SAS30021

Methods	A stratified, randomised, double‐blind, placebo‐controlled, parallel‐group study for 12 weeks from November 2001 to February 2004, at 164 centres (United States (153), Latin America (11)) A stratified, randomised, double‐blind, placebo‐controlled, parallel‐group, 12‐week trial evaluating the safety and efficacy of the fluticasone propionate/salmeterol Diskus combination product 100/50 μg once daily vs fluticasone propionate Diskus 100 μg once daily and placebo in symptomatic paediatric subjects (4 to 11 years) with asthma
Participants	Population: 908 children (4 to 11 years) with asthma  Baseline characteristics: mean age 8 years; FEV₁ not reported % predicted Concomitant ICS used by 0% of participants   Inclusion criteria: 4 to 11 years of age with diagnosis of asthma for at least 6 months and treated with SABA only or non‐ICS controller medications for at least 1 month before screening; FEV₁ % predicted between 50% and 85%; bronchodilator reversibility by an increase of at least 15% in FEV₁ over baseline within 30 minutes following 2 puffs of albuterol at screening. At the randomisation visit, participants were required to demonstrate AM PEF reproducibility of +15% of the screening visit pre‐albuterol PEF, to demonstrate a PM PEF 50% to 90% of predicted normal, and to have an asthma symptom score of at least 2 on 4 or more days in the week before randomisation, or to have used albuterol on at least 4 days in the week before randomisation Exclusion criteria: not reported
Interventions	• Fluticasone propionate and salmeterol 100/50 μg once daily • Fluticasone propionate 100 μg once daily Delivery was Diskus device
Outcomes	Primary efficacy endpoint: change from baseline in % predicted PM PEF over weeks 1 to 12
Notes	Sponsored by GSK
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	Low risk	Double blind
Independent Assessment of causation (detection bias) Asthma‐related events	High risk	Causation of SAEs not independently assessed
Incomplete outcome data (attrition bias) All outcomes	Low risk	715/908 (79%) completed the study
Selective reporting (reporting bias)	Low risk	Data on GSK website