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

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
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