NL-OMON49549撤回不适用
*Differences in effect of treatment with mepolizumab and benralizumab on resident and inflammatory eosinophils. - DIMENSIO
niversitair Medisch Centrum Utrecht0 个研究点目标入组 72 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Age * 18
- •* Diagnosis of severe refractory eosinophilic asthma
- •* Eligible for mepolizumab or benralizumab therapy according the national
- •recommendations for severe asthma of the Dutch society for lung diseases and
- •tuberculosis (NVALT guideline 2013): Patients with asthma, for whom alternative
- •diagnoses are excluded, comorbidity optimally treated, provoking factors
- •minimized and therapy compliance optimized, but despite this still have
- •insufficient asthma control (* 1.5 ACQ-7 or other questionnaire) or frequent
- •(*2 annually) severe exacerbations (systemic CS needed) while routinely using
- •high-dose asthma medication (* 1000 mcg/day fluticasone propionate equivalent
- •and/or daily OCS in combination with LABA or other controller medication); or
- •patients who can achieve asthma control only with systemic CS and are therefore
- •are risk for adverse effects or the corticosteroids.
- •* Treated with mepolizumab or benralizumab for at least 4 months.
- •* Before treatment with biologics a blood eosinophilia (* 150
- •eosinophils/microl blood) irrespective of steroid use
排除标准
- •* Any infection (eg. HIV, Hepatitis, STDs)
- •* Insulin dependent diabetes
- •* Smoking at present or in the last 12 months and/or a past history of more
- •than 10 pack years
- •* Proven allergic bronchopulmonary aspergillosis
- •* Auto-immune diseases
- •* Use of medication, excluding:
- •o Anticonceptives
- •o Pain killers, if used on average less than once a week
- •* exuberant alcohol consumption (for males > 36 glasses per week, for females
- •>24 glasses per week)
- •* Drug use
- •* History of cancer
- •* Use of biologicals other than mepolizumab or benralizumab
- •* daily oral steroid therapy during the three months preceding inclusion
研究者
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