| 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: Described
Jadad Score: 2 |
| Participants |
Study site:
No eligible:
No randomised: 88 (40;48)
No completed: Not stated
Sex: Intervention 1: 43% males; Intervention 2: 46% males
Age (mean, SD): 1: 34.3 (11.3); 2: 35.3 (14.6)
Diagnostic criteria for asthma: Not stated
Inclusion criteria: FEV1 65‐95% predicted and at least 30 days of treatment with medium dose ICS, patients had to become clinically unstable when ICS was decreased to FP 100mcg bid.
Exclusion criteria: Not stated
Baseline severity of asthma: FEV1 (mean, SE) Intervention 1: 84.5% (1.5); Intervention 2: 81.2% (1.4) |
| Interventions |
Run in phase 1: 2 weeks. Patients stable on FP 250 mcg bid or equivalent dose.
Run in phase 2: 5‐28 days. Stable patients decreased ICS to FP 100mcg bid ‐ those who became unstable were eligible to continue in trial.
Run in phase 3: 4 weeks. FP dose increased to 250mcg bid. If stable on FP 250mcg bid eligible for trial
Intervention 1: FSC 100/50mcg bid (200/100mcg daily)
Intervention 2: FP 250mcg bid (FP 500mcg daily)
Delivery device: DPI, single device
Duration of treatment: 24 weeks
Other: |
| Outcomes |
BAL/biopsy ‐ airway inflammation
Measured as change from baseline: Morning & evening PEF (l/min), FEV1 (L), rescue medications (puffs/day), % rescue free days), daily symptom score, % symptom free days, |
| Notes |
Poster 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 |
