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. 2008 Apr 23;2008(2):CD007031. doi: 10.1002/14651858.CD007031

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
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Notes Unpublished data set available from http://www.clinicalstudyresults.org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