Neltenexine versus carbocysteine in the treatment of exacerbations of mild chronic obstructive pulmonary disease: A randomized, controlled, open-label study

Abstract

Background: Despite the positive results of several long-term, randomized, controlled studies of mucoactive drugs for chronic obstructive pulmonary disease (COPD), the European Respiratory Society and American Thoracic Society guidelines do not recommend the prescription of these drugs in COPD. New efficacy data on mucoactive drugs may help calculate the sample size for future large studies evaluating COPD exacerbation frequency, changes in quality of life, and pharmacoeconomic factors. Objective: The aim of this randomized, open-label, controlled study was to compare the efficacy and tolerability of neltenexine versus carbocysteine in patients with COPD exacerbations treated concurrently with antibiotics. Methods: Patients with COPD exacerbation were treated with standard antibiotic therapy (ampicillin 1 g IM BID for 6 days) and randomly assigned to receive 1 of 2 treatments: neltenexine oral powder 1 sachet TID for 12 days or carbocysteine 5% syrup, 50 mg TID for 12 days. Treatment with aminophylline in standard doses was also allowed. The efficacy variables were sputum characteristics and volume, cough, difficulty in expectorating, dyspnea, pulmonary auscultation findings, vital capacity (VC), peak expiratory flow, and forced expiratory volume in 1 second (FE 1). Results: A total of 30 patients were enrolled, with 15 patients randomized to each group. All patients completed the study. The differences between neltenexine and carbocysteine in terms of cough reduction and improvement in sputum characteristics was significantly different ( P < 0.05). The time to improvement in difficulty expectorating, cough, and sputum characteristics was significantly shorter for patients in the neltenexine group ( P < 0.05, P < 0.02, and P < 0.02, respectively, at day 4). No statistically significant changes versus baseline were observed in VC, FEV 1, or peak expiratory flow. Only 1 patient, in the neltenexine group, experienced an adverse event (heartburn). Conclusions: These results confirm the efficacy and tolerability of neltenexine in patients with exacerbations of COPD. Neltenexine may be a good therapeutic alternative to carbocysteine during exacerbations of COPD treated with antibiotics.