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Antihistamine
Azelastine + Mometasone Irrigation/Spray for Chronic Rhinitis
Phase 4
Recruiting
Research Sponsored by NorthShore University HealthSystem
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of Chronic Rhinitis.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 month, 3 months, 6 months
Awards & highlights
Study Summary
This trial aims to find the best combo of drugs & delivery methods to treat chronic rhinitis. It'll compare 3 med regimens: irrigation & sprays of saline, azelastine & mometasone.
Who is the study for?
Adults over 18 with chronic rhinitis who haven't had surgery for it can join this trial. They must be willing to try topical treatments for six months. People allergic to the drugs being tested, pregnant or breastfeeding women, smokers, and those on oral antihistamines or steroids (unless they stop these medications for four weeks) cannot participate.Check my eligibility
What is being tested?
The study is testing if high volume nasal irrigation with a combination of Azelastine and Mometasone is more effective than standard nasal sprays in treating chronic rhinitis. Participants will follow one of three treatment plans involving different combinations and delivery methods of these medications over six months.See study design
What are the potential side effects?
Possible side effects include irritation inside the nose, sneezing, nosebleeds, headache, bitter taste in mouth after use of azelastine spray/irrigation; mometasone may cause similar nasal irritation as well as throat irritation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with chronic rhinitis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 month, 3 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 month, 3 months, 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement seen in the Sino-Nasal Outcome Test (SNOT)-22 score
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Mometasone Nasal IrrigationExperimental Treatment1 Intervention
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.
Group II: Azelastine and Mometasone Nasal IrrigationExperimental Treatment1 Intervention
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.
Group III: Azelastine and Mometasone Nasal SprayActive Control1 Intervention
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.
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Who is running the clinical trial?
NorthShore University HealthSystemLead Sponsor
132 Previous Clinical Trials
737,581 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken oral antihistamines or steroids in the last 4 weeks.I have been diagnosed with chronic rhinitis.I am an adult with chronic rhinitis and open to six months of topical treatment.You use tobacco, marijuana, or vaping products.I have conditions like a deviated septum or sinusitis causing my symptoms, not just chronic rhinitis.
Research Study Groups:
This trial has the following groups:- Group 1: Azelastine and Mometasone Nasal Spray
- Group 2: Mometasone Nasal Irrigation
- Group 3: Azelastine and Mometasone Nasal Irrigation
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a risk to utilizing Mometasone Nasal Irrigation?
"As the Mometasone Nasal Irrigation has already reached Phase 4 of clinical trials, there is ample evidence to suggest its safety; thus, it was given a score of 3."
Answered by AI
Is enrollment still open for this trial?
"Contrary to what a potential participant may have hoped for, clinicaltrials.gov elucidates that this medical research is no longer recruiting patients; it was first published on December 1st 2022 and last updated November 30th 20222. However, there are 64 additional trials actively seeking participants at the present time"
Answered by AI
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