Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lyra Therapeutics
This is a 24-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period to evaluate the efficacy and safety of LYR-210 compared with sham control for treatment in adults with CRS.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥18
Diagnosed as having CRS
Bilateral ethmoid disease confirmed on 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
If currently on a waiting list for sinonasal surgery, willing to be removed from the waiting list or have preplanned surgery date cancelled for the duration of the study. \[Note: this does not preclude a participant from receiving or being recommended for sinonasal surgery as rescue treatment during the study\].
You may not be if
Inability to tolerate topical anesthesia
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 or diagnosis (in either eye) of glaucoma or ocular hypertension
Past or present functional vision in only 1 eye
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
Clareo Health | Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2)
