A Phase IV Clinical Study to Evaluate the Efficacy and Safety of Bresol and Septilin Tablets in Combination for Chronic Allergic Rhinitis and Recurrent Bacterial Sinusitis along with Impact on Immune System

Author(s):

Somashekara M, Srinivas S and Palaniyamma D*

The aim of the study was to evaluate the efficacy and safety of Bresol and Septilin tablets in combination in the management of chronic allergic rhinitis and recurrent bacterial sinusitis. A Phase IV clinical study was conducted to provide symptomatic relief in chronic allergic rhinitis and recurrent bacterial sinusitis along with impact on Immune System in 200 subjects. Subjects were assessed for all the details as per the inclusion and exclusion criteria. All the subjects were screened, as per the protocol and the eligible subjects were enrolled in the study and were subjected to study specific safety and clinical assessment, Hematological and biochemical investigations, recording adverse events during assessment visits at Day 30, 60 and 90. This study observed a significant symptomatic reduction in the mean scores for sneezing, nasal congestion, itching of the eyes, itching of nose, postnasal drip, rhinorrhea, headache, cough, and wheezing, nasal obstruction, watery eyes in both adults as well as in pediatric subjects with Bresol and Septilin tablets treatment in combination at recommended doses.