A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

Inclusion criteria

• Aged between 40 and 75 years, inclusive.
• History of smoking with a cumulative exposure of ≥10 pack-years, and having ceased smoking for at least one month prior to study participation.
• Diagnosis of moderate-to-severe COPD confirmed by post-bronchodilator spirometry: FEV1/FVC < 0.7 and FEV1 between 30% and 80% of predicted value.
• Willing and able to provide written informed consent and comply with all study-related procedures.

Exclusion criteria

• Pregnancy or lactation.
• Use of nicotine-containing products (e.g., patches, gum) within the past month.
• Current diagnosis of asthma or any other active respiratory condition considered non-COPD by the investigator.
• Physical obstruction of the nasal passages.
• Experienced a COPD exacerbation within the past month requiring initiation or escalation of systemic corticosteroids.
• Impaired left ventricular systolic function, defined as left ventricular ejection fraction (LVEF) < 50%.
• Significant valvular heart disease (moderate/severe aortic or mitral stenosis/regurgitation) or prior mitral valve replacement.
• Use of approved pulmonary hypertension medications (e.g., sildenafil, bosentan, prostacyclins) within 30 days prior to screening or during the study.
• Participation in another interventional clinical trial involving drugs or devices within 30 days prior to enrollment.
• Any other medical or psychiatric condition that, in the investigator's judgment, would compromise patient safety or study integrity.