July 22, 2005
NEW ORLEANS - The Tulane University Section of Pulmonary Diseases and Critical Care Medicine received a five-year grant for more than $800,000 from the National Institutes of Health (NIH) to lead a Gulf South regional network for clinical research with patients who have idiopathic pulmonary fibrosis (IPF). IPF involves scarring of the lung, which causes a progressive reduction in the capacity to transfer oxygen into the bloodstream.
In the United States, there are an estimated 30,000 new patients diagnosed with IPF each year. Almost as many patients will die from IPF in the United States annually as die from breast cancer. The disease afflicts both smokers and non-smokers. The cause of IPF is not known, and no medicine has met the standards of the U.S. Food and Drug Administration to receive a recommendation for treatment of the disease.
Symptoms of IPF include shortness of breath, particularly with exertion, and a dry, hacking cough. Misdiagnosis as "heart failure" or "just getting old" is not uncommon. It is very important to seek medical attention early for these symptoms because early therapy is likely to be of greater benefit.
"Typically, patients are in their fifties or older when they are diagnosed with IPF. These are people who have worked all of their lives and are cheated by the disease from a well-deserved active retirement," says Joseph Lasky, principal investigator for the research network that will reach out to IPF patients in Louisiana, Mississippi, Alabama, Texas and Florida to study the effectiveness of innovative drug regimens.
"Frequently patients have lost a third or more of their lung capacity by the time they see a doctor," says Lasky, professor of medicine and chief of pulmonology at Tulane. "Within three years, about half of the newly-diagnosed IPF patients die with shortness of breath."
The clinical research network, comprised of Tulane and 10 other U.S. centers, will determine which pharmacological agents show the most promise to treat lung scarring and prolong life for IPF patients. For the Gulf South "hub" of the network, Lasky has partnered with Vincent Valentine at Ochsner Medical Foundation along with Mitch Olman and Joao DeAndrade at the University of Alabama - Birmingham. Enrollment into these NIH sponsored trials for IPF is expected to begin in the late Spring of 2006.
"There are currently no proven effective medicinal treatments that will cure IPF," Lasky says. "A minority of patients afflicted with IPF may receive a lung transplant as treatment for their disease, however, lung transplantation is not an option for the vast majority of patients with IPF because of the paucity of available organs and because of concomitant ailments that preclude lung transplantation."
Importantly, Lasky says, the NIH has invested in basic science research to better understand the mechanism of lung scarring over the past decades in the belief that this knowledge will lead to the development of effective therapy.
"The basic research is beginning to pay off as several novel agents are now coming forward into clinical trials for the treatment of IPF," Lasky says.
Meanwhile, Lasky and colleagues currently are studying 120 patients to determine whether oral administration of the drug Gleevecý, which has revolutionized the treatment of chronic myelogenous leukemia, will benefit those suffering from IPF. The Tulane pulmonary medicine section shares lead institution status with the Mayo Clinic for this nationwide trial.
In addition, Tulane is participating in the INSPIRE Trial, an international study evaluating the therapeutic potential of interferon gamma-1b for the treatment of IPF. Tulane is one of 75 medical centers in North America and Europe participating in the INSPIRE Trial.
Those eligible for enrollment in the study will receive either the interferon-gamma-1b or placebo by injection three times a week for a minimum of two years. For more information about IPF studies at Tulane, call Chodie Gabor, study nurse coordinator, at (504) 988-6966.
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