Campbell 1991.
Methods | Setting: multicentre study UK, primary care. Randomisation: yes, computer‐generated randomisation schedule Allocation concealment: yes Design: parallel Intervention period: 8 weeks Masking: double blind Excluded: not stated Withdrawals: stated Baseline characteristics: comparable Jadad score=4 | |
Participants | 141 subjects: 74M 67F Inclusion criteria: Age > 12 years Reversibility of airway obstruction in response to inhaled beta2 agonists Inhaled bronchodilator at least once per day or experiencing asthma symptoms despite current treatment Exclusion criteria: Oral steroid use within previous month Current respiratory tract infection Pregnancy | |
Interventions | BUD: 200mcg 2 pfs 1xdaily (400 mcg/d) Placebo: 2 pfs 1xdaily Delivery device: Turbohaler DPI |
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Outcomes | Change in morning PEFR compared to baseline
Change in evening PEFR compared to baseline
Change in clinic PEFR compared to baseline
Change in beta2 agonist use (puffs/d) compared to baseline % patients with improved: wheeze at rest and on activity; difficulty in breathing; cough; disturbed sleep; interference with usual routine (clinic assessment) % patients with improved: sleep disturbance; ease of falling asleep; no wheeze on waking; rested on waking; wheeze at rest; limitation of activity; hours active per day; satisfaction with lifestyle (diary card assessment) Withdrawal due to asthma exacerbation |
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Notes | Reply from author confirming details of randomisation method. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |