LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study) (NCT05035654) | Clinical Trial Compass
CompletedPhase 2
LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)
United States48 participantsStarted 2021-11-23
Plain-language summary
This study will assess the safety, tolerability, pharmacokinetics and efficacy of two LYR-220 designs in symptomatic adult chronic rhinosinusitis (CRS) subjects who have had a prior functional endoscopic sinus surgery.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Diagnosis of chronic rhinosinusitis.
* Has had a prior bilateral total ethmoidectomy.
* Has computed tomography (CT) ethmoid cavity opacification.
* Has a Sinonasal Outcome Test (SNOT-22) ≥ 20 at Screening Visit.
* Minimum cardinal symptom score.
* Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site or regulatory authority if applicable by national law.
* Agrees to comply with all study requirements.
Exclusion Criteria:
* Pregnant or breast feeding.
* Known history of hypersensitivity or intolerance to corticosteroids.
* History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
* Known history of hypothalamic pituitary adrenal axial dysfunction.
* Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
* Past or present functional vision in only one eye.
* Past, present, or planned organ transplant or chemotherapy with immunosuppression.
* With prior cataract surgery or presence (in either eye) of posterior subcapsular cataract of grade 2 or higher, nuclear cataract of grade 3 or higher, or cortical cataract of grade 2 or higher or involving a minimum of center optic zone of 3 mm diameter.
* Ethmoidectomy that was unilateral or partial.
* Currently participating in an investigational drug or device study.