Using inhaled nitric oxide to improve exercise capacity in COPD patients

Efficacy and Safety of Inhaled Nitric Oxide in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease: a Prospective, Single-center Clinical Trial

This study is testing if inhaled nitric oxide can help people with moderate to severe COPD exercise better and feel safer while doing it.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05896800 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of inhaled nitric oxide (iNO) on exercise capacity and safety in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Participants will receive iNO at doses of 10 ppm or 40 ppm for two hours daily over a week. The goal is to identify safe and effective treatment methods for COPD, focusing on improving patients' ability to exercise. The study will include assessments of lung function and overall health during the treatment period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 to 75 with a history of smoking and diagnosed with moderate to severe COPD.

Not a fit: Patients with asthma or other non-COPD respiratory diseases, or those with significant heart conditions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance exercise capacity and overall quality of life for COPD patients.

How similar studies have performed: While the use of inhaled nitric oxide has been explored in various respiratory conditions, this specific application in COPD is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 40 years, ≤ 75 years;
2. Previous smoking history ≥ 10 pack-years, and had stopped smoking for one month before study entry;
3. Met the diagnosis criteria of moderate and severe COPD: a post-bronchodilator FEV1/FVC \< 0.7, and 30%\< FEV1 \< 80% predicted;
4. Signed informed consent and performed all the study mandated procedures.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Current or recent month user of nicotine-like substances (including nicotine patches, etc.);
3. A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator;
4. Lack of patency of nares upon physical examination;
5. Experienced during the last month an exacerbation requiring start of or increase in systemic oral corticosteroid therapy;
6. Left ventricular systolic dysfunction: left ventricular ejection fraction (LVEF) \< 50%;
7. 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;
8. Use within 30 days of screening or current use of approved pulmonary hypertension medications such as sildenafil, bosentan or prostacyclines;
9. Use of investigational drugs or devices within 30 days prior to enrollment into the study;
10. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study.

Where this trial is running

Nanjing, Jiangsu

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

Study contacts

• Study coordinator: Linfu Zhou, Doctor

Conditions Chronic Obstructive Pulmonary Disease