Emory Researchers Participate In INSPIRE Trial For Patients With Fatal Lung Disease

The INSPIRE trial, being conducted in 70 centers in North America, Europe, and Canada, is testing the safety and efficacy of Actimmune (interferon gamma-1b), a disease-modifying drug with a low side effect profile. Interferon gamma-1b is a cytokine produced naturally by the body and has anti-fibrotic properties (i.e. helps prevent thickening or scarring of connective tissue). The phase three trial testing interferon gamma-1b is currently in the most advanced phase of a number of treatment options for IPF.

Jesse Roman, MD, is the director of the division of Pulmonary Allergy and Critical Care Medicine at Emory University, and director of the Emory ILD Center.

"We strive to provide patients and their physicians with advanced experimental treatment regimens and we're enthusiastic about discoveries that will allow us to develop new and better therapies for their lung condition," Dr. Roman says.

The INSPIRE trial is a phase three, randomized, double-blind, placebo-controlled study sponsored by InterMune, Inc. The trial is recruiting 600 IPF patients between the ages of 40 and 79 for a two-year evaluation period. Patients are randomized at a 2:1 ratio into a group receiving 200 mcg of interferon-gamma subcutaneously three times weekly for two years or into a group receiving placebo only. A physical examination, vital signs, electrocardiogram, hematology, urinalysis, and blood chemistry profiles will evaluate safety, and a high-resolution computerized tomography of the chest will be performed. Adverse events including infections and death will also be recorded. The primary efficacy outcome measure of the study will be survival time from date of randomization in patients diagnosed with IPF.

IPF is classified as an interstitial lung disease (ILD), a group of lung conditions that is characterized by a buildup of scar tissue in the lungs. The disease damages the air sacs of the lower respiratory tract as the scar tissue forms and thickens, causing an irreversible reduction of the transfer of oxygen to the bloodstream. Although no definite cause has been discovered, it is thought to be caused by injury or inflammation induced by an unknown agent. Pulmonary fibrosis is mostly attributed to inhaled environmental exposures, connective tissue, drug toxicity from chemotherapy radiation, diseases such as sclerodoma, lupus or sarcoidosis, and inherited causes.

Pulmonary hypertension and respiratory failure threaten the lives of IPF patients, Dr. Roman notes.

"Many patients are unable to perform their usual daily activities because of shortness of breath. Their lungs continue to deteriorate and soon they're also plagued with an unyielding dry cough and appetite loss," Dr. Roman says. "However we hope treatments that may be derived from studies like the INSPIRE trial will help improve their quality of life or ultimately successfully treat the disease."

According to the Coalition for Pulmonary Fibrosis, an estimated 31,000 new cases of IPF are diagnosed each year and approximately 83,000 Americans suffer from IPF. An estimated two-thirds of those patients die within five years of diagnosis.

Interested patients needing complete inclusion criteria for the clinical trial should contact the study coordinator Patricia Alvarez, MD at (404) 727-6821.