Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (NCT05219968) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults
United States196 participantsStarted 2022-01-27
Plain-language summary
Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* 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:
* 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 o…
What they're measuring
1
Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps.