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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

The purpose of this study is to evaluate the influence of exercise capacity and safety of iNO at doses of 10 ppm or 40 ppm for 2 hours per day after continuous treatment for one week, which is of great significance for finding safe and effective methods for treating COPD.

Key facts

Study ID

NCT05896800

Run by

The First Affiliated Hospital with Nanjing Medical University

People needed

24

Starts

2023-06-01

Expected to finish

2026-06-30

Last updated by the study team

2025-06-18

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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