A Placebo-Controlled Study of Inhaled Pirfenidone in PPF
Research type
Research Study
Full 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)
IRAS ID
1009856
Contact name
Howard Lazarus
Sponsor organisation
Avalyn Pharma Inc.
Eudract number
2023-508429-29
Clinicaltrials.gov Identifier
Research summary
This is a phase 2b research study to evaluate the safety and efficacy of Pirfenidone solution for inhalation (AP01) in participants with Progressive Pulmonary Fibrosis (PPF).
Pulmonary fibrosis is a serious, lifelong lung disease. It causes lung scarring (tissues scar and thicken over time), making it harder to breathe. Symptoms may come on quickly or take years to develop.
AP01is an experimental drug that may slow PPF symptoms and participants will inhale the study drug using the eFlow® nebuliser.The active component of the investigational drug (pirfenidone) is approved as treatment for certain types of Interstitial Lung Disease (ILD) when it is given as a capsule for oral use, but in this study, it is investigational because it will be given as a solution for inhalation.
The purpose of this study is to see how safe and effective multiple doses of AP01 compared with placebo (a dummy treatment), over 52 weeks in participants with PPF. During the study, AP01 will be added to participants current PPF treatment regimen.
The study will also look at how the study drug behaves inside the body and how it leaves the body. For this reason, blood samples will be collected to measure study drug within participants body.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
24/SC/0203
Date of REC Opinion
11 Jul 2024
REC opinion
Further Information Favourable Opinion