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

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
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