Inhaled Iloprost, Dynamic Hyperinflation, and Oxidative Stress in COPD Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Dynamic hyperinflation during maximal cardiopulmonary exercise test
研究概览
简要总结
The purpose of this study is to investigate the role of the pulmonary vasculature in the development and progression of chronic obstructive pulmonary disease (COPD). To accomplish this, an inhaled prostacyclin (iloprost) will be given to patients with COPD and changes in oxidative stress and lung volumes during exercise will be measured.
详细描述
Chronic obstructive pulmonary disease (COPD), the 3rd leading cause of death in the US, is a progressive disorder for which new treatments are urgently needed, as existing therapies are focused primarily on symptom relief. Oxidative stress, in part arising from inducible nitric oxide synthase (iNOS) released by the pulmonary vasculature, is critical for the development and progression of COPD; a treatment strategy focused on the pulmonary vasculature is hypothesized to be beneficial in COPD patients. This will be studied with the use of an inhaled prostacyclin analogue, iloprost, which has been approved for pulmonary hypertension and investigated in small studies of COPD patients. Potential mechanisms include reductions in dynamic hyperinflation during exercise in COPD patients or improvements in oxidative stress
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years old or older
- •Physician diagnosis of chronic obstructive pulmonary disease
- •10 or more pack-year smoking history
- •FEV1/FVC <0.70
- •FEV1 35-80% of predicted
排除标准
- •Acute exacerbation of COPD within the last 30 days
- •Pregnant or breast-feeding
- •Contraindications to cardiopulmonary exercise testing
- •Known intolerance or allergy to iloprost
- •On oral corticosteroids (may be included if off for 7 days prior to testing)
- •Supplemental oxygen need
- •Known inflammatory disease other than COPD
- •Active solid organ/hematologic malignancy
研究组 & 干预措施
Placebo
Nebulized normal saline. Single administration
干预措施: Placebo (Drug)
Inhaled iloprost 5.0 mcg
Single administration
干预措施: Inhaled iloprost 5.0 mcg (Drug)
结局指标
主要结局
Dynamic hyperinflation during maximal cardiopulmonary exercise test
时间窗: Acute response (exercise testing performed 30 minutes after study drug administration)
Dynamic hyperinflation will be measured as EELV/TLC ratio (end-expiratory lung volume/total lung capacity ratio) during exercise
次要结局
- Exercise time and external work performed(measured during exercise test 30 minutes after study drug administration)
- Blood markers of oxidative stress(Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration))
- B-type natriuretic peptide(Acute response (measured 30 and 40 minutes after study drug administration))
- Metabolic and gas exchange parameters during cardiopulmonary exercise test(Acute response (throughout exercise, starting 30 minutes after study drug administration))
- Blood markers of inflammation(Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration))
- Dead space fraction(Acute response (measured every 2 minutes during exercise, starting 30 minutes after study drug administration))
- Partial pressure of oxygen(Acute response (measured 30 minutes after study drug administration and every 2 minutes during exercise))
- Blood cyclic AMP levels(Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration))
- Blood iloprost levels(Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration))
- Borg dyspnea and leg scores(During exericse (starting 30 minutes after study drug administration))
研究者
Matthew Lammi
Assistant Professor of Medicine
Louisiana State University Health Sciences Center in New Orleans