LEEP is a randomized clinical trial evaluating the effect of Losartan in helping people with Chronic Obstructive Pulmonary Disease (COPD) with emphysema – a disease of the lungs. We are looking for adults 40 years of age or older, current or former smokers, with COPD to join our study. The study is conducted in different states across the country.
COPD is often caused by cigarette smoking. It includes the symptoms of emphysema and chronic bronchitis. Although some medications improve breathing, reduce symptoms, and prevent exacerbations, few medications have been shown to reduce the damage to the lungs in people with COPD.
Losartan is a medicine used for treatment of high blood pressure. It has been shown to slow the damage to lungs caused by COPD in animals. We want to learn if Losartan can slow the damage to lungs caused by COPD in people too. Lung damage will be determined from high resolution CT scans of the lungs taken at the beginning and end of the study. We also want to learn if Losartan effects breathing tests. Participants will be randomly assigned to receive Losartan or placebo and be in the study for one year, with clinic visits every 3 months. Participants will be compensated for their time and expenses.
The PTC partners with the American Lung Association to bring this clinical trial to the patients’ community. For more information on the American Lung Association, go to: www.lung.org
Several batches of Losartan (and similar drugs) have been recalled by the FDA because of contamination with a suspected carcinogen, one or more nitrosamine compounds. Elevated levels of nitrosamines are associated with an increased risk of cancer. The Lorsartan used for this trial has not been recalled. The study drug used for the trial has been tested and meets FDA safety standards for nitrosamines.