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Clinical Trial Summary

A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.


Clinical Trial Description

This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 (pirfenidone solution for inhalation) 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 Design


Related Conditions & MeSH terms


NCT number NCT06329401
Study type Interventional
Source Avalyn Pharma Inc.
Contact Craig S. Conoscenti, MD
Phone 206-707-0304
Email cconoscenti@avalynpharma.com
Status Recruiting
Phase Phase 2
Start date April 3, 2024
Completion date April 2026