World Journal of
Pharmaceutical and Life Sciences

EFFICACY AND SAFETY FOR THE COMBINATION OF DEXTROMETHORPHAN HYDROBROMIDE AND CHLORPHENIRAMINE MALEATE FOR THE TREATMENT OF UNPRODUCTIVE COUGH: A PHASE IV CLINICAL TRIAL

Dr. Mayuresh Kiran*, Lalit Pawaskar and Shaheen Sheikh

ABSTRACT

Introduction: Cough is one of the most common global complaint for which most of the patients requires the medical attention as it adversely affects the quality of life and lifestyle. Allergic rhinitis is one of the most common cause of unproductive cough. Unproductive cough due to allergic rhinitis can be treated by the combination of Dextromethorphan Hydrobromide (DMH) and Chlorpheniramine Maleate (CPM). So the study drug combination of DMH 10 mg and CPM 2 mg per 5 ml syrup was used to conduct an open-labelled, multicentric, post-marketing surveillance to substantiate the Safety and Efficacy in patients of unproductive cough caused due to allergic rhinitis. Methods: Of total 200 enrolled patients, 146 patients completed the study. Efficacy assessment was made by reduction in cough severity score (CSS) extrapolated to four point Likert-type scales. Safety assessment was done by analysing the adverse events throughout the study. Results: Reduction in mean CSS was done from 6.157 (baseline) to 3.335 (day 3) to 1.034 (day 5). One point reduction occurred in Likert-type symptom scale from moderate to mild occured in 3 days. At visit 2 and 3 there was decrease in CSS by 45.828 % and 83.203 % respectively as compared to baseline. Adverse events occurred in the duration of clinical trial were of mild intensity. Conclusion: A combination of Dextromethorphan Hydrobromide and Chlorpheniramine Maleate is safe as well as efficacious for the treatment of unproductive cough caused due to allergic rhinitis.

[Full Text Article]   [Download Certificate]