2023-506268-15-00已完成3 期
ENLIGHTEN 2: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis (CRS) in Adults
Lyra Therapeutics Inc.27 个研究点 分布在 5 个国家目标入组 94 人开始时间: 2023年10月5日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 27
- 主要终点
- The primary endpoint is the change from baseline (CFBL) in the 7-day average composite score of the 3 cardinal symptoms (3CS) of nasal blockage/obstruction/congestion, facial pain/pressure, and anterior/posterior nasal discharge at Week 24 in participant without nasal polyps.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Diagnosed as having CRS
- •Bilateral ethmoid disease confirmed on computed tomography (CT)
- •Mean 3 cardinal symptom (3CS) score
- •Undergone at least 2 trials of medical treatments in the past
- •Has been informed of the nature of the study and provided written informed consent
- •Agrees to comply with all study requirements.
- •Willing to cancel or be removed from waitlist for any preplanned elective sinonasal surgery for the duration of the study
排除标准
- •Inability to tolerate topical anesthesia
- •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 1 or both eyes
- •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
- •Previous nasal surgery or polypectomy within 3 months 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
- •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
- •Obstruction preventing proper placement and retention of LYR-210 as seen on endoscopy and CT
- •History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis
- •Anatomic variation that, in the opinion of the investigator, would adversely impact placement of LYR-210 as seen on CT
结局指标
主要结局
The primary endpoint is the change from baseline (CFBL) in the 7-day average composite score of the 3 cardinal symptoms (3CS) of nasal blockage/obstruction/congestion, facial pain/pressure, and anterior/posterior nasal discharge at Week 24 in participant without nasal polyps.
The primary endpoint is the change from baseline (CFBL) in the 7-day average composite score of the 3 cardinal symptoms (3CS) of nasal blockage/obstruction/congestion, facial pain/pressure, and anterior/posterior nasal discharge at Week 24 in participant without nasal polyps.
次要结局
- 1.CFBL in the 7-day average composite score of 3CS at Week 24
- 2.CFBL in the 7-day average CS score of nasal blockage/obstruction/congestion at Week 24
- 3.CFBL in the 7-day average CS score of anterior/posterior nasal discharge at Week 24
- 4.CFBL in the 7-day average CS score of facial pain/pressure at Week 24
- 5.CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) total score at Week 24
- 6.Rescue treatment through Week 24
- 7. CFBL in the percent opacification of the bilateral anterior and posterior ethmoids at Week 20, as determined by 3-D volumetric CT analysis.
研究者
Clinical Trial Information
Scientific
Lyra Therapeutics Inc.
研究点 (27)
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