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Clinical Trials


Carbon Monoxide Trial

  • A randomized, double blind, placebo-controlled, multi-center trial of inhaled carbon monoxide (CO) for the treatment of Idiopathic Pulmonary Fibrosis (IPF).  Subjects will be randomized to treatment with inhaled CO 100-200 parts per million (ppm) for two hours twice weekly for three months, or to placebo administration of inhaled 21% oxygen for two hours twice weekly for three months.
  • Approximately 6o subjects will be enrolled. Eligible subjects aged 18 to 85 must have a confident diagnosis of Idiopathic Pulmonary Fibrosis and meet protocol specific criteria. Trial participation is approximately 52 weeks.

Rainier Trial

  • 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
  • Approximately 500 subjects will be randomized at about 180 sites to receive GS-6624 or placebo. Eligible subjects aged 45 to 85 must have a confident clinical and radiographic diagnosis of idiopathic pulmonary fibrosis and meet protocol specific criteria. Trial participation will last approximately three and a half years.

BMS-986020 Trial

  • 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
  • Approximately 300 subjects will be enrolled to receive BMS-986020 once daily, twice daily or placebo. Eligible patients aged 40-80 years (inclusive) must have a confident clinical and radiographic diagnosis of IPF according to pre-specified criteria. Study participation will last approximately 34 weeks.

Pirfenidone Trial

  • A phase 3 randomized double blind placebo controlled efficacy and safety study of pirfenidone in patients with idiopathic pulmonary fibrosis.
  • Approximately 500 subjects will be randomized with equal probability to receive pirfenidone or placebo for approximately 52 weeks. Eligible patients aged 40-80 years (inclusive) must have a confident clinical and radiographic diagnosis of IPF according to pre-specified criteria. (Closed to enrollment)

Open Label Pirfenidone

  • An Open Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. To enter this trial subjects must have participated in one of the blinded pirfenidone trials.

Panther Trial

  • This is a randomized double blind placebo controlled trial to assess the safety and efficacy of NAC in subjects with idiopathic pulmonary fibrosis. (Closed to enrollment)

Chronic Obstructive Pulmonary Disease (COPD) Trial

  • A Phase 4, randomized, placebo-controlled, double-blind, parallel group, multi-center study to assess the safety and efficacy of tiotropium bromide    (18 μg) delivered via the HandiHaler® in Chronic Obstructive Pulmonary Disease(COPD) subjects recovering from hospitalization for an acute exacerbation.
  • Approximately 604 subjects, with a confident diagnosis of COPD will be enrolled to receive Tiotropium bromide (Spiriva®) inhalation capsules (18 mcg once daily) or placebo inhaled via the HandiHaler®. Eligible subjects must be current or ex-    smokers, at least 40 years old, recently hospitalized for COPD and meet protocol specific criteria. Trial participation will last approximately 1 to 2 years.

Cystic Fibrosis Trial

  • A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis(CF) Who Have the R117H-CFTR Mutation.
  • Approximately 40 to 80 subjects will be enrolled to receive Ivacaftor (Kalydeco) or placebo. Eligible subjects must be 6 years of age or older with a confident diagnosis of Cystic Fibrosis (CF), at least 1 allele of the R117H-CFTR mutation and meet protocol specific criteria. Trial participation will last about 8 months.

Cystic Fibrosis (Roll Over) Trial

  • A Phase 3, two-arm, rollover study to evaluate the safety of long-term ivacaftor treatment in subjects 6 years of age and older with cystic fibrosis and a non-G551D CFTR mutation.
  • Approximately 60 to 120 subjects will be enrolled into the Ivacaftor or Observational Arm. The study population will include subjects who participated in the previous qualifying study of Ivacaftor (VX11-770-110) and meet specific protocol criteria. Trial participation will last about 2 years.


For further information contact: Sandy Ditta @ (504) 988-4040 or email: sditta@tulane.edu

 

1430 Tulane Ave, New Orleans, LA 70112 504-988-5263 medsch@tulane.edu