UPMC First to Enroll Patients in Inaugural U.S. Trial Inserting Coils in Emphysema-diseased Lungs
PITTSBURGH, Feb. 25, 2013
is the first center in North America to enroll patients into a Food and Drug Administration-approved clinical trial that will test whether the insertion of small coils can collapse diseased lung areas and improve both lung function and exercise tolerance among patients with advanced emphysema. UPMC pulmonologists on Feb. 21 performed the procedure on a 65-year-old Hampton woman in a newly launched study that aims to recruit 315 patients across 30 U.S. and European centers.
The RENEW Lung Volume Reduction Coils provide a minimally invasive alternative to lung volume reduction surgery, which was pioneered by UPMC surgeons and pulmonologists more than a decade ago. Pulmonologists in Europe have been investigating this device for the past four years, but only a large, randomized trial such as this research can medically prove the effectiveness of this intervention, said Frank Sciurba, M.D.
, principal investigator of the local study arm, director of the UPMC Pulmonary Function and Exercise Physiology Laboratory, and professor, Division of Pulmonology, Allergy and Critical Care Medicine (PACCM)
, University of Pittsburgh School of Medicine
This trial extends PACCM’s legacy in taking a lead in creating or investigating novel approaches to treating patients with advanced lung disease, said Mark Gladwin, M.D.
, the division’s chief and the director of Pitt’s Vascular Medicine Institute
“This represents an innovative approach to non-invasively improve the lung function of patients with COPD, unlike prior approaches that required major surgery,” he added.
The RENEW trial is funded by the California-based company PneumRx
, which developed the device. The coils are small, super-elastic, shape-memory coils made of a metal commonly used in medical implants. In a simple, hour-long procedure employing a bronchoscope, Sciurba and fellow UPMC pulmonologist Maria Crespo, M.D., F.C.C.P.
, associate medical director, UPMC Lung Transplantation Program
, implanted up to 10 coils in wire form into one lung of the patient. The wires recoil after deployment, pulling in the damaged, overinflated lung area so that the healthier, remaining lung can inflate and deflate more effectively, improving airway function and breathing both at rest and during exercise. Four months later, up to 10 coils go into the other lung.
Candidates for the trials include patients who have severe emphysema and impaired exercise tolerance after quitting smoking. In the Hampton woman’s case, she gave up cigarettes more than a quarter-century ago.
Emphysema is an irreversible, incurable disease where sufferers become progressively less mobile, enduring shortness of breath and increasing discomfort with any activity, to the point of becoming homebound. Current treatments include medicine therapy such as bronchodilators, inhaled steroids and antibiotics. However, such treatments show limited benefits, and patients progress over time to where few options remain, leaving sufferers with a declining quality of life.
“I always ask my patients, ‘What was the last important activity that you had to give up?’ and I consider their answer to be our target for successful treatment,” Dr. Sciurba said. “If the RENEW trial is successful in proving these coils can improve exercise tolerance, we will have an important new tool to offer our patients with advanced emphysema that will help them regain the lost activities so important to their quality of life.”
For more information about participating in the trial, emphysema sufferers over the age of 35 who quit smoking at least two months prior should call Christina Ledezma, Ph.D., clinical research coordinator, at 866-948-2673.