Inhaled Nitric Oxide for High Amplitude Pulmonary Edema (HAPE)

NCT06852924 · tracked via the Priya Life Science China tracker

Sponsor

Novlead Inc.

Phase

Not applicable

Started

2023-08-10

Last updated

2025-02-28

Condition(s) studied

High Altitude Pulmonary Hypertension

Investigational drug(s) / intervention(s)

Nitric Oxide Generation and Delivery System

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.

Study summary

High Altitude Pulmonary Edema (HAPE) is a critical, non-cardiogenic pulmonary edema that manifests in high-altitude conditions, marked by the rapid onset of symptoms such as dyspnea, cough, frothy sputum, and cyanosis. It represents a significant cause of mortality among high-altitude illnesses due to its swift progression and elevated fatality rates if not addressed promptly. The pathophysiological mechanisms underlying HAPE include excessive hypoxic pulmonary vasoconstriction, increased permeability of the pulmonary vasculature, impaired clearance of fluid from the lungs, and systemic fluid retention. A pivotal factor in HAPE is pulmonary arterial hypertension (PAH), characterized by a progressive rise in pulmonary arterial pressure and resistance, which can ultimately lead to right heart failure. Recent developments in the management of HAPE have introduced inhaled nitric oxide (iNO) as a selective pulmonary vasodilator, which effectively lowers pulmonary arterial pressure and enhances oxygenation without inducing systemic hypotension. The INOwill N300 device, created by Nanjing Novlead Biotech, is a portable iNO delivery system that produces nitric oxide gas on-site, thereby obviating the need for gas cylinders. This device also facilitates real-time monitoring of nitric oxide, nitrogen dioxide, and oxygen concentrations, ensuring safe and effective treatment. This innovative strategy shows potential for improving clinical outcomes in patients with HAPE while addressing logistical challenges encountered in high-altitude environments.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: 1. Individuals aged between 18 and 65 years. 2. A score on the Lake Louise Acute Mountain Sickness Scale ranging from 3 to 9 points, as outlined in Annex 2, recorded in 2018. 3. Chest X-ray findings that demonstrate either thickening of the lung texture bilaterally or the presence of nodular opacities in the lower regions of both lungs. 4. Capacity to provide informed consent in accordance with local regulatory requirements. Exclusion Criteria: 1. Confirmed contraindications for the use of nitric oxide include the following (refer to "5.3.4 NO Contraindications"): * Severe hypoplasia of the left heart or duct-dependent congenital heart disease; * Life-threatening congenital anomalies and congestive heart failure; * Congenital methemoglobinemia; * Severe hemorrhagic conditions, including intracranial hemorrhage, intraventricular hemorrhage, and pulmonary hemorrhage. 2. Severe left ventricular dysfunction, characterized by a left ventricular ejection fraction (LVEF) of less than 40%. 3. Pulmonary edema resulting from other cardiac, pulmonary, thoracic, or systemic disorders. 4. Coexistence with high altitude cerebral edema. 5. A history of lung malignancy, lung resection, or lung transplantation. 6. Barotrauma, which may include pneumothorax, subcutaneous and mediastinal emphysema, or the presence of a closed drainage tube in the thoracic cavity. 7. Clinically significant or persistent thrombocytopenia, defined as a platelet count of less than 50×10\^9/L. 8. Administration of pulmonary hypertension medications, such as sildenafil, bosentan, or prostacyclins, within the preceding 30 days. 9. Noncompliance with study protocols and unwillingness to provide informed consent. 10. Any other conditions that the clinician deems render the subject unsuitable for participation in the study.

Primary outcome measure(s)

Change of Oxygen Index — Through study completion, an average of 5 days
The change of oxygenation index (PaO2 or SpO2/FiO2) from baseline, and the time required for oxygenation index to improve by ≥20%

Trial sites (1)

Facility	City	Region	Status
Tibet Fokang Hospital	Lhasa	Tibet	Recruiting

More Novlead Inc. trials in China

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

A Real-world Study of Nitric Oxide Generator and Delivery System Recruiting

FeNO Detection in Asthma Diagnosis: A New Technology Approach Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06852924 on ClinicalTrials.gov ↗ ← All trials in China