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

Primary Purpose

Chronic Rhinitis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
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
Sponsored by
NorthShore University HealthSystem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinitis focused on measuring mometasone, azelastine, irrigation, topical therapy, nasal spray, chronic rhinitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Northshore University HealthSystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Azelastine and Mometasone Nasal Spray

Mometasone Nasal Irrigation

Azelastine and Mometasone Nasal Irrigation

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Improvement seen in the Sino-Nasal Outcome Test (SNOT)-22 score
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.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2022
Last Updated
July 25, 2023
Sponsor
NorthShore University HealthSystem
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1. Study Identification

Unique Protocol Identification Number
NCT05626621
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2022 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NorthShore University HealthSystem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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: Saline irrigation followed by azelastine spray and mometasone spray Mometasone saline irrigation 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinitis
Keywords
mometasone, azelastine, irrigation, topical therapy, nasal spray, chronic rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
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
Allocation
Randomized
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Azelastine and Mometasone Nasal Spray
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mometasone Nasal Irrigation
Arm Type
Experimental
Arm Description
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.
Arm Title
Azelastine and Mometasone Nasal Irrigation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Azelastine (137 mcg/spray) Nasal Spray and Mometasone (50 mcg/spray) Nasal Spray
Other Intervention Name(s)
Astelin, Nasonex
Intervention Description
Participants will follow this medication regimen for 6 months.
Intervention Type
Drug
Intervention Name(s)
Mometasone Nasal Irrigation (1 mg capsule)
Other Intervention Name(s)
Nasonex
Intervention Description
Participants will follow this medication regimen for 6 months.
Intervention Type
Drug
Intervention Name(s)
Mometasone (1 mg) and Azelastine (1 mg) Nasal Irrigation
Other Intervention Name(s)
Astelin, Nasonex
Intervention Description
Participants will follow this medication regimen for 6 months.
Primary Outcome Measure Information:
Title
Improvement seen in the Sino-Nasal Outcome Test (SNOT)-22 score
Description
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.
Time Frame
Baseline, 1 month, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Northshore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Auddie Sweis, MD
Phone
847-570-1700
Email
asweis@northshore.org

12. IPD Sharing Statement

Plan to Share IPD
No
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Efficacy of Azelastine and Mometasone Irrigation in Comparison to Nasal Sprays in Patients With Chronic Rhinitis

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