G Fadda1. 1. Department of Respiratory Diseases, Alivesi Hospital, Ospedali Riuniti di Sassari, Ittiri (Sassari), Italy.
Abstract
BACKGROUND: The synthetic mucolytic neltene-xine is an amide derivative of ambroxol and thiophencarboxylic acid. The aim of this open, randomised, controlled study versus sobrerol was to evaluate the efficacy and tolerability of neltenexine (oral granules in sachets) as compared with sobrerol (oral granules in sachets), administered to patients with obstructive airways disease. METHODS:Thirty male and female patients were recruited. The exclusion criteria were allergy to neltenexine or sobrerol, an assessed diagnosis of severe bronchospasm requiring beta2-agonists, corticosteroids or aminophylline, pregnant or nursing women, cystic fibrosis, active tuberculosis or an assessed diagnosis of bronchiectasis. No infections of other organs (such as urinary tract infections) were present at baseline. Concomitant treatment with antitussives or other mucolytic agents was not allowed during the course of the study. Fifteen patients were randomised to treatment with neltenexine, 1 sachet thrice daily for 20 days orally (neltenexine group) and 15 patients to treatment with sobrerol, 1 sachet thrice daily for 20 days orally (sobrerol group). The efficacy parameters were: sputum characteristics and volume, difficulty in expectorating, cough, dyspnoea, pulmonary auscultation. Tolerability was monitored and adverse events were reported. RESULTS: The study highlighted that neltenexine has a good efficacy in the treatment of patients with obstructive airways disease entailing significant impairment of clinical parameters. CONCLUSIONS:Neltenexine can be an effective therapeutic alternative to sobrerol.
RCT Entities:
BACKGROUND: The synthetic mucolytic neltene-xine is an amide derivative of ambroxol and thiophencarboxylic acid. The aim of this open, randomised, controlled study versus sobrerol was to evaluate the efficacy and tolerability of neltenexine (oral granules in sachets) as compared with sobrerol (oral granules in sachets), administered to patients with obstructive airways disease. METHODS: Thirty male and female patients were recruited. The exclusion criteria were allergy to neltenexine or sobrerol, an assessed diagnosis of severe bronchospasm requiring beta2-agonists, corticosteroids or aminophylline, pregnant or nursing women, cystic fibrosis, active tuberculosis or an assessed diagnosis of bronchiectasis. No infections of other organs (such as urinary tract infections) were present at baseline. Concomitant treatment with antitussives or other mucolytic agents was not allowed during the course of the study. Fifteen patients were randomised to treatment with neltenexine, 1 sachet thrice daily for 20 days orally (neltenexine group) and 15 patients to treatment with sobrerol, 1 sachet thrice daily for 20 days orally (sobrerol group). The efficacy parameters were: sputum characteristics and volume, difficulty in expectorating, cough, dyspnoea, pulmonary auscultation. Tolerability was monitored and adverse events were reported. RESULTS: The study highlighted that neltenexine has a good efficacy in the treatment of patients with obstructive airways disease entailing significant impairment of clinical parameters. CONCLUSIONS:Neltenexine can be an effective therapeutic alternative to sobrerol.