Status:
COMPLETED
LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
Lead Sponsor:
Lyra Therapeutics
Conditions:
Chronic Sinusitis
Chronic Rhinosinusitis (Diagnosis)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
LYR-210 is a drug depot, which contains the anti-inflammatory medication mometasone furoate (MF) pre-loaded in a single use applicator. LYR-210 is intended to be placed bilaterally into the sino-nasal...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2021
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04041609
Start Date
May 9 2019
End Date
February 4 2021
Last Update
July 25 2023
Active Locations (22)
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1
Royal Brisbane and Woman's Hospital
Brisbane, Australia
2
Monash Health
Clayton, Australia, 3168
3
The ENT Centre
Hornsby, Australia, 2077
4
Westmead Hospital
Westmead, Australia, 2145