Pulmonary, Critical Care - Clinical Trials

The Tulane Pulmonary Section is offering several clinical trials, registries and support groups available for patient participation. Currently there are trials open to enrollment for patients with idiopathic pulmonary fibrosis, cystic fibrosis, scleroderma, rheumatoid lung, and pulmonary hypertension due to interstitial lung disease. Some of the trials that are open for enrollment are listed below. Should you need additional information please contact: 

Cystic Fibrosis Trials

  • A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects with Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF) VX20-121-102 PI: Ross Klingsberg M.D. (Enrollment Closed).
  • A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects with Cystic Fibrosis Who Are Homozygous for F508del or Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation. PI: Ross Klingsberg M.D. VX20-121-103 (Enrollment Closed).
  • A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy in Subjects with Cystic Fibrosis. PI: Ross Klingsberg M.D.
  • MAYFLOWERS (Maternal and Fetal Outcomes in the Era of Modulators) is a prospective, observational, multicenter clinical trial focusing on the health outcomes of pregnant women with CF and infants born to mothers with CF during pregnancy and two years after delivery. PI: Christine Bojanowski, M.D.

Idiopathic Pulmonary Fibrosis Trials

  • A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of GKT137831 in Patients with Idiopathic Pulmonary Fibrosis. PI: Joseph Lasky, M.D.
  • A Phase 2 Multicenter, Randomized, Double-blind, Placebo controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TTI-101 in Participants with Idiopathic Pulmonary Fibrosis. PI: Joseph Lasky, M.D.
  • A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis. PI: Joseph Lasky, M.D.
  • A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis. PI: Joseph Lasky, M.D.
  • An Open-label Extension Study of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis. PI: Joseph Lasky, M.D.
  • 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). PI: Joseph Lasky, M.D. (Enrollment Closed).
  • Boehringer Ingelheim:  Analysis of Peptide Slicing Variants as a Biomarker for Progression of Pulmonary Fibrosis. PI: Joseph Lasky, M.D.   
  • Prospective treatment efficacy IPF using genotype for Nac selection (Precisions) trial. PI: Joseph Lasky M.D.  
  • Boehringer Ingelheim:  IPF-PRO/ILD-PRO, Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry and Chronic Fibrosing Interstitial Lung Disease with Progressive Phenotype Prospective Outcomes (ILD-PRO) Registry.  PI:Joseph Lasky M.D.

Progressive Fibrosing Interstitial Lung Diseases

  • 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-ILD) PI: Joseph Lasky, M.D.
  • A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Progressive Pulmonary Fibrosis (TETON-PPF) PI: Joseph Lasky, M.D.

Asthma Trials

  • The CHRONICLE Study:  A Longitudinal Prospective Observational Study of the Characteristics, Treatment Patterns and health Outcomes of Individuals with Severe Asthma in the United States.  PI: Nereida Parada, M.D.
  • A Multicenter, Single-arm, Open-Label, Post-Authorization, Phase 4 Effectiveness and Safety Study of Tezepelumab in Adult and Adolescent Participants with Severe Asthma including Several Under-Studies Populations in the United States (PASSAGE). PI: Nereida Parada, M.D.

Chronic Obstructive Pulmonary Disease

  • A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPD PI: Ramsy Abdelghani, M.D.

Inpatient Pneumonia Trial

  • Study Title: Arrest Respiratory Failure due to Pneumonia (ARREST PNEUMONIA). A multi-center, double-blind, phase III randomized clinical trial to establish the efficacy of early treatment with an inhaled corticosteroid combined with a beta-agonist vs. placebo for the prevention of ARF in hospitalized participants with pneumonia and hypoxia. PI: Joshua Denson M.D. 

Global Health

  • Sex differences in chronic lung disease and cardiovascular disease in Kenyan adults with HIV (Zifodya - PI)
  • Clinical and biologic risk factors for post-tuberculosis lung disease (PTLD) in people with and without HIV (Zifodya – PI)
  • Implementation of a post-tuberculosis screening clinic (Zifodya – Co-I)