Idiopathic Pulmonary Fibrosis: Two New Trials

Idiopathic pulmonary fibrosis is a progressive fibrosing lung disorder that affects over 120,000 Americans. To date, no FDA-approved drugs have been shown to reverse or halt the progression of this disease, which is often deadly.

To address this problem, the National Institutes of Health established the IPF Clinical Research Network (IPFnet), which includes more than 20 centers across the United States charged with designing and conducting clinical trials in IPF. Recently, the network finished a clinical trial testing the use of sildenafil, a vasodilator, in patients with advanced IPF; the trial was published this year (N. Engl. J. Med. 2010;363:620).

The IPFnet is now engaged in two new clinical trials testing drugs that block pathways considered key for the development of tissue fibrosis. The first trial, termed PANTHER, will evaluate the effectiveness of antioxidants. An earlier study suggested a promising role for antioxidants in IPF, but too few patients were evaluated. PANTHER will also examine the role of steroids and related drugs.

“Many patients are treated with these types of drugs, yet we still don't know whether steroids and antioxidants are effective. PANTHER will answer these questions once and for all, but only if patients enroll in this trial,” said Dr. Jesse Roman, professor and chair of the department of medicine at the University of Louisville and chair of the IPFnet Education Committee.

The second trial being conducted by the IPFnet is called ACE. The ACE trial will explore the effectiveness of anticoagulants in treating IPF based on published data suggesting a role for coagulation in lung fibrogenesis. ACE was designed to test the benefits of this intervention. “Well-designed clinical trials are being conducted in search of safe and effective treatments for IPF, but patient involvement in these trials is crucial for their success,” said Dr. Imre Noth, of the University of Chicago.

The new trials, PANTHER and ACE, are currently enrolling patients. To enroll patients or learn more, visit the IPFnet Web site (www.IPFnet.org

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