Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2)
NCT ID: NCT05295459
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
182 participants
INTERVENTIONAL
2022-05-13
2025-04-02
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
DOUBLE
Study Groups
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LYR-210
Single administration of LYR-210 drug matrix (7500 μg)
LYR-210
LYR-210 drug matrix (mometasone furoate)
Background therapy
Daily Saline Irrigation
Sham procedure control
Single mock administration procedure
Sham procedure control
Sham procedure control
Background therapy
Daily Saline Irrigation
Interventions
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LYR-210
LYR-210 drug matrix (mometasone furoate)
Sham procedure control
Sham procedure control
Background therapy
Daily Saline Irrigation
Eligibility Criteria
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Inclusion Criteria
* Diagnosed as having CRS
* Bilateral ethmoid disease confirmed on CT
* Mean 3 cardinal symptom (3CS) score
* Undergone at least 2 trials of medical treatments in the past
* Has been informed of the nature of the study and provided written informed consent
* Agrees to comply with all study requirements
* If currently on a waiting list for sinonasal surgery, willing to be removed from the waiting list or have preplanned surgery date cancelled for the duration of the study. \[Note: this does not preclude a participant from receiving or being recommended for sinonasal surgery as rescue treatment during the study\].
Exclusion Criteria
* Previous nasal surgery
* Presence of nasal polyp grade 2 or higher
* Seasonal allergic rhinitis
* Perennial rhinitis with symptoms that are well controlled by regular use of intranasal corticosteroids
* Severe asthma
* History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis
* Obstruction preventing proper placement and retention of LYR-210 as seen on endoscopy
* Anatomic variation that, in the opinion of the investigator, would adversely impact placement of LYR-210 as seen on CT
* Known history of hypersensitivity or intolerance to corticosteroids
* Known history of hypothalamic pituitary adrenal axial dysfunction
* Previous pituitary or adrenal surgery
* Dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
* Past or present acute or chronic intracranial or orbital complications of CRS
* History or diagnosis (in either eye) of glaucoma or ocular hypertension
* Past or present functional vision in only 1 eye
* Past, present, or planned organ transplant or chemotherapy with immunosuppression
* Currently positive for COVID-19 or residual sinonasal symptoms from a previous COVID-19 infection
* Pregnant or breast feeding. Females of child-bearing potential must test negative for pregnancy at the time of screening
* Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments
* Currently participating in an investigational drug or device study
* Determined by the investigator as not suitable to be enrolled
18 Years
ALL
No
Sponsors
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Lyra Therapeutics
INDUSTRY
Responsible Party
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Locations
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Novak Clinical Trials
Tucson, Arizona, United States
Keck School of Medicine at USC Medical Center
Arcadia, California, United States
Sensa Health Clinical Research
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California - Irvine Medical Center
Orange, California, United States
Sacramento Ear Nose and Throat Surgical and Medical Group, Inc
Roseville, California, United States
University of California - Davis
Sacramento, California, United States
Regional Head & Neck Consulting - SENTA Clinic
San Diego, California, United States
Breathe Clear Institute
Torrance, California, United States
Colorado ENT and Allergy
Colorado Springs, Colorado, United States
Ear, Nose and Throat Associates of South Florida, P.A.
Boynton Beach, Florida, United States
ENT and Allergy Associates of Florida - Brandon
Brandon, Florida, United States
ENT and Allergy Associates of Florida - Plantation - Dr. Johnson
Plantation, Florida, United States
ENT and Allergy Associates of Florida - Plantation - Dr. Wright
Plantation, Florida, United States
ENT and Allergy Associates of Florida
Port Saint Lucie, Florida, United States
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Kansas Medical Center (KUMC)
Fairway, Kansas, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
University of Missouri-Columbia
Columbia, Missouri, United States
St Louis University
St Louis, Missouri, United States
ENT and Allergy Associates, LLP - Fifth Avenue New York
New York, New York, United States
Columbia University
New York, New York, United States
University of Rochester
Rochester, New York, United States
ENT and Allergy Associates - White Plains
White Plains, New York, United States
Carolina Ear, Nose, & Throat Clinic/CENTRI, Inc.
Orangeburg, South Carolina, United States
Houston Methodist Hospital
Houston, Texas, United States
ENT Associates of Texas
McKinney, Texas, United States
Lyra Investigational Site
Ogden, Utah, United States
Lyra Investigational Site
Richmond, Virginia, United States
University Hospital Gent
Ghent, , Belgium
Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
University Multiprofile Hospital for Active Treatment
Burgas, , Bulgaria
UMHAT Kaspela Ltd
Plovdiv, , Bulgaria
Military Medical Academy Multiprofile Hospital
Sofia, , Bulgaria
Diagnostic and Consulting Center Mladost - Varna
Varna, , Bulgaria
HNO Praxis Dr. Andrea Kienle-Gogolok
Baden, , Germany
HNO Zentrum am Kudamm
Berlin, , Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
HNO Landsberg
Landsberg, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Semmelweis Egyetem - Nyaksebeszeti Klinika
Budapest, , Hungary
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, , Hungary
Szent Imre Korhaz
Budapest, , Hungary
Eszak-Pesti Centrumkorhaz - Honvedkorhaz
Budapest, , Hungary
Budapesti Uzsoki Utcai Korhaz
Budapest, , Hungary
Lyra Investigational Site
Nyíregyháza, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, , Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, , Hungary
Sleepmedica
Bialystok, , Poland
"Farma-Med." Kujawskie Centrum Medyczne Sp. z o.o.
Inowrocław, , Poland
Promed P.Lach R.Glowacki Spolka Jawna
Krakow, , Poland
Velocity Lublin
Lublin, , Poland
Mazowiecki Szpital Brodnowski Sp. z o.o. - Zespol Oddzialow Otolaryngologii
Warsaw, , Poland
Lyra Investigational Site
Warsaw, , Poland
Panstwowy Instytut Medyczny MSWiA - Klinika Otolaryngologii
Wroclaw, , Poland
Countries
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Other Identifiers
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LYR-210-2021-005
Identifier Type: -
Identifier Source: org_study_id
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