LYR-210 for Chronic Sinusitis
(ENLIGHTEN 1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of a new treatment, LYR-210, for individuals with chronic sinusitis, a condition that causes long-term stuffiness and sinus pressure. LYR-210, an implantable drug delivery system, is compared to a placebo to determine its effectiveness in reducing symptoms. This trial may suit those who have experienced chronic sinusitis for an extended period, have tried at least two other treatments without success, and have both sides of the sinus affected. Participants must not have undergone nasal surgery or have severe asthma. As a Phase 3 trial, this study represents the final step before FDA approval, providing an opportunity to access a potentially effective treatment early.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have perennial rhinitis controlled by intranasal corticosteroids, you might not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that LYR-210 is generally safe and well-tolerated. During a 24-week treatment period, studies found no major safety issues in patients using LYR-210. The treatment was tested in different doses and remained safe over time. While some patients reported side effects, these were not serious.
This treatment is in an advanced testing stage, indicating that earlier studies have reviewed its safety. These testing phases ensure a treatment is safe enough for large groups of people. Overall, evidence suggests that LYR-210 is a safe option for treating chronic sinusitis.12345Why are researchers excited about this study treatment for chronic sinusitis?
Most treatments for chronic sinusitis, like nasal corticosteroids and saline irrigations, aim to reduce inflammation and manage symptoms. But LYR-210 works differently, delivering a sustained-release formulation of mometasone furoate directly to the sinus tissues over several months. This novel delivery method allows for a steady, localized treatment, potentially reducing the need for daily medication and enhancing patient compliance. Researchers are excited because this approach could provide long-lasting relief from sinusitis symptoms with just a single administration, offering a significant improvement over current treatment options.
What evidence suggests that LYR-210 could be an effective treatment for chronic sinusitis?
Research has shown that LYR-210, which participants in this trial may receive, may effectively treat chronic sinusitis. In an earlier study, patients using LYR-210 experienced significant symptom relief compared to those who received a sham procedure control. The treatment also noticeably reduced inflammation in the nasal passages. Studies suggest that LYR-210 could help people with ongoing nasal problems, including inflammation and growths called polyps. The ENLIGHTEN 2 trial supported these findings by showing clear improvements in patients' conditions. Overall, LYR-210 seems to offer hope for people with chronic sinusitis seeking effective treatment options.12346
Are You a Good Fit for This Trial?
Adults over 18 with chronic sinusitis, confirmed by CT scan, who've tried at least two medical treatments without success. They must understand the study and consent to participate. Excluded are those with previous nasal surgery, severe allergies well-controlled by steroids, current participation in other studies, pregnancy or breastfeeding women, and various conditions that could interfere with LYR-210 placement or affect survival.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive LYR-210 or sham control for 24 weeks
Safety Extension
Participants may continue treatment or crossover to LYR-210 for additional safety monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Background Therapy
- LYR-210
- Sham procedure control
Background Therapy is already approved in European Union, United States, Japan for the following indications:
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Atypical hemolytic uremic syndrome (aHUS)
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Atypical hemolytic uremic syndrome (aHUS)
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Atypical hemolytic uremic syndrome (aHUS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lyra Therapeutics
Lead Sponsor