Lee 2004.
Methods | STUDY DESIGN: Crossover LOCATION, NUMBER OF CENTRES: Single centre in Scotland DURATION OF STUDY: 4 weeks CONCEALMENT OF ALLOCATION: Not reported COCHRANE QUALITY SCORE: DESCRIBED AS RANDOMISED: Yes DESCRIBED AS DOUBLE BLIND: Yes METHOD OF RANDOMISATION WELL DESCRIBED/APPROPRIATE: METHOD OF BLINDING WELL DESCRIBED/APPROPRIATE: Double dummy (identical devices used). DESCRIPTION OF WITHDRAWALS/DROPOUTS: 9/28 JADAD SCORE (5‐1): 4 TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): Bonferroni correction set at 95% CI in order to obviate pairwise comparisons. COMPLIANCE: Not reported. CONFOUNDERS: Not reported. | |
Participants | N SCREENED: Not reported. N RANDOMISED: 28 N COMPLETED: 19 M = 9 F = 10 MEAN AGE: 45 years BASELINE DETAILS: FEV1 predicted 84%; am PEF: 470 L/min; rescue medication usage: 0.2 puffs/d; AQLQ: 6.15 INCLUSION CRITERIA: Non‐smokers, mild‐moderate asthma; stable for three months prior to study entry; BDP equivalent 2000mcg/d (half of this if used in conjunction with additional controller therapy). EXCLUSION: Oral steroids or antibiotics in 3 months prior to study entry | |
Interventions | 1. Ciclesonide 400mcg OD
2. Fluticasone 250mcg BID DELIVERY: CIC: HAD‐MDI; FP: Evohaler TREATMENT PERIOD: 2 x 4 week treatment periods RESCUE: Not clear. CO‐INTERVENTIONS PERMITTED: Montelukast and Salmeterol given during washout phase to prevent withdrawals. CO‐INTERVENTIONS: Montelukast and Serevent. % on ICS baseline: 100 |
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Outcomes | Methacholine challenge; FEV1; am PEF; pm PEF; symptoms; rescue medication; AQLQ | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |