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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-23

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Arm 1 is not blinded because this is the spray group. Arm 2 and 3 are blinded because these are both irrigation groups-either just mometasone or mometasone combined with azelastine

Study Groups

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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.

Group Type ACTIVE_COMPARATOR