Study of Safety and Efficacy for the Combination of Chlorpheniramine maleate and Phenylephrine in Infants suffering from Allergic Rhinitis and Associated Symptoms

ABSTRACT

Introduction: The epidemiological data suggest that thereis alarming rise in the prevalence of allergic rhinitis. It oftengoes intractable in small children. A combination of nasaldecongestant and antihistaminic drug is preferred over thevarious aetiologies associated with allergic rhinitis. Studyobjective was to evaluate the efficacy and safety for thecombination of Chlorpheniramine maleate and Phenylephrinein patients of allergic rhinitis and associated symptoms.Material and Methods: Total 215 patients were enrolledout of which 177 patients completed the study and efficacyassessment was made by reduction in TSS and four pointLikert-Type scales. Safety assessment was made by analysingthe adverse events during clinical trial.Results: There was significant reduction in TSS from 5.677(baseline) to 2.711 (day 3) and 0.542 (day 5). At day 3 andday 5 there was reduction of 52.23% and 90.44% as comparedto baseline. Nearly all the patients had > 50% reduction insymptom score at all visits and majority of patients hadcomplete relief from the symptom.Conclusion: A combination of Phenylephrine andChlorpheniramine maleate was found to be efficacious as wellas safe in the treatment of allergic rhinitis.