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 |
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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 |