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 |