LYR-210 for Chronic Sinusitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called LYR-210 for individuals with chronic sinusitis, a condition that causes long-term sinus inflammation. The goal is to determine if LYR-210 reduces symptoms more effectively than a sham procedure. Participants will receive either the new treatment or the sham. Ideal candidates have chronic sinusitis confirmed by a CT scan and have tried at least two other treatments without success. As a Phase 3 trial, this is the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team to get a clear answer.
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. In earlier studies, including one lasting 24 weeks, participants using LYR-210 reported only a few side effects. These studies found that LYR-210 was safe at various doses and helped reduce symptoms quickly and for an extended period. Another study showed positive results, with significant symptom improvement compared to a placebo group. Overall, the evidence suggests that LYR-210 is a promising treatment with a good safety record for people with chronic sinusitis.12345
Why do researchers think this study treatment might be promising for chronic sinusitis?
Unlike the standard of care for chronic sinusitis, which typically involves antibiotics, corticosteroids, or surgery, LYR-210 offers a novel approach by delivering a sustained-release medication directly to the nasal cavity. This unique delivery method allows the drug matrix to continuously release the active ingredient over several weeks, potentially reducing inflammation and symptoms more effectively and with fewer systemic side effects. Researchers are excited about LYR-210 because it targets the condition locally and could offer long-term relief with a single administration, making it a promising option for those seeking alternatives to frequent medication or invasive procedures.
What evidence suggests that LYR-210 might be an effective treatment for chronic sinusitis?
Research has shown that LYR-210, which participants in this trial may receive, effectively treats chronic sinusitis. In one study, patients experienced significant symptom relief and reduced inflammation over 24 weeks. The ENLIGHTEN 2 trial demonstrated that LYR-210 provided better results than a sham procedure, another arm in this trial. This treatment involves a small implant placed in the nose that slowly releases medicine to reduce inflammation and ease symptoms. These findings suggest that LYR-210 could offer real relief for those struggling with chronic sinusitis.12346
Are You a Good Fit for This Trial?
This trial is for adults with chronic sinusitis confirmed by a CT scan, who have not had sinus surgery. Participants should be experiencing symptoms like nasal blockage, runny nose, facial pain, or loss of smell for at least 3 months and these should significantly affect their daily life. They must have used steroid nasal sprays for at least 4 weeks.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single administration of LYR-210 or a sham procedure for 24 weeks
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lyra Therapeutics
Lead Sponsor