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

NCT05626621 Phase 4 RECRUITING

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.

Details

Lead sponsor	Endeavor Health
Phase	Phase 4
Status	RECRUITING
Enrolment	81
Start date	2022-11-23
Completion	2026-08

Conditions

• Chronic Rhinitis

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

Primary outcomes

• Improvement seen in the Sino-Nasal Outcome Test (SNOT)-22 score — Baseline, 1 month, 3 months, 6 months
  Sino-Nasal Outcome Test (SNOT-22) scores will be measured at baseline, 1 month, 3 months, and 6 months. Scores will be compared between three arms. The Sino-Nasal Outcome Test is a self-administered questionnaire that is used to assess nasal symptoms using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT-22 consists of 22 questions, rated from 0 to 5 for a minimum score of 0 to maximum score of 110, with higher scores indicating worse symptoms.

Countries

United States