Methods	Parallel-group, multicentre study (61 centres in UK) Jadad quality score = 4
Participants	Moderately severe steroid using asthmatic adults % ELIGIBLE OF SCREENED POPULATION: Not reported % RUN-IN PARTICIPANTS RANDOMISED: Not reported RANDOMISED: 68 (FP/SAL: 35; BDP: 33) WITHDRAWALS: FP/SAL: 10; BDP: 10 AGE: mean: 44 GENDER (% male): 50 SEVERITY: Moderate BASELINE % PREDICTED FEV1 (mean): 75 BASELINE DOSE OF ICS: 400 to 500 mcg/d BDP ASTHMA DURATION: Not reported ATOPY (%): Not reported ELIGIBILITY CRITERIA: >= 12 years of age; 400-500 mcg/d BDP equivalent; >= 50% < 85% predicted PEF during run-in; relief medication on >= 2 occasions on 3 of last 7 days; >= 2 on symptom scores on 3 of last 7 days on baseline OR >= 1 on night symptoms during same period 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: Current ICS treatment INTERVENTION PERIOD: 12 weeks TEST GROUP: Combination fluticasone and salmeterol 100/50 mcg bid CONTROL GROUP: Beclomethasone 400 mcg bid DEVICE: FP/SAL: Evohaler; BDP: Accuhaler NUMBER OF DEVICES: 1 (double-dummy design meant that participants given 2 inhalers) COMPLIANCE: Not assessed CO-TREATMENT: prn SABA
Outcomes	PULMONARY FUNCTION TEST: am PEF*; pm PEF SYMPTOM SCORES: Percentage symptom-free days* FUNCTIONAL STATUS: Rescue medication usage; health-related quality of life (AQLQ) INFLAMMATORY MARKERS: Not reported ADVERSE EFFECTS: Reported WITHDRAWALS: Reported Primary outcome measures*
Notes	Unpublished full data set available from http://www.ctr.gsk.co.uk Source of funding: GSK Confirmation of methodology and data: Obtained for methods User defined number: 800
Risk of bias
Item	Authors’ judgement	Description
Adequate sequence generation?	Yes	See Appendix 3
Allocation concealment?	Yes	See Appendix 3
Blinding? All outcomes	Yes	Double-dummy design
Incomplete outcome data addressed? All outcomes	Unclear	“The intention-to-treat (ITT) sample was used for the efficacy and safety analyses. This consisted of all subjects randomised to and receiving at least one dose of study medication.”
Free of selective reporting?	Yes	OCS-treated exacerbations available on request from study sponsor