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    November 27, 2006
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Temple to lead mid-Atlantic consortium for national oxygen study


Gerard J. Criner, M.D.
Gerry Criner, director of the Temple Lung Center, examines a COPD patient who uses supplemental oxygen, a form of therapy at the heart of the LOTT trial.
(Photo by Joseph V. Labolito / University Photography)

The Temple Lung Center will lead the mid-Atlantic consortium for the Long-term Oxygen Treatment Trial (LOTT), a six-year, nationwide study of the effectiveness and safety of long-term, home oxygen therapy for chronic obstructive pulmonary disease, or COPD. The trial is supported by the National Heart, Lung and Blood Institute (NHLBI) and the Centers for Medicare & Medicaid Services.


Under the direction of Gerard J. Criner, M.D., the mid-Atlantic consortium will serve as one of 14 regional clinical centers in what is the largest randomized clinical trial to date of continuous oxygen vs. oxygen administered only as needed in patients with moderate COPD. Although oxygen therapy has been shown to improve survival in patients with COPD and severe hypoxemia (low blood oxygen), the effects of treatment have not been adequately studied in patients with less severe disease. Criner, director of the Lung Center and chief of pulmonary and critical care medicine at Temple University Hospital, is a professor of medicine at Temple University School of Medicine.


“The rationale to provide supplemental oxygen in severe COPD with only mild to moderate hypoxemia is based on relatively few studies, conducted in a small number of subjects, with benefits found only in those most severely ill. Some studies have found oxygen to be potentially harmful,” Criner said. “Given the 1 million patients with COPD currently receiving oxygen, this trial is imperative.”


The ultimate goal of the trial is to improve the management of COPD, with increased length and quality of life for patients. The results will help Medicare decide whether to extend coverage for home oxygen treatment to patients with mild to moderate hypoxemia.  Currently, Medicare limits coverage of home oxygen therapy to beneficiaries with COPD and severe hypoxemia.


COPD, the fourth-leading cause of death in the United States, is most often caused by smoking, and leaves sufferers winded, weak and too fatigued to pursue their regular activities.


Each Regional Center will organize and manage a network of cooperating hospitals, clinics, pulmonary rehabilitation centers and physician offices through which patients can participate in the trial. Approximately 3,500 participants will be enrolled over a three-year period and followed for up to three and one-half years. The Mid-Atlantic Regional Center spans the greater Philadelphia, South Jersey and Baltimore regions.


Additionally, the consortium is planning several important sub-studies including the impact of oxygen therapy on sleep, exercise performance, cardiovascular function and shortness of breath.


“The research is needed not only to demonstrate efficacy in terms of survival and quality of life, but also to find out which patients will most likely benefit -- or be harmed -- and to assess cost-effectiveness,” Criner said.


Temple is well-suited to play a leading role in LOTT, already providing care to a large number of patients with COPD, including high proportions of African-American, Hispanic and Asian COPD patients, ensuring that the LOTT patient population will be ethnically diverse. Additionally, the Temple Lung Center has a great deal of experience conducting large, multi-center trials. It was the East Coast’s top recruiter for the National Emphysema Treatment Trial, which studied lung volume reduction surgery (LVRS), a treatment for emphysema; is an active clinical site for the NHLBI’s COPD Clinical Research Network and the lead institution on the Pennsylvania Study of COPD Exacerbations.


The Temple Lung Center has been highly commended for its leadership in respiratory disease diagnosis, treatment and research, as well as for high safety standards and quality of care. U.S. News & World Report ranked Temple University Hospital as one of the nation’s top hospitals for respiratory disorders in their 2006 “Best Hospitals” survey. 

And the Joint Commission on Accreditation of Healthcare Organizations granted national certification to Temple as a Center for LVRS, making it the first hospital in Philadelphia, and among the first academic hospitals in the nation, to receive the Joint Commission’s Gold Seal of Approval for LVRS.

NHLBI Announcement: http://www.nhlbi.nih.gov/new/press/06-11-20.htm


Eryn Jelesiewicz




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