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Background:The efficacy of montelukast (MONT),a cysteinyl leukotriene receptor antagonist,in nonasthmatic eosinophilic bronchitis (NAEB),especially its influence on cough associated life quality is still indefinite.We evaluated the efficacy of MONT combined with budesonide (BUD) as compared to BUD monotherapy in improving life quality,suppressing airway eosinophilia and cough remission in NAEB.Methods:A prospective,open-labeled,multicenter,randomized controlled trial was conducted.Patients with NAEB (aged 18-75 years) were randomized to inhaled BUD (200 μg,bid) or BUD plus oral MONT (10 μg,qn) for 4 weeks.Leicester cough questionnaire (LCQ) life quality scores,cough visual analog scale (CVAS) scores,eosinophil differential ratio (Eos),and eosinophil cationic protein (ECP) in induced sputum were monitored and compared.Results:The control and MONT groups contained 33 and 32 patients,respectively,with similar baseline characteristics.Significant with-in group improvement in CVAS,LCQ scores,Eos,and ECP was observed in both groups during treatment.After 2-week treatment,add-on treatment of MONT was significantly more effective than BUD monotherapy for CVAS decrease and LCQ scores improvement (both P ＜ 0.05).Similar results were seen at 4-week assessment (both P ＜ 0.05).4-week add-on therapy of MONT also resulted in a higher percentage of patients with normal sputum Eos (＜2.5％) and greater decrease of ECP (both P ＜ 0.05).Conclusions:MONT combined with BUD was demonstrated cooperative effects in improvement of life quality,suppression ofeosinophilic inflammation,and cough remission in patients with NAEB.