Price 2003.

Methods	DESIGN ‐multicentre ALLOCATION ‐random ‐computer generated random numbers ‐assignment by numbered coded Rx supplied by pharmacy BLINDING ‐triple blind ‐identical placebo ‐double ‐dummy WITHDRAWALS/ DROPOUT ‐described JADAD's Quality Score = 5 Confirmation of methodology confirmed
Participants	SYMPTOMATIC PARTICIPANTS RANDOMISED ‐ N= 889 ‐M10 + BUD = 448 ‐2 X ICS= 441 WITHDRAWALS ‐M10 + BUD 800 = 20 (4.5%) ‐2 X ICS= 26 (6%) GENDER (% male) ‐M10 + BUD= 41% ‐2 X ICS =39% AGE (SD) years ‐M10 + BUD = 43 ± 14 ‐2 X ICS= 43 ± 14 (SD) SEVERITY ‐not specified BASELINE PREDICTED FEV1 % (SD) ‐M10 + BUD = 69.0 ± 13.3 ‐2 X ICS = 68.3 ± 13.4 ALLERGEN TRIGGERS ‐not described ASTHMA DURATION (SD) years ‐ M10 + BUD = 18 ±14 ‐2 X ICS = 17 ± 15 ELIGIBILITY CRITERIA ‐non‐smokers or ex‐smokers ‐diagnosis of asthma > 1 year ‐age 15 to 75 ‐not optimally controlled on ICS 600 to 1200 mcg/day of BUD, BDP, triamcinolone, flunisolide, or 300‐800 mcg FP ‐FEV1 >= 50% predicted ‐>=12% improvement in FEV1 after B2‐agonist use ‐symptoms requiring at least 1 puff/day of B2‐agonist during the last 2 weeks of the run‐in EXCLUSION CRITERIA ‐other active pulmonary disorders ‐respiratory infection within 3 weeks of visit 1 or during the run‐in period ‐ER visit for asthma in past 2 months of visit 1 ‐systemic corticosteroid treatment within 1 month ‐cromones or leukotriene receptor antagonists within 2 weeks ‐long‐acting antihistamine within 1 week (astemizole 3 months) ‐long acting B2 agonist or anticholinergic agents within 24 hours
Interventions	PROTOCOL ‐AL + ICS vs. DOUBLE dose ICS DURATION ‐run‐in period = 4 weeks ‐treatment period = 12 weeks TEST GROUP ‐ICS (BUD 800mcg/day) + 10 mg/day montelukast CONTROL GROUP ‐ICS (BUD 1600mcg/day) + placebo DEVICE ‐Turbohaler CO‐TREATMENT ‐ none reported
Outcomes	INTENTION‐TO‐TREAT ANALYSES PULMONARY FUNCTION TESTS ‐change in FEV1 (L) ‐*change in AM PEF (L/min) SYMPTOM SCORES (PP) ‐change in symptom score (scale 0 to 6) FUNCTIONAL STATUS (PP) ‐change in mean daily use of B2‐agonist (puffs/day) ‐change in quality of life score (range 1‐7) ‐change in nocturnal awakenings INFLAMATORY MARKERS ‐change in peripheral blood eosinophil count ADVERSE EFFECTS ‐reported WITHDRAWALS ‐reported * primary outcome
Notes	‐Full text 2003 ‐Funding: Merck & Co ‐Confirmation of methodology and data extraction obtained by DB Price, August 2003 ‐User‐defined order: 80 (mean intervention ICS dose of 800 mcg/ day X 0.1)
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	Study investigators unaware as to order of treatment group assignment (Cochrane Grade A)