Researchers at the University of Nebraska Medical Center are conducting a study to evaluate the potential of interferon gamma-1b in the treatment of idiopathic pulmonary fibrosis (IPF), a debilitating and deadly lung disease. UNMC is one of 75 leading medical centers in North America and Europe participating in a phase III clinical trial called INSPIRE (International Study of Survival Outcomes in Idiopathic Pulmonary Fibrosis with Interferon Gamma- 1b Early Intervention).
IPF is a disease characterized by progressive scarring (fibrosis) of the lungs. Symptoms include a progressively worsening shortness of breath, which makes it difficult to perform routine tasks, such as walking. Ultimately the loss of lung function leads to death. The cause of IPF is unknown, and currently there is no FDA-approved treatment for the more than 80,000 patients in the United States who have it.
Anthony Floreani, M.D., principal investigator of the UNMC study, said the drug will be evaluated for its effectiveness in stopping the disease progression and for its ability to improve survival and quality of life. “We are looking at patients who have early or mild to moderate forms of the disease. Over time, IPF affects a patient’s ability to do day-to-day activities, until finally patients become breathless at rest,” Dr. Floreani said.
He said the cause is unknown.
When one of Dr. Floreani’s patients, Harlan Cordry, began having symptoms, he thought he had pneumonia. “I thought it would pass. I was having shortness of breath and an uncomfortable feeling in my chest,” Cordry said.
Cordry, who went into semi-retirement this year, said he is happy about his involvement in the study. “The drug is very expensive,” he said. “This is one way to get it. I don’t think insurance will cover it. What I’ve read on the Internet indicates it has a good chance of working. I’m optimistic. I feel good, but I want to keep feeling good. I’m worried about it getting worse.”
Interferons belong to a family of naturally occurring proteins produced by cells of the immune system. There are three classes of interferons: alfa, beta and gamma. Although their activities overlap, each class has different effects. Interferons direct immune system attacks on viruses, bacteria, tumors and other foreign substances that can invade the body. Once interferons have detected and attacked a foreign substance, they alter it by slowing, blocking, or changing its growth or function.
Adults with IPF may be eligible to participate in the INSPIRE Trial if they are between the ages of 40 and 79, have been diagnosed within the past 36 months, and meet trial eligibility requirements. Those enrolled will receive either the investigational study drug or placebo by subcutaneous injection three times a week for a minimum of two years.
For more information, contact Jim Melson at UNMC, (402) 559-8592, or visit www.inspiretrial.com.