LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)

• Status: Unknown status
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects with Chronic Sinusitis.

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

Details

• Lead Sponsor: Lyra Therapeutics
• Treatments: Mometasone Furoate

Criteria

Inclusion Criteria:

• Diagnosis of CS.

• Two trials of medical treatments for CS in the past.

• Minimum CS symptom score.

• Ability to tolerate topical anesthesia.

• 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.

• Agrees to comply with all study requirements.

Exclusion Criteria:

• Have undergone previous sinus surgery.

• 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 or having a morning serum cortisol level at screening outside of the normal range.

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

• Past or present functional vision in only one eye.

• Has cataracts

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

• Currently participating in an investigational drug or device study