Methods	Parallel-group, multicentre study (124 centres in France). Three treatment groups (FP/SAL 250/50; FP/SAL 100/50; FP250) Jadad quality score = 4
Participants	Moderately severe well-controlled asthmatic adults % ELIGIBLE OF SCREENED POPULATION: Not reported % RUN-IN PARTICIPANTS RANDOMISED: Not reported RANDOMISED: 318 (FP/SAL: 158; FP: 159) WITHDRAWALS: FP/SAL: 15; FP: 30 AGE mean: 45 GENDER (% male): 50 SEVERITY: Moderately severe BASELINE % PREDICTED FEV1: 90 BASELINE DOSE OF ICS: 1000 mcg/d BDP ASTHMA DURATION: Not reported ATOPY (%): Not reported ELIGIBILITY CRITERIA: >= 18 years of age; documented history of asthma for at least 6 months; treatment with high dose BDP and LABA for 4 weeks; symptoms < 2 days per week; use of rescue medication < 2 days and < 4 occasions per week; PEF > 80% every day during run-in EXCLUSION CRITERIA: Significant smoking history; RTI in 4 weeks prior to randomisation; exacerbation in 4 weeks prior to baseline; use of depot steroid in 12 weeks prior to visit 1; change in asthma medication
Interventions	LABA + ICS versus INCREASED dose ICS OUTCOMES TIMING: 24 weeks RUN-IN: 8 weeks DOSE OF ICS DURING RUN-IN: 500 mcg/d (combination FP/SAL 250/50 mcg bid) INTERVENTION PERIOD: 12 weeks TEST GROUP: Combination fluticasone and salmeterol 100/50 mcg bid CONTROL GROUP: Fluticasone 250 mcg bid DEVICE: Diskus NUMBER OF DEVICES: 1 COMPLIANCE: Not assessed CO-TREATMENT: prn SABA
Outcomes	PULMONARY FUNCTION TEST: am PEF*; pm PEF; FEV1 SYMPTOM SCORES: Not reported FUNCTIONAL STATUS: Exacerbations (not defined) INFLAMMATORY MARKERS: Not reported ADVERSE EFFECTS: Reported WITHDRAWALS: Reported Primary outcome measure*
Notes	Full unpublished data set available from http://www.ctr.gsk.co.uk Source of funding: GSK Confirmation of methodology and data: Obtained for methods, not obtained for data User defined number: 1000
Risk of bias
Item	Authors’ judgement	Description
Adequate sequence generation?	Yes	See Appendix 3
Allocation concealment?	Yes	See Appendix 3
Blinding? All outcomes	Yes	Identical inhaler devices used
Incomplete outcome data addressed? All outcomes	Unclear	“Full Analysis Set (FAS) population consisted of all subjects who received at least one dose of study medication and for whom the assessment data for at least one assessment criterion was available.”
Free of selective reporting?	Yes	OCS-treated exacerbations available on request from study sponsor