SAM40012

Methods	A  randomised, double‐blind, double‐dummy, multi‐centre, parallel‐group study over 24 weeks from June 2000 to June 2001, at 38 centres in 7 countries (Bulgaria, Hungary, Israel, Poland, Russia, Spain, United Kingdom). Run‐in 2 weeks Comparison of 3 treatments: (1) salmeterol/fluticasone propionate (SFC) (50/100 μg strength) twice daily via Diskus/ACCUHALER inhaler, (2) fluticasone propionate 200 μg twice daily via Diskus/ACCUHALER inhaler, (3) fluticasone propionate 100 μg twice daily via Diskus/ACCUHALER inhaler in children aged 4 to 11 years with asthma
Participants	Population: 548 children (4 to 11 years) with asthma Baseline characteristics: mean age 8 years; FEV₁ not reported % predicted Concomitant ICS used by 100% of participants  Inclusion criteria: aged 4 to 11 years, inclusive, with documented evidence of asthma and receiving BDP, BUD, or equivalent at a dose of 400 to 500 μg/d or fluticasone propionate at a dose of 200 to 250 μg/d for at least 4 weeks before visit 1. Recorded symptom score (i.e. total score of daytime and night‐time scores) of at least 2 on the electronic daily record card on at least 3 of the last 7 consecutive days of the run‐in period and had a mean morning PEF (calculated from the last 7 days of the run‐in period) of between 50% and 85% of the PEF measured 15 minutes after administration of 400 μg of salbutamol at the randomisation visit. In addition, patients had to have recorded at least 70% of data into their electronic daily record cards  Exclusion criteria: not reported
Interventions	• Fluticasone propionate and salmeterol 100/50 μg twice daily • Fluticasone propionate 100 μg twice daily • Fluticasone propionate 200 μg twice daily Delivery was Diskus device (third arm not used in this review)
Outcomes	Primary efficacy endpoint: percentage of combined symptom‐free days and nights during weeks 1 to 24
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	513/548 (94%) completed the study
Selective reporting (reporting bias)	Low risk	Data on GSK website