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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: 

  • Sandy Ditta, Senior Research Administrator 504‐988‐4040 
  • Christine Glynn, RN/Clinical Research Coordinator 504‐988‐0743 
  • Carol Rockwell, RN/Clinical Research Coordinator 504‐988‐2325
     
COVID-19

  • A Phase 2/3 Study to Evaluate the Safety and Efficacy of Dociparstat Sodium for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure (Lasky - Study PI)
  • ClinSeqSer observational study for COVID19 patients (Denson - Co-I)
  • Denson to be PI for an upcoming clinical trial for COVID19 patients to receive the drug Mavrilinumab, an anti-GM-CSF mAb for COVID19 ARDS (Denson - Site PI)
  • A randomized controlled trial starting that is not related to COVID call STOPTHEBURN, and this will enrolled healthcare workers in the ICU into a study to prevent burnout (Denson - PI)
  • Stress related disorders in family members of COVID-19 patients admitted to the intensive care unit: a multi-site, mixed-methods study (Halvorson - Site PI)
  • Socioeconomic and racial determinates of outcomes in COVID-19 (Zifodya - PI)
Pulmonary Fibrosis

  • (TRAIL) A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease (Lasky – Site PI)
  • GLPG1690-CL-303/304 study as add on therapy for patients with idiopathic pulmonary fibrosis (Lasky - Site PI)
  • SCENIC Trial: Randomized, double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF) (Lasky – Site PI)
  • A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of GKT137831 in Patients with Idiopathic Pulmonary Fibrosis
  • Prospective treatment Efficacy in IPF using genOtype for Nac Selection (PRECISIONS) trial (Lasky- Site PI)
  • Pulmonary Fibrosis Foundation Clinical Care Network (Lasky - Site Director)
  • PF-PRO Registry (Lasky - Site PI)
Scleroderma

  • Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
  • A double-blind, randomized, placebo‐controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SScILD)
Cystic Fibrosis

  • A Phase3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation (Klingsberg – Site PI)
  • Novartis CTBM100C2407: A prospective Observational Study in cystic fibrosis patients with chronic respiratory Pseudomonas aeruginosa infection treated with TOBI® Podhaler™ (tobramycin inhalation powder) or other FDA approved inhaled antipseudomonal antibacterial drugs (Klingsberg – Site PI).
  • Study Title: VX18-121-101: A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis (Klingsberg - Site PI)
  • Study Title: VX17-445-105: A Phase3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508delMutation (Klingsberg - Site PI)
  • Cystic Fibrosis Foundation Patient Registry (Klingsberg - Site PI)
  • Study Title: Simplify-IP-19:  A master protocol to test the impact of discontinuing chronic therapies in people with cystic fibrosis on highly effective CFTR modulator therapy (SIMPLIFY)
  • Klingsberg Cystic Fibrosis Therapeutic Development Network (TDN) (Klingsberg - Site PI)
ICU

  • A Randomized double-blind placebo-controlled multicenter Phase 3 study of efficacy and safety of AR-301 as adjunct therapy to antibiotics in the treatment of Ventilator-Associated Pneumonia (VAP) caused by S. aureus (Halvorson - Site PI)
Myocobacterial Disease

  • Protocol Title: A Phase 3 multicenter randomized double-blind placebo-controlled study to evaluate the efficacy and safety of once daily amikacin liposome inhalation suspension in adults with Mycobacterium abscesses pulmonary disease - Adult CF or Non-CF Subjects – (MAB Study). (Klingsberg - Site PI)
  • Multiple Patient Program for Lamprene (clofazimine) for the treatment of Non-Tuberculous Mycobacterial (NTM) Infections - CLAM320B2002M (Klingsberg - Site PI)
  • Study Title: NTM: Observational Study of Pulmonary Nontuberculous Mycobacterial Disease Investigator Initiated (Klingsberg - Co-PI)
Global Health

  • Sex differences in chronic lung disease and cardiovascular disease in Kenyan adults with HIV (Zifodya - PI)
  • Predicting Risk for Impaired Lung Function, Latent Tuberculosis, and Cardiovascular Disease among HIV-Infected and Uninfected Kenyan Adults (Zifodya - PI)