INTRANASAL FLUTICASONE VERSUS FLUTICASONE-AZELASTINE COMBINATION

NCT07415278 | Active Not Recruiting Phase 4

• 1 other identifier: 60116787-020-308649
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergic Rhinitis

Keywords

Allergic rhinitis; intranasal corticosteroids; combination therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Fluticasone Propionate Monotherapy

EXPERIMENTAL

Drug: Fluticasone propionate nasal spray

Drug: Fluticasone propionate nasal spray

Fluticasone-Azelastine Combination

EXPERIMENTAL

Drug: Fluticasone propionate-azelastine nasal spray

Drug: Fluticasone propionate-azelastine nasal spray

Interventions

Fluticasone propionate-azelastine nasal spray DRUG

Fixed-dose intranasal combination of fluticasone propionate and azelastine hydrochloride administered according to recommended dosing schedules.

Fluticasone-Azelastine Combination

Fluticasone propionate nasal spray DRUG

Intranasal fluticasone propionate is administered according to standard dosing recommendations for the treatment of moderate-to-severe allergic rhinitis.

Fluticasone Propionate Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Pamukkale, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open-label study. Both participants and investigators were aware of the assigned treatments, and no blinding was applied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants with moderate-to-severe allergic rhinitis were randomly assigned to one of two parallel treatment groups: intranasal fluticasone propionate monotherapy or a fixed-dose combination of fluticasone propionate and azelastine hydrochloride. Each group received its assigned treatment throughout the 2-month study period without crossover.

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: December 1, 2022
• Primary Completion: October 30, 2023
• Study Completion (Estimated): October 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)