| Methods |
Setting: multicentre study Sweden, hospital outpatient clinic
Length of intervention: 4 weeks
Design: crossover, no washout
Randomisation: yes, random number table
Allocation concealment: unclear
Masking: double blind
Excluded: not stated
Withdrawals: stated
Baseline characteristics: no details
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 mcg/d
Exclusion criteria:
Cardiovascular disease or diabetes mellitus |
| Interventions |
Four treatment allocations:
1) BDP 200 micrograms 2xdaily (400 mcg/day)
2) BUD 200 micrograms 2xdaily (400 mcg/day)
3) BDP 500 micrograms 2xdaily (1000 mcg/day)
4) BUD 400 micrograms 2xdaily (800 mcg/day)
All via MDI |
| Outcomes |
FEV1
FVC
Morning PEFR
Evening PEFR
Daily asthma symptom score |
| Notes |
No reply from author to clarify if allocation concealment was employed
Not stated if carryover effects were tested for.
Significant improvements in morning/evening PEFR, beta2 agonist use, symptoms in BDP and BUD groups compared to non‐randomised placebo. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
