Chronic Sinusitis Clinical Trial
Official title:
BEACON: A Phase II, Patient-blinded, Two-part, Randomized, Parallel-group Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LYR-220 in Chronic Rhinosinusitis (CRS) Patients Who Have Had a Prior Ethmoidectomy
Verified date | February 2023 |
Source | Lyra Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | August 30, 2023 |
Est. primary completion date | August 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Lyra Investigational Site | Bedford Park | |
Australia | Lyra Investigational Site | Brisbane | |
Australia | Lyra Investigational Site | Melbourne | |
United States | Lyra Investigational Site | Baltimore | Maryland |
United States | Lyra Investigational Site | Bethlehem | Pennsylvania |
United States | Lyra Investigational Site | Carlsbad | California |
United States | Lyra Investigational Site | Chapel Hill | North Carolina |
United States | Lyra Investigational Site | Chicago | Illinois |
United States | Lyra Investigational Site | Chicago | Illinois |
United States | Lyra Investigational Site | Fort Worth | Texas |
United States | Lyra Investigational Site | La Mesa | California |
United States | Lyra Investigational Site | Louisville | Kentucky |
United States | Lyra Investigational Site | Marrero | Louisiana |
United States | Lyra Investigational Site | McKinney | Texas |
United States | Lyra Investigational Site | New Albany | Indiana |
United States | Lyra Investigational Site | New Hyde Park | New York |
United States | Lyra Investigational Site | New York | New York |
United States | Lyra Investigational Site | Orangeburg | South Carolina |
United States | Lyra Investigational Site | Roseville | California |
United States | Lyra Investigational Site | San Antonio | Texas |
United States | Lyra Investigational Site | South Ogden | Utah |
United States | Lyra Investigational Site | Spartanburg | South Carolina |
United States | Lyra Investigational Site | Spokane | Washington |
United States | Lyra Investigational Site | Torrance | California |
United States | Lyra Investigational Site | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Lyra Therapeutics |
United States, Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Product-related unexpected serious adverse events | Product-related unexpected serious adverse events | Through Week 28 | |
Primary | Plasma MF concentrations | Plasma MF concentrations | Through Week 25 | |
Secondary | Adverse Events | Severity and percentage of subjects reporting treatment-emergent adverse events and serious adverse events | Through Week 28 | |
Secondary | Laboratory Values (hematology and chemistry) | Percentage of subjects with abnormal and clinically significant abnormal laboratory values | Through Week 25 | |
Secondary | Endoscopic findings | Percentage of subjects with newly identified or worsened endoscopic findings in the ethmoid cavity (mild, moderate, or severe) | Through Week 25 | |
Secondary | Ophthalmic Assessment: Intraocular Pressure (IOP) | Percentage of subjects with clinically significant increase in IOP | Through Week 25 | |
Secondary | Ophthalmic Assessment: Cataract | Percentage of subjects with newly identified or worsened cataract in one or both eyes | Through Week 25 | |
Secondary | Improving Chronic Rhinosinusitis (CRS) specific Quality of Life as per the 22-item sino-nasal outcome test (SNOT-22) questionnaire | Change from baseline in total patient-reported outcome measures. Each symptom is scored as it has been over the past two weeks on a 6-point scale (0 to 5: 0 = no problem to 5 = problem as bad as it can be). Higher scores indicate severity of symptoms. | Through Week 28 | |
Secondary | Change in Chronic Rhinosinusitis (CRS) symptom scores | Change from baseline in the average composite score | Through Week 28 |
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