Boe 1989.
Methods | Setting: multicentre study Sweden, hospital outpatient clinic Randomisation: yes, using 4x4 Williams square Allocation concealment: unclear Masking: double blind Design: crossover, no washout Length of intervention period: 4 weeks Excluded: not stated Withdrawals: stated Baseline characteristics: no baseline demographic data presented Jadad score: 4 | |
Participants | 128 adults: 67M 61F
Age range 18‐77 years
Inclusion criteria:
Asthma as defined by ATS criteria
Requirement for inhaled steroids in a dose range of 400‐800 micrograms
Exclusion criteria:
Cardiovascular disease or diabetes mellitus Baseline asthma control Symptom frequency: not stated FEV1 (% predicted): not stated |
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Interventions | 1. BUD 200 mcg 2xdaily (400 mcg/d) 2.) BUD 400 mcg 2xdaily (800 mcg/d) Delivery device: MDI |
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Outcomes | FEV1 FVC Morning PEFR Evening PEFR Daily asthma symptom score | |
Notes | No reply from author to clarify if allocation concealment had been employed. This study was designed as a four period crossover trial. Additional treatment periods with BDP 400 mcg/d and 1000 mcg/d were included: results not considered here. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |