Vaquerizo 2003.

Methods	DESIGN ‐parallel‐group ‐multi‐centre (80 sites in Spain) ALLOCATION ‐random ‐central computer generated schedule ‐treatment assignments (1:1) stratified according to site and 3 BUD dose levels (400‐800 mcg/day ; 801‐1200 mcg/day ; and 1201‐1600 mcg/day) ‐Mode of treatment allocation not described WITHDRAWALS/ DROPOUTS ‐described JADAD's quality score = 5 Confirmation of methodology: requested but not obtained
Participants	WELL‐CONTROLLED PARTICIPANTS RANDOMISED ‐N = 639 ‐BUD + M = 326 ‐BUD + placebo = 313 WITHDRAWALS ‐BUD + M = 34 (10%) ‐BUD + placebo = 32 (10%) AGE years (SD) ‐range 18‐79 ‐BUD + M = 42 (15) years ‐BUD + placebo = 44 (16) years GENDER (% male) ‐BUD + M = 62% ‐BUD + placebo = 61% SEVERITY ‐mild to moderate asthma BASELINE % PREDICTED FEV1 (SD) ‐BUD + M = 81 (19) ‐BUD + placebo = 81 (21) ALLERGEN TRIGGERS ‐not described ELIGIBILITY CRITERIA ‐non‐smokers ‐aged 18‐70 (*age of participants outside of range*) ‐treated with 400‐1600mcg/day BUD for at least 8 weeks ‐FEV1 >= 55% predicted ‐reversible airway obstruction (increase >= 12% of baseline FEV1) ‐minimum total daytime asthma symptom score of 64 during the 2 week run‐in period ‐using a mean of at least 1 puff/day of B2‐agonist during run‐in period ‐negative pregnancy test (urine B‐human chorionic gonadotropin) ‐use of contraceptive 2 weeks prior to treatment and 2 weeks after study EXCLUSION: ‐not described
Interventions	PROTOCOL ‐AL + ICS vs. SAME dose ICS + placebo DURATION ‐2 week run‐in period ‐16 week treatment period TEST GROUP ‐montelukast (10mg/day) + BUD (400‐1600 mcg/day) CONTROL GROUP ‐placebo + BUD (400‐1600 mcg/day) DEVICE ‐Turbuhaler CO‐TREATMENT ‐use of B2‐agonist as needed
Outcomes	INTENTION‐TO‐TREAT ANALYSES PULMONARY FUNCTION TESTS ‐% change from baseline at end point ‐% change in am and pm PEFR (L/min) ‐% change in FEV1 (L) SYMPTOM SCORE ‐% change from baseline in daily daytime symptom score (range not specified) FUNCTIONAL STATUS ‐*% of asthma exacerbation days ‐% change in mean daily use of B2‐agonist (puffs/day) ‐change in nocturnal awakenings ‐change in asthma specific quality of life (32 questions, range 0‐6) INFLAMATORY MARKERS ‐none documented ADVERSE EFFECTS ‐described ‐influenza, headache, URI, worsening asthma, epigastric pain, urinary tract infections, rhinitis, pharyngitis, bronchitis WITHDRAWALS ‐reported * Primary outcome
Notes	‐Full text (2003) ‐Funded by Merck Sharp and Dohme Spain ‐Confirmation of methodology and data extraction requested:not obtained ‐user‐defined order: 80 mcg/day (mean ICS dose about 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)