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A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease | Clinical Trials | Clareo Health

RECRUITINGNA

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

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

NCT07382258•Novlead Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Key Dates

Start Date

May 17, 2023

Primary Completion Date

April 30, 2026

Completion Date

April 30, 2026

Last Updated

February 2, 2026

Enrollment

ESTIMATED participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Nitric Oxide Generation and Delivery System

DEVICE

Contacts

Chenxi Wu, Master

CONTACT

+8615850568410 chenxi.wu@novlead.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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