Pulmonary Diseases, Critical Care, & Environmental Medicine

Pirfenidone Trial

• PIPF-016 - This is a Phase 3, randomized, double-blind, placebo-controlled, efficacy and safety study of pirfenidone in patients with IPF.
• Approximately 500 patients will be randomized with equal probability to receive pirfenidone 2403 mg/d or placebo for 52 weeks.
• Eligible patients aged 40-80 years (inclusive) must have a confident clinical and radiographic diagnosis of IPF according to pre-specified criteria.  Patients will be required to have a %FVC ≥50% and ≤90% and percent predicted cardon monoxide diffusing capacity (%Dlco) ≥30% and ≤90%. 
  
• Open to Enrollment

Panther-IPF

• This three-arm, randomized, placebo-controlled trial tests N-acetylcysteine monotherapy versus a combination of prednisone, azathioprine, and N-acetylcysteine versus placebo  (1:1:1 randomization) in patients with IPF. The results of this trial will likely provide results that could alter the standard approach to therapy of IPF patients while definitively addressing an intense, ongoing controversy regarding the role of combined immunomodulatory therapy in IPF.
• Inclusion criteria are FVC greater than or equal to 50% predicted, DLCO greater than or equal to 30% predicted, and HRCT changes consistent with IPF or a lung biopsy consistent with UIP.
• 390 patients to be recruited, age 35 – 85 years.
• Endpoints include change in FVC measurements over 60 weeks.
• Open to Enrollment

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