The Coalition for Pulmonary Fibrosis (CPF) is urging the more than 128,000 people known to suffer from the deadly lung disease, pulmonary fibrosis (PF), to consider clinical trials, including two new ones funded by the National Institutes of Health (NIH). Clinical trials of potential drug therapies are critical to the discovery of treatments for any disease and for a disease like PF that claims as many lives each year as breast cancer with virtually no survivors, they are the likely path to answers and saved lives.
Among the clinical trials currently underway in PF (see www.coalitionforpf.org or www.clinicaltrials.gov for more information on treatment trials in PF), are two new trials being conducted by the Idiopathic Pulmonary Fibrosis Clinical Research Network (IPFnet) (www.ipfnet.org).
"The only way to defeat PF is by finding new safe and effective treatments through well-designed clinical trials," said Mishka Michon, CEO of the CPF.
The new clinical trials are testing drugs that block pathways considered key for the development of tissue fibrosis, yet, have, until now, never been adequately tested for their effectiveness in PF. The first trial, termed PANTHER, will evaluate the effectiveness of anti-oxidants. An earlier study suggested a promising role for anti-oxidants in PF, but the limited number of patients tested in that study prevented investigators from reaching a firm conclusion. PANTHER has been adequately designed to address this issue and this sophisticated design also allows for this clinical trial to test whether steroids and related drugs are helpful.
"Many PF patients are treated with these types of drugs, yet the usefulness of steroids remains in question. PANTHER will answer this question once and for all, but only if patient enrollment goals are met," said Jesse Roman, Professor and Chair of the Department of Medicine at University of Louisville and chair of the Education Committee in the IPFnet. "It is critical that PF patients participate in this study so that we begin to obtain answers that might lead to effective and safe treatments. Patients are crucial for the success of this research. These trials should provide valuable answers, but only if patient participation is strong."
The second trial, also conducted by the IPFnet, is called ACE. The ACE Trial will explore the effectiveness of anti-coagulants (blood thinners) in treating PF. Anticoagulation with Coumadin and related drugs is common in patients with vascular disorders, but it has not been tested extensively in the setting of PF even though animal studies and small clinical studies suggest it may be beneficial. ACE was designed to test this.
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