Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults
NCT ID: NCT05219968
Last Updated: 2025-05-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
196 participants
INTERVENTIONAL
2022-01-27
2024-09-16
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
* Undergone at least 2 trials of medical treatments in the past
* Mean 3 cardinal symptom (3CS) score
* Bilateral ethmoid disease confirmed on CT
* Has been informed of the nature of the study and provided written informed consent
* Agrees to comply with all study requirements
* If on a waiting list for sinonasal surgery, willing to be removed from list or have surgery date cancelled for the duration of 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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Lyra Investigational Site
Birmingham, Alabama, United States
Lyra Investigational Site
Escondido, California, United States
Lyra Investigational Site
La Mesa, California, United States
Lyra Investigational Site
Sacramento, California, United States
Lyra Investigational Site
Torrance, California, United States
Lyra Investigational Site
Boca Raton, Florida, United States
Lyra Investigational Site
Boynton Beach, Florida, United States
Lyra Investigational Site
Plantation, Florida, United States
Lyra Investigational Site
Port Saint Lucie, Florida, United States
Lyra Investigational Site
Chicago, Illinois, United States
Lyra Investigational Site
Louisville, Kentucky, 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
New York, New York, United States
Lyra Investigational Site
New York, New York, United States
Lyra Investigational Site
Winston-Salem, North Carolina, United States
Lyra Investigational Site
Charleston, South Carolina, United States
Lyra Investigational Site
Spartanburg, South Carolina, United States
Lyra Investigational Site
Nashville, Tennessee, United States
Lyra Investigational Site
Fort Worth, Texas, United States
Lyra Investigational Site
Houston, Texas, United States
Lyra Investigational Site
Mansfield, Texas, United States
Lyra Investigational Site
San Antonio, Texas, United States
Lyra Investigational Site
South Ogden, Utah, United States
Lyra Investigational Site
Norfolk, Virginia, United States
Lyra Investigational Site
Graz, , Austria
Lyra Investigational Site
Klagenfurt, , Austria
Lyra Investigational Site
Linz, , Austria
Lyra Investigational Site
Vienna, , Austria
Lyra Investigational Site
Brno, , Czechia
Lyra Investigational Site
Hradec Králové, , Czechia
Lyra Investigational Site
Motol, , Czechia
Lyra Investigational Site
Olomouc, , Czechia
Lyra Investigational Site
Prague, , Czechia
Lyra Investigational Site
Bydgoszcz, , Poland
Lyra Investigational Site
Bydgoszcz, , Poland
Lyra Investigational Site
Elblag, , Poland
Lyra Investigational Site
Katowice, , Poland
Lyra Investigational Site
Krakow, , Poland
Lyra Investigational Site
Krakow, , Poland
Lyra Investigational Site
Krosno, , Poland
Lyra Investigational Site
Lublin, , Poland
Lyra Investigational Site
Nadarzyn, , Poland
Lyra Investigational Site
Warsaw, , Poland
Lyra Investigational Site
Warsaw, , Poland
Lyra Investigational Site
Wroclaw, , Poland
Lyra Investigational Site
Barcelona, , Spain
Lyra Investigational Site
Barcelona, , Spain
Lyra Investigational Site
Bilbao, , Spain
Lyra Investigational Site
Cadiz, , Spain
Lyra Investigational Site
Granada, , Spain
Lyra Investigational Site
Madrid, , Spain
Lyra Investigational Site
Navarro, , Spain
Lyra Investigational Site
Santander, , Spain
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-210-2021-004
Identifier Type: -
Identifier Source: org_study_id
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