DFI6153.
Methods | STUDY DESIGN: Parallel group LOCATION, NUMBER OF CENTRES: USA, 66 centres DURATION OF STUDY: 6 weeks (2 week run‐in on FP 100mcg) 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 clear DESCRIPTION OF WITHDRAWALS/DROPOUTS: Not clear JADAD SCORE (5‐1): 2 TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT COMPLIANCE: Not reported CONFOUNDERS: Not clear | |
Participants | N SCREENED: Not clear N RANDOMISED: 1145 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 before screening); treatment with ICS for >1 month before screening; FEV1 >40% and <80% predicted. EXCLUSION: Not reported. | |
Interventions | 1. Ciclesonide 100mcg BD
2. Ciclesonide 200mcg BD
3. Ciclesonide 400mcg BD
4. CIcliesonide 400mcg BD
5. Ciclesonide 800mcg BD
6. Placebo DELIVERY: CIC: DPI (CIC group 3 given via MDI) TREATMENT PERIOD: 6 weeks RESCUE: Salbutamol MDI 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 |