Phase 2
N=71
LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
Chronic Sinusitis · Chronic Rhinosinusitis (Diagnosis)
Bottom Line
View on ClinicalTrials.gov: NCT04041609 ↗Enrolled (actual)
71
Serious AEs
2.9%
Results posted
Jun 2023
Primary outcome: Primary: Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4 — -2.24; -2.65; -2.28 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LYR-210 (Drug); Sham comparator (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lyra Therapeutics
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4 |
-2.24; -2.65; -2.28 | — |
| SECONDARY Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24 |
-30.0; -40.7; -21.7 | — |
| SECONDARY CFBL in Chronic Sinusitis Symptom Scores at Week 24 |
-3.36; -4.32; -2.68 | — |
| SECONDARY Participants With Improved Bilateral Zinreich Score at Week 24 |
13; 14; 10 | — |
| SECONDARY The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks |
11; 5; 5 | — |
| SECONDARY Plasma Drug Concentrations of MF at Week 4 |
13.6110; 45.3500 | — |
| SECONDARY Plasma Drug Concentrations of MF at Week 12 |
21.6500; 30.9143 | — |
Summary
This is a Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects with Chronic Sinusitis.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of CS.
- Two trials of medical treatments for CS in the past.
- Minimum CS symptom score.
- Ability to tolerate topical anesthesia.
- Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
- Agrees to comply with all study requirements.
Exclusion Criteria
- Have undergone previous sinus surgery.
- Pregnant or breast feeding.
- Known history of hypersensitivity or intolerance to corticosteroids.
- History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
- Known history of hypothalamic pituitary adrenal axial dysfunction or having a morning serum cortisol level at screening outside of the normal range.
- Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
- Past or present functional vision in only one eye.
- Has cataracts
- Past, present, or planned organ transplant or chemotherapy with immunosuppression.
- Currently participating in an investigational drug or device study
Data sourced from ClinicalTrials.gov (NCT04041609). 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.