A Clinical Study of Inhaled Nitric Oxide in Moderate-to-Severe Chronic Obstructive Pulmonary Disease (NOVEL)
Chronic Obstructive Pulmonary Disease
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria: Age ≥ 40 years, ≤ 75 years; Previous smoking history ≥ 10 pack-years, and had stopped smoking for one month before study entry; Met the diagnosis criteria of moderate and severe COPD: a post-bronchodilator FEV1/FVC < 0.7, and 30%< FEV1 < 80% predicted; Signed informed consent and performed all the study mandated procedures. Exclusion Criteria: Pregnant or lactating women; Current or recent month user of nicotine-like substances (including nicotine patches, etc.); A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator; Lack of patency of nares upon physical examination; Experienced during the last month an exacerbation requiring start of or increase in systemic oral corticosteroid therapy; Left ventricular systolic dysfunction: left ventricular ejection fraction (LVEF) < 50%; Clinically significant valvular heart disease, including aortic valvular disease (moderate or severe aortic stenosis or regurgitation) and/or mitral valve disease (moderate or severe mitral stenosis or regurgitation), or status post mitral valve replacement; Use within 30 days of screening or current use of approved pulmonary hypertension medications such as sildenafil, bosentan or prostacyclines; 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
- The First Affiliated Hospital with Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Low concentration group
High concentration group
inhaled nitric oxide (iNO) 10ppm,≥2 hours/day for 7 days
iNO 40ppm,≥2 hours/day for 7 days