drugset / Trial / NCT02238353

AZELASTINE/FLUTICASONE (AZE/FLU) Nasal Spray on Symptom Control, Nasal Mediators and Nasal Hyperresponsiveness in Allergic Rhinitis (AR)

NCT02238353

Phase 4 Unknown 45 enrolled Universitaire Ziekenhuizen KU Leuven
RandomizedParallel-groupTriple-blindTreatment

Summary

Comparative analysis of the efficacy of intranasal MP29-02 (a novel formulation of azelastine and FP) has already been conducted in patients with moderate-to-severe seasonal AR. The combination formulation appeared to be superior in these patients with better symptomatic relief. However, objective analysis of the effect of this treatment on nasal mediators and/or nasal hyperreactivity has not yet been performed and would help in understanding the additional benefit of the combination treatment over monotherapy with nasal corticosteroids.

Timeline

Start
2014-10
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Azelastine Small molecule 137 ug Intranasal
Subject Fluticasone Other / unclassified 50 ug Intranasal