NCT07076290尚未招募1 期
A Repeat Ascending Dosing Study of the Safety and Clinical Activity of R-3750 in Patients With Mild to Moderate COPD
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 27
- 主要终点
- To assess the treatment-related adverse events of R-3750
研究概览
简要总结
The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-3750) in patients with mild to moderate chronic obstructive pulmonary disease (COPD)
详细描述
Patients will take an oral dosage of probiotic (R-3750) and provide patient-reported and scored measure of their chronic obstructive pulmonary disease (COPD). Blood and fecal evaluations of inflammation and assessment of probiotic (R-3750) on fecal levels will also be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a clinically documented history of COPD for at least 1 year in accordance with the definition by the American Thoracic Society/European Respiratory Society.
- •Subjects must present with the following: a measured pre and post-salbutamol Forced expiratory volume in one second/ Forced vital capacity (FEV1/FVC) ratio of <0.70 to confirm the diagnosis of COPD; a measured post-salbutamol FEV1>20% and ≤80% of predicted normal values
- •Baseline mMRC dyspnea score 1 to 3
- •Post-bronchodilator FEV1 > 50% predicted (GOLD COPD grade 1-2)
- •Smoking pack years ≥ 10 years
- •Age ≥ 40 years
- •Acceptable standard-of-care COPD maintenance therapy includes long-acting beta-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), inhaled corticosteroids (ICS), or combinations thereof (e.g., dual LABA/LAMA, or triple LABA/LAMA/ICS therapy). The patient must have been on a stable dose and regimen for at least 4 weeks prior to screening with no changes anticipated during the study unless medically necessary.
- •A history of ≥ 1 exacerbations in the last 12 months
- •Be able to provide written consent; compliant with study procedures and study visits.
排除标准
- •Patients whose treatment is considered palliative (life expectancy <12 months) Comorbid severe lung disease, such as bronchiectasis, pulmonary fibrosis
- •Current smoker or cessation within 3 months of screening, or current use of vaping device
- •Patients with pneumonia or COPD exacerbation or lower respiratory infections within the 4 weeks prior to study Day 1
- •Uncontrolled co-morbid conditions, such as diabetes mellitus, hypertension and heart failure [e.g. New York Heart Association (NYHA) class III (e.g. less than ordinary activity causes fatigue, palpitation, or dyspnea), and class IV (e.g. Symptoms of heart failure at rest)] that will affect the study.
- •Myocardial infarction, unstable angina or stroke within 12 months prior to screening
- •Diagnosis of malignancy within 5 years of study Day 1(except for excised localized carcinoma of skin not including malignant melanoma)
- •Clinically significant ECG changes, which in the opinion of investigator warrants further investigations
- •Evidence of alcohol, drug or solvent abuse.
- •Pregnant, breastfeeding, or lactating women. Women of child-bearing potential (i.e. not surgically sterilized or post- menopausal) must have a negative blood serum pregnancy test performed at the screening visit and must agree to use two methods of birth control (one of which must be a barrier method) for at least 3 months past the last day on the study.
- •Participation in an interventional clinical study within 3 months of study Day 1 or receipt of any investigational medicinal product within 3 months or 5 half- lives.
- •Lung volume reduction surgery or bronchoscopic lung volume reduction within the last 12 months.
- •Historical or current evidence of clinically significant neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
- •Other conditions that could lead to elevated eosinophils such as Hypereosinophilic syndromes including Eosinophilic Granulomatosis with Polyangiitis, or Eosinophilic Esophagitis.
- •Cirrhosis or current unstable liver disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice. Stable noncirrhotic chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C -e.g., presence of hepatitis B surface antigen [HbsAg] or positive hepatitis C antibody test result) is acceptable if the participant otherwise meets entry criteria.
- •Active blood born infection (e.g. HIV, Hepatitis A, B or C)
- •Current or recent (<2 weeks) treatment with oral steroids, theophylline, chronic azithromycin or other methylxanthines, roflumilast, or Dupixent
- •Current infection or antibiotic treatment
- •Use of probiotics within 2 weeks of study Day 1
- •Subjects with a current diagnosis of asthma (those with a prior history are eligible if they meet inclusion criteria for a current diagnosis of COPD)
- •Subjects receiving treatment with oxygen more than 4.0 Litres/minute (L/min). While breathing supplemental oxygen, subjects should demonstrate oxyhemoglobin saturation greater than or equal to 89 percent.
研究组 & 干预措施
Open Label R-3750
Other
Open Label Drug - R-3750
干预措施: R-3750 (Drug)
结局指标
主要结局
To assess the treatment-related adverse events of R-3750
时间窗: 12 weeks
To assess the number of participants with treatment-related adverse events after taking R-3750 (probiotics)
次要结局
- Clinical Response based on St. George's Respiratory Questionnaire (SGRQ)(12 weeks)
研究者
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