Efficacy of Azelastine and Mometasone Irrigation in Comparison to Nasal Sprays in Patients With Chronic Rhinitis

Last updated: July 25, 2023
Sponsor: NorthShore University HealthSystem
Overall Status: Active - Recruiting

Phase

4

Condition

Allergy

Nasal Obstruction

Common Cold

Treatment

Azelastine (137 mcg/spray) Nasal Spray and Mometasone (50 mcg/spray) Nasal Spray

Mometasone Nasal Irrigation (1 mg capsule)

Mometasone (1 mg) and Azelastine (1 mg) Nasal Irrigation

Clinical Study ID

NCT05626621
EH22-362
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this clinical trial is to determine the best combination of drugs and drug delivery routes to treat surgically naive chronic rhinitis patients. The main question it aims to answer is:

Do high volume, high pressure delivery mechanisms in nasal irrigation improve the efficacy of azelastine combined with nasal steroid mometasone as compared to the standard low pressure, low volume delivery mechanisms in nasal sprays?

Subjects will complete six months of one of three medication regimens:

  1. Saline irrigation followed by azelastine spray and mometasone spray

  2. Mometasone saline irrigation

  3. Azelastine saline irrigation combined with mometasone saline irrigation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults 18 years and older seeking treatment for chronic rhinitis and willing toundergo six months of topical therapy.
  • Diagnosis of Chronic Rhinitis.

Exclusion

Exclusion Criteria:

  • The patient has diagnosis(es) other than chronic rhinitis that can account for his/hersymptoms (septal deviation, nasal valve collapse, chronic sinusitis).
  • Use of oral antihistamines or oral steroids, unless patient undergoes a 4 week washoutperiod.
  • Smokers (tobacco, marijuana, vaping, etc.).
  • Known or suspected pregnancy, or lactation.
  • Other medical conditions that the investigator believed would confound the study.
  • Allergy to study drugs.

Study Design

Total Participants: 81
Treatment Group(s): 3
Primary Treatment: Azelastine (137 mcg/spray) Nasal Spray and Mometasone (50 mcg/spray) Nasal Spray
Phase: 4
Study Start date:
November 23, 2022
Estimated Completion Date:
August 31, 2026

Study Description

The purpose of this research is to determine whether patients with chronic rhinitis treated with mometasone and azelastine irrigations will show significant clinical improvement when compared to patients treated with mometasone and azelastine nasal sprays, and also compared to nasal irrigation with mometasone alone. Patients with chronic rhinitis require lifelong treatment options that are safe yet efficacious. Topical therapies, such as antihistamine sprays and steroid sprays as well as saline irrigations, are appropriate options as they offer symptom control without the side effects often seen in antibiotics. Azelastine and mometasone are FDA approved medications for the treatment of chronic rhinitis. Using these drugs in an off-label format in the form of irrigations rather than sprays is standard of care in rhinology. Prior studies suggest irrigation may be better than spray for topical mometasone, but more data is needed to establish the same for the combination of mometasone and azelastine. Eligible patients who are enrolled in the study will be randomized and will complete six months of one of three medication regimens. Subjects will come back to the office for three follow up visits at 4, 12, and 24 weeks after the treatment, where they will have a basic nasal endoscopy performed and be asked to complete a questionnaire about their nasal blockage symptoms.

Connect with a study center

  • Northshore University HealthSystem

    Evanston, Illinois 60201
    United States

    Active - Recruiting

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