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

NCT05626621 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: EH22-362
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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. 1.Saline irrigation followed by azelastine spray and mometasone spray
2. 2.Mometasone saline irrigation
3. 3.Azelastine saline irrigation combined with mometasone saline irrigation.

Conditions

Chronic Rhinitis

Keywords

mometasone; azelastine; irrigation; topical therapy; nasal spray; chronic rhinitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 1 month, 3 months, 6 months

Study Arms (3)

Azelastine and Mometasone Nasal Spray

ACTIVE COMPARATOR

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.

Drug: Azelastine (137 mcg/spray) Nasal Spray and Mometasone (50 mcg/spray) Nasal Spray

Mometasone Nasal Irrigation

EXPERIMENTAL

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.

Drug: Mometasone Nasal Irrigation (1 mg capsule)

Azelastine and Mometasone Nasal Irrigation

EXPERIMENTAL

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.

Drug: Mometasone (1 mg) and Azelastine (1 mg) Nasal Irrigation

Interventions

Azelastine (137 mcg/spray) Nasal Spray and Mometasone (50 mcg/spray) Nasal Spray DRUG

Participants will follow this medication regimen for 6 months.

Also known as: Astelin, Nasonex

Azelastine and Mometasone Nasal Spray

Mometasone Nasal Irrigation (1 mg capsule) DRUG

Participants will follow this medication regimen for 6 months.

Also known as: Nasonex

Mometasone Nasal Irrigation

Mometasone (1 mg) and Azelastine (1 mg) Nasal Irrigation DRUG

Participants will follow this medication regimen for 6 months.

Also known as: Astelin, Nasonex

Azelastine and Mometasone Nasal Irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years and older seeking treatment for chronic rhinitis and willing to undergo six months of topical therapy.
• Diagnosis of Chronic Rhinitis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

Northshore University HealthSystem

Evanston, Illinois, 60201, United States

RECRUITING

Related Publications (18)

• Horak F. Effectiveness of twice daily azelastine nasal spray in patients with seasonal allergic rhinitis. Ther Clin Risk Manag. 2008 Oct;4(5):1009-22. doi: 10.2147/tcrm.s3229.

  PMID: 19209282 BACKGROUND

• McTavish D, Sorkin EM. Azelastine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential. Drugs. 1989 Nov;38(5):778-800. doi: 10.2165/00003495-198938050-00005.

  PMID: 2574665 BACKGROUND

• Mosges R, Klimek L. Azelastine reduces mediators of inflammation in patients with nasal polyps. Allergy Asthma Proc. 1998 Nov-Dec;19(6):379-83. doi: 10.2500/108854198778612663.

  PMID: 9876778 BACKGROUND

• Debbaneh PM, Bareiss AK, Wise SK, McCoul ED. Intranasal Azelastine and Fluticasone as Combination Therapy for Allergic Rhinitis: Systematic Review and Meta-analysis. Otolaryngol Head Neck Surg. 2019 Sep;161(3):412-418. doi: 10.1177/0194599819841883. Epub 2019 Apr 9.

  PMID: 30961435 BACKGROUND

• Harvey R, Hannan SA, Badia L, Scadding G. Nasal saline irrigations for the symptoms of chronic rhinosinusitis. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD006394. doi: 10.1002/14651858.CD006394.pub2.

  PMID: 17636843 BACKGROUND

• Thomas WW 3rd, Harvey RJ, Rudmik L, Hwang PH, Schlosser RJ. Distribution of topical agents to the paranasal sinuses: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2013 Sep;3(9):691-703. doi: 10.1002/alr.21172. Epub 2013 May 31.

  PMID: 23729216 BACKGROUND

• Smith KA, Rudmik L. Delivery of Topical Therapies. Adv Otorhinolaryngol. 2016;79:114-20. doi: 10.1159/000445145. Epub 2016 Jul 28.

  PMID: 27466853 BACKGROUND

• Pynnonen MA, Mukerji SS, Kim HM, Adams ME, Terrell JE. Nasal saline for chronic sinonasal symptoms: a randomized controlled trial. Arch Otolaryngol Head Neck Surg. 2007 Nov;133(11):1115-20. doi: 10.1001/archotol.133.11.1115.

