Jones 1994.
Methods | Setting: multicentre study UK, primary care Randomisation: yes, method not stated Allocation concealment: unclear Design: parallel Intervention period: 12 weeks Masking: double blind Excluded: not stated Withdrawals: stated Baseline characteristics: comparable Jadad score=4 | |
Participants | 340 subjects: 178M 166F Age range: 12‐70 years Inclusion criteria: Mild to moderate asthma and a 'documented response' to inhaled beta2 agonists PEFR (% predicted) 60 or greater Symptom score of 1 or greater during run‐in Exclusion criteria: Regular use of corticosteroids within last 6 months Short courses of corticosteroid within last 2 months Use of nedocromil or sodium cromoglycate within last 2 months Asthma exacerbation within last 2 months | |
Interventions | BUD:
1. 400 mcg morning (400mcg/d)
2. 400 mcg evening (400mcg/d)
3. 200 mcg 2xdaily (400mcg/d) Placebo: 2 pfs 2xdaily Delivery device: Turbohaler DPI |
|
Outcomes | Change morning PEFR compared to baseline Change evening PEFR compared to baseline Change in daytime and night‐time symptom scores compared to baseline Change in daytime and night‐time beta2 agonist use compared to baseline Withdrawal due to asthma exacerbation | |
Notes | No reply from author to clarify details of randomisation method. Three daily dose schedules were evaluated, all assessing 400 mcg/d. Only the data for outcomes for those patients assigned to BUD 200 mcg twice daily were used in this meta‐analysis. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |