Brambilla 1994.
Methods | Setting: multicentre study France, hospital outpatient clinic Length of intervention: 12 weeks Design: parallel group, dose down‐titration Randomisation: yes, method not stated Allocation concealment: unclear Masking: none Excluded: not stated Withdrawals: stated Baseline characteristics: comparable Jadad score: 2 | |
Participants | 146 adults Inclusion criteria: Recurrent acute exacerbations of breathlessness and wheezing 15% or greater variability in FEV1 Bronchial responsiveness to methacholine or histamine (PD20 FEV1 2mg or less) Receiving inhaled BDP 1000‐2000 mcg/d for at least 6 months Exclusion criteria: Airways disease other than asthma Smoker > 5 packs cigarettes per year Significant co‐existent disease | |
Interventions | BDP: 800 to 2000 mcg total daily dose via MDI BUD: 800 to 1600 mcg total daily dose via Turbohaler DPI |
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Outcomes | FEV1 Morning PEFR Evening PEFR Number of puffs of inhaled corticosteroid per day Number asthma exacerbations/week Number night awakenings requiring beta2 agonist use/week Daily beta2 agonist use (puffs/day) Withdrawal due to asthma exacerbation Incidence of local oral side effects | |
Notes | Reply from author but unable to clarify details of randomisation procedure. Dose down titration study design: patients were randomised to receive either BDP or BUD at a dose considered to be equivalent to their pre‐study dose of BDP. BDP 250 mcg/puff via MDI was considered equivalent to BUD 200 mcg/actuation via Turbuhaler DPI. During the study daily dose of ICS was reduced according to pre‐defined criteria based on experience of asthma symptoms in the week prior to assessment. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |