LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
- Conditions
- Chronic SinusitisChronic Rhinosinusitis (Diagnosis)
- Interventions
- Other: Sham comparator
- Registration Number
- NCT04041609
- Lead Sponsor
- Lyra Therapeutics
- Brief 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.
- Detailed Description
LYR-210 is a drug depot, which contains the anti-inflammatory medication mometasone furoate (MF) pre-loaded in a single use applicator. LYR-210 is intended to be placed bilaterally into the sino-nasal passages by an otolaryngologist. Once in place, each LYR-210 drug depot is designed to gradually deliver sustained topical doses of MF to the inflamed mucosal sinus tissue over 24 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LYR-210 (High Dose) LYR-210 In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus LYR-210 (Low Dose) LYR-210 In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus Sham Procedure Sham comparator In-office bilateral sham procedure
- Primary Outcome Measures
Name Time Method Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4 Week 4 Participants score their CS symptoms on a 4-point scale as follows: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom present but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The scores are summed and averaged over the proceeding 7 days; higher scores indicate higher severity of symptoms of CS.
- Secondary Outcome Measures
Name Time Method Plasma Drug Concentrations of MF at Week 12 12 weeks To evaluate the pharmacokinetics of LYR-210
Plasma Drug Concentrations of MF at Week 4 4 Weeks To evaluate the pharmacokinetics of LYR-210
Participants With Improved Bilateral Zinreich Score at Week 24 Week 24 Each sinus is assigned a score based on the percentage of opacification as follows: 0 = 0%, 1 = 1% to 25%, 2 = 26% to 50%, 3 = 51% to 75%, 4 = 76 % to 99%, 5 = 100% or completely occluded. Each sinus pair has a bilateral score in the range of 0 to 10. Higher scores indicate higher severity of sinus opacification. Responder is defined as a participant with at least a 1-point decrease in the imaging score at Week 24 compared with baseline.
CFBL in Chronic Sinusitis Symptom Scores at Week 24 Week 24 Participants score their CS symptoms on a 4-point scale as follows: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom present but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The scores are summed and averaged over the proceeding 7 days; higher scores indicate higher severity of symptoms of CS.
Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24 24 weeks Participants score the severity of their symptoms and social/emotional consequences of CS on a 6-point scale: 0 = no problem, 1 = very mild problem, 2 = mild or slight problem, 3 = moderate problem, 4 = severe problem, 5 = problem as bad as it can be. The scores are summed in the range of 0-110; higher scores indicate higher severity of symptoms or social/emotional consequences of CS.
The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks 24 weeks To evaluate the safety and tolerability of LYR-210
Trial Locations
- Locations (22)
Provita Sp. z o.o. Centrum Medyczne Angelius Provita
🇵🇱Katowice, Poland
Centrum Medyczne PROMED
🇵🇱Kraków, Poland
Vistamed Sp. z o.o.
🇵🇱Wrocław, Poland
University Hospital for Otorhinolaryngology, Medical University of Graz
🇦🇹Wien, Austria
Centrum Medyczne Plejady
🇵🇱Kraków, Poland
Centrum Zdrowia MDM
🇵🇱Warszawa, Poland
Monash Health
🇦🇺Clayton, Australia
Westmead Hospital
🇦🇺Westmead, Australia
The ENT Centre
🇦🇺Hornsby, Australia
Royal Brisbane and Woman's Hospital
🇦🇺Brisbane, Australia
Fakultni Nemocnice Hradec Kralove Klinika otorinolaryngologie a chirurgie hlavy a krku
🇨🇿Hradec Králové, Prague, Czechia
St Anne's Faculty Hospital
🇨🇿Brno, Czechia
Fakultnà nemocnice Plzeň
🇨🇿Plzen, Czech Republic, Czechia
Fakultni Nemocnice Brno OR
🇨🇿Brno, Czechia
Southern Clinical Trials Waitemata
🇳🇿Auckland, New Zealand
Clinical Trials New Zealand
🇳🇿Hamilton, New Zealand
Southern Clinical Trials Ltd
🇳🇿Christchurch, New Zealand
Middlemore Clinical Trials
🇳🇿Papatoetoe, New Zealand
P3 Research Tauranga
🇳🇿Tauranga, New Zealand
P3 Research Wellington
🇳🇿Wellington, New Zealand
Wellington Hospital
🇳🇿Wellington, New Zealand
Centrum Medyczne All-Med
🇵🇱Kraków, Poland