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Clinical Trial Details
A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Subjects with Progressive Pulmonary Fibrosis (PPF)
Clinical Trial ( IRB ) #: U25-159-1
Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Subjects with Progressive Pulmonary Fibrosis (PPF)
Principal Investigator: Dr. Ameer Rasheed
Description: The Sponsor is developing AP01 (also referred to in this document as the “study drug”) for use in the treatment of Progressive Pulmonary Fibrosis. AP01 is an experimental drug that we hypothesize may slow your PPF symptoms. You will inhale the study drug using the eFlow® Nebulizer System. The nebulizer used to deliver AP01 is approved in Europe, but is an investigational device for use in the United States and Canada (not approved by FDA or Health Canada).
Classification:
  Breathing and Lung
Eligibility Criteria: Check with study contact
How to Contact: Nicole Glidden. Telephone: 860-679-8511 or 860-679-4647. Email: DOMClinicalResearch@uchc.edu
Enrollment Status/Comments: Enrolling/recruiting. For current recruitment status, please check with study contact.