UCLA researchers seek adults, ages 40-74, who have been diagnosed with severe emphysema for a study comparing the effectiveness of an investigational device to standard treatment for improving symptoms. According to researchers, the current treatments for severe emphysema, including surgery and inhaled medications have not been that effective so patients have few options.
Severe emphysema is a chronic, irreversible lung disease affecting about 100,000 Americans. The condition causes the lungs to lose elasticity, which is critical for their ability to take in and expel air. Damaged areas can no longer push out air, creating dead spaces that do not contribute to respiration. Symptoms include shortness of breath, chronic cough and trouble breathing during exercise.
"Lung transplant or lung volume reduction surgery have typically been the only options for patients with severe emphysema," said Dr. Christopher Cooper, principal investigator and Professor of Medicine and Physiology at David Geffen School of Medicine, UCLA. "In recent years, one-way valve implants have been developed that may provide a less invasive, reversible alternative for patients."
According to Cooper, the study will assess the ability of one-way valve implants to help improve breathing function when compared to standard treatment, which includes inhaled medications.
The study will last six months. Following an initial screening visit, study volunteers will be assigned at random (similar to flipping a coin) to receive either the valve implants or a standard bronchoscopy examination. At the study's conclusion, patients who did not receive the valves will be offered the procedure.
The valves are delivered by inserting a bronchoscope through the patient's mouth and into the upper lobes of the lungs. Once deployed, each valve expands like an umbrella to block an affected airway, preventing air from entering the damaged areas while permitting trapped air and secretions to escape.
Volunteers will participate in pulmonary function tests to measure lung ability; six-minute walking tests to gauge shortness of breath; computed tomography (CT) scans to reveal detailed views of the lungs and heart function tests.
Side effects related to implanting the valves have included device dislodgement or the development of bronchitis and pneumonia. Rare longer term effects have included airway damage or collapsed lung.
The study is funded by Spiration, Inc., manufacturers of the IBV® Valve System. For more information about the study, please call 310-206-0396.