Inhaled nitric oxide to improve exercise tolerance in moderate-to-severe COPD

A Prospective, Single-Center Study of Inhaled Nitric Oxide in Individuals Diagnosed With Moderate-to-Severe Chronic Obstructive Pulmonary Disease

This test tries whether breathing inhaled nitric oxide can improve exercise ability and is safe for adults 40–75 with moderate-to-severe COPD who are former smokers.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: Novlead Inc. (Industry-sponsored)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07382258 on ClinicalTrials.gov

What this trial studies

This interventional study delivers inhaled nitric oxide using a nitric oxide generation and delivery system to adults with moderate-to-severe COPD to see effects on exercise tolerance and safety. Participants are selected by spirometry (post-bronchodilator FEV1/FVC <0.7 and FEV1 30–80% predicted) and a history of ≥10 pack-years of smoking but having quit at least one month prior. Safety monitoring and exercise tolerance measurements are performed during and after treatment periods at the single study site in Nanjing, Jiangsu. Key exclusions include pregnancy, recent COPD exacerbation, active non-COPD respiratory disease, current nicotine product use, nasal obstruction, and left ventricular ejection fraction <50%.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40–75 with post-bronchodilator spirometry showing FEV1/FVC <0.7 and FEV1 between 30% and 80% predicted, a ≥10 pack-year smoking history who quit at least one month prior, and ability to consent and comply with visits.

Not a fit: Those unlikely to benefit include people who are currently using nicotine products, have asthma or other non-COPD respiratory diseases, recent COPD exacerbations, significant left ventricular dysfunction (LVEF <50%), pregnancy, or nasal obstruction.

Why it matters

Potential benefit: If successful, this approach could provide a new symptomatic therapy that improves exercise capacity and breathing comfort for people with moderate-to-severe COPD.

How similar studies have performed: Previous uses of inhaled nitric oxide have been established in other pulmonary conditions, but trials specifically targeting exercise tolerance in COPD are limited and have reported only preliminary or mixed results.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Where this trial is running

Nanjing, Jiangsu

• The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Chenxi Wu, Master

Conditions Chronic Obstructive Pulmonary Disease; COPD