SAS30023

Methods	A randomised, double‐blind, multi‐centre, placebo‐controlled, parallel‐group study over 12 weeks from April 2002 to April 2003, at 69 centres in 9 countries (Australia, France, UK, Hungary, Ukraine, Italy, Philippines, Thailand, Russia) Study to compare the efficacy and tolerability of fluticasone propionate/salmeterol combination (SERETIDE/VIANI/ADVAIR) 88/42 μg once daily in the morning with fluticasone propionate 88 μg once daily in the morning and placebo (short‐acting beta₂‐agonist as required only) once daily in the morning, all via the HFA MDI as initial maintenance therapy in mild asthmatic patients
Participants	Population: 464 adolescents and adults (12 to 80 years) with mild asthma  Baseline characteristics: mean age 34 years; FEV₁ not reported % predicted Concomitant ICS used by 0% of participants  Inclusion criteria: documented clinical history of asthma for ≥ 6 months who were currently receiving short‐acting beta₂‐agonists alone Exclusion criteria: not reported
Interventions	• Fluticasone propionate and salmeterol 50/25 μg 2 puffs once daily • Fluticasone propionate 50 μg 2 puffs once daily Delivery was MDI device with HFA propellant
Outcomes	Primary efficacy endpoint: morning PEF
Notes	No SAEs at all were reported in the double‐blind phase of the study
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	433/464 (93%) completed the study
Selective reporting (reporting bias)	Low risk	Data on GSK website