Finn 2000.

Methods	DESIGN ‐parallel‐group ‐multicentre trial ‐Analysed by co‐treatment with ICS ALLOCATION ‐Random ‐Methods of randomisation: not described ‐Means of treatment assignment: not described BLINDING ‐double‐blind ‐Means of concealment: not described WITHDRAWAL/DROPOUT ‐not described JADAD's Quality Score =2 ‐Confirmation of methodology: not obtained
Participants	SYMPTOMATIC PARTICIPANTS RANDOMISED N = 479 of which only 98 were co‐treated with inhaled glucocorticoids Zafirlukast + ICS = 56 ICS alone = 42 WITHDRAWALS AMONG CHILDREN WITH CO‐TX WITH ICS not described Zafirlukast: % Control: % AGE: 5‐11 years old Zafirlukast: years Control: years GENDER (% male) not described SEVERITY: mild‐moderate asthma BASELINE % predicted FEV1 Zafirlukast: 72 ± 12 (SD) Control: 71 ± 12 ALLERGIC RHINITIS: Zafirlukast: 76% Control: 74% EXERCISE‐INDUCED ASTHMA: Zafirlukast: 88% Control: 83% ASTHMA DURATION: Zafirlukast: 19 (0.5 to 62) years Control: 18 (0.5 to 59) years ELIGIBILITY CRITERIA ‐Age: > 15 years old ‐healthy, non‐smoking ‐history of >= one year of intermittent or persistent asthma symptoms ‐ICS treatment >= 6 wks prior to pre‐study visit (ICS dose comparable to beclomethasone 400 to 500 mcg) ‐50 to 85% FEV1 Pred ‐improvement > 15% FEV1 after B2‐agonist ‐ >= 1 puff/day of B2‐agonist EXCLUSION CRITERIA: ‐Upper respiratory tract infection < 3 weeks
Interventions	PROTOCOL: AL + ICS vs SAME dose ICS DURATION: ‐Run‐in Period: 7‐14 days ‐Intervention Period: 10 weeks TEST GROUP Accolate 10 mg bid +/‐ ICS (dose not specified) CONTROL GROUP Placebo +/‐ ICS (dose not specified) DEVICE ‐not specified ‐CO‐TREATMENT: not described
Outcomes	INTENTION‐TO‐TREAT ANALYSES: not described PULMONARY FUNCTION TESTS ‐*change in AM PEF (L/min) SYMPTOM SCORES (PP) ‐not reported FUNCTIONAL STATUS (PP) ‐change in mean daily use of B2‐agonist (puffs/day) ‐change in nocturnal awakenings/week INFLAMATORY MARKERS ‐not described ADVERSE EFFECTS ‐not reported WITHDRAWALS ‐not reported * primary outcome
Notes	‐Abstract 2000 ‐Funded by Astra‐Zenece ‐Confirmation of methodology and data extraction: not obtained. User‐defined order: not specified (mean intervention ICS dose in mcg/day X 0.1)
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	Information not available (Cochrane Grade B)