Tomari 2001.

Methods	DESIGN ‐parallel‐group ALLOCATION ‐random: not specified ‐Mode of allocation (not described) BLINDING ‐not described WITHDRAWALS/ DROPOUTS ‐described JADAD's Quality Score = 2 Confirmation of methodology not obtained
Participants	SYMPTOMATIC PARTICIPANTS RANDOMISED ‐N=41 ‐BDP + pranlukast = 21 ‐2 X BDP = 20 WITHDRAWALS ‐none AGE years (SEM) ‐BDP + pranlukast = 53.7 (3.1) (SEM) ‐2 X BDP = 56.1 (3.2) (SEM) GENDER (% male) ‐BDP + pranlukast = 38% ‐2 X BDP = 45% SEVERITY ‐ moderate asthma BASELINE % PREDICTED FEV1 ‐not documented BASELINE % PREDICTED PEF ‐BDP + pranlukast = 72.1 ± 2.8 (SEM) ‐2 X BDP =69.5 ± 3.1 (SEM) ALLERGEN TRIGGERS ‐not reported ASTHMA DURATION years (SEM) ‐BDP + pranlukast = 14.8 (2.7) (SEM) ‐2 X BDP = 14.1 (2.7) (SEM) ELIGIBILITY CRITERIA ‐diagnosis of asthma ‐treated with 800 mcg/day of BDP ‐PEFR < 80% predicted EXCLUSION CRITERIA ‐pulmonary or bronchial diseases for 2 weeks before study
Interventions	PROTOCOL: AL + ICS vs DOUBLE dose ICS DURATION ‐2 week run‐in period ‐16 week treatment period TEST GROUP ‐BDP 800 mcg/day + 450 mg/day pranlukast CONTROL GROUP ‐2 X BDP (1600 mcg/day) DEVICE ‐not specified CO‐TREATMENT ‐theophylline and B2‐agonists if previously in use
Outcomes	INTENTION‐TO‐TREAT ANALYSES ‐outcome reported at 16 weeks PULMONARY TESTS ‐pre and post treatment am PEFR (%) ‐pre and post treatment in daily variability of PEFR (%) SYMPTOM SCORES ‐pre and post treatment symptom score (sum of 7 symptoms scored from 0‐3) FUNCTIONAL STATUS ‐pre and post treatment B2‐agonists use/week INFLAMATORY MARKERS ‐not reported ADVERSE EFFECTS ‐reported WITHDRAWALS ‐no withdrawals * Primary outcome not mentioned
Notes	‐Full text 2001 ‐Funding not specified (information requested) ‐Confirmation of methodology and data extraction not obtained. ‐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)	Unclear risk	Information not available (Cochrane Grade B)