Clinical Trials

Updated 01/13/15

NCT Protocol Title Sponsor Site PI Condition Description Treatment Clinic SC Name SC phone SC email open or closed
N/A Pathogenesis and Progression of Chronic Lung Diseases PI initiated; PCCM Desai, Tushar Chronic Lung Disease Tissue banking protocol for a variety of chronic lung diseases N/A Chest Susan Jacobs 650 725 8083 ssjpulm@stanford.edu open
N/A Molecular Profiling of Alveolar Immune Cell Populations in Healthy Individuals PI initiated; PCCM Desai, Tushar Normal healthy volunteers Collection of blood and bronchoalveolar lavage fluid from normal, healthy volunteers N/A Chest Susan Jacobs 650 725 8083 ssjpulm@stanford.edu open
1775774 A Phase 1/ 2, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells for the Treatment of Acute Respiratory Distress Syndrome NIH Levitt, Joseph Acute Respiratory Distress Syndrome Placebo controlled trial evaluating efficacy of allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells vs placebo in the treatment of ARDS stem cells or placebo ICU Rosemary Vojnik 650 723 7409 rvojnik@stanford.edu open
1783821 LIPS-B: Lung Injury Prevention Study with Budesonide and Beta Agonist NIH Levitt, Joseph Acute Respiratory Distress Syndrome placebo controlled study of preventing lung injury with budesonide and beta agonist vs placebo budesonide and beta agonist or placebo ICU Rosemary Vojnik 650 723 7409 rvojnik@stanford.edu open
1681225 A Phase ll Study of Mechanical Ventilation Directed by Transpulmonary Pressures NIH Levitt, Joseph Critically Ill Patients randomized controlled study evaluating transplulmonary pressure-guided mechanical ventilation compared to usual mechanical ventilation transpulmonary pressure-guided mechanical ventilation or usual mechanical ventilation ICU Rosemary Vojnik 650 723 7409 rvojnik@stanford.edu open
1504867 LIPS-A: Lung Injury Prevention Study with Aspirin NIH Levitt, Joseph Critically Ill Patients randomized placebo controlled study to evaluate the effectiveness of aspirin in preventing lung injury aspirin or placebo ICU Rosemary Vojnik 650 723 7409 rvojnik@stanford.edu open
N/A Acute respiratory Distress Syndrome (ARDS) Phenotyping PCCM; PI initiated Levitt, Joseph Acute Respiratory Distress Syndrome prospective data and blood sample collection on patients with ARDS N/A ICU Tola Asuni 650 497 6801 tolasuni@stanford.edu open
662038 PIPF -012: An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) InterMune/ Genentech Mohabir, Paul K Idiopathic Pulmonary Fibrosis Open label protocol for pirfenidone in IPF pts. to collect data re: longterm safety oral pirfenidone ILD Susan Jacobs 650 725 8083 ssjpulm@stanford.edu ongoing; closed to enrollment
N/A Interstitial Lung Disease Database PI initiated, PCCM Mohabir, Paul K Interstitial Lung Disease Prospective collection of clinical and physiologic data on Interstitial Lung Disease patients N/A ILD Susan Jacobs 650 725 8083 ssjpulm@stanford.edu open
1874223 Prospective Validation of Cough, Dyspnea, and Quality of Life Questionnaires in Patients with Idiopathic Pulmonary Fibrosis PI initiated, Celgene Mohabir, Paul K Idiopathic Pulmonary Fibrosis Assessment of cough,quality of life, and progression of IPF through written questionnairesand physiologic testing every 6 months for 1 ½ years N/A ILD Susan Jacobs 650 725 8083 ssjpulm@stanford.edu open
1915511 Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry (IPF-PRO) Boehringer-Ingelheim Mohabir, Paul K Idiopathic Pulmonary Fibrosis Collection of patient reported outcomes related to quality of life, symptoms, and health care cost utilization by written questionnaires every 6 months for up to 5 yrs; also includes blood draw at time of questionnaires N/A ILD Tal Alfasi 650 736 8083 alfasit@stanford.edu to open Feb 2015
