Effects of Anti-IgE Antibody Omalizumab (Xolair) on Patients With Chronic Sinusitis and a Positive Allergen Test
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Subjects will have QOL measures (RSDI, SNOT 20, SF-36), NPIF, and nasal lavage repeated. Exacerbations of sinusitis requiring additional treatments will be recorded. Paranasal sinus CT scans will be obtained at the screening and final visits
研究概览
简要总结
We propose to study the effects of Xolair on patients with chronic sinusitis with or without nasal polyps. Because of the similarities between the inflammatory processes found in asthmas and rhinitis to those found in chronic sinusitis, we hypothesize that sinusitis should respond to Xolair, just as asthma.
详细描述
We propose to study the effects of Xolair on patients with chronic sinusitis with or without nasal polyps. Since Xolair has been shown to be effective in asthmatic subjects with evidence of atopy and elevated IgE, we will limit our study to patients with chronic sinusitis and these parameters. The primary objective is to determine if Xolair decreases mucosal thickness on CT scan after 6 months of treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between 18 and 75 years of age
- •Chronic sinusitis as defined by symptoms for greater than 12 weeks despite treatment.
- •Paranasal sinus CT scan showing evidence of chronic sinusitis.
- •Positive skin or RAST test to an inhalant allergen.
- •Serum total IgE between 30 and 700 International Units/ml.
- •Body weight less than 150kg.
- •Impaired quality of life as measured by the Rhinosinusitis Disability Index (RSDI).
排除标准
- •Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are breastfeeding.
- •Known sensitivity to Xolair
- •Patients with severe medical conditions that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease).
- •Use of any other investigational agent in the last 30 days.
- •No measurable disability on the RSDI.
- •Immunocompromised patients or patients with ciliary disorders.
研究组 & 干预措施
A
Subjects to receive placebo treatment for 6 months
干预措施: Placebo (Drug)
B
Subjects to receive Xolair treatment for 6 months
干预措施: Xolair (Drug)
结局指标
主要结局
Subjects will have QOL measures (RSDI, SNOT 20, SF-36), NPIF, and nasal lavage repeated. Exacerbations of sinusitis requiring additional treatments will be recorded. Paranasal sinus CT scans will be obtained at the screening and final visits
时间窗: At entry and every 4 weeks
次要结局
未报告次要终点