Methods	Parallel-group trial, single centre in Netherlands Jadad quality score = 4
Participants	Moderately severe asthmatic adults % ELIGIBLE OF SCREENED POPULATION: Not reported % RUN-IN PARTICIPANTS RANDOMISED: Not reported RANDOMISED: 12 (FP/SAL: 5; FP: 7) WITHDRAWALS: 0 AGE: mean: 39 GENDER (% male): 5 SEVERITY: Moderate BASELINE % PREDICTED FEV1: Not reported BASELINE DOSE OF ICS: 500 to 1000 mcg/d FP ASTHMA DURATION: Not reported ATOPY (%): Not reported ELIGIBILITY CRITERIA: Requirement for 500 to 1000 mcg/d FP; morning PEF during run-in 50% to 85%; cumulative symptom score indicating moderate asthma; PC20 > 4 mg/ml histamine EXCLUSION CRITERIA: Dermatitis; recent lower RTI; exacerbation in last 3 months; smoking history of at least 10 pack-years
Interventions	LABA + ICS versus INCREASED dose ICS OUTCOMES TIMING: 58 weeks RUN-IN: Not specified DOSE OF ICS DURING RUN-IN: Not specified INTERVENTION PERIOD: 58 weeks TEST GROUP: Combination fluticasone and salmeterol 250/50 mcg bid CONTROL GROUP: Fluticasone 500 mcg bid DEVICE: Diskus NUMBER OF DEVICES: 1 COMPLIANCE: Not assessed CO-TREATMENT: prn SABA
Outcomes	PULMONARY FUNCTION TEST: Not reported SYMPTOM SCORES: Not reported FUNCTIONAL STATUS: Exacerbations (not defined) INFLAMMATORY MARKERS: PC20* ADVERSE EFFECTS: Reported WITHDRAWALS: Reported Primary outcome measure*
Notes	Unpublished full data set from http://www.ctr.gsk.co.uk Source of funding: GSK Confirmation of methodology and data: Not obtained User defined number: 2000
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	Yes	No withdrawals occurred
Free of selective reporting?	Yes	Exacerbations described in trial report available; OCS-treated exacerbations could not be identified from the data available. Data used in sensitivity analysis (see Analysis 3.1)