Magnussen 2007.
Methods | STUDY DESIGN: Parallel group LOCATION, NUMBER OF CENTRES: Europe, number of centres not reported DURATION OF STUDY: 12 weeks (1‐4 weeks prn SABA) 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: Both treatments given via MDIs DESCRIPTION OF WITHDRAWALS/DROPOUTS: Stated JADAD SCORE (5‐1): 4 TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT and PP COMPLIANCE: Not reported CONFOUNDERS: Balanced groups at baseline | |
Participants | N SCREENED: Not reported N RANDOMISED: 808 N COMPLETED: 764 M = 409; F = 398 MEDIAN AGE: 29‐33 BASELINE DETAILS: FEV1 predicted: 79%; reversibility: 25% INCLUSION CRITERIA: ATS defined asthma; 12‐75 years; 61‐90% predicted (if treated with ICS), or 61‐105% predicted if not treated with ICS; maximum daily dose was FP 250 mcg; post‐run in participants had to demonstrate FEV1 between 60‐90% predicted. EXCLUSION: Concomitant severe disease; smoking history of >10 pack years; LABA or OCS treatment in previous 4 weeks. | |
Interventions | 1. Ciclesonide 100 mcg OD
2. Ciclesonide 200 mcg OD
3. Fluticasone 100 mcg BID DELIVERY: MDI TREATMENT PERIOD: 12 weeks RESCUE: Salbutamol CO‐INTERVENTIONS PERMITTED: Not reported CO‐INTERVENTIONS: Not reported % on ICS: Not reported |
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Outcomes | FEV1; peak flow; asthma symptoms; asthma exacerbations requiring oral steroids | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |