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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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%.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Chenxi Wu, Master
• Email: chenxi.wu@novlead.com
• Phone: +8615850568410

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.