| Methods |
Study Design: Parallel RCT
Randomisation: Computer generated sequence in blocks of four.
Concealment of Allocation: sequentially administered coded containers.
Double Blinding: Yes
Withdrawals / dropouts: Described
Adverse events: Described
Statistical analysis: Described
Jadad Score: 5 |
| Participants |
Study site: multicentre trial in 62 medical centres
No eligible: Not stated
No randomised: 267 (67/67/63/70)
No completed: 224 (61/55/56/52)
Sex: Male 126/238 (53%), Female 112/238 (47%)
Age: mean (SD) Intervention 1: 50.4(15); Intervention 2: 47.8(15.9); Intervention 3: 50.9 (15.5); Intervention 4: 50.6 (14.2)
Diagnostic criteria for asthma: Not stated
Inclusion criteria: PEF 50‐80% predicted, stable perennial symptoms of asthma > 3 days/week during run in
Exclusion criteria: Glucocorticoid use within 1 month of study, respiratory tract infection in previous 4 weeks, other dominant respiratory disease, cardiovascular disease, hepatic or renal disease.
Baseline severity of asthma: mild asthma 147/238 (62%); Mod asthma 88/238 (37%); Severe asthma 3/238 (1%) |
| Interventions |
1:BUD 800mcg/day (400mcg bd)
2: BUD 400mcg/day (200mcg bd)
3: BUD 200mcg/day (100mcg bd)
4: Placebo
Delivery device: DPI
Duration of treatment: 6 weeks
Run in phase: 2 weeks
Other: oropharyngeal rinsing after each dose to minimise oral candidiasis |
| Outcomes |
PEF, FEV1, symptoms, safety, Doctor efficacy assessment, adverse events, hospitalisations, ER visits, lost production, symptoms, costs |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer generated sequence in blocks of four. |
