EFC6163a.
Methods | STUDY DESIGN: Parallel group LOCATION, NUMBER OF CENTRES: USA, 38 centres DURATION OF STUDY: 6 weeks (1 week run‐in on FP <440mcg) 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: identical devices DESCRIPTION OF WITHDRAWALS/DROPOUTS: Not clear JADAD SCORE (5‐1): 3 TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT COMPLIANCE: Not reported CONFOUNDERS: Not clear | |
Participants | N SCREENED: Not clear N RANDOMISED: 456 N COMPLETED: Not clear M=not clear ; F= not clear MEDIAN AGE (range): Not clear BASELINE DETAILS: Not available INCLUSION CRITERIA: >12 years; history of persistent asthma (6 months); ICS monotherapy for >1 month or use of ICS/LABA combination therapy for >1 month; FEV1 60‐90% predicted (ICS monotherapy)/FEV1 70‐95% (ICS/LABA combination therapy); </=440mcg/d FP or equivalent or </=200/100 FP/SAL equivalent. EXCLUSION: Not reported. | |
Interventions | 1. Ciclesonide 100mcg BD
2. Ciclesonide 200mcg OD
3. Placebo DELIVERY: CIC: MDI TREATMENT PERIOD: weeks RESCUE: Not reported CO‐INTERVENTIONS PERMITTED: % on ICS baseline: 100 |
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Outcomes | FEV1; am PEF; rescue medication use; symptoms; nocturnal awakenings; safety | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |