European Journal of Biomedical and Pharmaceutical Sciences

POST-MARKETING SURVEILLANCE STUDY TO SUBSTANTIATE THE EFFICACY AND SAFETY FOR THE COMBINATION OF PHENYLEPHRINE AND LEVOCETIRIZINE IN THE PATIENTS OF ALLERGIC RHINITIS IN INDIAN POPULATION

Dr. Mayuresh Kiran, Lalit Pawaskar*, Pramita Waghambare and Shaheen Sheikh

ABSTRACT

Introduction: Allergic rhinitis is most commonly encountered disease in clinical practises. Allergic rhinitis is developed due to release of histamine from mast cells due to hypersensitivity to any of the allergen to which the patient has been exposed. This study was conducted to test the efficacy and safety for the treatment of allergic rhinitis patients for the fixed dose combination of Phenylephrine 10 mg and Levocetirizine 2.5 mg per tablet in Indian population. Methodology: Out of 165 enrolled, 150 trial subjects completed the study. Efficacy assessment was made by total symptom score for which the trial subjects were asked to rate the symptoms on 11-point scale ranging from 0 means no symptoms at all to 10 means the maximum tolerated symptoms. Total symptom score was further extrapolated to four-point Likert-type symptom severity scale. Reported adverse events by the recruited trial subjects during the study were used to determine the safety of the Investigational product. Results: Reduction in Total Symptom Score was from 6.98 (baseline) to 3.15 (day 3) to 0.60 (day 5). Nearly all trial subjects had >50% reduction in total symptom score at all visits and most of the trial subjects had complete relief from the symptom of allergic rhinitis. Also, no serious or un-expected adverse event was reported during the study. Conclusion: Combination of Phenylephrine and Levocetirizine was found efficacious as well as safe for the treatment of allergic rhinitis.

Keywords: Phenylephrine, Levocetirizine, Allergic Rhinitis.