INTRANASAL FLUTICASONE VERSUS FLUTICASONE-AZELASTINE COMBINATION

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Fluticasone propionate nasal spray; Drug: Fluticasone propionate-azelastine nasal spray

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Pamukkale
    • Denizli, Pamukkale, Turkey (Türkiye), 20070
      • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 years and older
• Clinical symptoms consistent with allergic rhinitis
• Positive skin prick test results
• Moderate-to-severe allergic rhinitis defined as a Score for Allergic Rhinitis (SFAR) of 7 or higher
• Willingness to participate and provide informed consent

Exclusion Criteria:

• Patients under 18 years of age
• Patients with atopic diseases (e.g., atopic dermatitis) or asthma, other than allergic rhinitis
• Those with a recent respiratory tract infection, nasal polyps, or septal deviation
• Patients who had previously undergone sinonasal surgical treatment
• Individuals who use tobacco, alcohol, or illicit drugs
• Those who have used the following medications:

Antihistamines (within the last week) Nasal or oral decongestants (within the last week) Topical corticosteroids (within the last 2 weeks) Membrane stabilizers (within the last 2 weeks) Leukotriene antagonists (within the last 2 weeks) Systemic corticosteroids (past 4 weeks) Immunotherapy (within the past 5 years)

• Patients with allergic rhinitis symptom score <7

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluticasone Propionate Monotherapy; Drug: Fluticasone propionate nasal spray	Drug: Fluticasone propionate nasal spray; Intranasal fluticasone propionate is administered according to standard dosing recommendations for the treatment of moderate-to-severe allergic rhinitis.
Experimental: Fluticasone-Azelastine Combination; Drug: Fluticasone propionate-azelastine nasal spray	Drug: Fluticasone propionate-azelastine nasal spray; Fixed-dose intranasal combination of fluticasone propionate and azelastine hydrochloride administered according to recommended dosing schedules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) total score	Change in the total score of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) from baseline to 2 months after treatment initiation.	Baseline to Month 2

Collaborators and Investigators

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): October 30, 2023
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Allergic rhinitis; intranasal corticosteroids; combination therapy
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: 60116787-020-308649

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be publicly shared to protect participant confidentiality and in accordance with institutional and ethical regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No