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. 2000 Apr 24;2000(2):CD003271. doi: 10.1002/14651858.CD003271

Kraan 1988.

Methods Setting: The Netherlands, hospital outpatient clinic 
 Randomisation: yes, method not stated 
 Allocation concealment: unclear 
 Design: parallel group 
 Length of intervention period: 8 weeks 
 Masking: double blind 
 Excluded: not stated 
 Withdrawals: stated (none) 
 Baseline Characteristics: significant difference between groups for FEV1 
 Jadad score: 3
Participants 30 adults: 22M 8F 
 Age range: 18‐37 years 
 Inclusion criteria: 
 History of episodic wheezing 
 Strongly positive skin tests for at least two common allergens including house dust mite 
 Mild symptoms are controlled by bronchodilators or prophylactic drugs (cromolyn sodium or inhaled steroids) 
 FEV1 (% predicted) 70 or greater 
 Methacholine bronchial responsiveness (PC20 FEV1) less than 8 mg/ml 
 Exclusion criteria: 
 Regular use of oral steroids
Baseline asthma control 
 Symptom frequency: symptoms controlled 
 FEV1 (% predicted): range 76‐108
Interventions 1. BUD 50 mcg 2 puffs 2xdaily (200mcg/day) via MDI
2. BUD 200 micrograms 2 puffs 2xdaily (800 mcg/day) via MDI
Outcomes FEV1 (% predicted) 
 Methacholine bronchial responsiveness (PC20 FEV1) 
 Clinic assessed asthma symptom score 
 Blood eosinophil count 
 Withdrawal due to asthma exacerbation
Notes No reply from author to clarify details of randomisation method.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear