A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

NCT07382258 | Recruiting

• 1 other identifier: INO-COPD
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to assess the impact on exercise tolerance and the safety of inhaled nitric oxide in subjects with moderate-to-severe COPD. The findings are expected to contribute to the development of safe and effective therapeutic strategies for COPD management.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD

Outcome Measures

Primary Outcomes (4)

• Change in Maximal Oxygen Uptake (VO2max)

  The difference in VO2max values measured during cardiopulmonary exercise testing before and after the one-week iNO treatment period.

  Baseline, Day 7

• Change in Ventilatory Efficiency (VE/VCO2)

  The difference in the minute ventilation-to-carbon dioxide output (VE/VCO2) ratio measured during cardiopulmonary exercise testing before and after the one-week iNO treatment period.

  Baseline, Day 7

• Change in Oxygen Uptake to Work Rate Ratio (ΔVO2/ΔW)

  The difference in the ratio of change in oxygen uptake to change in work rate (ΔVO2/ΔW) measured during cardiopulmonary exercise testing before and after the one-week iNO treatment period.

  Baseline, Day 7

• Change in Perceived Exertion (Borg Score)

  The difference in Borg scale scores for perceived exertion recorded during cardiopulmonary exercise testing before and after the one-week iNO treatment period.

  Baseline, Day 7

Secondary Outcomes (6)

• Change in COPD Assessment Test (CAT) Score

  Baseline, Day 7

• Change in Modified Medical Research Council (mMRC) Dyspnea Scale Score

  Baseline, Day 7

• Change in Six-Minute Walk Distance (6MWD)

  Baseline, Day 7

• Change in Forced Expiratory Volume in 1 Second (FEV1)

  Baseline, Day 7

• Change in Forced Vital Capacity (FVC)

  Baseline, Day 7

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Baseline up to Day 7

Study Arms (2)

iNO 10 ppm Dose Group

EXPERIMENTAL

Participants will receive inhaled nitric oxide at a concentration of 10 ppm, for a minimum of 2 hours per day, over 7 consecutive days.

Device: Nitric Oxide Generation and Delivery System

iNO 40 ppm Dose Group

EXPERIMENTAL

Participants will receive inhaled nitric oxide at a concentration of 40 ppm, for a minimum of 2 hours per day, over 7 consecutive days.

Device: Nitric Oxide Generation and Delivery System

Interventions

Nitric Oxide Generation and Delivery System DEVICE

A device designed to deliver a stable, user-prescribed concentration of nitric oxide gas into the inspiratory circuit of the patient's breathing apparatus for inhalation therapy.

iNO 10 ppm Dose Group; iNO 40 ppm Dose 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:

• Aged between 40 and 75 years, inclusive.
• History of smoking with a cumulative exposure of ≥10 pack-years, and having ceased smoking for at least one month prior to study participation.
• Diagnosis of moderate-to-severe COPD confirmed by post-bronchodilator spirometry: FEV1/FVC \< 0.7 and FEV1 between 30% and 80% of predicted value.
• Willing and able to provide written informed consent and comply with all study-related procedures.

You may not qualify if:

• Pregnancy or lactation.
• Use of nicotine-containing products (e.g., patches, gum) within the past month.
• Current diagnosis of asthma or any other active respiratory condition considered non-COPD by the investigator.
• Physical obstruction of the nasal passages.
• Experienced a COPD exacerbation within the past month requiring initiation or escalation of systemic corticosteroids.
• Impaired left ventricular systolic function, defined as left ventricular ejection fraction (LVEF) \< 50%.
• Significant valvular heart disease (moderate/severe aortic or mitral stenosis/regurgitation) or prior mitral valve replacement.
• Use of approved pulmonary hypertension medications (e.g., sildenafil, bosentan, prostacyclins) within 30 days prior to screening or during the study.
• Participation in another interventional clinical trial involving drugs or devices within 30 days prior to enrollment.
• Any other medical or psychiatric condition that, in the investigator's judgment, would compromise patient safety or study integrity.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Chenxi Wu, Master

CONTACT

+8615850568410; chenxi.wu@novlead.com

Study Design

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

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 2, 2026
• Study Start: May 17, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)