drugset / Trial / NCT02551536

Montelukast and Fexofenadine Versus Montelukast and Levocetrizine Combination in Allergic Rhinitis

NCT02551536

Phase 4 Completed 70 enrolled Indira Gandhi Medical College, Shimla
RandomizedParallel-groupDouble-blindTreatment

Summary

Objectives: Allergic Rhinitis (AR) is a global health problem. 10-25% of population worldwide is affected by AR. Oral/intranasal H1-antihistamine, decongestants, leukotriene receptor antagonists, intranasal corticosteroids are the pillars in the management of AR.Materials and methods: Seventy patients with allergic rhinitis participated in a prospective, randomized, double-blind, parallel, active controlled, comparative 4 week trial. The patients between age group of 18-65 years of either gender having moderate-severe intermittent or mild persistent allergic rhinitis were included. The study inclusion criteria required the subjects with Total Nasal Symptom Score (TNSS) of 5 or higher. The patients were randomly divided into two treatment groups with montelukast-levocetrizine (10 mg and 5 mg) in one group and montelukast-fexofenadine (10 mg and 120 mg) in another group. TNSS parameter was the main effectiveness parameter.

Timeline

Start
2014-04
Primary completion
2015-04
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Fexofenadine Unknown 120 mg Oral
Comparator Levocetrizine Unknown 5 mg Oral
Subject Montelukast Other / unclassified 10 mg Oral

Indications