  PMID: 18025315 BACKGROUND

• Derendorf H, Meltzer EO. Molecular and clinical pharmacology of intranasal corticosteroids: clinical and therapeutic implications. Allergy. 2008 Oct;63(10):1292-300. doi: 10.1111/j.1398-9995.2008.01750.x.

  PMID: 18782107 BACKGROUND

• Bollinger ME, Diette GB, Chang CL, Stephenson JJ, Sajjan SG, Fan T, Allen-Ramey FC. Patient characteristics and prescription fill patterns for allergic rhinitis medications, with a focus on montelukast, in a commercially insured population. Clin Ther. 2010 Jun;32(6):1093-102. doi: 10.1016/j.clinthera.2010.06.003.

  PMID: 20637964 BACKGROUND

• Papagiannopoulos P, Brown HJ, Kim YJ, Houser TK, Ganti A, Raad RA, Kuan EC, Losavio P, Batra PS, Tajudeen BA. Improved sinonasal symptom and endoscopy sinus scores with dose-escalated intranasal mometasone irrigation in patients with refractory chronic rhinosinusitis. Int Forum Allergy Rhinol. 2022 Jul;12(7):955-957. doi: 10.1002/alr.22940. Epub 2022 Jan 5. No abstract available.

  PMID: 34894112 BACKGROUND

• Snidvongs K, Pratt E, Chin D, Sacks R, Earls P, Harvey RJ. Corticosteroid nasal irrigations after endoscopic sinus surgery in the management of chronic rhinosinusitis. Int Forum Allergy Rhinol. 2012 Sep-Oct;2(5):415-21. doi: 10.1002/alr.21047. Epub 2012 May 7.

  PMID: 22566474 BACKGROUND

• Jiramongkolchai P, Patel S, Schneider JS. Use of Off-Label Nasal Steroid Irrigations in Long-Term Management of Chronic Rhinosinusitis. Ear Nose Throat J. 2021 Jun;100(5):329-334. doi: 10.1177/0145561321998521. Epub 2021 Mar 8.

  PMID: 33683979 BACKGROUND

• Harvey RJ, Snidvongs K, Kalish LH, Oakley GM, Sacks R. Corticosteroid nasal irrigations are more effective than simple sprays in a randomized double-blinded placebo-controlled trial for chronic rhinosinusitis after sinus surgery. Int Forum Allergy Rhinol. 2018 Apr;8(4):461-470. doi: 10.1002/alr.22093. Epub 2018 Feb 2.

  PMID: 29394004 BACKGROUND

• Rudmik L, Hoy M, Schlosser RJ, Harvey RJ, Welch KC, Lund V, Smith TL. Topical therapies in the management of chronic rhinosinusitis: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2013 Apr;3(4):281-98. doi: 10.1002/alr.21096. Epub 2012 Oct 8.

  PMID: 23044832 BACKGROUND

• Park DY, Choi JH, Kim DK, Jung YG, Mun SJ, Min HJ, Park SK, Shin JM, Yang HC, Hong SN, Mo JH. Clinical Practice Guideline: Nasal Irrigation for Chronic Rhinosinusitis in Adults. Clin Exp Otorhinolaryngol. 2022 Feb;15(1):5-23. doi: 10.21053/ceo.2021.00654. Epub 2022 Feb 15.

  PMID: 35158420 BACKGROUND

• Jiramongkolchai P, Peterson A, Kallogjeri D, Lee JJ, Kukuljan S, Liebendorfer A, Schneider JS, Klatt-Cromwell CN, Drescher AJ, Piccirillo JF. Randomized clinical trial to evaluate mometasone lavage vs spray for patients with chronic rhinosinusitis without nasal polyps who have not undergone sinus surgery. Int Forum Allergy Rhinol. 2020 Aug;10(8):936-943. doi: 10.1002/alr.22586. Epub 2020 May 29.

  PMID: 32470217 BACKGROUND

• Harvey RJ, Debnath N, Srubiski A, Bleier B, Schlosser RJ. Fluid residuals and drug exposure in nasal irrigation. Otolaryngol Head Neck Surg. 2009 Dec;141(6):757-61. doi: 10.1016/j.otohns.2009.09.006.

  PMID: 19932850 BACKGROUND

MeSH Terms

Interventions

azelastine; Nasal Sprays; Mometasone Furoate; Nasal Lavage

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Therapeutic Irrigation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 25, 2022
• Study Start: November 23, 2022
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)