| Methods |
Study Design: Parallel RCT
Randomisation: computer generated random numbers
Concealment of Allocation: opaque consecutive numbered envelopes, identical placebo
Double Blinding: Yes
Withdrawals / dropouts: Described
Adverse events: exacerbations only
Statistical analysis: 'per protocol ' analysis
Jadad Score: 5 |
| Participants |
Study site: multicentre
No eligible: 70
No randomised: 60 (29/31)
No completed: not stated
Sex: Males‐24 (40%);Females‐36 (60%)
Age (mean, range): Intervention1:34.7 (19‐59); Intervention 2: 37.6 (19‐69)
Diagnostic criteria for asthma: doctor diagnosis and objective lung function
Inclusion criteria: asthma diagnosis > 6 months, maintenance ICS > 3 months and constant ICS dose in past month, FEV1 > 50% predicted, > 15% reversibility.
Exclusion criteria: > 2000mcg BDP, >1600mcg BUD, or > 800mcg FP per day, 3 courses OCS or hospitalisation in past 6 months
Baseline severity of asthma: FEV1 (mean, se): 2.87(0.18)/2.52(0.14)L; FEV1 % predicted: 82.6(3.6)/76.1(3.0) |
| Interventions |
Run in phase: BUD 800mcg/day for 1 month then randomised if compliance 75‐125% recommended dose and asthma stable for last 10 days of run in.
1: BUD 100mcg + Formoterol 12mcg twice daily
2: BUD 400mcg + placebo twice daily
Delivery device: DPI
Duration of treatment: 12 months
Other: |
| Outcomes |
Exacerbations, % episode free days, rescue medications, nocturnal awakenings, airway inflammation, FEV1 % predicted, evening PEF, morning and evening symptom scores. |
| Notes |
Comparison 1: Constant dose ICS |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Computer generated random numbers |
| Allocation concealment? |
Low risk |
Opaque consecutive numbered envelopes |
| Blinding?
All outcomes |
Low risk |
Identical placebo |
