Study of Daily Tadalafil to Reduce Breathlessness in Veterans with COPD and Pulmonary Hypertension

What this Trial Is About

Researchers are evaluating whether the drug tadalafil can improve shortness of breath in 126 Veterans with Chronic Obstructive Pulmonary Disease COPD complicated by pulmonary hypertension PH. The study focuses on whether tadalafil reduces the severity of dyspnea, a common and debilitating symptom in COPD, and also examines its effects on quality of life, daily physical activity, exercise endurance, frequency of COPD flare-ups, lung blood pressure, and lung function. This is a phase 2, randomized, double-blind, placebo-controlled trial funded by the Department of Veterans Affairs. Participants will be randomly assigned to receive either daily oral tadalafil or an identical inactive placebo capsule for six months. The tadalafil dose will be one or two 20 mg tablets taken once daily. Both groups will continue their usual COPD care. The trial includes scheduled follow-up visits at 1, 2, 3, 4, 5, and 6 months, with assessments at 1, 3, and 6 months including questionnaires on dyspnea and testing of lung blood pressure and lung function. The study aims to determine if tadalafil improves respiratory symptoms more than placebo. During the study, participants will be closely monitored through clinic visits or telephone calls for side effects and safety. Researchers will collect data on patient-reported shortness of breath using a specific questionnaire, physical activity via daily step counts, exercise capacity by a 6-minute walk test, and health-related quality of life. The trial also includes imaging tests like CT scans and echocardiography to explore changes in pulmonary hypertension. Total participation is six months, with ongoing evaluation of lung health and symptom changes.

Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH