A Mechanistic Study of Inhaled Nitric Oxide in COPD

NCT05785195 | Unknown

• 1 other identifier: 2022-HX-110
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Ventilation-perfusion ratio

  Change in ventilation-perfusion ratio (V/Q) from Baseline after treatment with iNO, measured by pulmonary ventilation/perfusion imaging

  Baseline, Minutes 30

• Tricuspid regurgitation velocity (TRV)

  Change in TRV from Baseline after treatment with iNO, measured by echocardiogram

  Baseline, Day 3

• Pulmonary arterial systolic pressure (sPAP)

  Change in sPAP from Baseline after treatment with iNO, measured by echocardiogram

  Baseline, Day 3

Secondary Outcomes (17)

• Percutaneous arterial oxygen saturation (SpO2)

  Baseline, Day 3

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

  Baseline, Day 3

• Pulmonary function: Forced vital capacity （FVC）

  Baseline, Day 3

• Pulmonary function: FEV1/FVC

  Baseline, Day 3

• Pulmonary function: Diffusion lung capacity for carbon monoxide（DLCO)

  Baseline, Day 3

Study Arms (1)

Inhaled Nitric Oxide (iNO)

EXPERIMENTAL

iNO 20ppm，≥8 hours/day for 3 days

Device: Nitric Oxide Generation and Delivery System

Interventions

Nitric Oxide Generation and Delivery System 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.

Inhaled Nitric Oxide (iNO)

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
• Currently smoking or former smokers with at least 10 pack-years of tobacco cigarette smoking history
• 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
• Echocardiogram with technical adequacy demonstrating with Pulmonary Hypertension: Tricuspid regurgitation velocity (TRV) \> 2.8 m/s or pulmonary arterial systolic pressure (sPAP) ≥38mmHg
• Signed informed consent prior to the initiation of any study mandated procedures or assessments

You may not qualify if:

• Experienced an exacerbation requiring start of or increase in systemic oral corticosteroid therapy during the last month
• Treatment with antibiotics
• Respiratory failure requiring supplemental oxygen therapy
• A diagnosis of Interstitial lung disease, asthma, tuberculosis, bronchiectasis, pneumonia, lung cancer, pulmonary embolism, or other non-COPD respiratory disease
• Any history of lung resection
• Left ventricular dysfunction: left ventricular ejection fraction (LVEF) \< 40%
• 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
• Use within 30 days of screening or current use of approved PH medications such as sildenafil, bosentan or prostacyclines
• Neuromuscular disease or musculoskeletal injuries that unable to complete exercise trials
• 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

• Ting YANG: lead
• Novlead Inc.: collaborator

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ruoxi He

CONTACT

+8618874167666; heruoxi1985@yeah.net

Zhou Fang

CONTACT

+8615655595707; zhou.fang@novlead.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 27, 2023
• Study Start: March 14, 2023
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)