Bateman 2006a.
Methods | STUDY DESIGN: Parallel group LOCATION, NUMBER OF CENTRES: Multicentre DURATION OF STUDY: 12 weeks (2‐4 weeks on FP250mcg/d) 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 as most likely) COMPLIANCE: Not reported CONFOUNDERS: Not reported | |
Participants | N SCREENED: Unknown N RANDOMISED: 680 (eligible patients) N COMPLETED: Not reported M= unknown F= unknown MEDIAN AGE Not reported BASELINE DETAILS: Not reported INCLUSION CRITERIA: Severe asthma; FEV1 < 70% predicted age 12‐75 years EXCLUSION: Not reported | |
Interventions | 1. Ciclesonide 200mcg OD
2. Ciclesonide 400mcg BD DELIVERY: HFA‐MDI TREATMENT PERIOD: 12 weeks RESCUE: Not reported CO‐INTERVENTIONS PERMITTED: Not reported CO‐INTERVENTIONS: Not reported % on ICS baseline: 100 (FP 250mcg BD) |
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Outcomes | FEV1, am PEF; symptoms; asthma exacerbations | |
Notes | Unpublished conference abstract | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |