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 (LANTERN Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 22
- 主要终点
- Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
LYR-210 (Low Dose)
In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus
干预措施: LYR-210 (Drug)
LYR-210 (High Dose)
In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus
干预措施: LYR-210 (Drug)
Sham Procedure
In-office bilateral sham procedure
干预措施: Sham comparator (Other)
结局指标
主要结局
Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4
时间窗: 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.
次要结局
- Plasma Drug Concentrations of MF at Week 12(12 weeks)
- Plasma Drug Concentrations of MF at Week 4(4 Weeks)
- Participants With Improved Bilateral Zinreich Score at Week 24(Week 24)
- CFBL in Chronic Sinusitis Symptom Scores at Week 24(Week 24)
- Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24(24 weeks)
- The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks(24 weeks)