Tjwa 1995.
Methods | Setting: The Netherlands, hospital outpatient clinic Length of intervention: 8 weeks Design: crossover, 4 week washout Randomisation: yes, by computerised randomisation algorithm Allocation concealment: unclear Masking: none Excluded: not stated Withdrawals: stated Baseline characteristics: comparable Jadad score: 3 | |
Participants | 16 adults: 14M 2F Inclusion criteria: 18 years of age or older Asthma for more than 2 years %predicted FEV1 40‐85 15% or greater improvement in FEV1 after inhaled beta2 agonist Bronchial hyper‐responsiveness to histamine (PC20 FEV1 less than or equal to 1.0mg/ml) Currently receiving inhaled steroid 150‐800 mcg/daily Exclusion criteria: Pregnancy or significant co‐existent disease Asthma exacerbation or respiratory tract infection in previous 2 months | |
Interventions | BDP: 200 mcg 1 actuation 2xdaily (400 mcg daily) via Rotahaler DPI BUD: 200 mcg 1 actuation 2xdaily (400 mcg daily) via Turbuhaler DPI |
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Outcomes | FEV1 FVC Morning PEFR Evening PEFR Daytime wheeze score Daytime breathlessness score Daytime cough score Night‐time wheeze score Night‐time breathlessness score Night‐time cough score Daytime beta2 agonist use (puffs/day) Night‐time beta2 agonist use (puffs/day) Bronchial responsiveness to histamine (PC20 FEV1) | |
Notes | Author confirmed method of random order generation and provided original data for all outcomes. Carryover effects were tested for and excluded. Significant improvement in at least one efficacy measure for both BDP and BUD groups compared to placebo washout | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |