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 0
Exclusion criteria
Exclusion criteria: •Inability to tolerate topical anesthesia •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 •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 1 or both eyes •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
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: 1. Evaluate the efficacy of LYR-210, compared with a sham procedure, 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. 2. Evaluate the efficacy of LYR-210, compared with sham control, in improving the individual CRS symptoms, CRS-related quality of life, the extent of inflammation in the ethmoid sinuses, and the need for rescue treatment in CRS participants without nasal polyps or with nasal polyps of Grade 1, 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 7-day average CS score of nasal blockage/obstruction/congestion at Week 24 3.CFBL in the 7-day average CS score of anterior/posterior nasal discharge at Week 24 4.CFBL in the 7-day average CS score of facial pain/pressure at Week 24 5.CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) total score at Week 24 6.Rescue treatment through Week 24 7.CFBL in the 3-D volumetric CT analysis at Week 20 ;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Countries
Belgium, Bulgaria, Germany, Hungary, United States
Contacts
Public ContactClinical Trial Information
Lyra Therapeutics, Inc.
Outcome results
None listed