Abstract

CLINICAL EFFICACY AND SAFETY OF KOFAREST DROPS IN PRODUCTIVE COUGH

Dr. Mayuresh Dilip Kiran*, Sharvari Jayant Lotankar and Lalit Jeevan Pawaskar

Abstract

Introduction- Cough accounts for the most frequent reason for the visit to the pulmonologist and the primary care physicians along with being one of the commonest symptoms that the physicians face with the pediatric population at majority. Methods- A Non-randomized, non-comparative, user-initiated trial was conducted across the 12 investigational centers for a duration of 5 days. A total of 231 patients were enrolled and screened for the study out of which 217 patients completed the study trial and 14 patients were lost to followup. Results- A reduction in CSS was observed and the mean of the cough symptom score (CSS) was recorded at all the visits (V0, V1 and V2). The mean CSS at V0 or the baseline visit at day 1 or V1 was 6.09 which was reduced to 3.31 at V2 at day 3 and further reduced to 0.61 on V3 or day 5. The reduction in CSS corresponded with the improvement in general and physical examination of the patients. The overall incidence of reported study drug related adverse events were 49 seen in 28 patients. Overall 41 adverse events related to study drug formulation was reported. Adverse event such as vomiting was the most documented adverse event in this study affecting 3.68 % of the study population. Conclusion- Thus, Kofarest drops (ambroxol drops) is considered to be safe and effective and provides symptomatic relief for the treatment of productive cough.

Keywords: CSS, Adverse Events, Cough, Ambroxol.