Swystun 1998.
Methods | Setting: Canada, hospital outpatient clinic Length of intervention period: 7 days Randomisation: yes, computer‐generated randomisation sequence Allocation concealment: yes Design: 4 way crossover with 6 day washout periods Masking: double blind Excluded: not stated Withdrawals: stated Baseline characteristics: comparable Jadad score=4 | |
Participants | 12 adults: 5M 7F Age range: 20‐48 years Inclusion criteria: Adults with mild to moderate atopic asthma Documented response to a specific allergen in skin prick testing or inhalation challenge FEV1 (% predicted FEV1) > 70 Methacholine BHR (PC20 FEV1) 8 mg/ml or less Exclusion criteria: Requirement for any asthma medication in last 4 weeks Respiratory tract infection within last 4 weeks | |
Interventions | BUD:
1. 100 mcg 1 actuation 2xdaily (200 mcg/d)
2. 200 mcg 1 actuation 2xdaily (400 mcg/d)
3. 400 mcg 1 actuation 2xdaily (800 mcg/d) Placebo: 1 actuation 2xdaily Delivery device: Turbuhaler DPI |
|
Outcomes | Allergen BHR (PC15 FEV1) Methacholine BHR (PC15 FEV1) FEV1 | |
Notes | Reply from author to clarifying method of random order generation and that allocation concealment was employed. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |