Baena Cagnani 2006.
Methods | STUDY DESIGN: Parallel group LOCATION, NUMBER OF CENTRES: Multicentre, USA, South America DURATION OF STUDY: 12 months (6 month run‐in period reported, unclear treatment regime) 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: 661 (eligible patients) N COMPLETED: Unknown M= unknown F= unknown MEDIAN AGE: Range ‐ males 5‐8.5 years; females 5‐7.5 years BASELINE DETAILS: Unknown INCLUSION CRITERIA: Mild persistent asthma; children EXCLUSION: Not reported | |
Interventions | 1. Ciclesonide 50mcg OD
2. Ciclesonide 100cg OD
3. Placebo DELIVERY: MDI TREATMENT PERIOD: 12 months RESCUE: Not reported CO‐INTERVENTIONS PERMITTED: Not reported CO‐INTERVENTIONS: Not reported % on ICS baseline: Not reported |
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Outcomes | Growth velocity; adverse events; withdrawals | |
Notes | Unpublished conference abstract | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |