LYR-210 for Chronic Sinusitis
Recruiting at 121 trial locations
LC
Overseen ByLyra Clinical
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Lyra Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
Multicenter, phase III, randomized, blinded, controlled, parallel group.
Eligibility Criteria
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
Bilateral ethmoid disease confirmed on CT
Mean 3 cardinal symptom (3CS) score
Diagnosed as having CRS
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a single administration of LYR-210 or a sham procedure for 24 weeks
24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Background therapy
- LYR-210
- Sham procedure control
Trial Overview The study is testing LYR-210 against a sham procedure to see if it's better in treating chronic sinusitis when added to regular background therapy. It's a large-scale phase III trial where participants are randomly assigned to either the test drug or control group without knowing which one they're getting.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LYR-210Experimental Treatment2 Interventions
Single administration of LYR-210 drug matrix (7500 μg)
Group II: Sham procedure controlPlacebo Group2 Interventions
Single mock administration procedure
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lyra Therapeutics
Lead Sponsor
Trials
5
Recruited
520+
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