New Placebo-Controlled Study of Inhaled Pirfenidone in Progressive Pulmonary Fibrosis

We have recently commenced a new study sponsored by Avalyn Pharma and led at Nottingham University Hospitals by Dr Sy Giin Chong.

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)

What is the purpose of this research?

This is a research study to test AP01. AP01 is not approved by the Medicines and Healthcare Regulatory Agency (MHRA) in the UK and therefore, it can only be used in research studies such as this one.

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 may slow your PPF symptoms. You will inhale the study drug using the eFlow Nebuliser System.

The active component of the study drug (pirfenidone) is approved as treatment for certain types of Interstitial Lung Disease (ILD) when it is given as a capsule or tablet for oral use, but in this study, it is investigational because it will be given as a solution for inhalation, which is a new form of administration for this drug, that you will inhale using the eFlow Nebulizer System.

To date, the Sponsor has completed 2 clinical studies and has one other ongoing study of AP01 besides this one. The other ongoing study is closed for enrolment. In total, there have been 30 healthy volunteers and 156 patients who have taken AP01 (128 patients with IPF and 28 patients with PPF). Some participants have been on the study drug as long as 63 months at the time of this Participant Information Sheet version.

The purpose of this study is to see how safe and effective multiple doses of AP01 compared with placebo (a study treatment containing no active ingredients), over 52 weeks in patients with PPF. During the study, AP01 will be added to your current PPF treatment regimen.

The study will also look at how the study drug behaves inside the body and how it leaves the body. This is called the pharmacokinetics (PK) of the study drug. For this reason, blood samples will be collected to measure study drug within your body.

Approximately 300 participants will participate in this study at approximately 125 study site(s).