A Mechanistic Study of Inhaled Nitric Oxide in COPD

NCT ID: NCT05785195

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-14
• Study Completion Date: 2024-03-31

Brief Summary

There is a lack of effective treatments for chronic obstructive pulmonary disease (COPD) complicated with pulmonary hypertension. Previous studies have found that inhaled nitric oxide (iNO) can reduce pulmonary artery pressure and improve exercise capacity in COPD with pulmonary hypertension patients. However, the specific mechanism is unclear. The study aims to evaluate pulmonary ventilation/perfusion, pulmonary artery pressure, oxygenation, symptoms and quality of life in COPD with pulmonary hypertension patients after short-term treatment with iNO. Observing a series of pathophysiological changes caused by the treatment of pulmonary hypertension with iNO in COPD, the investigators hope to provide new theoretical basis and research ideas.

Conditions

Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inhaled Nitric Oxide (iNO)

iNO 20ppm，≥8 hours/day for 3 days

Group Type: EXPERIMENTAL

Nitric Oxide Generation and Delivery System

Intervention Type: DEVICE

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.

Interventions

Nitric Oxide Generation and Delivery System

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 40 years, ≤ 75 years

2. Currently smoking or former smokers with at least 10 pack-years of tobacco cigarette smoking history

3. Diagnosis of moderate and severe COPD by the Global initiative for chronic Obstructive Lung Disease (GOLD) 2022 criteria: A post-bronchodilatory forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 0.7, and 30%< FEV1 < 80% predicted

4. Echocardiogram with technical adequacy demonstrating with Pulmonary Hypertension: Tricuspid regurgitation velocity (TRV) > 2.8 m/s or pulmonary arterial systolic pressure (sPAP) ≥38mmHg

5. Signed informed consent prior to the initiation of any study mandated procedures or assessments

Exclusion Criteria

1. Experienced an exacerbation requiring start of or increase in systemic oral corticosteroid therapy during the last month

2. Treatment with antibiotics

3. Respiratory failure requiring supplemental oxygen therapy

4. A diagnosis of Interstitial lung disease, asthma, tuberculosis, bronchiectasis, pneumonia, lung cancer, pulmonary embolism, or other non-COPD respiratory disease

5. Any history of lung resection

6. Left ventricular dysfunction: left ventricular ejection fraction (LVEF) < 40%

7. Clinically significant valvular heart disease, including aortic valvular disease (moderate or greater aortic stenosis or regurgitation) and/or mitral valve disease (moderate or greater mitral stenosis or regurgitation), or status post mitral valve replacement

8. Use within 30 days of screening or current use of approved PH medications such as sildenafil, bosentan or prostacyclines

9. Neuromuscular disease or musculoskeletal injuries that unable to complete exercise trials

10. Use of investigational drugs or devices within 30 days prior to enrollment into the study

11. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novlead Inc.

INDUSTRY

Sponsor Role: collaborator

Ting YANG

OTHER

Sponsor Role: lead

Responsible Party

Ting YANG

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

China-Japan Friendship Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ruoxi He

Role: CONTACT

heruoxi1985@yeah.net

+8618874167666

Zhou Fang

Role: CONTACT

zhou.fang@novlead.com

+8615655595707

Facility Contacts

Ke HUANG, M.D.

Role: primary

010-84206408

Other Identifiers

2022-HX-110

Identifier Type: -

Identifier Source: org_study_id