SMART Use of Biologics in Chronic Rhinosinusitis With Nasal Polyposis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 504
- 试验地点
- 2
- 主要终点
- Disease-Specific Quality of Life
研究概览
简要总结
The prevalence of Chronic Sinusitis with Nasal Polyps (CRSwNP) in the United States is estimated at roughly 4%, which equates to over 13 million Americans. Until recently, the only medical treatment options available for patients with CRSwNP were corticosteroids, with surgery reserved for medical failure. The development of biologic medications over the last 5 years has revolutionized the treatment of CRSwNP. Three biologic medications have been FDA approved and available for the treatment of CRSwNP: dupilumab, omalizumab, and mepolizumab. However, data from the clinical trials for these drugs do not show universal improvement across all patients with CRSwNP. In fact, there is a wide range of outcomes for patients in these trials. The result is that clinicians have no way of knowing which specific biologic would be the best option for any given patient, nor do they know whether biomarkers can be used to predict response to biologics. It is hoped that findings from this study will inform whether any one biologic has superior outcomes to another and whether clinicians can identify patients at baseline who are most likely to improve on biologic therapy.
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
- None
盲法说明
The laboratory analyzing the samples will be blinded to the intervention
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
- •Age > 18 years
- •Confirmed diagnosis of chronic rhinosinusitis with nasal polyposis using ICAR-21 (International Consensus Statement 20215) criteria
- •Bilateral nasal polyposis visible on sinonasal endoscopy
- •Nasal polyp score > 5
- •Baseline SNOT-22 total score > 30
- •Patient elects biologic therapy for the management of CRSwNP
- •Capable of receiving all 3 biologic therapy medications.
- •Treatment with intranasal mometasone ≥200 μg. once daily (or equivalent of another intranasal corticosteroid) for 1-month prior to baseline visit.
排除标准
- •Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- •Endoscopic sinus surgery within 6-months preceding enrollment / randomization.
- •Oral corticosteroid use within 30-days preceding enrollment / randomization.
- •Serum IgE level outside the dosing range for omalizumab (i.e., <30 IU/ml. or a weight-based dose with insufficient data to determine dose as per FDA dosing chart)
- •Comorbid atopic dermatitis, urticaria, or any other condition that would require a specific biologic per the standard of care.
- •Currently pregnant or plan to become pregnant within the 6 months after enrollment / randomization.
- •Any previous treatment with any of the 3 biologic medications.
- •Comorbid cystic fibrosis, CVID, or ciliary dyskinesia.
- •Comorbid systemic inflammatory disorders (e.g., GPA, EGPA, Sarcoidosis, SLE)
- •Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks for participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.
研究组 & 干预措施
Mepolizumab
干预措施: Biologic Agents (Biological)
Dupilumab
干预措施: Biologic Agents (Biological)
Omalizumab
干预措施: Biologic Agents (Biological)
结局指标
主要结局
Disease-Specific Quality of Life
时间窗: 24 weeks
The 22-item SinoNasal Outcome Test (SNOT-22; ©2006, Washington University, St. Louis, MO) will serve as the primary outcome of interest for all study aims/objectives. The SNOT-22 survey is a CRS-specific QOL instrument containing 22 questions (total summarized score range: 0-110) with high internal consistency and high test-retest reliability. The SNOT-22 utilizes Likert scales numbering from 0 ("No problem") to 5 "Problem as bad as it can be"). The SNOT-22 has been shown to discriminate between subjects with CRS and healthy controls, as well as identify significant differences after both medical and surgical treatments.
次要结局
未报告次要终点