EUCTR2018-001953-28-RO进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients with Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with Type 2 inflammation - BOREAS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,054
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
- •-Participants with a physician diagnosis of COPD who meet the following criteria:
- •-Current or former smokers with a smoking history of =10 pack-years.
- •-Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity [FVC] =70% and post-bronchodilator FEV1 % predicted >30% and =70%).
- •-Medical Research Council (MRC) Dyspnea Scale grade =2.
- •-Patient-reported history of signs and symptoms of chronic bronchitis (chronic productive cough) for 3 months in the year up to screening in the absence of other known causes of chronic cough.
- •-Documented history of high exacerbation risk defined as exacerbation history of =2 moderate or =1 severe within the year prior to inclusion.
- •Moderate exacerbations are recorded by the investigator and defined as acute exacerbation of COPD (AECOPD) that require either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations has to require the use of systemic corticosteriods.
- •Severe exacerbations are recorded by the investigator and defined as AECOPD requiring hospitalization/emergency room
- •visit or result in death.
- •-Background triple therapy (inhaled corticosteroid [ICS] + long acting beta agonist [LABA] + long acting muscarinic agonist [LAMA]) for 3 months prior to randomization with a stable dose of medication for =1 month prior to Visit 1; Double therapy (LABA + LAMA) allowed if ICS is contraindicated.
- •-Evidence of Type 2 inflammation: Patients with blood eosinophils =300 cells/microliter at Visit 1.
- •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 1588
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 466
排除标准
- •- COPD diagnosis for less than 12 months prior to randomization.
- •- A current diagnosis of asthma according to the 2018 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines; or a history of asthma with age of onset = 40 years of age.
- •- Significant pulmonary disease other than COPD (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome etc) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
- •- Cor pulmonale, evidence of right cardiac failure.
- •- Treatment with oxygen of more than 12 hours per day.
- •- Hypercapnia requiring Bi-level ventilation.
- •- AECOPD as defined in inclusion criteria within 4 weeks prior to screening, or during the screening period.
- •- Respiratory tract infection within 4 weeks prior to screening, or during the screening period.
- •- History of, or planned pneumonectomy or lung volume reduction surgery. Patients who are participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation <4 weeks prior to screening (Note: patients in the maintenance phase of a rehabilitation program can be included).
- •- Diagnosis of a-1 anti-trypsin deficiency.
研究者
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