Impact of Mepolizumab Treatment on the Nasal Microbiome and Local and Systemic Immune Response in Eosinophilic Granulomatosis With Polyangitis (eGPA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The effect mepolizumab treatment has on the nasal microbiome profiles
研究概览
简要总结
Rationale: Eosinophilic Granulomatosis with Polyangiitis (eGPA), eosinophilic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) are airway diseases where eosinophils and interleukine-5 are involved in the pathogenesis. eGPA differs from the other diseases with respect to involvement of other organs. The investigators hypothesize that nasal microbiome dysbiosis with a central augmenting role for S. Aureus plays an important role in disease expression. The investigators expect that anti-interleukin-5 treatment with mepolizumab restores the changes of the nasal microbiome and immune responses to a healthy control phenotype. To study this, the nasal microbiome, the local and systemic immune response and the effect of mepolizumab treatment will be assessed.
详细描述
See Brief summary.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age
- •able to give informed consent
- •In CRSwNP group: availability of bilateral nasal polyps as diagnosed by endoscopy or CT scan
- •In Severe asthma group: clinical diagnosis of asthma with forced expiratory volume at one second(FEV1) <80% AND either FEV1 reversibility >12% initial or documented positive metacholine challenge (PC20 < 8 mg/ml)
- •In eGPA group: Fulfilling the 2022 ACR/EULAR criteria for eGPA (Wechsler et al., 2017)
- •In GPA group: fulfilling the American College of Rheumatology (ACR)/EULAR GPA criteria (Robson et al., 2022)
- •In healthy controls: absence of asthma symptoms, no bronchial hyperresponsiveness
排除标准
- •unable to give informed consent
- •Active smoking < (less than) 6 months from baseline visit
- •Concomitant use of dupilumab within 6 months of baseline visit
- •pregnant or breastfeeding woman
- •in CRSwNP group: current use of asthma medication, eGPA
- •in healthy controls: chronic use of local anti-inflammatory agents
- •in healthy controls: use of immunosuppressive medication
- •in healthy controls: use of antibiotics within the last month (before start study/screening/)
结局指标
主要结局
The effect mepolizumab treatment has on the nasal microbiome profiles
时间窗: three months
Paired change in microbiome diversity index for patients treated with mepolizumab.
次要结局
未报告次要终点