| Methods |
Study Design: Parallel RCT
Randomisation: Random stated, method not described.
Concealment of Allocation: Not stated.
Double Blinding: Yes
Withdrawals / dropouts: Not described.
Adverse events: Not described.
Statistical analysis: Not described.
Jadad Score: 2 |
| Participants |
Study site:
No eligible:
No randomised: 467
No completed: Not stated
Sex: Not stated
Age: mean 41 yrs
Diagnostic criteria for asthma: Objective lung function
Inclusion criteria: mild to moderate asthma not fully controlled on ICS alone, > 12% bronchodilator reversibility.
Exclusion criteria:
Baseline severity of asthma: Mean FEV1 82% predicted, mean ICS/day= 390mcg |
| Interventions |
Run in phase: Not stated
1: Budesonide/formoterol 80/4.5mcg x 2 (160/9 mcg/day)
2: Budesonide 200mcgx2 (400mcg/day)
Delivery device: DPI, single device
Duration of treatment: 12 weeks
Other: |
| Outcomes |
Morning & evening PEF, % symptom free days, exacerbations, asthma control days |
| Notes |
Abstract only
Comparison 1: Constant dose ICS |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Described as randomised; no other information available |
| Allocation concealment? |
Unclear risk |
Information not available |
| Blinding?
All outcomes |
Unclear risk |
Information not available |
