? ? Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive lung disease with no proven therapy. The outcome in most patients includes gradual progression of restrictive lung disease to respiratory failure in half the patients within a period of 3-5 years. Estimates for prevalence suggest that there are 100,000 patients in the US with IPF, and it is the commonest cause of death among patients awaiting lung transplant for end-stage lung disease. Many available pharmaceutical agents have actions which would predict improved outcomes in IPF but have not been tested in patients. It is crucial that well-designed, multi-center, randomized, placebo-controlled trials be conducted promptly to examine whether an effective therapy for IPF can be identified. ? ? We plan to determine the effects of treatment of IPF with everolimus in a multi-center, randomized, placebo-controlled clinical trial which will enroll 240 IPF patients. In a subsequent trial of 360 IPF patients, we will determine the effects of treatment of IPF with prednisone or pirfenidone, or both, in a multi-center, randomized, placebo-controlled clinical trial. Finally, we will participate fully as a clinical center in all of the multi-center, randomized, placebo-controlled trials as directed by the Steering Committee of the IPF Clinical Research Network. (End of Abstract) ? ?

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HL080370-03
Application #
7227015
Study Section
Special Emphasis Panel (ZHL1-CSR-M (F1))
Program Officer
Reynolds, Herbert Y
Project Start
2005-05-01
Project End
2010-04-30
Budget Start
2007-05-01
Budget End
2008-04-30
Support Year
3
Fiscal Year
2007
Total Cost
$192,907
Indirect Cost
Name
Vanderbilt University Medical Center
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004413456
City
Nashville
State
TN
Country
United States
Zip Code
37212
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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