Study Name:
MIST: A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Participants With Progressive Pulmonary Fibrosis
Targeted Disease(s):
Pulmonary Fibrosis
Purpose of Study:
This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 versus placebo on top of standard of care in participants with PPF over 52 weeks. Up to 300 eligible participants will be randomized to 1 of 3 treatment arms: AP01 high dose, AP01 low dose, or placebo.
Study Dates:
March 1, 2024 - December 31, 2026
Type of Study:
Pre-Market
Study Design:
Controlled Design
Study Location:
Nationwide
Lead Institution:
Avalyn Pharma
Contact:
Craig Conoscenti
cconoscenti@avalynpharma.com
MISTPPFStudy@avalynpharma.com
