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

Kivity 1994.

Methods Setting: Israel, hospital outpatient clinic 
 Randomisation: yes, method not stated 
 Allocation concealment: unclear 
 Design: parallel 
 Intervention period: 8 weeks 
 Masking: double blind 
 Excluded: not stated 
 Withdrawals: stated 
 Baseline characteristics: comparable 
 Jadad score=3
Participants 39 adults: 23 M 16F 
 Age range: 17‐49 years 
 Inclusion criteria: 
 Mild to moderate asthma 
 FEV1 (% predicted) > 60 
 15% or greater increase in FEV1 after inhaled beta2 agonist, or 15% fluctuation in daily PEFR during run‐in 
 Methacholine BHR (PC20 FEV1) < 8mg/ml 
 Exclusion criteria: 
 Co‐existent serious illness or other pulmonary disease
Interventions BUD: 400 mcg 1 pf 2xdaily (800mcg/d)
Placebo: 1 pf 2xdaily
Delivery device: Turbohaler DPI
Outcomes Change in FEV1 compared to baseline 
 Change in morning PEFR compared to baseline 
 Change in evening PEFR compared to baseline 
 Methacholine BHR (PD20 FEV1) 
 Daily asthma symptom score 
 Daily use of beta2 agonists 
 Withdrawal due to asthma exacerbation
Notes No reply from author to clarify details of randomisation method.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear