DETROIT MI– Researchers at Henry Ford Hospital today announced the start of the EASE (Exhale Airway Stents for Emphysema) Trial, an international, multi-center clinical trial to explore an investigational treatment that may offer a significant new option for those suffering with advanced emphysema. The study focuses on a new procedure, called airway bypass, that involves creating pathways in the lung for trapped air (one of the primary causes of shortness breath) to escape.
Henry Ford is the only hospital in Detroit participating in the study.
Chronic obstructive pulmonary disease (COPD) is a term referring to two lung diseases, chronic bronchitis and emphysema, that are characterized by obstruction to airflow that interferes with normal breathing. COPD is the fourth leading cause of death in the United States and is projected to be the third leading cause of death for men and women by the year 2020. There is no cure for COPD.
Emphysema is an irreversible disease characterized by the destruction of lung tissue and a subsequent decrease of the lung’s natural elasticity, which causes the small airways of the lungs to collapse. Shortness of breath worsens as this process progresses, eventually leading to a situation where all of the inhaled air cannot be exhaled, and in essence air becomes trapped in the chest. This “hyperinflation” significantly contributes to the shortness of breath experienced by patients with emphysema.
“We are excited to be part of this study because currently there are limited treatment options for most patients with emphysema beyond lung transplantation. Patients usually have very poor quality of life, as each breath can be difficult,” says Michael Simoff, M.D., a Henry Ford pulmonologist and principal investigator of the study.
“By creating new pathways for airflow with the airway bypass procedure, we hope to reduce hyperinflation and all the problems it causes for patients. If patients can breathe easier, our work will be worth it.”
Physicians commonly use bronchoscopes to examine the airways within the lungs. During the airway bypass procedure physicians will first use a Doppler probe inserted through the bronchoscope to identify a site in the airway that is free of blood vessels. A special needle is then used to make a small opening and an Exhale® Drug-Eluting Stent is placed in the passageway to keep it open. The procedure involves placing up to six drug-eluting stents. The total time of the procedure is approximately two hours.
“The airway bypass procedure could be an excellent option for those who are not suitable candidates for lung transplant surgery or as a bridge for those who could possibly spend years on a lung transplant list,” Dr. Simoff says.
Patients eligible for the study must be older than 35, don’t smoke and were diagnosed with advanced widespread emphysema. They also will receive any medical procedures at no cost, receive at least 14 weeks of pulmonary rehabilitation therapy and have eight to 16 physician appointments. For more information about the study, call 866-431-3273 or visit www.EASEtrialUS.com.
EDITOR’S NOTE: Dr. Simoff and a patient are available for interviews.