Status:
COMPLETED
Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults
Lead Sponsor:
Lyra Therapeutics
Conditions:
Chronic Sinusitis
Chronic Rhinosinusitis (Diagnosis)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.
Detailed Description
This is a 52-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period followed by a safety extension phase with crossover or continued treatment to...
Eligibility Criteria
Inclusion
- Age ≥18
- 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
- Inability to tolerate topical anesthesia or endoscopic procedure
- 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
Key Trial Info
Start Date :
January 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2024
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT05219968
Start Date
January 27 2022
End Date
September 16 2024
Last Update
May 2 2025
Active Locations (55)
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1
Lyra Investigational Site
Birmingham, Alabama, United States, 35294-0012
2
Lyra Investigational Site
Escondido, California, United States, 92025
3
Lyra Investigational Site
La Mesa, California, United States, 91942
4
Lyra Investigational Site
Sacramento, California, United States, 95661