Study of Inhaled Nitric Oxide Using the INOwill N300 Device to Treat High Altitude Pulmonary Edema HAPE in Adults

What this Trial Is About

Researchers are evaluating inhaled nitric oxide iNO therapy for patients with mild to moderate High Altitude Pulmonary Edema HAPE, a serious lung condition that develops quickly in high-altitude environments and can be life-threatening. The study aims to compare the effects of iNO delivered by a novel portable device against traditional treatment methods. This trial focuses on understanding how iNO impacts oxygen levels, symptom improvement, and hospital stay duration in people affected by HAPE. The study involves three groups a control group receiving standard treatment including intravenous medications and oxygen, and two experimental groups receiving the same standard treatment plus inhaled nitric oxide at different durations 30 minutes or 2 hours twice daily. The iNO is delivered using the INOwill N300 device, which produces nitric oxide on-site without gas cylinders and monitors gas concentrations continuously to ensure safety. The treatments are administered twice a day, once in the morning and once in the afternoon. Participants will be monitored over an average of 5 days to assess changes in oxygen levels, symptom relief, disease progression, and hospital stay length. Evaluations include imaging studies and symptom scoring using the Lake Louise Acute Mountain Sickness Scale. Researchers will ensure treatment adherence and safety through real-time gas monitoring and clinical assessments. This study is sponsored by Novlead Inc. and aims to improve management options for HAPE patients.

Inhaled Nitric Oxide for High Amplitude Pulmonary Edema (HAPE)