NCT05626621 Efficacy of Azelastine and Mometasone Irrigation in Comparison to Nasal Sprays in Patients With Chronic Rhinitis
| NCT ID | NCT05626621 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Endeavor Health |
| Condition | Chronic Rhinitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2022-11-23 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 81 participants in total. It began in 2022-11-23 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. Saline irrigation followed by azelastine spray and mometasone spray 2. Mometasone saline irrigation 3. Azelastine saline irrigation combined with mometasone saline irrigation.
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.
Frequently Asked Questions
Who can join the NCT05626621 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Rhinitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05626621 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05626621 currently recruiting?
Yes, NCT05626621 is actively recruiting participants. Visit ClinicalTrials.gov or contact Endeavor Health to inquire about joining.
Where is the NCT05626621 trial being conducted?
This trial is being conducted at Evanston, United States.
Who is sponsoring the NCT05626621 clinical trial?
NCT05626621 is sponsored by Endeavor Health. The trial plans to enroll 81 participants.