Rojas 2007

Methods	A randomised, double‐blind, multi‐centre, parallel‐group study over 12 weeks from February 2003 to September 2003, at 48 centres worldwide (Argentina (4), Czech Republic (8), France (9), Israel (4), Italy (9), Poland (4), Slovakia (6), Turkey (4)). Run‐in 2 weeks
Participants	Population: 362 adolescents and adults (12 to 78 years) with moderate persistent asthma Baseline characteristics: mean age 41 years; FEV₁ 72% predicted Concomitant ICS used by 0% of participants   Inclusion criteria: 12 to 80 years with documented clinical history of persistent asthma for at least 6 months and currently receiving inhaled short‐acting beta₂‐agonists alone. FEV₁ % predicted between 60% and 80%, bronchodilator reversibility by an increase of at least 15% in FEV₁ over baseline after 400 μg salbutamol, or a mean morning PEF during the last 7 days of the run‐in of < 85% of post‐bronchodilator value, and a daytime symptom score ≥ 2 on at least 4 of the last 7 days of the run‐in. Exclusion criteria: taken corticosteroids within 12 weeks; LTRA within 4 weeks or long‐acting inhaled or oral beta₂‐agonists, sodium cromoglycate, nedocromil sodium, ketotifen, methylxanthines, or inhaled anticholinergics within 2 weeks of entering the study; had an acute asthma exacerbation requiring hospital treatment within 6 weeks; had a respiratory tract infection within 4 weeks of entering the study or a smoking history of > 10 pack‐years
Interventions	• Fluticasone propionate and salmeterol 250/50 μg twice daily • Fluticasone propionate 250 μg twice daily Delivery was Diskus inhaler
Outcomes	Primary efficacy variable: mean morning PEF Paper reports: "Only three serious adverse events occurred and none were considered related to study treatment"
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	350/362 (97%) completed the study
Selective reporting (reporting bias)	Low risk	Full data on GSK website