RecruitingPhase 4NCT05626621

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


Sponsor

Endeavor Health

Enrollment

81 participants

Start Date

Nov 23, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria6

  • The patient has diagnosis(es) other than chronic rhinitis that can account for his/her symptoms (septal deviation, nasal valve collapse, chronic sinusitis).
  • Use of oral antihistamines or oral steroids, unless patient undergoes a 4 week washout period.
  • 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.

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Interventions

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

Participants will follow this medication regimen for 6 months.

DRUGMometasone Nasal Irrigation (1 mg capsule)

Participants will follow this medication regimen for 6 months.

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

Participants will follow this medication regimen for 6 months.


Locations(1)

Northshore University HealthSystem

Evanston, Illinois, United States

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NCT05626621


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