1619085 Open label extension study of oral triple kinase inhibitor in IPF pts. BIPI 1199.33 Boehringer-Ingelheim Mohabir, Paul K Idiopathic Pulmonary Fibrosis Open label extension study of oral triple kinase inhibitor in IPF pts.to collect longterm safety data nintedanib ILD Rosemary Vojnik 650 723 7409 rvojnik@stanford.edu ongoing; closed to enrollment
N/A Pulmonary Function Testing Patterns in Idiopathic Pulmonary Fibrosis PI initiated; InterMune Mohabir, Paul K Idiopathic Pulmonary Fibrosis Retrospective chart review of longitudinal clinical and PFT data for IPF patients; collaboration with Vanderbilt University and University of Alabama N/A ILD Susan Jacobs 650 725 8083 ssjpulm@stanford.edu ongoing; closed to enrollment
N/A Physiologic Predictors of Cough Severity in ILD and Related Patient Management Strategies PI initiated; PCCM Mohabir, Paul K Idiopathic Pulmonary Fibrosis Retrospective review of patient-reported outcomes related to cough severity and patient management strategies N/A ILD Susan Jacobs 650 725 8083 ssjpulm@stanford.edu open
N/A Detection of Serum Biomarkers for FDG-PET Positive Lung Nodules (LUNG0045) PI Initiated; PCCM/Radiology Nair, Viswam Lung Cancer Prospective collection of clinical and physiologic data on patients FDG-PET positive Lung Nodules N/A Nuclear Medicine Pragya Tripathi 650 736 6524 pragyat@stanford.edu open
Pending Blood Biomarkers for Patients Undergoing Lung Cancer Screening by Computed Tomography (LUNG 0060) PCCM and Radiology/MD Anderson Cancer Center Nair, Viswam Lung Cancer Screening Prospective blood biomarker evaluation of patients undergiong CT imaging for lung cancer screening N/A Redwood City Outpatient Center Selvi Sabapathy 650 736 6524 selvis1@stanford.edu open
1766817 Safety and Efficacy of A Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis; A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Efficacy of BMS-986020 in Subjects with Idiopathic Pulmonary Fibrosis (Clinical Protocol IM136003) Bristol Myers Squibb Patel, Kapilkumar Idiopathic Pulmonary Fibrosis 6 month RCT of oral LPAI 1 inhibitor for patients with IPF to determine impact on disease progression oral LPAI 1 inhibitor or placebo ILD Karen Morris 650 497 2929 kkmorris@stanford.edu open
1769196 A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) Gilead Patel, Kapilkumar Idiopathic Pulmonary Fibrosis RCT of weekly subcutaneous injections of LOXL2 inhibitor simtuzumab/placebo to determine impact on IPF disease progression SQ simtuzumab or placebo ILD Karen Morris 650 497 2929 kkmorris@stanford.edu open
1759511 A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects with Idiopathic Pulmonary Fibrosis (ATLAS) Gilead Patel, Kapilkumar Idiopathic Pulmonary Fibrosis Open label trial of simtuzumab in patients with IPF to assess safety and efficacy SQ simtuzumab ILD Susan Jacobs 650 725 8083 ssjpulm@stanford.edu ongoing; closed to enrollment
2141087 PIPF 031: A Treatment Protocol to Allow Patients in the US with Idiopathic Pulmonary Fibrosis Access to Pirfenidone InterMune/ Genentech Patel, Kapilkumar Idiopathic Pulmonary Fibrosis Open label, expanded access protocol for pirfenidone in IPF pts. oral pirfenidone ILD Tal Alfasi 650 736 8083 alfasit@stanford.edu ongoing; closed to enrollment
N/A Stanford ICU Biorepository for ARDS PCCM; PI initiated Rogers, Angela Acute Respiratory Distress Syndrome prospective data and blood sample collection on patients with ARDS N/A ICU Tola Asuni 650 497 6801 tolasuni@stanford.edu open
N/A Contribution of Mycobacterial Pathogenesis to Airways Injury in Human Non-Tuberculous Mycobacterial Lung Infection PI initiated; PCCM Ruoss, Stephen Non-Tuberculous Mycobacterial Disease Retrospective molecular analysis of banked NTM sputum samples N/A Chest Susan Jacobs 650 725 8083 ssjpulm@stanford.edu open
