BY9010/M1‐137.
Methods | STUDY DESIGN: Parallel group LOCATION, NUMBER OF CENTRES: 9 centres in Taiwan and Malaysia DURATION OF STUDY: 12 weeks (prn SABA) CONCEALMENT OF ALLOCATION: Not clear 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: Double‐dummy DESCRIPTION OF WITHDRAWALS/DROPOUTS: Not reported JADAD SCORE (5‐1): 3 TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): Per protocol and ITT COMPLIANCE: Not assessed CONFOUNDERS: Groups balanced at baseline | |
Participants | N SCREENED: Not reported N RANDOMISED: 125 N COMPLETED: Not reported M = not reported F = not reported MEAN AGE: 48 BASELINE DETAILS: FEV1 72% predicted INCLUSION CRITERIA: 18‐ 75 years; ATS defined asthma for at least 6 months; treatment with ICS for 4 weeks (maximum 250mcg fluticasone propionate or equivalent); FEV1 80‐105% of predicted. | |
Interventions | 1. Ciclesonide 200 mcg OD
2. Budesonide 400 mcg OD DELIVERY: Ciclesonide: MDI; Budesonide: Turbohaler TREATMENT PERIOD: 12 weeks RESCUE: Salbutamol CO‐INTERVENTIONS PERMITTED: prn SABA CO‐INTERVENTIONS: Not reported % on ICS at baseline: 100 |
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Outcomes | FEV1; FVC; symptoms; adverse events | |
Notes | Unpublished data set available from http://www.clinicalstudyresults.org | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |