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

NCT05896800 | Recruiting

• 1 other identifier: 2023-COPD-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 great significance for finding safe and effective methods for treating COPD.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (4)

• Cardiopulmonary Exercise Test: Maximal oxygen uptake（VO2max）

  Change in VO2max from Baseline after treatment with iNO

  Baseline, Day 7

• Cardiopulmonary Exercise Test: Minute ventilation-to-carbon dioxide output（VE/VCO2）

  Change in VE/VCO2 from Baseline after treatment with iNO

  Baseline, Day 7

• Cardiopulmonary Exercise Test: Borg score

  Change in Borg score from Baseline after treatment with iNO

  Baseline, Day 7

• Cardiopulmonary Exercise Test: oxygen uptake/work (△VO2/△W) ratio

  Change in △VO2/△W ratio from Baseline after treatment with iNO

  Baseline, Day 7

Secondary Outcomes (7)

• Pulmonary function:Forced expiratory volume in 1 second（FEV1）

  Baseline, Day 7

• Pulmonary function: Forced vital capacity （FVC）

  Baseline, Day 7

• Pulmonary function：FEV1/FVC

  Baseline, Day 7

• Life quality and symptom severity questionnaires: COPD assessment test (CAT)

  Baseline, Day 7

• Life quality and symptom severity questionnaires: Modified Medical Research Council (mMRC) Dyspnea Scale

  Baseline, Day 7

Study Arms (3)

Low concentration group

EXPERIMENTAL

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

Other: Inhaled nitric oxide (NO)

High concentration group

EXPERIMENTAL

iNO 40ppm，≥2 hours/day for 7 days

Other: Inhaled nitric oxide (NO)

Placebo group

PLACEBO COMPARATOR

patient inhaled placebo treatment

Other: air

Interventions

Inhaled nitric oxide (NO) OTHER

The Nitric Oxide Generation and Delivery System is used to deliver nitric oxide for inhalation therapy into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath.

High concentration group; Low concentration group

air OTHER

use air（21%O2）as the placebo of inhaled treatment

Placebo group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Novlead Inc.: collaborator

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Air

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Central Study Contacts

Linfu Zhou, Doctor

CONTACT

+8613611573618; linfu.zhou@126.com

Liuchao Zhang, Master

CONTACT

+8615850423930

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 9, 2023
• Study Start: June 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)