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. 2008 Apr 23;2008(2):CD007031. doi: 10.1002/14651858.CD007031

Adachi 2007.

Methods STUDY DESIGN: Parallel group 
 LOCATION, NUMBER OF CENTRES: 59 centres in Japan DURATION OF STUDY: 8 weeks (4 week run‐in period CFC‐BDP 800 mcg/day). 
 CONCEALMENT OF ALLOCATION: Unclear 
 COCHRANE QUALITY SCORE: B 
 DESCRIBED AS RANDOMISED: Yes 
 DESCRIBED AS DOUBLE BLIND: No 
 METHOD OF RANDOMISATION WELL DESCRIBED/APPROPRIATE: Not stated 
 METHOD OF BLINDING WELL DESCRIBED/APPROPRIATE: Open label 
 DESCRIPTION OF WITHDRAWALS/DROPOUTS: Not stated 
 JADAD SCORE (5‐1): 1 
 TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): Not clear 
 COMPLIANCE: Not reported 
 CONFOUNDERS: Balanced groups at baseline
Participants N SCREENED: 478 
 N RANDOMISED: 316 (213 to groups of interest to this review) 
 N COMPLETED: Not clear 
 M = 105; F = 108 
 MEAN AGE: 52.3 years 
 BASELINE DETAILS: FEV1 69% predicted; FVC: 2.76 L 
 INCLUSION CRITERIA: 16‐75 years; moderate to severe asthma according to the Japanese Guidelines; treated with >800 mg/day CFC‐BDP or > 400 mg/day of FP for more than four weeks; mean morning PEF during last week of run‐in of <80% predicted PEF; reversibility of airflow limitation of >15%. 
 EXCLUSION: Significant coexisting respiratory disease; hospitalization, emergency room care for asthma or treatment with systemic steroids < 4 weeks before run‐in.
Interventions 1. Ciclesonide 200 mcg BID (400 mcg/d) 
 2. Ciclesonide 400 mcg BID (800 mcg/d) 
 3. Beclomethasone 400 mcg BID (800 mcg/d) 
 DELIVERY: CIC: HFA‐MDI; BDP: CFC‐MDI + spacer 
 TREATMENT PERIOD: 8 weeks 
 RESCUE: SABA 
 CO‐INTERVENTIONS PERMITTED: 
 Not stated 
 % on ICS baseline: 100
Outcomes am PEF; pm PEF; FEV1; FVC; symptoms; use of rescue medication
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear