Shingo 2001.

Methods	DESIGN ‐parallel‐group study ‐multicentre ALLOCATION ‐Random ‐computer‐generated ‐assignment by numbered coded solutions supplied by Merck BLINDING ‐double‐blind ‐identical placebo WITHDRAWAL/DROPOUT ‐described JADAD's Quality Score =5 Methodology confirmed
Participants	WELL‐CONTROLLED PARTICIPANTS N = 22 patients montelukast: 10 placebo: 12 WITHDRAWALS: Montelukast: 10% Placebo: 8% AGE (Mean, SD): Montelukast: 41.0 ± 11.03 years Placebo: 37.00 ± 8.64 years GENDER(% male): Montelukast: 60% Placebo: 25% BASELINE % PRED FEV1 mean (SD): Montelukast:84.48± 8.68 % Placebo: 84.68 ± 8.4 % ATOPY: not described BASELINE DOSE OF ICS: 793 beclo‐equivalent:1523 (536) mcg/day or 761 mcg/day of BPD‐equivalent montelukast: 1600 mcg/day or 800 mcg/day of BDP‐equivalent placebo: 1350 mcg/day or 675 mcg/day of BDP equivalent ELIGIBILITY CRITERIA ‐non‐smoking patients ‐age 15 to 70 years ‐Stable asthma ‐Baseline FEV1>= 75% of predicted ‐improvement in FEV1>= 15% after inhaled beta2‐agonist ‐daytime symptom score <= 7 averaged over the run‐in period ‐stable doses of inhaled glucocorticoids for >= 21 days, namely BDP (600 to 1600 mcg/day), flunisolide (1000 to 2000 mcg/day), or triamcinolone (1200 to 3200 mcg/day) Exclusion criteria: not described
Interventions	PROTOCOL AL + ICS vs same dose ICS (TAPERING ICS dose) Duration ‐Run‐in Period: 7 to 10 days ‐Intervention Period : 8 weeks TEST GROUP ‐Montelukast 10 mg qd p.o. ‐Inhaled glucocorticoids: dose (median: 761 mcg/day of BDP equivalent) CONTROL GROUP ‐Placebo die ‐Inhaled glucocorticoids: dose (median: 675 mcg/day of BDP equivalent) DEVICE ‐not specified CO‐INTERVENTION: theophylline (? %) of patients
Outcomes	INTENTION‐TO‐TREAT ANALYSIS OUTCOMES REPORTED AT 8 WEEKS PULMONARY FUNCTION TESTS (measured but not reported) ‐% Change from baseline FEV1 ‐Change in am and pm PEFR (L/min) averaged over ? weeks ‐ diurnal PEFR variation FUNCTIONAL STATUS (measured but not reported) ‐Use of rescue beta2‐agonist (puffs/days) ‐Change in daytime symptom score (0‐6) ‐night‐time awakening ‐exacerbations requiring systemic steroids or hospital admission (reported upon request) ICS DOSE REDUCTION: ‐Number of patients tapered off ICS (mcg) INFLAMMATORY MARKERS: ‐not reported ADVERSE EVENTS: reported upon request WITHDRAWALS: reported upon request Primary outcome: change in baseline dose of ICS
Notes	‐Full‐text publication and unpublished data ‐Funded by Merck ‐Confirmation of methodology and data extraction graciously received from T.F Reiss and G.P. Noonan, Merck Frosst, USA, June 2001 user‐defined order: 80 (mean intervention ICS dose of 800 mcg/day of BDP‐equivalent 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)