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.

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

Use of implantable intravascular delivery system (PIVOT) for Treprostinil delivery in patients with Pulmonary Arterial Hypertension.
Murali Chakinala, MD. Medtronics, Inc.

United States Chronic Thromboembolic Pulmonary Hypertension Registry.
Murali Chakinala, MD. 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.
Murali Chakinala, MD. 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.
Murali Chakinala, MD. Reata Pharmaceuticals, Inc. 402-C-1504. 

An extended access program to assess long-term safety of Bardoxolone Methyl in patients with pulmonary arterial hypertension.
Murali Chakinala, MD. Reata Pharmaceuticals, Inc. 402-C-1504. 

Registry: Uptravi (Selexipag) – the Users Drug Registry
Murali Chakinala, MD. 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.
Murali Chakinala, MD. 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.
Murali Chakinala, MD. 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.
Murali Chakinala, MD. 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.
Murali Chakinala, MD. 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).
Murali Chakinala, MD. 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.
Murali Chakinala, MD. Actelion.

Retrospective Evaluation of Pulmonary Arterial Hypertension (PAH) Patients: Real World Experience from the Trio Health Network.
Murali Chakinala, MD. Trio.

A study evaluating the efficacy and safety of RalinEpag to improve treatment outcomes in PAH patients.
Murali Chakinala, MD. 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. 
Murali Chakinala, MD. Altavant.

A 16-Week, Multicenter, Open-label Study of Remodulin Induction Followed by Orenitram Optimization in Subjects with Pulmonary Arterial Hypertension. 
Murali Chakinala, MD. United Therapeutics.

Extracorporeal Photopheresis for the Management of Progressive Brochiolitis Obliterans Syndrome in Medicare-Eligible Recipients of Lung Allografts. 
Ramsey Hachem, MD. 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.
Ramsey Hachem, MD. 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.
Ramsey Hachem, MD. BT-L-CsA-302-SLT.

A Phase 2, Randomized, Double-Blind, Controlled Study to Evaluate the Safety of VX-152 Combination Therapy in Adults with Cystic Fibrosis.
Dan Rosenbluth, MD. 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. 
Dan Rosenbluth, MD. 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. 
Dan Rosenbluth, MD. 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.
Dan Rosenbluth, MD. 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.
Dan Rosenbluth, MD. 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. 
Dan Rosenbluth, MD. Vertex. 947188.

IPF-PRO: Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry.
Tonya Russell, MD. Boehringer-Ingelheim. 

An open-label extension trial to assess the long-term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD).
Tonya Russell, MD. Boehringer-Ingelheim. BI 1199.225. 

Chronic Fibrosing Interstitial Lung Disease with Progressive Phenotype Prospective Outcomes (ILD-PRO) Registry. 
Tonya Russell, MD. Boehringer-Ingelheim.

Isabela: A Phase 3, randomized, double-blind, parallel-group, placebo controlled multicenter study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis. 
Tonya Russell, MD. Galapagos. GLPG1690-CL-303. 

Extracorporeal Photopheresis for the Management of Progressive Brochiolitis Obliterans Syndrome in Medicare-Eligible Recipients of Lung Allografts. 
Adrian Shifren, MD. Therakos, Inc. Despotis.  

Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma (PAS2). 
Adrian Shifren, MD. Boston Scientific. 201104349.  

Efficacy and Safety of Beta-adrenoceptor Inverse Agonist, Nadolol in Mild Asthma. 
Adrian Shifren, MD. Invion. 201210088. 

Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) and Chronic Fibrosing Interstitial Lung Disease With Progressive Phenotype Prospective Outcomes (ILD-PRO) Registry.  
Adrian Shifren, MD. Boehringer Ingelheim. 201704127.

An Open-Label Extension study of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease.  
Adrian Shifren, MD. 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.  
Adrian Shifren, MD. United Therapeutics. 201704034. 

A phase 2b, randomized, double-blind, placebo-controlled dose escalation clinical study to assess the safety and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in subjects with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2). 
Adrian Shifren, MD. Bellerophon. 201805201. 

A Phase II, subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with Idiopathic Pulmonary Fibrosis. 
Adrian Shifren, MD. Novartis. 201806108. 

A Study to Estimate the Effect Sizes of HRCT Endpoints in Response to Glucocorticoid Induction Therapy in Subjects With Pulmonary Sarcoidosis. 
Adrian Shifren, MD. Celgene. 201805147. 

An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD).
Adrian Shifren, MD. Boehringer Ingelheim. 201805189. 

A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects with Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care (ISABELA1). 
Adrian Shifren, MD. Galapagos. 201901105. 

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. 
Cajal Sumino, MD. 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). 
Cajal Sumino, MD. 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. 
Cajal Sumino, MD. AstraZeneca Ponente. 947258. 

A multi-center, proof-of-mechanism study of multiple, oral doses of fevipiprant (QAW039) in COPD patients with eosinophilia. 
Cajal Sumino, MD. 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. 
Cajal Sumino, MD. 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. 
Cajal Sumino, MD. 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.  
Cajal Sumino, MD. 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.   
Cajal Sumino, MD. Knopp Biosciences. KNS760704AS201.

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