? ? Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease that commonly results in respiratory failure and death with a median survival of three years after diagnosis. Recent studies demonstrate traditional therapy consisting of corticosteroids and cytotoxic agents to be ineffective in improving survival. There is currently no effective treatment for this disorder. Recent advances in basic research on the pathogenesis of IPF and the development of novel therapeutic agents have increased the need for a cooperative clinical research network in evaluating new management strategies. An established group of clinical investigators (Mayo Interstitial Lung Disease Group) with a longstanding interest and track record in IPF proposes the development of a clinical center at Mayo Clinic to participate in the NIH-funded IPF Clinical Research Network for conducting collaborative therapeutic trials. These clinical investigators and their research staff of the Pulmonary Clinical Research Center have considerable experience in recruitment and retention of subjects for clinical trials in IPF and other lung diseases. This clinical center proposes two treatment studies for consideration by the network. The first study will examine the effects of combined imatinib and pentoxifylline regimen compared to placebo in the treatment of IPF. The second project will study the effects of combined colchicines and N-acetylcysteine therapy compared to placebo. To conduct these and other IPF Clinical Research Network studies, this clinical center will draw from 200-250 new patients with IPF seen each year at Mayo Clinic Rochester. The Mayo Interstitial Lung Disease Clinic registry and computerized databases will allow identification and participation of other subjects with IPF previously seen at this clinical center. This clinical center will also have access to other potential participants seen at Mayo Clinic Jacksonville (FL) and Mayo Clinic Scottsdale (AZ). (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 #
5U10HL080274-02
Application #
7060030
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
2006-05-01
Budget End
2007-04-30
Support Year
2
Fiscal Year
2006
Total Cost
$177,784
Indirect Cost
Name
Mayo Clinic, Rochester
Department
Type
DUNS #
006471700
City
Rochester
State
MN
Country
United States
Zip Code
55905
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

Showing the most recent 10 out of 12 publications