Neltenexine tablets in smoking and non-smoking patients with COPD. A double-blind, randomised, controlled study versus placebo

Abstract

Background: The aim of this double-blind, randomised, controlled study vs placebo was to evaluate the efficacy and tolerability of neltenexine (tablets) versus placebo (tablets), administered to smoking and non-smoking patients with chronic obstructive pulmonary disease (COPD).

Methods: Sixty patients with mild stable COPD were recruited. The exclusion criteria were lung cancer, pulmonary tuberculosis, asthma, cystic fibrosis, bronchiectasis, community-acquired pneumonia (CAP), intercurrent infections, concomitant treatment with corticosteroids, antitussives, beta2 agonists, anticholinergic and other mucolytic agents. The patients were allocated randomly to receive neltenexine (20 smokers and 20 non-smokers) or a matching placebo (20 smokers), 1 tablet twice daily for 20 days. The efficacy criteria were sputum characteristics and volume, difficulty in expectorating, cough, dyspnoea, pulmonary auscultation, forced expiratory volume in one second (FEV1), vital capacity and arterial partial oxygen pressure (PO2). Tolerability was monitored and adverse events were reported.

Results: At the study end, the improvement of patients treated with neltenexine (smokers and non-smokers) was greater and statistically significant as compared with the patients in the placebo group in terms of improvement of dyspnoea (p<0.02), cough (p<0.02), pulmonary auscultation (p<0.02), and difficulty in expectorating (p<0.02). Furthermore, a significant improvement of the sputum characteristics (p<0.02) and volume (p<0.01) was evidenced, as compared with patients treated with placebo, in non smoking patients treated with neltenexine and in smoking patients treated with neltenexine.

Conclusions: The study confirmed earlier clinical experiences showing that neltenexine is effective in the treatment of COPD patients and highlighted the correlation between abstention from smoking and the efficacy of mucoactive treatment.