Clinical Trials

The following list represents open investigator-initiated and sponsored clinical trials available through Pulmonary and Critical Care Medicine, Adult Thoracic Surgery and Adult Lung Transplantation.

Steven Brody, MD:

  • Investigation of the requirement of notch signaling for the maintenance of the secretory cell fate in COPD airway epithelial cell cultures. Genentech, Inc.

Murali Chakinala, MD:

  • Use of implantable intravascular delivery system (PIVOT) for Treprostinil delivery in patients with Pulmonary Arterial Hypertension. Medtronics, Inc.
  • United States Chronic Thromboembolic Pulmonary Hypertension Registry. Bayer: University of California, San Diego.
  • The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study. Actelion Pharmaceuticals, Ltd. AC-065A308.
  • A study of the efficacy and safety of Bardoxolone Methyl in patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension. Reata Pharmaceuticals, Inc. 402-C-1504.
  • An extended access program to assess long-term safety of Bardoxolone Methyl in patients with pulmonary arterial hypertension. Reata Pharmaceuticals, Inc. 402-C-1504.
  • Registry: Uptravi (Selexipag) – the Users Drug Registry. Actelion Pharmaceuticals, Ltd.
  • A multi-center, double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of macitentan in subjects with heart failure with preserved ejection fraction and pulmonary vascular disease. Actelion Pharmaceuticals, Ltd.
  • A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal. Bayer.
  • A phase 3 open-label, multi-center study to evaluate the long-term safety and tolerability of inhaled LIQ861 (Tresprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) patients. Liquidia.
  • A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension. Phase Bio. PB1046PTCL004.
  • Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects with Pulmonary Arterial Hypertension (PAH). Complexa.
  • A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. Actelion.
  • Retrospective Evaluation of Pulmonary Arterial Hypertension (PAH) Patients: Real World Experience from the Trio Health Network. Trio.
  • A study evaluating the efficacy and safety of RalinEpag to improve treatment outcomes in PAH patients. United Therapeutics.
  • A Phase 2a, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of RVT-1201 over placebo in patients with pulmonary arterial hypertension. Altavant.
  • A 16-Week, Multicenter, Open-label Study of Remodulin Induction Followed by Orenitram Optimization in Subjects with Pulmonary Arterial Hypertension. United Therapeutics.

Ramsey Hachem, MD:

  • Extracorporeal Photopheresis for the Management of Progressive Brochiolitis Obliterans Syndrome in Medicare-Eligible Recipients of Lung Allografts. Therakos, Inc. Despotis.
  • A phase III, prospective, multicenter, randomized, controlled clinical trial to demonstrate the effectiveness and safety of liposomal cyclosporine A (L-CsA) inhalation solution delivered via the PARI investigational eFlow device plus standard of care versus standard of care alone in the treatment of bronchiolitis obliterans syndrome in patients post double lung transplantation. BT-L-CsA-302-DLT.
  • A phase III, prospective, multicenter, randomized, controlled clinical trial to demonstrate the effectiveness and safety of liposomal cyclosporine A (L-CsA) inhalation solution delivered via the PARI investigational eFlow device plus standard of care versus standard of care alone in the treatment of bronchiolitis obliterans syndrome in patients post single lung transplantation. BT-L-CsA-302-SLT.

Daniel Rosenbluth, MD:

  • A Phase 2, Randomized, Double-Blind, Controlled Study to Evaluate the Safety of VX-152 Combination Therapy in Adults with Cystic Fibrosis. Vertex. 946253.
  • A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects with Cystic Fibrosis who are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)/VX17-659-102. Vertex. 946817.
  • VX17-659-103: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects with Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F). 2018. Vertex. 946850.
  • VX17-659-105: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation. 2018. Vertex. 946910.
  • A phase 2, randomized, doubleblind, placebo-controlled study to evaluate the safety, and efficacy of spi-1005 in cystic fibrosis patients with acute pulmonary exacerbation receiving iv tobramycin at risk for ototoxicity. Sound Pharmaceuticals, Inc. 947195.
  • Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older with Cystic Fibrosis. Vertex. 947188.

Tonya Russell, MD:

  • Chronic Fibrosing Interstitial Lung Disease with Progressive Phenotype Prospective Outcomes (ILD-PRO) Registry. Boehringer-Ingelheim.
  • A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Idiopathic Pulmonary Fibrosis (IPF). Boehringer-Ingelheim FIBRONEER-IPF 1305-0014.
  • A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). Boehringer-Ingelheim FIBRONEER-ILD 1305-0023.
  • A randomized, double-blind, placebo-controlled, phase 3 study of the efficacy and safety of inhaled treporstinil in subjects with idiopathic pulmonary fibrosis.Tonya Russell, MD. United Therapeutics TETON RIN-PF-301.

Adrian Shifren, MD:

  • Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma (PAS2). Boston Scientific. 201104349.
  • Efficacy and Safety of Beta-adrenoceptor Inverse Agonist, Nadolol in Mild Asthma. Invion. 201210088.
  • An Open-Label Extension study of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease. United Therapeutics. 201704035.
  • A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease. United Therapeutics. 201704034.
  • A Study to Estimate the Effect Sizes of HRCT Endpoints in Response to Glucocorticoid Induction Therapy in Subjects With Pulmonary Sarcoidosis. Celgene. 201805147.

Cajal Sumino, MD:

  • A Multi-Center, randomized, double-blind, parallel group, placebo-controlled, Phase 3b Study to Evaluate the efficacy of Benralizumab 30 mg sc in patients with severe asthma uncontrolled on standard care treatment. AstraZeneca ANDHI. 946623.
  • A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma (NAVIGATOR). AstraZeneca Navigator. 947047.
  • A multicenter, open-label, phase 3b efficacy and safety study of benralizumab 30 mg administered subcutaneously to reduce oral corticosteriod use in adult patients with severe eosinophilic asthma on high-dose inhaled corticosteriod plus long-acting b2 agonist and chronic oral corticosteriod therapy. AstraZeneca Ponente. 947258.
  • A multi-center, proof-of-mechanism study of multiple, oral doses of fevipiprant (QAW039) in COPD patients with eosinophilia. Novartis. QAW039E12201.
  • A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients with Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with Type 2 inflammation. Sanofi COPD.
  • A phase 2b, randomized, double-blind, dose-ranging, multi-center study to evaluate the efficacy and safety of GB001 as maintenance therapy in a moderate to severe eosinophilic asthma population. Gossamer GB001-2001.
  • A multi-center, randomized, double-blind, placebo controlled, parallel group study to investigate the effect of treatment with benralizumab on features of airway remodeling, airway physiology and airway inflammation in adult subjects with severe eosinophilic asthma. AstraZeneca-Chinook.
  • A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients with Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with Type 2 inflammation. Knopp Biosciences. KNS760704AS201.

Roger D. Yusen, MD, MPH:

  • Extracoporeal Photopheresis for the Management of Progressive Bronchiolitis Obliterans Syndrome in Medicare-Eligible Recipients of Lung Allografts (ECP Registry). Contract CMS Identifier. CAG-00324R2.