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

Nanjing Medical University

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: air; Other: Inhaled nitric oxide (NO)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05896800

2023-COPD-002

Details and patient eligibility

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups, including a placebo group

Low concentration group

Experimental group

Description:

inhaled nitric oxide (iNO) 10ppm，≥2 hours/day for 7 days

Treatment:

Other: Inhaled nitric oxide (NO)

High concentration group

Experimental group

Description:

iNO 40ppm，≥2 hours/day for 7 days

Treatment:

Other: Inhaled nitric oxide (NO)

Placebo group

Placebo Comparator group

Description:

patient inhaled placebo treatment

Treatment:

Other: air