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 |
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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 |