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. 2002 Jan 21;2002(1):CD003530. doi: 10.1002/14651858.CD003530

Svendsen 1992.

Methods Setting: Denmark, hospital outpatient clinic
 Length of intervention: 6 weeks 
 Design: crossover, no washout
 Randomised: yes, method not stated
 Allocation concealment: unclear
 Masking: double‐blind
 Excluded: not stated
 Withdrawals: stated
 Baseline characteristics: comparable
 Jadad score: 3
Participants 39 adults
 Age range: 18 years or older
 Inclusion criteria:
 Asthma poorly controlled with inhaled steroids, daily dose 300 ‐ 500 mcg/day
 FEV1, FVC or PEFR < 70% predicted 
 15% or greater improvement in FEV1 after inhaled beta2 agonist 
 Bronchial hyper‐responsiveness to histamine (PC20 FEV1 2 mg/ml or less)
 Exclusion criteria: 
 Regular oral steroids during 3 months prior to the trial
 Unable to use aerosols correctly
 Pregnancy or significant co‐existent disease
 Respiratory infections within last 4 weeks
Interventions BDP: 250 mcg 3 puffs 2xdaily (1500 mcg/day) via MDI and placebo via MDI+Inhalet spacer
BUD: 200 mcg 4 puffs 2xdaily (1600 mcg) via MDI+Inhalet spacer and placebo via MDI
Outcomes FEV1 
 FVC 
 Morning PEFR 
 Evening PEFR 
 Clinic PEFR 
 Histamine BHR (PC20 FEV1) 
 Sleep disturbance, wheeze and activity restriction score 
 Rescue beta2 agonist use (puffs/day) 
 Plasma cortisol (time not stated) 
 Plasma cortisol 30 min post 250 mcg iv tetracosactrin
Notes Reply from author but unable clarify details of randomisation procedure
 Not stated if carryover effects were tested for.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear