Abstract

SAFETY AND EFFICACY OF A COMBINATION OF PARACETAMOL, PHENYLEPHRINE AND FEXOFENADINE IN ADULT PATIENTS OF COMMON COLD AND ALLERGIC RHINITIS: PHASE IV STUDY

Dr. Mayuresh Dilip Kiran* and Lalit Jeevan Pawaskar

Abstract

Introduction: Common cold and allergic rhinitis both are most commonly encountered diseases in clinical practises in India. Though self-limiting, it accounts for major loss of school and work days. Symptomatic therapy is often used to treat the symptoms. Combination of analgesic/anti-inflammatory/antipyretic, anti-histaminic and nasal decongestant is popular in the treatment of common cold and allergic rhinitis. This Phase IV study evaluated the efficacy and safety of one such combination of Paracetamol, Phenylephrine and Fexofenadine in treatment of common cold and allergic rhinitis. Materials and Methods: Of total 189 enrolled patients, 154 patients completed the study. Efficacy assessment was made by reduction in Total Symptom Score and four point Likert-type scales. Safety assessment was made by analysing the adverse events through the study. Results: Reduction in mean TSS was done from 6.90 (baseline) to 3.42 (day 3) to 0.88 (day 5). Two points were reduced in Likert-type symptom scale from Severe to Mild in 3 days. Nearly all the patients had >50% reduction in their total symptom score at all visit and majority of patients had complete relief from the symptoms at visit 3. Four episodes of adverse events occurred and all of them were of mild intensity. Conclusion: A combination of Paracetamol, Phenylephrine and Fexofenadine is safe and effective in the treatment of common cold and allergic rhinitis.

Keywords: Paracetamol, Phenylephrine, Fexofenadine, Common Cold, Allergic Rhinitis.