Nasal Mometasone for Chronic Sinusitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if using mometasone in nasal rinses affects cortisol levels in individuals with chronic rhinosinusitis, a common sinus condition. Mometasone may alleviate sinus symptoms by reducing inflammation, but researchers want to ensure it doesn't excessively lower cortisol, which could lead to fatigue and low blood pressure. Participants will be divided into groups receiving different doses of mometasone to identify the most effective and safe dosage. Ideal candidates are those with chronic rhinosinusitis who have undergone sinus surgery and are not currently using systemic steroids. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to early-stage medical discoveries.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used systemic corticosteroids in the past month or are taking medications that affect the HPA axis (a system that controls stress response and other body processes).
Is there any evidence suggesting that nasal mometasone rinse is likely to be safe for humans?
Research has shown that using mometasone as a nasal rinse is safe for short-term use in people with chronic rhinosinusitis (CRS). One study found that it does not affect cortisol levels, a hormone that helps manage stress, indicating that mometasone is well-tolerated as a nasal rinse.
Mometasone is already used in nasal sprays for allergies, supporting its safety for treating nasal issues. Although using mometasone in nasal rinses is a newer approach with less data, its established use in sprays offers some reassurance about its safety.
This trial will test different doses of mometasone (1mg, 2mg, or 4mg). Currently in the early stages, the trial focuses mainly on safety. Understanding how the body reacts to the treatment and identifying any possible side effects is crucial.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the nasal mometasone rinse because it offers a new way to deliver medication directly to the nasal passages for conditions like chronic sinusitis. Unlike traditional corticosteroid nasal sprays, this treatment uses a high-volume irrigation method, potentially enhancing the drug's effectiveness by ensuring more extensive coverage of the nasal and sinus cavities. Additionally, by experimenting with varying dosages (1mg, 2mg, and 4mg), researchers aim to identify the optimal dose that maximizes benefits while minimizing systemic cortisol suppression, a common concern with corticosteroid use. This innovative approach could lead to more effective and safer treatment options for patients suffering from sinus issues.
What evidence suggests that this trial's treatments could be effective for chronic rhinosinusitis?
Research shows that mometasone nasal rinses can ease symptoms of chronic rhinosinusitis, a condition causing long-term sinus swelling. Studies have found that large amounts of mometasone rinses work better than regular nasal sprays, especially for those who have had sinus surgery. One study showed that patients using mometasone rinses felt much better than those who did not. However, researchers continue to gather evidence and investigate the best doses and long-term effects. Mometasone reduces swelling in the nasal passages, relieving congestion and other sinus problems.26789
Who Is on the Research Team?
Bobby Tajudeen, MD
Principal Investigator
Rush University Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nasal mometasone irrigations in varying dosages for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nasal Mometasone Rinse
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rush University Medical Center
Lead Sponsor
Advanced Rx
Industry Sponsor