Study of Inhaled Nitric Oxide Treatment for Adults Aged 40 to 75 With Moderate-to-Severe Chronic Obstructive Pulmonary Disease

What this Trial Is About

Researchers are investigating the effects of inhaled nitric oxide iNO on exercise capacity and safety in people with moderate-to-severe chronic obstructive pulmonary disease COPD. The study evaluates two doses of iNO, 10 parts per million ppm and 40 ppm, each administered for at least 2 hours daily over one week. This research aims to find safe and effective treatment methods for COPD, focusing on lung function and exercise performance. Participants are randomly assigned to one of three groups inhaled nitric oxide at 10 ppm, inhaled nitric oxide at 40 ppm, or a placebo treatment using air. Each treatment is inhaled for at least 2 hours per day for 7 consecutive days. The iNO is delivered through a specialized system that ensures a constant concentration during inhalation. The placebo group inhales air with 21% oxygen, mimicking the treatment process without active nitric oxide. During the study, participants undergo cardiopulmonary exercise tests measuring oxygen uptake, ventilation efficiency, and breathlessness scores at the start and end of the 7-day treatment period. Lung function tests, symptom questionnaires, a six-minute walk test, and safety monitoring for adverse events are also performed. The study tracks changes from baseline to day 7 to assess the impact of the treatments on exercise capacity and respiratory health.

A Clinical Study of Inhaled Nitric Oxide in Moderate-to-Severe Chronic Obstructive Pulmonary Disease