drugset / Trial / NCT07415278

INTRANASAL FLUTICASONE VERSUS FLUTICASONE-AZELASTINE COMBINATION

NCT07415278

Phase 4 Active not recruiting 61 enrolled Pamukkale University
RandomizedParallel-groupOpen-labelTreatment

Summary

This prospective comparative study was conducted to evaluate the clinical efficacy, onset of action, and side-effect profiles of intranasal fluticasone propionate (FP) monotherapy and a fluticasone propionate-azelastine (MP-AzeFlu) combination in adult patients with moderate-to-severe allergic rhinitis. Patients with positive skin prick test results were randomly assigned to receive either FP monotherapy or MP-AzeFlu combination therapy. Symptom severity and quality of life were assessed at baseline, day 7, month 1, and month 2 using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and a visual analog scale (VAS). The primary objective was to compare changes in quality-of-life scores between treatment groups. Secondary outcomes included onset of symptom relief and treatment-related sensory side effects.

Timeline

Start
2022-12-01
Primary completion
2023-10-30
Completion
2026-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Azelastine Small molecule Intranasal
Subject Fluticasone propionate Other / unclassified Intranasal

Indications