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Efficacy, Safety, Tolerability Study of LYR-210 Depot in Chronic Sinusitis
EU CTIS ID: 2023-506268-15-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age ≥18.
- 2. Diagnosed as having CRS
- 3. Bilateral ethmoid disease confirmed on computed tomography (CT)
- 4. Mean 3 cardinal symptom (3CS) score
- 5. Undergone at least 2 trials of medical treatments in the past
- 6. Has been informed of the nature of the study and provided written informed consent
You likely can't join if
- 1. Inability to tolerate topical anesthesia
- 10. Known history of hypersensitivity or intolerance to corticosteroids
- 11. Known history of hypothalamic pituitary adrenal axial dysfunction
- 12. Previous pituitary or adrenal surgery
- 13. Dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
- 14. Past or present acute or chronic intracranial or orbital complications of CRS
See the full eligibility criteria
- 1. Age ≥18.
- 2. Diagnosed as having CRS
- 3. Bilateral ethmoid disease confirmed on computed tomography (CT)
- 4. Mean 3 cardinal symptom (3CS) score
- 5. Undergone at least 2 trials of medical treatments in the past
- 6. Has been informed of the nature of the study and provided written informed consent
- 7. Agrees to comply with all study requirements.
- 8. Willing to cancel or be removed from waitlist for any preplanned elective sinonasal surgery for the duration of the study
- 1. Inability to tolerate topical anesthesia
- 10. Known history of hypersensitivity or intolerance to corticosteroids
- 11. Known history of hypothalamic pituitary adrenal axial dysfunction
- 12. Previous pituitary or adrenal surgery
- 13. Dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
- 14. Past or present acute or chronic intracranial or orbital complications of CRS
- 15. History or diagnosis (in either eye) of glaucoma or ocular hypertension
- 16. Past or present functional vision in 1 or both eyes
- 17. Past, present, or planned organ transplant or chemotherapy with immunosuppression
- 18. Currently positive for COVID-19 or residual sinonasal symptoms from a previous COVID-19 infection
- 19. Pregnant or breast feeding. Females of child-bearing potential must test negative for pregnancy at the time of screening
- 2. Previous nasal surgery or polypectomy within 3 months of screening
- 20. Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments
- 21. Currently participating in an investigational drug or device study
- 22. Determined by the investigator as not suitable to be enrolled
- 3. Presence of nasal polyp grade 2 or higher
- 4. Seasonal allergic rhinitis
- 5. Perennial rhinitis with symptoms that are well controlled by regular use of intranasal corticosteroids
- 6. Severe asthma
- 7. Obstruction preventing proper placement and retention of LYR-210 as seen on endoscopy and CT
- 8. History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis
- 9. Anatomic variation that, in the opinion of the investigator, would adversely impact placement of LYR-210 as seen on CT
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.