Double blind study with neltenexine vs placebo in patients affected by acute and chronic lung diseases

BACKGROUND: The aim of this double-blind, randomised, controlled study vs placebo was to evaluate the efficacy and the tolerability of neltenexine, a recent mucoactive drug, in acute and chronic lung diseases. METHODS: Twenty-eight patients (5 cases of acute bronchitis, 3 cases of pneumonia and 20 cases of chronic bronchitis or emphysematous bronchitis) have been enrolled. The exclusion criteria were pulmonary tuberculosis, lung cancer, allergy to neltenexine, asthma, cystic fibrosis, bronchiectasis, pregnant or nursing women. Concomitant treatment with corticosteroids, beta 2-agonists, aminophyllin, antitussives, anticholinergic and other mucolytic agents were not allowed. The patients were allocated randomly to receive neltenexine (14 patients) or a matching placebo (14 patients), 1 tablet thrice daily, for 10 to 12 days. The efficacy criteria were sputum characteristic and volume, difficulty in expectorating, cough (intensity and quality), dyspnea, pulmonary auscultation. Tolerability was monitored and adverse events were reported. RESULTS: Neltenexine was statistically more active than placebo in terms of improving volume of sputum, dyspnea, pulmonary auscultation, quality of cough and difficulty in expectorating. The global assessment of overall therapeutic efficacy showed 12 positive cases for neltenexine and only 6 for placebo. The neltenexine tolerability was reported to be excellent or good. CONCLUSION: The study confirmed the previous clinical experiences showing that neltenexine is effectivee in the treatment of patients with acute and chronic lung diseases.