Ongoing Clinical Trial Testing Tadalafil for Pulmonary Hypertension Due to COPD
A new pilot clinical trial for Pulmonary Hypertension in Chronic Obstructive Pulmonary Disease (COPD) is now recruiting participants – U.S. veterans between 40 to 85 years old and suffering from Chronic Obstructive Pulmonary Disease who are willing to participate (the study accepts both males and females). The study is entitled “Tadalafil for Pulmonary Hypertension associated with Chronic Lung Disease” and is actively recruiting participants. The trial is an interventional randomized study to test the potential of Tadalafil in decreasing Pulmonary Hypertension due to COPD when compared to placebo.
The trial is sponsored by the U.S. Department of Veterans Affairs, since U.S veterans are largely affected by COPD (it’s the 5th most common chronic disease). The study’s primary endpoint is to determine alterations in the 6-minute walk test within 12 months, as well as to assess the changes in the distance walked in 6 minutes from starting baseline after a daily dose of 40 mg of Tadalafil administration when compared to placebo controls. Additionally, the study will also determine a series of secondary outcomes, including the maximum volume of oxygen inhaled during exercise; pulmonary vascular resistance; mean pulmonary artery pressure, among other features.
The trial began in October 2013 and the estimated date of primary outcome data completion is December 2017. The trial will end in August 2018.
The study is currently looking for participants that include male and females U.S. veterans (with 40 to 85 years old) that have Gold Stage II COPD (as determined by pulmonary functional tests performed within 6 months before the recruitment date). Additionally, participants are required to suffer from Pulmonary Hypertension, with a confirmed diagnosis by transthoracic echocardiogram no more than 6 months before recruitment date.
Patients are encouraged to participate but are advised to consult with their doctor and family. The application, as well as further information, should include the ClinicalTrials.gov identifier NCT01862536 and can be found here:
Ronald H Goldstein, MD (857)-203-6578 [email protected]
Bradley A Maron, MD (857)-525-4857 [email protected]