Study on the Mechanism of Inhaled Nitric Oxide in the Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) Complicated With Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pulmonary arterial systolic pressure (sPAP)
研究概览
简要总结
There is a lack of effective treatments for chronic obstructive pulmonary disease (COPD) complicated with pulmonary hypertension. Previous studies have found that inhaled nitric oxide (iNO) can reduce pulmonary artery pressure and improve exercise capacity in COPD with pulmonary hypertension patients. However, the specific mechanism is unclear. The study aims to evaluate pulmonary ventilation/perfusion, pulmonary artery pressure, oxygenation, symptoms and quality of life in COPD with pulmonary hypertension patients after short-term treatment with iNO. Observing a series of pathophysiological changes caused by the treatment of pulmonary hypertension with iNO in COPD, the investigators hope to provide new theoretical basis and research ideas.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years, ≤ 75 years
- •Currently smoking or former smokers with at least 10 pack-years of tobacco cigarette smoking history
- •Diagnosis of moderate and severe COPD by the Global initiative for chronic Obstructive Lung Disease (GOLD) 2022 criteria: A post-bronchodilatory forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 0.7, and 30%< FEV1 < 80% predicted
- •Echocardiogram with technical adequacy demonstrating with Pulmonary Hypertension: Tricuspid regurgitation velocity (TRV) > 2.8 m/s or pulmonary arterial systolic pressure (sPAP) ≥38mmHg
- •Signed informed consent prior to the initiation of any study mandated procedures or assessments
排除标准
- •Experienced an exacerbation requiring start of or increase in systemic oral corticosteroid therapy during the last month
- •Treatment with antibiotics
- •Respiratory failure requiring supplemental oxygen therapy
- •A diagnosis of Interstitial lung disease, asthma, tuberculosis, bronchiectasis, pneumonia, lung cancer, pulmonary embolism, or other non-COPD respiratory disease
- •Any history of lung resection
- •Left ventricular dysfunction: left ventricular ejection fraction (LVEF) < 40%
- •Clinically significant valvular heart disease, including aortic valvular disease (moderate or greater aortic stenosis or regurgitation) and/or mitral valve disease (moderate or greater mitral stenosis or regurgitation), or status post mitral valve replacement
- •Use within 30 days of screening or current use of approved PH medications such as sildenafil, bosentan or prostacyclines
- •Neuromuscular disease or musculoskeletal injuries that unable to complete exercise trials
- •Use of investigational drugs or devices within 30 days prior to enrollment into the study
- •Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study
结局指标
主要结局
Pulmonary arterial systolic pressure (sPAP)
时间窗: Baseline, Day 3
Change in sPAP from Baseline after treatment with iNO, measured by echocardiogram
Ventilation-perfusion ratio
时间窗: Baseline, Minutes 30
Change in ventilation-perfusion ratio (V/Q) from Baseline after treatment with iNO, measured by pulmonary ventilation/perfusion imaging
Tricuspid regurgitation velocity (TRV)
时间窗: Baseline, Day 3
Change in TRV from Baseline after treatment with iNO, measured by echocardiogram
次要结局
- Pulmonary function: FEV1/FVC(Baseline, Day 3)
- Cardiopulmonary Exercise Test: Anaerobic threshold（AT）(Baseline, Day 3)
- Pulmonary function: Diffusion lung capacity for carbon monoxide（DLCO)(Baseline, Day 3)
- Cardiopulmonary Exercise Test: Minute ventilation-to-carbon dioxide output（VE/VCO2）(Baseline, Day 3)
- Arterial blood gas: Arterial partial pressure of carbon dioxide (PaCO2)(Baseline, Day 3)
- Life quality and symtom severity questionnaires: Modified Medical Research Council (mMRC) Dyspnea Scale(Baseline, Day 3)
- Adverse events(Baseline up to Day 3)
- Pulmonary function:Forced expiratory volume in 1 second（FEV1）(Baseline, Day 3)
- Pulmonary function: Forced vital capacity （FVC）(Baseline, Day 3)
- Percutaneous arterial oxygen saturation (SpO2)(Baseline, Day 3)
- Cardiopulmonary Exercise Test: Maximal oxygen uptake（VO2max）(Baseline, Day 3)
- Six-minute walk distance (6MWD)(Baseline, Day 3)
- Arterial blood gas: Alveolar-arterial oxygen partial pressure difference (A-aDO2)(Baseline, Day 3)
- Life quality and symtom severity questionnaires: COPD assessment test (CAT)(Baseline, Day 3)
- Life quality and symtom severity questionnaires: Saint George Respiratory Questionnaire (SGRQ)(Baseline, Day 3)
- Cardiopulmonary Exercise Test: Physiological dead space ventilation (physiological deadspace volume/tidal volume, Vd/Vt)(Baseline, Day 3)
- Arterial blood gas: Arterial partial pressure of oxygen (PaO2)(Baseline, Day 3)
研究者
Ting YANG
Clinical Professor
China-Japan Friendship Hospital