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Clinical Trials in Turkey / NCT07415278
Active, not recruiting Phase 4

INTRANASAL FLUTICASONE VERSUS FLUTICASONE-AZELASTINE COMBINATION

NCT07415278 · tracked via the Priya Life Science Turkey tracker
Sponsor
Pamukkale University
Phase
Phase 4
Started
2022-12-01
Last updated
2026-02-17

Condition(s) studied

Allergic Rhinitis

Investigational drug(s) / intervention(s)

Fluticasone propionate nasal spray →Fluticasone propionate-azelastine nasal spray

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) total score — Baseline to Month 2
    Change in the total score of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) from baseline to 2 months after treatment initiation.

Trial sites (1)

FacilityCityRegionStatus
Pamukkale University Denizli Pamukkale

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07415278 on ClinicalTrials.gov ↗ ← All trials in Turkey