Abstract: AIM: To evaluate the efficacy and safety of montelukast in elderly patients affected by stable moderate to severe chronic obstructive pulmonary disease(COPD). METHODS: In this randomized, prospective, single-blind, and controlled study, 60 COPD patients treated with formoterol plus budesonide were randomized to receive treatment of oral montelukast for 6 months(montelukast group) or not(control group).The baseline dyspnea index(BDI), the St George's Respiratory Questionnaire (SGRQ) scores, pulmonary function tests(PFTs), induce sputum and the levels of LTB₄ were compared before and after the treatment in two groups.RESULTS: 47 patients had completed the study, no severe montelukast relevant side effects were reported during the observation period. After the treatment,the BDI was increased in the two groups,but the SGRQ score and the percentage of neutrophil of induced sputum were decreased(P<0.05),the pulmonary functions were not markedly improved(P>0.05). Compared with the control group,the percentage of neutrophils of induced sputum in montelukast group was decreased;the BDI,the SGRQ score,the levels of LTB₄ had significant improvement,there were statistically significant difference(P<0.05).CONCLUSION: The treatment of montelukast added to inhaled budesonide and formoterol in elderly stable patients with moderate to severe COPD is effective and safe.

Key words: Montelukast, Leukotriene receptor antagonist, Chronic obstructive pulmonary disease, Therapeutic effect