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

Wempe 1992a.

Methods Setting: The Netherlands, hospital outpatient clinic 
 Randomisation: yes, method not stated 
 Allocation concealment: unclear 
 Design: crossover, no washout 
 Intervention period: 4 weeks 
 Masking: double blind 
 Excluded: not stated 
 Withdrawals: stated (none) 
 Baseline characteristics: comparable 
 Jadad score=3
Participants 8 adults: 5M 3F 
 Age range: 18 ‐40 years 
 Inclusion criteria: 
 Adult patients with asthma 
 Positive skin prick test and elevated specific IgE to house dust mite 
 FEV1 (% predicted) > 60 
 Histamine BHR (PC20 FEV1) < 8 mg/ml 
 Diurnal PEFR variability > 15% 
 Exclusion criteria: 
 Asthma exacerbation within last 2 months
Interventions BUD: 200mcg 2 pfs 2 x daily (800mcg/d)
Placebo: 2 pfs 2 x daily
Delivery device: Turbuhaler DPI
Bambuterol: 20mg tablet 1xdaily
Each group received appropriate additional placebo tablet or inhaler to maintain blinding
Outcomes 24 hour mean FEV1 (% predicted) 
 Diurnal change in FEV1 (% predicted) 
 Histamine BHR (PC20 FEV1) 
 Diurnal change in histamine BHR (PC20 FEV1) 
 Daytime cough, breathlessness and wheeze scores 
 Night‐time cough, breathlessness and wheeze scores
Notes No reply from author to clarify details of randomisation method. 
 Patient group with daily PEFR variability > 15%
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear