Svendsen 1992.
Methods | Setting: Denmark, hospital outpatient clinic Length of intervention: 6 weeks Design: crossover, no washout Randomised: yes, method not stated Allocation concealment: unclear Masking: double‐blind Excluded: not stated Withdrawals: stated Baseline characteristics: comparable Jadad score: 3 | |
Participants | 39 adults Age range: 18 years or older Inclusion criteria: Asthma poorly controlled with inhaled steroids, daily dose 300 ‐ 500 mcg/day FEV1, FVC or PEFR < 70% predicted 15% or greater improvement in FEV1 after inhaled beta2 agonist Bronchial hyper‐responsiveness to histamine (PC20 FEV1 2 mg/ml or less) Exclusion criteria: Regular oral steroids during 3 months prior to the trial Unable to use aerosols correctly Pregnancy or significant co‐existent disease Respiratory infections within last 4 weeks | |
Interventions | BDP: 250 mcg 3 puffs 2xdaily (1500 mcg/day) via MDI and placebo via MDI+Inhalet spacer BUD: 200 mcg 4 puffs 2xdaily (1600 mcg) via MDI+Inhalet spacer and placebo via MDI |
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Outcomes | FEV1 FVC Morning PEFR Evening PEFR Clinic PEFR Histamine BHR (PC20 FEV1) Sleep disturbance, wheeze and activity restriction score Rescue beta2 agonist use (puffs/day) Plasma cortisol (time not stated) Plasma cortisol 30 min post 250 mcg iv tetracosactrin | |
Notes | Reply from author but unable clarify details of randomisation procedure Not stated if carryover effects were tested for. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |