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.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HL080383-05
Application #
7615513
Study Section
Special Emphasis Panel (ZHL1-CSR-M (F1))
Program Officer
Reynolds, Herbert Y
Project Start
2005-05-01
Project End
2012-04-30
Budget Start
2009-05-01
Budget End
2012-04-30
Support Year
5
Fiscal Year
2009
Total Cost
$224,109
Indirect Cost
Name
Weill Medical College of Cornell University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
060217502
City
New York
State
NY
Country
United States
Zip Code
10065
Andrade, Joao de; Schwarz, Marvin; Collard, Harold R et al. (2015) The Idiopathic Pulmonary Fibrosis Clinical Research Network (IPFnet): diagnostic and adjudication processes. Chest 148:1034-1042
Durheim, Michael T; Collard, Harold R; Roberts, Rhonda S et al. (2015) Association of hospital admission and forced vital capacity endpoints with survival in patients with idiopathic pulmonary fibrosis: analysis of a pooled cohort from three clinical trials. Lancet Respir Med 3:388-96
Idiopathic Pulmonary Fibrosis Clinical Research Network; Martinez, Fernando J; de Andrade, Joao A et al. (2014) Randomized trial of acetylcysteine in idiopathic pulmonary fibrosis. N Engl J Med 370:2093-101
Swigris, Jeffrey J; Streiner, David L; Brown, Kevin K et al. (2014) Assessing exertional dyspnea in patients with idiopathic pulmonary fibrosis. Respir Med 108:181-8
Collard, Harold R; Brown, Kevin K; Martinez, Fernando J et al. (2014) Study design implications of death and hospitalization as end points in idiopathic pulmonary fibrosis. Chest 146:1256-1262
Han, MeiLan K; Bach, David S; Hagan, Peter G et al. (2013) Sildenafil preserves exercise capacity in patients with idiopathic pulmonary fibrosis and right-sided ventricular dysfunction. Chest 143:1699-1708
Idiopathic Pulmonary Fibrosis Clinical Research Network; Raghu, Ganesh; Anstrom, Kevin J et al. (2012) Prednisone, azathioprine, and N-acetylcysteine for pulmonary fibrosis. N Engl J Med 366:1968-77
Noth, Imre; Anstrom, Kevin J; Calvert, Sara Bristol et al. (2012) A placebo-controlled randomized trial of warfarin in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 186:88-95
Swigris, Jeffrey J; Han, Meilan; Vij, Rekha et al. (2012) The UCSD shortness of breath questionnaire has longitudinal construct validity in idiopathic pulmonary fibrosis. Respir Med 106:1447-55
(2010) The IPFnet Strategy: Creating a comprehensive approach in the treatment of idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 181:527-8

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