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 |
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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 |