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Temple University Hospital is participating in a multi-site, nationwide phase II clinical trial that is testing whether ibuprofen can reverse the effects of emphysema. Temple is one of only three medical centers in the country, and the only one in the Philadelphia region, chosen to take part in the three-year, $4.4 million study funded by the National Institutes of Health’s National Heart, Lung and Blood Institute.
“This trial is investigating whether a common over-the-counter, non-steroidal, anti-inflammatory drug can provide a novel treatment for emphysema,” said Gerard J. Criner, MD, Director of the Temple Lung Center, and local principal investigator of the trial. “Emphysema is a devastating type of chronic obstructive pulmonary disease (COPD) that results when lung damage exceeds the ability of the lung to repair itself. It has long been thought to be irreversible, but if this treatment is successful, it could restore lost lung function and change the course of treatment for millions of Americans living with emphysema.”
The trial – called Prostaglandin Inhibition for Emphysema (PIE) – will determine if taking ibuprofen can block the production of prostaglandin E (PGE) in the lower respiratory tract. Recent evidence indicates that repair processes present in the normal lung are diminished in COPD, due in part to increased levels of PGE. Ibuprofen is known to block the production of prostaglandins elsewhere in the body, and this study will determine if it can block them in the lung.
Participants in the randomized, double blind, placebo-controlled study will be assigned to receive either ibuprofen 600 mg three times daily, or a placebo. Researchers will then measure participants’ lung inflammation, in addition to using biochemical techniques to determine the extent of lung repair that occurs. The researchers will also compare previous CT scans and pulmonary function tests with results obtained before and after treatment.
The results of patients who received ibuprofen will be compared to those that receive the placebo. The measure of success for the trial will be whether the patients who receive ibuprofen have improvement in lung function and improvement in the lung’s ability to repair itself.
A total of 140 patients will be enrolled in the trial across the three participating centers. If the study proves to be successful, researchers will seek approval to conduct a larger clinical study in patients.
“This trial serves to expand the wide variety of investigative and currently available clinical options at Temple for patients with COPD, the third leading cause of death in the United States,” added Dr. Criner. “We are pleased to be one of only three centers in the nation able to offer this trial to patients, and are excited about the potential that this novel approach may hold for the future of COPD treatment.”
According to the National Emphysema Foundation, an estimated 3.1 million Americans have been diagnosed with emphysema and nearly 12 million adults have been estimated to have COPD. They are related lung conditions that are caused by several factors, including cigarette smoking. In emphysema, lung tissue is destroyed, making it more difficult to get air into and out of the lungs.
Temple is currently screening and enrolling patients in this trial. Interested individuals may contact Taylor Kenney, administrative specialist, at 215-707-8113 for more information.