Riccioni 2002.

Methods	DESIGN ‐parallel‐group ALLOCATION ‐random ‐method of randomization: computer generated ‐method of assessment: not described BLINDING ‐reported as double‐blind (patient and assessor) but without placebo WITHDRAWAL/DROPOUT ‐described JADAD = 3 CONFIRMATION OF METHODOLOGY: obtained (Oct 2003)
Participants	SYMPTOMATIC PARTICIPANTS RANDOMISED (N=45) M=15 BUD=15 M+BUD=15 WITHDRAWALS: M=1 (7%) BUD=1 (7%) M+BUD=1 (7%) AGE (± SD) M= 26.7 ± 8.6 BUD=26.9 ± 12.3 M+BUD=28.2 ± 10 GENDER (% male) M= 9 (60) BUD=8 (53.3) M+BUD=5(33.7) ASTHMA SEVERITY: ‐mild ASTHMA DURATION: ‐1 year % Pred. FEV1 M=97 (85‐123) BUD=97 (76‐123) M+BUD=99 (84‐131) Mean (+‐SD) beta2agonist use (puffs per day) ‐not described ATOPY: ‐100% (Definition not mentioned) ELIGIBILITY CRITERIA ‐asthma as per ATS criteria ‐confirmation of the presence of BHR by methacholine on the initial visit ‐regular attendance of the outpatient clinic over 4 months from the initial visit ‐PEF >= 80% of predicted ‐PEF variability <=20% as per NIH criteria EXCLUSION: ‐ER visit for asthma exacerbation within 1 month ‐ URTI in the past 4 weeks ‐hospitalization for asthma in past 6 months ‐treatment with antihistamines, anticholinergics, theophylline and cromones, LABA, inhaled and oral corticosteroids ‐bronchiectasis ‐gastroesophageal reflux ‐poor knowledge of the Italian language
Interventions	PROTOCOL Duration ‐Run‐in: 4 weeks ‐Intervention: 16 weeks TEST GROUP 1 ‐10 mg montelukast once daily TEST GROUP 2 10 mg Montelukast once daily + 400 ug budesonide bid CONTROL GROUP ‐400 Budesonide bid DEVICE ‐turbohaler CRITERIA FOR WITHDRAWAL ‐not described CO‐INTERVENTION: ‐none permitted
Outcomes	ANALYSIS PER PROTOCOL (not by ITT) OUTCOMES ‐reported at 16 weeks PULMONARY FUNCTION TEST ‐change from baseline in FVC ‐change from baseline in FEV1 ‐change from baseline in PC20 SYMPTOM SCORES ‐not reported FUNCTIONAL STATUS ‐Change in AQOL (Asthma Quality of Life Questionnaire ‐ Juniper) in each of 4 domains ‐Asthma exacerbations (defined as requiring systemic steroids or hospital admission or ED treatment for worsening asthma or decrease in morning PEF >25% INFLAMMATORY MEDIATORS ‐not reported ADVERSE EVENTS ‐not mentioned WITHDRAWALS ‐reported Primary outcome not specified
Notes	‐Full‐text publication Funded by University ‐confirmation of methodology and data extraction: obtained by Graziono Riccioni, Oct 2003 ‐confirmation of methodology and data obtained USER‐DEFINED ORDER: 800 (daily dose of BDP‐equivalent=800 mcg )
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	High risk	Study investigators aware as to treatment group assignment (Cochrane Grade C)