Bernstein 2004.
Methods | STUDY DESIGN: Parallel group LOCATION, NUMBER OF CENTRES: Multicentre STUDY DESIGN: Parallel group LOCATION, NUMBER OF CENTRES: Multicentre DURATION OF STUDY: 12 weeks (run‐in unclear) CONCEALMENT OF ALLOCATION: Not reported 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 reported JADAD SCORE (5‐1): 2 TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT(presumed) COMPLIANCE: Not reported CONFOUNDERS: Not reported. | |
Participants | N SCREENED: Not reported N RANDOMISED: 531 N COMPLETED: Not reported M= unknown; F= unknown MEDIAN AGE: Not reported BASELINE DETAILS: Not reported INCLUSION CRITERIA: Moderate‐severe asthma for 6 months or more; FEV1 of 40‐65%;age >= 12 years. EXCLUSION: unknown | |
Interventions | 1. Ciclesonide 200mcg BD
2. Ciclesonide 400mcg BD
3. Fluticasone 1000mcg BD
4. Placebo DELIVERY: CIC: MDI; FP CFC‐MDI TREATMENT PERIOD: 12 weeks RESCUE: unknown CO‐INTERVENTIONS PERMITTED: Not reported CO‐INTERVENTIONS: Not reported % on ICS baseline: Not reported |
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Outcomes | FEV1; am PEF; AQLQ symptom score; adverse events | |
Notes | Unpublished conference abstract | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |