or treatment with systemic steroids <4 weeks before run‐in.
Interventions 1. Ciclesonide 100mcg OD 
 2. Ciclesonide 200mcg OD 
 3. Ciclesonide 400mcg OD 
 4. Placebo
DELIVERY: MDI 
 TREATMENT PERIOD: 8 weeks 
 RESCUE: SABA 
 CO‐INTERVENTIONS PERMITTED: Not stated 
 CO‐INTERVENTIONS: Not reported 
 % on ICS baseline: 100
Outcomes am PEF; pm PEF; FEV1; FVC; symptoms; use of rescue medication; adverse events
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear