Clinical trial NCT05626621: Efficacy of Azelastine and Mometasone Irrigation in Comparison to Nasal Sprays in Patients With Chronic Rhinitis
Official title: Efficacy of Azelastine and Mometasone Irrigation in Comparison to Nasal Sprays in Patients With Chronic Rhinitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Rhinitis
Keywords: mometasone
azelastine
irrigation
topical therapy
nasal spray
chronic rhinitis
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2022-11-25
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement seen in the Sino-Nasal Outcome Test (SNOT)-22 score
timeFrame: Baseline, 1 month, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northshore University HealthSystem
state: Illinois
Study officials:
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