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 |
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Interventions | 1. BUD 50 mcg 2 puffs 2xdaily (200mcg/day) via MDI 2. BUD 200 micrograms 2 puffs 2xdaily (800 mcg/day) via MDI |
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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 |