Chronic Rhinosinusitis (CRS) in Adults MedDRA version: 20.1 Level: PT Classification code 10009137 Term: Chronic sinusitis System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Lyra Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age =18 - Diagnosed as having CRS - Bilateral ethmoid disease confirmed on computed tomography (CT) - Mean 3 cardinal symptom (3CS) score - Undergone at least 2 trials of medical treatments in the past - Has been informed of the nature of the study and provided written informed consent - Agrees to comply with all study requirements - Willing to cancel or be removed from waitlist for any preplanned elective sinonasal surgery for the duration of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Inability to tolerate topical anesthesia - Previous ethmoidectomy, or surgery of the middle meatus and/or middle turbinate preventing proper placement and retention of LYR-210 - Previous nasal surgery or polypectomy within 3 months of screening - 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 - Obstruction preventing proper placement and retention of LYR-210 as seen on endoscopy and CT - History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis - 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 - Oral steroid or monoclonal antibody dependent condition, including biologics use within 3 months of screening and systemic steroids use within 1 month of screening - SCS administered within 1 month prior to Screening visit - Known history of hypothalamic pituitary adrenal axial dysfunction - Previous pituitary or adrenal surgery - More than 1 episode of epistaxis with frank bleeding requiring medical attention within 2 months of Screening visit - Acute exacerbation of nasal allergy or CRS, upper respiratory tract infection (URTI), or common cold within 4 weeks of the Screening visit - 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 - Presence of posterior subcapsular cataract of grade 2 or higher, nuclear sclerosis 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 - Loss of functional vision in 1 or both eyes - Diagnosed with ongoing rhinitis medicamentosa - Known history of immune dysfunction including immune deficiency - 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 - History or diagnosis of ciliary dysfunction - Past or present systemic vasculitis - 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 - Previously received an experimental treatment another clinical study within 5 half-lives or 30 days - Currently participating in an investigational drug or device study - Determined by the investigator as not suitable to be enrolled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of LYR-210, compared with a sham procedure control, in improving the 3 cardinal symptoms of CRS in CRS participants without nasal polyps who had previously failed medical management.;Secondary Objective: Evaluate the efficacy of LYR-210, compared with sham control, in improving the 3 cardinal symptoms of CRS in CRS participants without nasal polyps or with nasal polyps of grade 1 who had previously failed medical management. Evaluate the efficacy of LYR-210, compared with sham control, in improving CRS related quality of life, CRS symptoms, the extent of inflammation in the ethmoid sinuses, and the need for rescue treatment in surgery naïve CRS participants without nasal polyps or who had previously failed medical management. ;Primary end point(s): The primary endpoint is the change from baseline (CFBL) in the 7-day average composite score of the 3 cardinal symptoms (3CS) of nasal blockage/obstruction/congestion, facial pain/pressure, and anterior/posterior nasal discharge at Week 24 in participant without nasal polyps. ;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.CFBL in the 7-day average composite score of 3CS at Week 24 2.CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) total score at Week 24 3.Rescue treatment through Week 24 4.CFBL in the 3-D volumetric CT analysis at Week 20 ;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Countries
Austria, Czech Republic, Spain, United States
Contacts
Public ContactClinical Trial Information
Lyra Therapeutics, Inc.
Outcome results
None listed