EUCTR2016-001213-24-NL进行中（未招募）1 期
Infection prevention and immune modulation by bacterial lysates: gaining insight into the mechanism of an old therapy in patients with asthma
Franciscus Gasthuis0 个研究点开始时间: 2016年4月25日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with proven asthma (airway responsiveness proven by reversibility and histamine PC20 < 8 mg/ml)) who have recurrent airway signs and symptoms despite optimal maintenance medication (medium/high dose inhalation corticosteroid and long-acting ß2-agonist; GINA 4).
- •Specific inclusion criteria
- •-= 2 documented asthma exacerbations in the past winter season (see definition below)
- •-and Asthma Control Questionnaire (ACQ) > 1.5 despite maintenance medication
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Other relevant respiratory conditions, e.g. OSAS, bronchiectasis
- •-Systemic immunological diseases
- •-Current smoking or past smoking > 10 pack years
- •-Other untreated co-morbidity, such as gastro-esophageal reflux disease, ENT problems, psychological disorders
- •-Non-compliance to current medication or inhalation technique
- •-Communication difficulties
- •-Pregnancy or planned pregnancy within 2 years
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