A Clinical Study of Inhaled Nitric Oxide in Moderate-to-Severe Chronic Obstructive Pulmonary Disease

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.