O'Sullivan 2003.

Methods	DESIGN ‐Cross‐over trial ALLOCATION ‐Random ‐Mode of randomisation: not described ‐Means of assignment: not described BLINDING ‐?triple‐blind ‐?double‐dummy ‐?identical placebo‐controlled WITHDRAWAL/DROPOUT ‐? described JADAD's Quality Score = ‐Confirmation of methodology obtained/not obtained
Participants	SYMPTOMATIC PARTICIPANTS RANDOMISED: N = 34 adults WITHDRAWALS: Montelukast: 3 (9%) Placebo: 2 (6%) + 1 no group specified AGE (Mean, SEM): ‐27.7 ± 1.1 years (range: 19 to 55) GENDER(% male): ‐53% Baseline mean FEV1 % Pred (± SD) ‐90.7± 3.4 % predicted ASTHMA SEVERITY: ‐mild ATOPY: ‐100 % atopic (one positive skin prick test to house dust mites or two other commonly inhaled allergens) ASTHMA DURATION: ‐not described ELIGIBILITY CRITERIA ‐Age: >=19 years ‐mild persistent asthma ‐FEV1 >=60% of predicted ‐change in FEV1 of 12% or more after salbutamol ‐provocative PD20% of 4 mg/mL or less ‐use of rescue B2‐agonists as needed ‐no inhaled steroids in previous 6 weeks ‐pre‐existing history of asthma Exclusion criteria: ‐not described
Interventions	PROTOCOL AL + ICS vs ICS (same dose) Duration ‐Run‐in Period: 2 weeks ‐Intervention Period 2: 8 weeks ‐Washout period: not reported TEST GROUP ‐Montelukast 10 mg qd p.o. ‐FP 100 mcg bid CONTROL GROUP ‐FP 100 mcg bid ‐Placebo montelukast capsule die DEVICE ‐Diskus CO‐INTERVENTION: ‐not described
Outcomes	ANALYSES not detailed (ITT vs per protocol) PULMONARY FUNCTION TESTS ‐change in FEV1 (L) ‐*change in AM PEF (L/min) ‐change in PM PEF (L/min) ‐methacholine PC20 SYMPTOM SCORES (PP) ‐change in symptom score (on a visual analogue scale) FUNCTIONAL STATUS (PP) ‐change in mean daily use of B2‐agonist (puffs/day) ‐change in quality of life score (range 1‐7) ‐change in Juniper Asthma Quality of Life INFLAMATORY MARKERS ‐change in induced sputum ‐exhaled nitric oxide ADVERSE EFFECTS ‐not reported WITHDRAWALS ‐not reported * primary outcome
Notes	‐Full text 2003 ‐Funding: GlaxoSmithKline R & D, UK ‐Confirmation of methodology and data extraction: not obtained ‐User‐defined order: 40 (intervention FP dose of 200 mcg/ day X 2)
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	Information not available (Cochrane Grade B)