A Clinical Study of Inhaled Nitric Oxide in Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Recruiting · NCT05896800 · Interventional (participants receive a specific treatment) · Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
View the official record on ClinicalTrials.gov →Interventions studied
Inhaled nitric oxide (NO)air
What this trial is about
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.
Who can take part
Age range
40 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
1 location listed.
- The First Affiliated Hospital with Nanjing Medical University - Nanjing, Jiangsu, China