A Mechanistic Study of Inhaled Nitric Oxide in COPD
Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- China-Japan Friendship HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Inhaled Nitric Oxide (iNO)
iNO 20ppm,≥8 hours/day for 3 days