Emphysema and COPD Treatment
EMPROVE Trial Aims to Ease Breathing for Emphysema Patients
A late-phase clinical trial led by University of Maryland researchers will focus on an innovative, minimally invasive bronchoscopic procedure that may significantly improve breathing for patients with COPD or emphysema.
Ashutosh Sachdeva, M.B.B.S., director of Interventional Pulmonology in the Division of Pulmonary and Critical Care at the University of Maryland Medical Center (UMMC), is the principal investigator (PI) on the trial, which will compare standard medical management of COPD or emphysema with results achieved from the placement of a small, one-way valve inside the airways of one lung that stops air from entering the most diseased portions. Known as EMPROVE, the randomized, controlled study plans to begin recruiting a total of 270 participants at about 20 sites across the United States. UMMC will begin recruiting patients for the trial by November.
The umbrella-shaped IBV valve, positioned with a catheter inside the bronchi of one lung, is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce lung over-inflation and may improve overall pulmonary function and quality of life for those with COPD or emphysema — which affects 16 million nationwide — most of whom developed the disease after years of smoking. EMPROVE patients will agree to stop smoking at least four months prior to enrolling in the study.
“Even after they’ve been on medications to decrease airway inflammation and improve airflow, many patients who have severe disease are limited in their activities and by severe shortness of breath,” says Dr. Sachdeva, also an assistant professor of medicine. “This is a seminal trial for patients who might benefit the most from this valve and provides an opportunity to engage in a clinical trial. We are quite optimistic the results will be favorable.”
Two-thirds of the 270 study participants will undergo the valve placement, while one-third will be randomized to standard medical management for COPD or emphysema, which includes the use of medications, oxygen, and pulmonary rehabilitation to maximize breathing and comfort. Valve recipients will be followed for 5 years and the medical management group for 2 years. Lung function, quality of life and dyspnea (shortness of breath) scores will be calculated using standardized questionnaires and tests, and all patients will be age 40 and older. Primary effectiveness of the treatment will be evaluated at end of 6 months.
Lung Volume Reduction Surgery
The minimally invasive valve procedure, known as bronchoscopic lung volume reduction, attempts to provide an alternative to chest surgery procedure that has proven to be a benefit in select patients with severe COPD or emphysema but came with significant morbidity and complication rates and excluded the sickest patients, Dr. Sachdeva says.
With the addition of bronchoscopic valve therapy, the University of Maryland will be able to provide the complete spectrum of emphysema treatment beyond optimal medical therapy. Currently, the University of Maryland is an established and recognized center for Lung Volume Reduction Surgery (LVRS) and Lung Transplant. By initiating an Endobronchial Valve Emphysema program, Dr. Sachdeva will evaluate patients in conjunction with the study’s Surgical Co-Investigator, Whitney Burrows, M.D., of Thoracic Surgery. Dr. Burrows acknowledges, “The EMPROVE trial fully compliments the University of Maryland’s multidisciplinary approach to emphysema and places the university in the very rare position to offer all the best treatment options to this disease.”
The IBV valve, not yet approved by the U.S. Food and Drug Administration, is one of the few products of its kind being tested to relieve emphysema symptoms.
Few Complications Anticipated
While valve recipients are in danger of complications that include pneumonia, exacerbation of COPD and coughing up blood, the risk of such problems is low based on prior trials, Dr. Sachdeva explains. Currently, UMMC is one of the few select centers with Institutional Review Board (IRB) approval for humanitarian use of the IBV valve “in special clinical situations where the patient suffers from persistent air leak after thoracic surgery or lung resection,” he says.
“For the patients in our trial, we’re hoping their lung function improves along with quality of life measures, and overall wellbeing and function,” Dr. Sachdeva says. “In essence, we want to make sure that they don’t only have lung function parameters that are better, but that they feel better and can be more productive.”