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

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
[email protected]
[email protected]

Register for Trial
Implementation and Interpretation of Spirometry
Belgrade, MT | Dec 05, 2024
Freedom From Smoking Clinic
Manchester, CT | Jan 06, 2025