Efficacy and safety for thecombination of bromhexine, salbutamol and etofylline in patients of acute exacerbations of chronic obstructive pulmonary disease: post-marketing surveillance study

Introduction - Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) can be treated with a combination of bronchodilators with various mechanisms of action and durations of action, as well as mucolytic agents. So the combination of Salbutamol, Etofylline and Bromhexine can be used for the treatment of AECOPD and to test the efficacy and safety this post marketing surveillance study was conducted.
Methodology –This study was conducted at 12 clinical trial sites and total 180 patients were recruited for the study out of which 168 patients completed the study. The reduction in cough Severity Score (CSS) and increase in %FEV1 were the efficacy assessment parameters for this study. Safety assessment was done by analysing the reported adverse events.
Results -CSS at baseline was 5.97 which was reduced to 3.35at day 3 and further reduced to1.01at day 5.FEV1 at baseline was 40.01%increased to59.84%at day 3 and further increased to 81.13% at day 5. Nearly all the Patients showed reduction in CSS and increase in FEV1 at all visits and the majority of Patients had complete relief from the symptom. There were 14 episodes of adverse events, all of them were mild in severity and non-serious in nature.
Conclusion - A fixed dose combination of Salbutamol 1mg, Etofylline 50mg and Bromhexine 4mg per 5ml was efficacious and safe for the treatment of AECOPD.