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Patient & Visitor Guides
Patient & Visitor Guides

Pulmonary Fibrosis

  • A 52 Week, Double-Blind, Randomized, Placebo-Controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients with Idipopathic Pulmonary Fibrosis (IPF)

    IPF causes the tissue deep in the lungs to become thick and stiff, or scarred, over time resulting in shortness of breath and an unproductive cough. As the lung tissue becomes thicker, the lungs lose their ability to move oxygen into your bloodstream. The study drug, referred to as BIBF 1120, was developed to treat IPF. This is a research study to test the new investigational drug BIBF 1120. Results of a previous trial suggest that the study drug, at a dose of 150 mg, has shown promising effects on lung function, health-related quality of life and acute exacerbations (worsening) of IPF. Currently there are no drugs approved by the FDA for IPF. In this research study, BIBF 1120 will be compared to a placebo. (David Lederer, MD, MS)

  • A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis

    Idiopathic pulmonary fibrosis (IPF) is a life-threatening and severely debilitating disease characterized by poor survival and a current lack of efficacious therapeutic options outside of the regions where pirfenidone is approved. Results from four controlled trials, suggest that pirfenidone treatment is safe and well tolerated and results in clinically meaningful benefits in a variety of domains, including lung volume (%FVC), exercise tolerance (change in 6MWT distance), and progression-free survival time in patients with IPF. Given the primacy of loss of lung volumes over time in patients with IPF, this protocol is intended to confirm that pirfenidone 2403 mg/d reduces decline in FVC over 52 weeks, as observed in the previous studies, compared with placebo in patients with IPF. (Nina Patel, MD)

  • NOVEL Lung Trial: Normothermic Ex-Vivo Lung Perfusion as an Assessment of Extended/Marginal Donor Lungs

    This is a two arm, non-randomized, open-label, study to evaluate the 30 day mortality of patients undergoing lung transplant lungs from marginal or extended donors treated with ex vivo lung perfusion (EVLP) versus those undergoing lung transplant with lungs considered transplant suitable. The University of Toronto group has systematically studied and developed an effective perfusion methodology to maintain donor lungs ex vivo (outside of the body) at physiologic body temperatures without adding further injury. Preclinical data shows that ex vivo perfusion with STEEN solution is as good if not better than the standard cold static preservation.The study proposes to use the EVLP technique to improve donor lung assessment preimplantation and, thereby safely increase the number of available lungs for transplant. If the lungs demonstrate a favorable ex vivo evaluation, the lungs will be transplanted into a patient. (Frank D'Ovidio, MD, PhD)

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