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

Part of paid clinical trials in Evanston, Illinois.

Sponsor
Endeavor Health
Study ID
NCT05626621
Phase
PHASE4
Status
Recruiting
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Conditions

  • Chronic Rhinitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Azelastine (137 mcg/spray) Nasal Spray and Mometasone (50 mcg/spray) Nasal Spray — DRUG
    Participants will follow this medication regimen for 6 months.
  • Mometasone Nasal Irrigation (1 mg capsule) — DRUG
    Participants will follow this medication regimen for 6 months.
  • Mometasone (1 mg) and Azelastine (1 mg) Nasal Irrigation — DRUG
    Participants will follow this medication regimen for 6 months.

Study Details

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.

Key Dates

Start date
Nov 23, 2022
Status verified
Jul 2023
Primary completion
Aug 31, 2025
Completion
Aug 31, 2026

Study Design

Enrollment
81 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Northshore University HealthSystemEvanstonIllinois60201
Auddie Sweis, MD
[email protected]
847-570-1700

Find similar trials in Evanston, IL

By research site
Northshore University HealthSystem· Evanston, IL

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