Status:

RECRUITING

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

Lead Sponsor:

The First Affiliated Hospital with Nanjing Medical University

Collaborating Sponsors:

Novlead Inc.

Conditions:

Chronic Obstructive Pulmonary Disease

Eligibility:

All Genders

40-75 years

Phase:

NA

Brief Summary

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 grea...

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.

Key Trial Info

Start Date :

June 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2026

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT05896800

Start Date

June 1 2023

End Date

June 30 2026

Last Update

June 18 2025

Active Locations (1)

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The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China, 210000

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