1315236 A Randomized, Double-Blind, Placebo-Controlled Study of Liposomal Amikacin For Inhalation (Arikace) in Patients with Recalcitrant Nontuberculous Mycobacterial Lung Disease. INSMED Ruoss, Stephen Non-Tuberculous Mycobacterial Disease RCT of nebulized liposomal amikacin in NTM pts. Nebulized liposomal amikacin or nebulized placebo Chest Susan Jacobs 650 725 8083 ssjpulm@stanford.edu completed
not yet available A Randomized, Open-Label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult patients with nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium aviumcomplex (MAC) that are refractory to treatment. Phase 3 INSMED Ruoss, Stephen Non-Tuberculous Mycobacterial Disease RCT of nebulized liposomal amikacin in NTM pts. Nebulized liposomal amikacin vs usual care Chest Susan Jacobs 650 725 8083 ssjpulm@stanford.edu recruitment anticipated Mar 2015
1796392 Lung Function Improvement after Bronchoscopic Lung Volume Reduction with Pulmonx Endobronchial Valves used in Treatment of Emphysema (LIBERATE STUDY) Pulmonx Sung, Arthur Severe Emphysema RCT testing effectiveness of endobronchial valve for lung volume reduction in patients with severe emphysema Endobronchial Valve insertion or usual care Chest Susan Jacobs 650 725 8083 ssjpulm@stanford.edu open
552357 Clinical Risk Factors For Primary Graft Dysfunction (LTOG) NIH Weinacker, Ann Lung Transplantation Prospective study of lung transplant recipients with collection of donor and recipient tissue samples and data during the first 3 post operative days N/A Lung Transplant Tal Alfasi 650 736 8083 alfasit@stanford.edu open
1841762 A Study of Macitentan in Pulmonary arterial HypertensiON to validate the PAH-SYMPACT A multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument (SYMPHONY) Actelion Zamanian, Roham Pulmonary Arterial Hypertension Open label study of oral macitentan in patients with PAH to validate questionnaire macitentan Chest Val Scott 650 725 9861 valscott@stanford.edu open
1086540 A Randomized, Double-blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) Protocol # ASC01 NIH Zamanian, Roham Systemic Sclerosis-Associated Pulmonary Hypertension Double blind trial evaluating monoclonal antibody to CD20 (Rituximab) vs placebo Rituximab or placebo PH Val Scott 650 725 9861 valscott@stanford.edu open
1908699 A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Oral BPS-314d-MR Added-on to Treprostinil, Inhaled (Tyvaso) in Subjects with Pulmonary Arterial Hypertension (BEAT Study) Lung Biotechnology Zamanian, Roham Pulmonary Hypertension Placebo controlled study of treprostinil alone vs treprostinil plus Beraprost treprostinil alone or treprostinil plus Beraprost PH Val Scott 650 725 9861 valscott@stanford.edu open
2036970 A Dose-ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with PAH. BARD Study. Phase 2 REATA Zamanian, Roham Pulmonary Arterial Hypertension Safety and efficacy of bardoxolone in patients with PAH bardoxolone PH Val Scott 650 725 9861 valscott@stanford.edu open
2234141 A  Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension Gilead Zamanian, Roham Pulmonary Arterial Hypertension placebo controlled study of GS-4997 in patients with PAH GS-4997 or placebo PH Patricia Del Rosa 650 721 2408 pdelrosa@stanford.edu open
N/A US-Based Observational, Drug Registry of Opsumit (Macitentan) New Users in Clinical Practice. OPUS. Actelion Zamanian, Roham Pulmonary Arterial Hypertension Observational Registry N/A PH Patricia Del Rosa 650 721 2408 pdelrosa@stanford.edu open
N/A Stanford Pulmonary Hypertension Database Vera Moulton Wall Center Zamanian, Roham All types of Pulmonary Arterial Hypertension Prospective collection of clinical, physiologic data plus blood sample for patients with PAH N/A PH Drew His 650 725 0780 ahsi@stanford.edu open