Temple University Hospital Offering New Treatment for Chronic Obstructive Pulmonary Disease

Temple University Hospital is one of only three hospitals nationwide participating in a Phase II clinical trial testing whether or not an investigational oral tablet therapy will suppress inflammation and ease breathing for patients suffering from moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

COPD is a group of diseases, including emphysema, chronic bronchitis, and in some cases asthmatic bronchitis, that cause airflow blockage and breathing-related problems. According to the Centers for Disease Control and Prevention, COPD is the third leading cause of death in the country, and affects 24 million Americans. Symptoms include coughing, shortness of breath, and sputum production.

"COPD is a very serious inflammatory lung disease. Therapeutic options for COPD patients are limited and there are no specific therapies for anti-inflammatory activities that are related to oxidant injuries," said Gerard J. Criner, MD, FACP, FACCP, Director of the Temple Lung Center and national principal investigator of the trial. "We are now recruiting patients who are interested in this study. The purpose of the trial is to see if this drug has anti-inflammatory, antioxidant properties in the lungs of people with COPD."

The randomized, double-blind, placebo-controlled study is testing a drug called YPL-001, which contains an herbal extract from a perennial plant called Speedwell. The herb has been used as traditional medicine in Korea and China for more than 100 years to treat inflammatory diseases, like asthma and COPD.

Participants in the study will be divided into three treatment groups assigned to orally receive either a low dose of 80 mg, a high dose of 160 mg, or a placebo. Over a 60-day period, researchers will check respiratory symptoms on a daily basis to see if there is a change in the inflammatory profile in the lungs and blood.

The results of patients who receive the low or high dosage will be compared to those who receive the placebo. The measure of success for the trial will be whether patients who receive the low or high dosage have improvement in inflammation due to COPD. If there are improvements in those patients, researchers will investigate which dose is more effective and move on to a Phase III trial to determine if the drug can prevent lung flare ups.

"The biologic principal of this is to target a hole in our current therapy for COPD right now," added Dr. Criner. "The drug won't cure COPD, but we hope it will improve the condition of the patients and decrease flare ups and exacerbations they have."

A total of 69 patients between the ages of 40 to 80 years of age, diagnosed with COPD, will be enrolled in the trial across the three participating centers. Temple is currently screening and enrolling patients in this trial. Interested individuals should contact Taylor Kenney, administrative specialist, at 215-707-8113 for more information.

The trial is sponsored by Yungjin Pharma, which manufactures YPL-001.

Editor's Note: Neither Dr. Criner nor any member of his immediate family has financial interest in Yungjin Pharma.