Phase 3
N=196
Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults
Chronic Sinusitis · Chronic Rhinosinusitis (Diagnosis)
Bottom Line
View on ClinicalTrials.gov: NCT05219968 ↗Enrolled (actual)
196
Serious AEs
5.0%
Results posted
May 2025
Primary outcome: Primary: Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps. — -2.13; -2.06 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- LYR-210 (Drug); Sham procedure control (Drug); Background Therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lyra Therapeutics
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps. |
-2.13; -2.06 | — |
| SECONDARY CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24. |
-2.35; -1.83 | — |
| SECONDARY CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24 |
-19.7; -15.7 | — |
| SECONDARY CFBL in the 3-D Volumetric CT Score at Week 20 |
-2.705; -0.279 | — |
| SECONDARY Participants With Rescue Treatments for CRS Through Week 24 |
12; 7 | — |
Summary
Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.
Eligibility Criteria
Inclusion Criteria
- Age ≥18
- Diagnosed as having CRS
- Undergone at least 2 trials of medical treatments in the past
- Mean 3 cardinal symptom (3CS) score
- Bilateral ethmoid disease confirmed on CT
- Has been informed of the nature of the study and provided written informed consent
- Agrees to comply with all study requirements
- If on a waiting list for sinonasal surgery, willing to be removed from list or have surgery date cancelled for the duration of the study.
Exclusion Criteria
- Inability to tolerate topical anesthesia or endoscopic procedure
- 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
Data sourced from ClinicalTrials.gov (NCT05219968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.