NCT01192178

Methods	A randomised, double‐blind, 16‐week, parallel‐group study in paediatric patients from 2 August 2010 to 16 December 2010, at 39 centres in the USA
Participants	Population: 339 children (4 to 11 years) with persistent asthma who were symptomatic on an ICS Baseline characteristics: 22% aged 4 to 5 years; 78% 6 to 11 years. Spacers were used by 78% of children at baseline Inclusion criteria: male and female children 4 to 11 years of age with diagnosis of asthma requiring an ICS for control of asthma. Patients were required to have an AM PEF ≥ 70% of predicted value at the screening visit. Patients also had to have a history of ≥ 1 exacerbation of asthma during the previous respiratory viral season that required use of outpatient systemic corticosteroids or an urgent care visit, an emergency room visit, or hospitalisation Exclusion criteria: life‐threatening asthma, unstable asthma, evidence of concurrent respiratory disease, history of any upper or lower respiratory tract infection within 4 weeks of randomisation that required use of an antibiotic or was accompanied by worsening asthma, other clinically significant medical conditions
Interventions	• Fluticasone propionate and salmeterol Diskus 100/50 μg, 1 inhalation twice daily • Fluticasone propionate Diskus 100 μg, 1 inhalation twice daily, for 16 weeks
Outcomes	Primary outcome: number of exacerbations of asthma during the double‐blind period. No deaths were reported; 2 children suffered SAEs on fluticasone propionate/salmeterol (1 was status asthmaticus) and 1 child suffered an SAE (syncope) on fluticasone propionate
Notes	Sponsored by GSK
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not stated
Allocation concealment (selection bias)	Unclear risk	Not stated
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	86% in both groups completed treatment
Selective reporting (reporting bias)	Low risk	Full data on GSK website