Idiopathic Pulmonary Fibrosis Clinical Trials
Pulmonary fibrosis is the result of damaged or scarred lung tissue, which makes it difficult for lungs to function properly. This condition may be caused by exposure to known injurious agents such as asbestos, particular medications, or inhaled particles. As a whole, they are classified as ‘interstitial lung diseases’ (ILD). However, many instances of pulmonary fibrosis present without a known cause, and these cases are categorized as ‘idiopathic pulmonary fibrosis’ (IPF).
This is a progressive disease. The thickened tissue in this condition cannot be repaired. No known effective medical therapy exists and besides transplantation, treatment options are limited. Symptoms include shortness of breath (dyspnea), a dry cough, fatigue and limitation of activities. The prognosis is associated with decreased survival, as it can lead to other complications which affect function and quality of life, such as lack of enough oxygen with increasing breathlessness, presence of reflux, sleeping disturbances, pulmonary hypertension (elevated blood pressure in the pulmonary vessels), which may lead to heart dysfunction, deconditioning and changes in mood. Use of oxygen as recommended by your physician, can be helpful.
Mount Sinai Part of a Select Group at the Forefront of Clinical Trial Studies
For more than a decade, Mount Sinai has actively participated in multicenter clinical trials researching medications that can potentially be helpful in this disease. While no treatment has emerged capable of reversing the disease, some hold promise of impacting the progression of the illness. Pirfenidone (trade name Esbriet), developed by InterMune Inc. for the treatment of IPF, may be such a drug. Our Lung Diseases research team for IPF, led by Director of the ILD/ALD Program Maria L. Padilla, MD, has engaged in four trials, studying the efficacy of Pirfenidone. The last trial has completed enrollment and data will be analyzed with the goal of submitting to the FDA for consideration of approval as a treatment agent for IPF.
Pirfenidone has recently been approved in Europe (trade name Esbriet), Japan (marketed as Pirespa), China, and Canada. Previous experimental studies have demonstrated antifibrotic and anti-inflammatory properties, as well as the ability to reduce fibroblast proliferation. The goal with Pirfenidone is to slow the process and pace of scarring among patients with IPF.
"IPF has been a long-standing interest of mine," notes Dr. Padilla, who has extensively studied the epidemiology, biomarkers/genetics, and comorbidities of IPF and managed a large population of patients suffering with this complex illness. "No drug has been approved for this disease by the FDA. If Pirfenidone succeeds in gaining approval, it will give hope to the nearly 180,000 patients living with this condition in the United States." While waiting for the results of the last trial, we continue our efforts conducting other studies that aim at antagonizing other mechanisms that may be very important in the development and progression of IPF.
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