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. 2004 Apr 19;2004(2):CD004109. doi: 10.1002/14651858.CD004109.pub2

Pedersen 1995.

Methods Study Design: 
 Crossover RCT
 Randomisation:Random stated, method not described.
 Concealment of Allocation: Identical drug canisters administered in randomized order
 Double Blinding: Yes
 Withdrawals / dropouts: Described 
 Adverse events: Not described 
 Statistical analysis: Described
 Jadad Score: 3
Participants Study site: multicentred
 No eligible: Not stated
 No randomised: 19 
 No completed: 18 
 Sex: Males:17(89%); Females 2(11%).
 Age: mean 11yrs
 Diagnostic criteria for asthma: Objective lung function
 Inclusion criteria: beta 2 use only, Symptoms> 3 days/week, >=20% bronchial reversibility post terbutaline or >=
 20% fall in FEV1 post exercise test.
 Exclusion criteria: Bronchopulmonary disease other than asthma, oral prednisolone within 1 month before study 
 Baseline severity of asthma: PC20 range: 22.5%‐76.5%; bronchial reversibility range: 26.5% ‐ 82.4%. mean duration of asthma: 7.5 yrs
Interventions 1: BUD 100mcg/day (50mcg bd)
 2: BUD 200mcg/day (100mcg bd)
 3: BUD 400mcg/day (200mcg bd)
Delivery device: metered‐dose inhaler with spacer 
 Duration of treatment: 4 weeks for each treatment period, no washout. Total treatment 12 weeks. 
 Run in phase: 2 weeks 
 Wash out phase: none
 Other: > 80% compliance
Outcomes PEF & FEV1 post exercise testing, AHR (exercise), rescue medication, symptoms, urinary cortisol
Notes no washout period between dose changes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Described as randomised; other information not available