EUCTR2017-003290-34-PL进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, parallel-group, Proof-of-Concept (PoC) study to assess the efficacy, safety and tolerability of SAR440340, in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 850
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 diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for at least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition.
- •-Participants with moderate-to-severe COPD (post-bronchodilator Forced Expiratory Volume in 1 Second [FEV1]/forced vital capacity [FVC] <70% and post-bronchodilator FEV1 % predicted <80%,
- •but =30%).
- •-Participants with COPD Assessment Test (CAT) score =10 at Screening Visit 1 and Visit 2/Randomization.
- •-Participants with reported history of signs and symptoms of chronic bronchitis (chronic productive cough for 3 months in the year up to screening in a patient in whom other causes of chronic cough [e.g., gastroesophageal reflux, chronic rhinosinusitis, bronchiectasis] have been excluded).
- •-Participants with a documented history (eg. medicla record verification) of =2 moderate exacerbations or =1 severe exacerbation within the year prior to screening. A moderate exacerbation is defined as an acute exacerbation of COPD (AECOPD) requiring systemic corticosteroids (oral, intravenous, or intramuscular) and/or treatment with antibiotics (however, use of antibiotics alone does not qualify as a moderate exacerbation unless documentation is available that use of antibiotics was necessary for treatment of worsening symptoms of COPD). A severe exacerbation is defined as an AECOPD that required a hospitalization.
- •- Participants with Standard of Care background therapy, for 3 months prior to Visit 2/Randomization and at a stable dose for at least 1 month prior to the screening, including either:
- •-Double therapy: Long acting beta agonist (LABA) + Long acting muscarinic agnoist (LAMA) or inhaled corticosteroid (ICS) + LABA or ICS + LAMA.
- •-Triple therapy: LABA + LAMA +ICS.
- •- Current or former smokers with a smoking history of =10 packs/year.
- •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 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 250
排除标准
- •-Concomitant severe diseases or diseases for which the use of Inhaled Corticosteroids (ICS) (e.g., active pulmonary tuberculosis, etc.) or Long Acting Beta Agonists (LABA) are contraindicated (e.g., diagnosis of a history of significant cardiovascular diseases, insulin-dependent diabetes mellitus, hyperthyroidism, thyrotoxicosis, pheochromocytoma, hypokalemia).
- •-Participants with Bronchial thermoplasty procedure (up to 3 years prior to Visit 1)
- •-Participants with Chornic Obstructive Pulmonary Disease (COPD) diagnosed within the 6 months prior to randomization.
- •-A current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines.
- •-Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, eosinophilic granulomatosis with polyangiitis, significant sleep apnea on Bilevel Positive Airway Pressure, etc) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
- •-Diagnosis of a-1 anti-trypsin deficiency.
- •-Advanced COPD with need for chronic (>15 hours/day) oxygen support.
- •-Participant with a moderate or severe Acute Exacerbation of COPD event within 4 weeks prior to screening.
- •-A participant who has experienced an upper or lower respiratory tract infection within 4 weeks prior to Screening/Visit 1 or during the screening period.
- •-Prior history of or planned pneumonectomy or lung volume reduction surgery.
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