Prednisone, Azathioprine, and N-Acetylcysteine: A study That Evaluates Responses in Idiopathic Pulmonary Fibrosis (PANTHER-IPF)
The study is a randomized, double-blind, placebo-controlled trial designed to assess the safety and efficacy of NAC as mono-therapy vs. placebo in subjects with mild or moderate IPF. Approximately 260 subjects who have mild to moderate IPF (diagnosed within the past 48 months will be enrolled. The study will employ a single-arm design with 1:1 randomization to NAC or placebo. Subjects will receive treatment for up to a maximum of 60 weeks, followed by a 4-week period for safety evaluation. The primary endpoint is the change in longitudinal forced vital capacity measurements over 60 weeks.
* Age 35 to 85 years, inclusive
* Forced vital capacity (FVC) greater than or equal to 50% of predicted value
* Diffusion capacity (DLCO) greater than or equal to 30% of predicted value
* Ability to unerstand and provide informed consent
* Diagnosis of IPF by modified American Thoracic Society (ATS) criteria in the 48 months before study entry