Prieto 1994.
Methods | Setting: Spain, hospital outpatient clinic Randomised: yes, computer‐generated randomisation schedule. Allocation concealment: not employed Design: parallel Intervention period: 4 months Masking: double blind Excluded: not stated Withdrawals: stated Baseline characteristics: comparable Jadad score=3 | |
Participants | 30 adults, 28 completed: 8M 20F Mean (SD) age: budesonide 33(3) years, placebo 35 (2) years Inclusion criteria: Patients with seasonal asthma for at least 2 years FEV1 (% predicted) > 80 Positive skin prick test to grass or other pollens but not to other allergens such as house dust mite, cat or dog Exclusion criteria: Inhaled corticosteroid use Serious coexistent disease Chest infection within last 4 weeks | |
Interventions | BUD: 400 mcg 1 pf 2xdaily (800mcg/d) Placebo: 1 pf 2xdaily Delivery device: MDI+spacer |
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Outcomes | FEV1 Methacholine BHR (PC20 FEV1) | |
Notes | Reply from author clarifying method of random order generation and that allocation concealment was not employed. Study was undertaken during the period of maximum allergen exposure (March to June). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | D ‐ Not used |