Current Clinical Research Trials for Patients with Pulmonary Fibrosis
1. Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study (BUILD 3 Study) PI Glenn Rosen, M.D., Study Coordinator Susan Jacobs RN, MS (650-725-8082)
This trial is aimed at determining the efficacy and the safety of bosentan (Tracleer®) in mild to moderate idiopathic pulmonary fibrosis (IPF). Bosentan is an FDA-approved drug used for treating pulmonary arterial hypertension in WHO Class III and IV. It has pharmacological properties that suggest it may be effective in modifying fibrogenesis. The trial, called BUILD 3, is sponsored by the manufacturer, Actelion Pharmaceuticals Ltd.,.
Additional BUILD 3 information can also be accessed at: http://www.build-3.com/.
This BUILD3 trial is no longer enrolling patients.
2. Clinical Studies Assessing Pirfenidone in IPF: Research of Efficacy and Safety Outcomes CAPACITY trial: PI Glenn Rosen, M.D., Study Coordinator Susan Jacobs RN, MS (650-725-8082) Sponsor: InterMune, Brisbane, CA
The purpose of the CAPACITY trial is to assess the impact of pirfenidone on IPF. Approximately 580 patients at 125 international centers will be randomized to receive either pirfenidone or placebo for 60 weeks. The primary efficacy endpoint is the change in percent predicted FVC from baseline to week 60. Additional endpoints include changes in other measures of pulmonary function, symptoms, quality of life, and functional status.
For information about this trial, please refer to the CAPACITY trial website at www.capacitytrials.com
As of May 2007, this CAPACITY trial is no longer enrolling patients. We are currently awaiting trial results in early 2009.
3. Biomarkers in Idiopathic Pulmonary Fibrosis: PI Glenn Rosen, M.D.,
Study Coordinator Susan Jacobs RN, MS (650-725-8082)
The purpose of trial is to identify blood markers that differentiate patients with Idiopathic Pulmonary Fibrosis from those without lung disease. 10 patients with a diagnosis of IPF and 10 patients with normal lung function will be enrolled. Each patient will have a blood sample drawn every two weeks for a total of seven samples over 12 weeks. Microarry analysis will be performed to detect differences in biomarkers in the blood.
As of August 2008, this trial is no longer enrolling patients.
4. Signaling Pathways in Idiopathic Pulmonary Fibrosis: PI Glenn Rosen, M.D.,
Study Coordinator Susan Jacobs RN, MS (650-725-8082)
The purpose of trial is to examine lung tissue specimens from patients with fibrotic lung disease in order to better understand the mechanisms of the formation of scar tissue in the lung. Our overall goal is to identify disease-specific differences in the phenotype of normal versus pulmonary fibrosis fibroblasts(scar cells) and to explain these differences to better understand disease pathogenesis and enable development of effective treatments for both IPF and other types of pulmonary fibrosis. Any patient undergoing either a lung biopsy, or lung or heart-lung transplant will be eligible to participate.
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