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 |
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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 |