Chronic RhinitisPhase 4NCT05626621

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

A Phase 4 study testing Azelastine (137 mcg/spray) Nasal Spray and Mometasone (50 mcg/spray) Nasal Spray, Mometasone Nasal Irrigation (1 mg capsule) and Mometasone (1 mg) and Azelastine (1 mg) Nasal Irrigation in people with Chronic Rhinitis, run by Endeavor Health at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Chronic Rhinitis
What is being tested?: Azelastine (137 mcg/spray) Nasal Spray and Mometasone (50 mcg/spray) Nasal Spray, Mometasone Nasal Irrigation (1 mg capsule) and Mometasone (1 mg) and Azelastine (1 mg) Nasal Irrigation
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 1 siteUnited States
Study dates: 23 Nov 2022to Aug 2026
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting

Northshore University HealthSystem
Evanston, Illinois, 60201
Auddie Sweis, MD, 847-570-1700, asweis@northshore.org
Recruiting

Other trials in United States

About this study

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.

Read the 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.

Conditions: Chronic Rhinitis
Being tested: 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
Keywords: mometasone, azelastine, irrigation, topical therapy, nasal spray, chronic rhinitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Azelastine (137 mcg/spray) Nasal Spray and Mometasone (50 mcg/spray) Nasal SprayDrug
Also called Astelin, Nasonex
Participants will follow this medication regimen for 6 months.
Mometasone Nasal Irrigation (1 mg capsule)Drug
Also called Nasonex
Participants will follow this medication regimen for 6 months.
Mometasone (1 mg) and Azelastine (1 mg) Nasal IrrigationDrug
Also called Astelin, Nasonex
Participants will follow this medication regimen for 6 months.

Study groups in NCT05626621
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: Mometasone (1 mg) and Azelastine (1 mg) Nasal Irrigation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 1 month, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Nov 2022Aug 2026

First posted25 Nov 2022
Study start23 Nov 2022
Primary completionAug 2025 (estimated)
Study completionAug 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Chronic RhinitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 81 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05626621
Sponsor's protocol ID: EH22-362
Status last verified: Jul 2023
First submitted: 15 Nov 2022
Last updated: 28 Jul 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 19209282
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.
PubMed 2574665
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.
PubMed 9876778
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.
PubMed 30961435
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.
PubMed 17636843
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.
PubMed 23729216
Smith KA, Rudmik L. Delivery of Topical Therapies. Adv Otorhinolaryngol. 2016;79:114-20. doi: 10.1159/000445145. Epub 2016 Jul 28.
PubMed 27466853
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.
PubMed 18025315
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.
PubMed 18782107
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.
PubMed 20637964
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.
PubMed 34894112
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.
PubMed 22566474
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.
PubMed 33683979
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.
PubMed 29394004
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.
PubMed 23044832

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Azelastine and Mometasone Irrigation in Comparison to Nasal Sprays in Patients With Chronic Rhinitis
ClinicalTrials.gov ID: NCT05626621
Acronym / sponsor ID: EH22-362
Conditions: Chronic Rhinitis
Keywords: mometasone, azelastine, irrigation, topical therapy, nasal spray, chronic rhinitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 81 participants (estimated)
Lead sponsor: Endeavor HealthUniversity, hospital or other
Study start: 23 Nov 2022 (actual)
Primary completion: Aug 2025 (estimated)
Study completion: Aug 2026 (estimated)
First posted: 25 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Azelastine and Mometasone Nasal Spray	Active comparator	Drug: Azelastine (137 mcg/spray) Nasal Spray and Mometasone (50 mcg/spray) Nasal SprayThe 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.
Mometasone Nasal Irrigation	Experimental	Drug: Mometasone Nasal Irrigation (1 mg capsule)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.
Azelastine and Mometasone Nasal Irrigation	Experimental	Drug: Mometasone (1 mg) and Azelastine (1 mg) Nasal IrrigationThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Azelastine (137 mcg/spray) Nasal Spray and Mometasone (50 mcg/spray) Nasal SprayAlso: Astelin, NasonexParticipants will follow this medication regimen for 6 months.	Drug	Azelastine and Mometasone Nasal Spray
Mometasone Nasal Irrigation (1 mg capsule)Also: NasonexParticipants will follow this medication regimen for 6 months.	Drug	Mometasone Nasal Irrigation
Mometasone (1 mg) and Azelastine (1 mg) Nasal IrrigationAlso: Astelin, NasonexParticipants will follow this medication regimen for 6 months.	Drug	Azelastine and Mometasone Nasal Irrigation

Primary outcome

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
Background: PubMed 19209282Horak 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.
Background: PubMed 2574665McTavish 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.
Background: PubMed 9876778Mosges 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.
Background: PubMed 30961435Debbaneh 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.
Background: PubMed 17636843Harvey 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.
Background: PubMed 23729216Thomas 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.
Background: PubMed 27466853Smith KA, Rudmik L. Delivery of Topical Therapies. Adv Otorhinolaryngol. 2016;79:114-20. doi: 10.1159/000445145. Epub 2016 Jul 28.
Background: PubMed 18025315Pynnonen 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.
Background: PubMed 18782107Derendorf 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.
Background: PubMed 20637964Bollinger 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.
Background: PubMed 34894112Papagiannopoulos 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.
Background: PubMed 22566474Snidvongs 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Northshore University HealthSystem

Evanston, United States

847-570-1700

asweis@northshore.org

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement seen in the Sino-Nasal Outcome Test (SNOT)-22 score (time frame: Baseline, 1 month, 3 months, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05626621, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.