LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)
NCT ID: NCT05035654
Last Updated: 2024-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2021-11-23
2023-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Part 1: Treatment Arm LYR-220 Design 1
Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
LYR-220 Design 1 (Part 1 only)
LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
Part 1 and Part 2: Treatment Arm LYR-220 Design 2
Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
LYR-220 Design 2 (Part 1 and Part 2)
LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
Part 2: Treatment Arm Bilateral sham procedure control
Bilateral sham procedure control
Bilateral sham procedure control (Part 2)
Bilateral sham procedure control
Interventions
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LYR-220 Design 1 (Part 1 only)
LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
LYR-220 Design 2 (Part 1 and Part 2)
LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
Bilateral sham procedure control (Part 2)
Bilateral sham procedure control
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* Ethmoidectomy that was unilateral or partial.
* Currently participating in an investigational drug or device study.
18 Years
ALL
No
Sponsors
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Lyra Therapeutics
INDUSTRY
Responsible Party
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Locations
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Lyra Investigational Site
Carlsbad, California, United States
Lyra Investigational Site
La Mesa, California, United States
Lyra Investigational Site
Roseville, California, United States
Lyra Investigational Site
Torrance, California, United States
Lyra Investigational Site
Chicago, Illinois, United States
Lyra Investigational Site
Chicago, Illinois, United States
Lyra Investigational Site
New Albany, Indiana, United States
Lyra Investigational Site
Louisville, Kentucky, United States
Lyra Investigational Site
Marrero, Louisiana, United States
Lyra Investigational Site
Baltimore, Maryland, United States
Lyra Investigational Site
New Hyde Park, New York, United States
Lyra Investigational Site
New York, New York, United States
Lyra Investigational Site
Chapel Hill, North Carolina, United States
Lyra Investigational Site
Winston-Salem, North Carolina, United States
Lyra Investigational Site
Bethlehem, Pennsylvania, United States
Lyra Investigational Site
Orangeburg, South Carolina, United States
Lyra Investigational Site
Spartanburg, South Carolina, United States
Lyra Investigational Site
Fort Worth, Texas, United States
Lyra Investigational Site
McKinney, Texas, United States
Lyra Investigational Site
San Antonio, Texas, United States
Lyra Investigational Site
South Ogden, Utah, United States
Lyra Investigational Site
Spokane, Washington, United States
Lyra Investigational Site
Bedford Park, , Australia
Lyra Investigational Site
Brisbane, , Australia
Lyra Investigational Site
Melbourne, , Australia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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LYR-220-2021-001
Identifier Type: -
Identifier Source: org_study_id