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

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Jun 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of inhaled nitric oxide (iNO) on people with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). The researchers want to understand how iNO might help improve people’s ability to exercise and ensure it is safe to use. Participants in the study will receive iNO for 2 hours each day at either low (10 ppm) or higher (40 ppm) doses for a week. This research is important as it could lead to new, effective treatments for COPD, a condition that makes it hard to breathe.

To join this study, participants need to be between 40 and 75 years old, have a history of smoking, and have been diagnosed with moderate to severe COPD. It's crucial that they haven't smoked for at least a month before starting the trial. However, pregnant or breastfeeding women, as well as those with certain heart conditions or other respiratory diseases, cannot participate. Those who qualify will be closely monitored and can expect to complete specific procedures to ensure their safety during the study.

Gender

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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.