Renzi 2010

Methods	A 24‐week, multi‐centre, randomised, double‐blind, parallel‐group trial to compare the efficacy and tolerability of salmeterol/fluticasone propionate (ADVAIR®) Diskus inhalation device 50/100 μg twice daily vs fluticasone propionate Diskus inhalation device 100 μg twice daily as initial maintenance treatment in adult and adolescent patients with symptomatic persistent asthma not controlled on short‐acting bronchodilators alone
Participants	Population: 532 adults and adolescents (12+ years) with a documented history of asthma treated with SABA only Inclusion criteria: male and female patients ≥ 12 years of age with a documented history of asthma treated with SABA only and with FEV₁ ≥ 80% predicted were eligible for recruitment to the 2‐week run‐in period. They were recruited to the trial if they were symptomatic for the last 7 days of run‐in on SABA alone Exclusion criteria: key exclusion criteria were use of asthma controller medications in the previous month or systemic corticosteroids in the previous 12 weeks; exacerbations requiring emergency room treatment in the previous 6 weeks or hospitalisation in the previous 12 weeks; smoking history of ≥ 10 pack‐years
Interventions	• Fluticasone propionate and salmeterol 100/50 μg twice daily • Fluticasone 100 μg  twice daily Delivery device Diskus
Outcomes	Change in morning PEF over 24 weeks; SAEs fully reported in paper and in GSK Web report (SAS40068)
Notes	Sponsored by GSK
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
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	Unclear risk	53/262 on fluticasone propionate/salmeterol and 46/270 on fluticasone propionate lost to follow‐up (withdrawn due to adverse events, 6 and 11, respectively)
Selective reporting (reporting bias)	Low risk	SAEs fully reported in paper and in GSK Web report (SAS40068)