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. 2002 Jan 21;2002(1):CD003530. doi: 10.1002/14651858.CD003530

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
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