Methods	Parallel-group, multicentre study (79 centres in Canada) Jadad quality score = 4
Participants	Controlled moderately severe asthmatic adults % ELIGIBLE OF SCREENED POPULATION: 71 % RUN-IN PARTICIPANTS RANDOMISED: Not reported RANDOMISED: 483 (FP/SAL: 242; FP: 241) WITHDRAWALS: FP/SAL: 43; FP: 41 AGE: mean: 39 GENDER (% male): 42 SEVERITY: Moderate BASELINE % PREDICTED FEV1: Not reported BASELINE DOSE OF ICS: >= BUD 400 mcg/d or equivalent ASTHMA DURATION: Not reported ATOPY (%): Not reported ELIGIBILITY CRITERIA: 12 to 70 years of age; clinical diagnosis of persistent asthma; ability to use HFA-salbutamol as prn SABA; >= BUD 400 mcg/d or equivalent; asthma control during run-in (defined by Canadian guidelines) EXCLUSION CRITERIA: Not reported
Interventions	LABA + ICS versus INCREASED dose ICS OUTCOMES TIMING: 12 weeks RUN-IN: 2 weeks DOSE OF ICS DURING RUN-IN: FP 250 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 SYMPTOM SCORES: % symptom-free days FUNCTIONAL STATUS: Rescue medication use; nocturnal awakenings INFLAMMATORY MARKERS: Not reported ADVERSE EFFECTS: Reported WITHDRAWALS: Reported Primary outcome measure*
Notes	Unpublished full data-set available from http://www.ctr.gsk.co.uk Source of funding: GSK Confirmation of methodology and data: Obtained for methods, not obtained for data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	“The primary population was the Intent-to-Treat (ITT) population. The ITT population was defined as subjects who were randomised and treated with at least one dose of investigational product.”
Free of selective reporting?	Yes	OCS-treated exacerbations available on request from study sponsor