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

Tjwa 1995.

Methods Setting: The Netherlands, hospital outpatient clinic
 Length of intervention: 8 weeks
 Design: crossover, 4 week washout
 Randomisation: yes, by computerised randomisation algorithm
 Allocation concealment: unclear
 Masking: none
 Excluded: not stated
 Withdrawals: stated 
 Baseline characteristics: comparable 
 Jadad score: 3
Participants 16 adults: 14M 2F
 Inclusion criteria:
 18 years of age or older
 Asthma for more than 2 years
 %predicted FEV1 40‐85
 15% or greater improvement in FEV1 after inhaled beta2 agonist
 Bronchial hyper‐responsiveness to histamine (PC20 FEV1 less than or equal to 1.0mg/ml)
 Currently receiving inhaled steroid 150‐800 mcg/daily
 Exclusion criteria:
 Pregnancy or significant co‐existent disease
 Asthma exacerbation or respiratory tract infection in previous 2 months
Interventions BDP: 200 mcg 1 actuation 2xdaily (400 mcg daily) via Rotahaler DPI
BUD: 200 mcg 1 actuation 2xdaily (400 mcg daily) via Turbuhaler DPI
Outcomes FEV1
 FVC
 Morning PEFR 
 Evening PEFR 
 Daytime wheeze score Daytime breathlessness score 
 Daytime cough score
 Night‐time wheeze score
 Night‐time breathlessness score
 Night‐time cough score
 Daytime beta2 agonist use (puffs/day)
 Night‐time beta2 agonist use (puffs/day)
 Bronchial responsiveness to histamine (PC20 FEV1)
Notes Author confirmed method of random order generation and provided original data for all outcomes.
 Carryover effects were tested for and excluded.
 Significant improvement in at least one efficacy measure for both BDP and BUD groups compared to placebo washout
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear