This study is now CLOSED
Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 1)
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 evaluate the efficacy and safety of LYR-210 compared with sham control for treatment in adults with CRS.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Inability to tolerate topical anesthesia
- 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
For more information please contact our research team at Research@AdvancedENTandAllergy.com or call 502.995.5525 and ask for the Research Department.
