EUCTR2015-001572-22-GB进行中（未招募）1 期
An exploratory, randomized, double-blind, placebo-controlled study of the effects of dupilumab on airway inflammation of adults with persistent asthma - EXPEDITIO
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
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
入选标准
- •Male and female adults with a physician diagnosis of persistent asthma for =12 months.
- •Existing treatment with medium to high dose inhaled corticosteroids in combination with a long acting beta agonist for at least 3 months with a stable dose =1 month prior to Visit 1 (Screening Visit).
- •Treatment with a third asthma controller for at least 3 months with a stable dose =1 month prior to Visit 1 is allowed.
- •Pre-bronchodilator forced expiratory volume (FEV1) 55 to 85% of predicted normal.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 42
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients <18 years or >65 years.
- •Fractional exhaled nitric oxide (FeNO) <26 ppb at Visit 1 (Screening Visit).
- •Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, eosinophilic granulomatosis with polyangiitis [Churg-Strauss Syndrome]) which may impair lung function.
- •A patient who experiences an asthma exacerbation that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to Visit 1.
- •A patient who has experienced an upper or lower respiratory tract infection within the 4 weeks prior to Visit 1.
- •Evidence of lung disease(s) other than asthma.
- •Previous smoker (smoking history >10 pack-years) or current smoker (within 6 months prior to Visit 1).
- •Comorbid disease that might interfere with the evaluation of investigational medicinal product or conduct of study procedures (eg, bronchoscopy).
- •Anti-immunoglobulin E (IgE) therapy (omalizumab) or any other biologic therapy within 6 months of Visit 1.
- •Exposure to another investigative study medication within a time period prior to Visit 1 that is less than 5 half-lives of the study medication.
- •Treatment with systemic (oral or injectable) corticosteroids within 28 days of Visit 1.
研究者
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