? ? The purpose of this initiative is to: 1) establish a Clinical Research Network (CRN) of 6 to 7 clinical centers to design and perform multiple therapeutic trials for treatment of patients with newly diagnosed idiopathic pulmonary fibrosis (termed IPF) - usual interstitial pneumonia variety. This CRN will create the infrastructure for conducting multiple, collaborative therapeutic trials with relative speed and efficiency. These trials may evaluate existing or new medications, combinations of medications, and defined management strategies. Weill Medical College is geographically poised to recruit patients from the New York metropolitan area, the largest in the country, and has all the necessary infrastructure to successfully carry out the requirements of this IPF CRN. We have organized our center to provide referral of >200 newly diagnosed IPF patients per year from numerous academic centers and hospitals. This will provide an adequate patient base from which to enroll 40-50 newly diagnosed IPF patients per year into therapeutic trials.
The specific aims of the project are: 1) to develop a center for state-of-the-art clinical research studies for patients with idiopathic pulmonary fibrosis at Weill Medical College of Cornell University/New York Presbyterian Hospital, and 2) to develop randomized multi-center trials to evaluate new therapies for treatment of idiopathic pulmonary fibrosis. The studies proposed are ? (a) single drug: [1. rapamycin + 2. low dose prednisone] vs. low dose prednisone alone; and (b) multi-drug: [1. angiotensin converting enzyme inhibitor (ACE-I) + 2.3-hydroxy-3-methylglutaryl co-enzyme A reductase inhibitor (statin) + 3. low dose prednisone] vs. low dose prednisone alone. (End of Abstract) ? ?
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