Utility of Biomarkers in Evaluating Responsiveness to Anti-IgE (Omalizumab) in Severe Asthma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in selected biomarkers in induced sputum
研究概览
简要总结
Eosinophil infiltration and degranulation in airways has been implicated in the pathology of asthma. Periostin is considered to be a marker of eosinophilic inflammation and is one of the highly expressed genes in epithelial cells and lung fibroblasts in asthma. Omalizumab is approved as add-on therapy in the treatment of severe allergic asthma. The aim of the study is to assess inflammatory biomarkers including: blood and sputum eosinophilia, periostin and IL-6 as long-term clinical outcomes of omalizumab therapy.
详细描述
Anti-IgE (omalizumab) has been shown to be an effective add-on therapy for patients with allergic severe asthma. In this observational study patients aged over 18 year with uncontrolled severe persistent asthma are selected for add-on therapy with omalizumab. Patients were on high dose of ICS and had a documented history of 2-6 exacerbations requiring treatment with systemic corticosteroids ( with >15 mg/day prednisone or other medications at similar dose, for at least 3 days). The individual dose and frequency of omalizumab administration is assessed from the dosing table. Lung function tests and asthma questionnaires (ACQ, AQLQ and RQLQ) are used in the aim of assessing clinical improvement after omalizumab treatment. Induced sputum (IS) and exhaled breath condensate (EBC) are used as a simple non-invasive methods for monitoring cellular and biochemical changes in the airways. Total blood eosinophil count, IS cytology, IS and EBC periostin and IL-6 concentrations are measured. Analyses are performed at entry and after 16, 52 and 104,156 weeks of omalizumab treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •positive history of atopy
- •serum total IgE level between 30 and 700 IU/ml
- •body weight not more than 150 kg
- •high dose of ICS and LABA
- •a documented history of 2-6 exacerbations requiring treatment with systemic corticosteroids ( with >15 mg/day prednisone or other medications at similar dose, for at least 3 days).
排除标准
- 未提供
结局指标
主要结局
Change in selected biomarkers in induced sputum
时间窗: baseline and after 156 weeks of omalizumab treament
IL-6
Change in selected biomarkers in peripheral blood
时间窗: baseline and after 156 weeks of omalizumab treament
eosinophil count
Change in selected biomarkers in exhaled breath condensate
时间窗: baseline and after 156 weeks of omalizumab treament
IL-6
次要结局
- Change in selected biomarkers in exhaled breath condensate(baseline and after at 16, 52, 104 weeks of omalizumab treament)
- Change in selected biomarkers in peripheral blood(baseline and after at 16, 52, 104 weeks of omalizumab treament)
- Change in selected biomarkers in induced sputum(baseline and after at 16,52,104 weeks of omalizumab treament)
研究者
Joanna Hermanowicz-Salamon
MD PhD
Medical University of Warsaw