LYR-210 for Chronic Sinusitis

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Verified Trial

Waitlist Available

Sponsor: Lyra Therapeutics

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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

I have had symptoms like nasal blockage or loss of smell for over 3 months.

Treatment Details

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.

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