Lorentzson 1990.
Methods | Setting: multicentre study Sweden & Norway, hospital outpatient clinic Randomisation: yes, method not stated Allocation concealment: unclear Design: parallel Intervention period: 6 weeks Masking: double blind Excluded: not stated Withdrawals: stated Baseline characteristics: comparable Jadad score=3 | |
Participants | 103 adults: 58M 45F Age range: 16‐59 years Inclusion criteria: Mild asthma Use of 35 puffs rescue beta2‐agonist during run in week and mean variation of 10‐30% in PEFR PEFR (% predicted) 75 or greater Exclusion criteria: Use of oral or inhaled steroids Serious co‐existent disease Respiratory infection or acute asthma exacerbation in last month | |
Interventions | BUD:
1. 100 mcg 1pf 2xdaily (200 mcg/d)
2. 200 mcg 1pf 2xdaily (400 mcg/d) Delivery device: MDI+spacer Placebo: 1 pf 2xdaily via MDI+spacer |
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Outcomes | Change in morning PEFR compared to baseline Change in evening PEFR compared to baseline Change in daily use beta2 agonists compared to baseline Daily asthma symptom score Withdrawal due to asthma exacerbation Incidence of oropharyngeal side effects Incidence of oropharyngeal Candidasis | |
Notes | No reply from author to clarify details of randomisation method. Two dosage schedules are used in this trial. Only data for those patients assigned to 400 mcg/d has been used in the meta‐analysis | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |