LYR-220 System for Adult Subjects With Chronic Rhinosinusitis (CRS)

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety, tolerability, and pharmacokinetics of two LYR-220 designs in symptomatic adult chronic rhinosinusitis (CRS) subjects who have had a prior bilateral total ethmoidectomy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lyra Therapeutics

Criteria

Inclusion Criteria:

• Diagnosis of chronic rhinosinusitis.

• Has had a prior bilateral total ethmoidectomy.

• Has computed tomography (CT) ethmoid cavity opacification.

• Has a Sinonasal Outcome Test (SNOT-22) ≥ 20 at Screening Visit.

• Minimum cardinal symptom score.

• Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site or regulatory authority if applicable by national law.

• Agrees to comply with all study requirements.

Exclusion Criteria:

• Ethmoidectomy that was unilateral or partial.

• Pregnant or breast feeding.

• Known history of hypersensitivity or intolerance to corticosteroids.

• History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.

• Known history of hypothalamic pituitary adrenal axial dysfunction.

• Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.

• Past or present functional vision in only one eye.

• Past, present, or planned organ transplant or chemotherapy with immunosuppression.

• With prior cataract surgery or presence (in either eye) of posterior subcapsular cataract of grade 2 or higher, nuclear cataract of grade 3 or higher, or cortical cataract of grade 2 or higher or involving a minimum of center optic zone of 3 mm diameter.

• Currently participating in an investigational drug or device study.