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

Tan 1998.

Methods Setting: Singapore, hospital outpatient clinic 
 Length of intervention period: 1 month 
 Randomisation: yes, method not described 
 Allocation concealment: unclear 
 Design: parallel (with crossover in one arm) 
 Masking: double blind 
 Excluded: not stated 
 Withdrawals: stated (none) 
 Baseline characteristics: comparable 
 Jadad score=3
Participants 30 adults: 20M 10F 
 Age range: 16‐65 years 
 Inclusion criteria: 
 Diagnosis of asthma for at least 1 year (ATS criteria) 
 Nocturnal wakening by wheeze or cough more than once per week in preceding month 
 20% or greater fall in FEV1 or PEFR from evening to morning on 2 consecutive days before study 
 15 % or greater Improvement in FEV1 after inhaled beta2 agonist 
 Histamine BHR (PC20FEV1) 8mg/ml or less 
 Exclusion criteria: 
 History of smoking 
 Respiratory tract infection in last 6 weeks
Interventions BUD: 1600 mcg/d
Placebo
Delivery device: MDI with built in extension piece (Pulmicort Misthaler)
Outcomes 4 pm, 10 pm, 4 am FEV1 
 4 pm, 10 pm, 4 am Thoracic Gas Volume 
 4 pm histamine BHR (PD20FEV1) 
 4 am histamine BHR (PD20FEV1) 
 4pm, 10pm, 4 am specific airway conductance (SGaw) 
 Serum neutrophil chemotactic activity 
 Number of night‐time wakenings per week due to asthma
Notes No reply from author to clarify details of randomisation method. 
 Patients were randomised to either a) 8 weeks of treatment with inhaled BUD or b) 4 weeks of treatment with placebo followed by 4 weeks of treatment with inhaled BUD. In this analysis results from the first 4 weeks only have been considered. 
 This study was specifically concerned with assessing the effects of each intervention on diurnal variability of the outcomes assessed. However in this analysis only the 4pm measurements have been considered.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear