NCT07415278

INTRANASAL FLUTICASONE VERSUS FLUTICASONE-AZELASTINE COMBINATION

INTRANASAL FLUTICASONE VERSUS FLUTICASONE-AZELASTINE COMBINATION AS FIRST-LINE THERAPY IN ALLERGIC RHINITIS: A PROSPECTIVE COMPARATIVE STUDY

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Pamukkale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Allergic rhinitis (AR) is a chronic inflammatory condition of the nasal mucosa that significantly affects patients' quality of life, sleep, and daily functioning. Intranasal corticosteroids are recommended as first-line therapy for moderate-to-severe AR; however, some patients experience delayed symptom relief or insufficient control. Combination therapy with an intranasal antihistamine and corticosteroid may provide faster and more effective symptom control, but comparative data on onset of action, quality-of-life outcomes, and side-effect profiles are limited. This prospective, randomized, comparative clinical study was conducted at a tertiary care otorhinolaryngology clinic. Adult patients presenting with symptoms of allergic rhinitis and positive skin prick test results were screened. Patients with moderate-to-severe symptoms, defined by a Score for Allergic Rhinitis (SFAR) of 7 or higher, were included. Eligible participants were randomly assigned to one of two treatment groups: intranasal fluticasone propionate (FP) monotherapy or a fixed-dose combination of fluticasone propionate and azelastine hydrochloride (MP-AzeFlu). Treatments were administered according to the recommended dosing schedules. Patients were evaluated at baseline and at day 7, month 1, and month 2 after treatment initiation. Clinical efficacy and quality of life were assessed using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and a visual analog scale (VAS). The onset of action was defined as the first day on which patients reported noticeable symptom improvement. Adverse effects, particularly taste and smell disturbances, were also evaluated using VAS scores. The primary objective was to compare changes in quality-of-life scores between the two treatment groups, while secondary objectives included onset of symptom relief and the assessment of treatment-related side effects.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Fluticasone propionate nasal spray	Intranasal fluticasone propionate is administered according to standard dosing recommendations for the treatment of moderate-to-severe allergic rhinitis.
DRUG	Fluticasone propionate-azelastine nasal spray	Fixed-dose intranasal combination of fluticasone propionate and azelastine hydrochloride administered according to recommended dosing schedules.

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-10-30
• Completion: 2026-10-30
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: Turkey (Türkiye)