Bloom 2003.
| Methods | Study Design: Parallel RCT Randomisation: Random stated, method not described. Concealment of Allocation: not stated. Double Blinding: Yes. Withdrawals / dropouts: Described. Adverse events: not stated. Statistical analysis: not stated. Jadad Score: 3 | |
| Participants | Study site: No eligible: No randomised: 574 No completed: 288 Sex: Males ‐not stated; Females ‐not stated Age: not stated. Diagnostic criteria for asthma: not stated. Inclusion criteria: Requiring moderate dose maintenance ICS (FP 220bid equivalent) to maintain asthma control. Exclusion criteria: not stated. Baseline severity of asthma: FEV1 mean 78% predicted | |
| Interventions | Run in phase: not stated
1: Fluticasone/Salmeterol 100/50mcg combination bid (200/100mcg/day)
2: Fluticasone 250mcg bid (500mcg/day)
Delivery device: DPI, single device
Duration of treatment: 24 weeks Other: |
|
| Outcomes | All measured as change from baseline: Withdrawal due to worsening asthma, FEV1(L), morning PEF (L/min), rescue medication use (puffs/day), % symptom free 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 |