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

January 25, 2026 updated by: Novlead Inc.

A Prospective, Single-Center Study of Inhaled Nitric Oxide in Individuals Diagnosed With Moderate-to-Severe Chronic Obstructive Pulmonary Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • The First Affiliated Hospital with Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iNO 10 ppm Dose Group
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
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.
Experimental: iNO 40 ppm Dose Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Maximal Oxygen Uptake (VO2max)
Time Frame: Baseline, Day 7
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)
Time Frame: Baseline, Day 7
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)
Time Frame: Baseline, Day 7
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)
Time Frame: Baseline, Day 7
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in COPD Assessment Test (CAT) Score
Time Frame: Baseline, Day 7
The difference in total CAT score (range 0-40, higher scores indicate worse health status) reported before and after the one-week iNO treatment period.
Baseline, Day 7
Change in Modified Medical Research Council (mMRC) Dyspnea Scale Score
Time Frame: Baseline, Day 7
The difference in mMRC dyspnea scale score (range 0-4, higher scores indicate greater breathlessness) reported before and after the one-week iNO treatment period.
Baseline, Day 7
Change in Six-Minute Walk Distance (6MWD)
Time Frame: Baseline, Day 7
The difference in the distance walked during a six-minute walk test performed before and after the one-week iNO treatment period.
Baseline, Day 7
Change in Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Baseline, Day 7
The difference in FEV1 values from pulmonary function tests performed before and after the one-week iNO treatment period.
Baseline, Day 7
Change in Forced Vital Capacity (FVC)
Time Frame: Baseline, Day 7
The difference in FVC values from pulmonary function tests performed before and after the one-week iNO treatment period.
Baseline, Day 7
Change in FEV1/FVC Ratio
Time Frame: Baseline, Day 7
The difference in the FEV1/FVC ratio from pulmonary function tests performed before and after the one-week iNO treatment period.
Baseline, Day 7

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: Baseline up to Day 7
Proportion of participants experiencing any adverse event during the treatment period, calculated as (Number of subjects with adverse events / Total number of treated subjects) * 100%.
Baseline up to Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novlead Inc.

Collaborators

The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2023

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

January 25, 2026

First Submitted That Met QC Criteria

January 25, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 25, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INO-COPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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