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. 1999 Oct 25;1999(4):CD003274. doi: 10.1002/14651858.CD003274

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
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