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. 2005 Oct 19;2005(4):CD005076. doi: 10.1002/14651858.CD005076.pub2

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