Recruiting

Azelastine & Mometasone

Sponsor:

Endeavor Health

Code:

NCT05626621

Conditions

Chronic Rhinitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

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

Study Details

Brief 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.

Conditions

Chronic Rhinitis

Study ID

NCT05626621

Start date

Nov 23, 2022

Status verified date

Jul, 2023

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

81 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Azelastine and Mometasone Nasal Spray

The study intervention will be saline irrigation (240 mL) followed by azelastine spray (137 mcg/spray) and mometasone spray (50 mcg/spray). Participants will have to dissolve the salt packet in a 240 mL sinus rinse bottle to create the saline solution. All participants will be instructed to perform the following twice a day: irrigation of right and left nasal cavity with half of the saline solution for each side followed by 2 sprays per nostril of both of the nasal sprays.

experimental: Mometasone Nasal Irrigation

The study intervention will be mometasone (1 mg/capsule). Participants will be required to dissolve the contents of the capsule into a 240 mL sinus rinse bottle along with the salt packet to create the rinse solution. All participants will be instructed to perform the following twice a day: irrigation of right and left nasal cavity with half of the rinse solution for each side.

experimental: Azelastine and Mometasone Nasal Irrigation

The study intervention will be azelastine (1mg) and mometasone (1 mg). The azelastine and mometasone will be provided in one capsule identical to the mometasone capsule. Participants will be required to dissolve the contents of the capsule into a 240 mL sinus rinse bottle along with the salt packet to create the rinse solution. All participants will be instructed to perform the following twice a day: irrigation of right and left nasal cavity with half of the rinse solution for each side.

Interventions

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

Participants will follow this medication regimen for 6 months.

Mometasone Nasal Irrigation (1 mg capsule)

Participants will follow this medication regimen for 6 months.

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

Participants will follow this medication regimen for 6 months.

Primary outcome measure

  • Improvement seen in the Sino-Nasal Outcome Test (SNOT)-22 score [ Time Frame: Baseline, 1 month, 3 months, 6 months ]

Central Contacts and Locations

Locations

Northshore University HealthSystem

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Auddie Sweis, MD

847-570-1700asweis@northshore.org

More Information

Sponsor

Endeavor Health

Last update posted

Jul 28, 2023

Last verified

Jul, 2023

Keywords

  • mometasone
  • azelastine
  • irrigation
  • topical therapy
  • nasal spray
  • chronic rhinitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2023-07-28.