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. 1999 Oct 25;1999(4):CD003274. doi: 10.1002/14651858.CD003274

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
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
Notes Reply from author confirming details of randomisation method.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate