Davies 1977.
Methods | Setting: Canada, hospital outpatient clinic Length of intervention period: 12 weeks Randomisation: yes, computer generated sequence Allocation concealment: yes Design: parallel Masking: double blind Excluded: not stated Withdrawals: not stated Baseline characteristics: comparable Jadad score: 4 | |
Participants | 33 adults: 15M 18F Mean age: 55 (BDP group) 43 (placebo group) Inclusion criteria: Requiring oral steroid treatment for asthma control for 1 year or longer 15% or greater improvement in FEV1 after inhaled beta2 agonist Exclusion criteria: Chronic atopic eczema or a history of chronic bronchitis as defined by ATS criteria. | |
Interventions | BDP 50mcg 2 pfs 4x daily (400mcg/d) Placebo 2 pfs 4xdaily Delivery device: MDI |
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Outcomes | FEV1 (% predicted) Daytime asthma symptom score Nighttime asthma symptom score Daily dose oral prednisolone Daily beta2 agonist use Blood eosinophil count 2 pm serum cortisol | |
Notes | Reply from authors 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 |