Efficacy, safety and tolerability of salbutamol + guaiphenesin + bromhexine (Ascoril) expectorant versus expectorants containing salbutamol and either guaiphenesin or bromhexine in productive cough: a randomised controlled comparative study

Abstract

Patients with acute bronchitis, acute exacerbations of chronic bronchitis and asthmatic bronchitis suffer from cough with tenacious bronchial secretions requiring expectorants in addition to bronchodilating therapy. The present one-week, multicentric, prospective, randomised, double-blind study compared the efficacy and tolerability of three expectorant formulations in 426 patients with productive cough associated with varied aetiology after approval by the institutional review boards. Selected patients received 7 days' treatment with either fixed dose combination (FDC) of salbutamol 2 mg + bromhexine HCI 8 mg + guaiphenesin 100 mg (group A) or salbutamol 2 mg+ guaiphenesin 100 mg expectorant (group B) or salbutamol 2 mg + bromhexine 8 mg (group C) thrice daily after obtaining their informed consent. In group A, there was improvement of symptoms in a larger number of patients and earlier onset of action in reducing cough frequency and severity and improving sputum characteristics as compared to the other two groups. More patients in group A reported excellent efficacy (44.4%) as compared to only 14.6% in Group B and 13% in Group C. Cough expectorant containing salbutamol + bromhexine +guaiphenesin could be the expectorant of choice in alleviating productive cough since it scored in terms of efficacy as well as tolerability over salbutamol with either bromhexine or guaiphenesin alone.