EUCTR2014-004940-36-PL进行中（未招募）1 期
A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients with Persistent Asthma - Liberty Asthma Quest
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,858
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
- •Adults and adolescent patients with a physician diagnosis of asthma for =12 months, based on the Global Initiative for Asthma (GINA) 2014 Guidelines and the following criteria:
- •- Existing treatment with medium to high dose ICS (=250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta agonist, leukotrine receptor antagonist) for at least 3 months with a stable dose =1 month prior to Visit 1.
- •- Note for Japan: for subjects aged 18 years and older, ICS must be on =200 mcg of fluticasone propionate twice daily or equivalent; for subjects aged 12 to 17 years, ICS must be =100 mcg of fluticasone propionate twice daily or equivalent).
- •- Patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose =1 month prior to Visit 1.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 84
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 254
排除标准
- •-Patients <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (For those countries where local regulations permit enrollment of adults only, subject recruitment will be restricted to those who are =18 years of age).
- •-Weight is less than 30 kilograms.
- •-Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function.
- •-A subject who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to the Screening Visit up to and including the Baseline Visit).
- •-Evidence of lung disease(s) other than asthma, either clinical evidence or imaging (Chest X-ray, CT, MRI) within 12 months of Visit 1 or at the screening visit, as per local standard of care.
- •-Note for Japan: According to the request from the health authority, chest X-ray should be performed at screening visit if there is no chest imaging (Chest X-ray, CT, MRI) available within 3 months prior to screening to exclude patients with suspected active or untreated latent tuberculosis.
- •-Current smoker or cessation of smoking within 6 months prior to Visit 1.
- •-Previous smoker with a smoking history >10 pack-years.
- •-Comorbid disease that might interfere with the evaluation of Investigational Medicinal Product.
研究者
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