progressive pulmonary fibrosis

.The purpose of this research study is to evaluate the safety and efficacy of multiple doses of AP01 compared with placebo, over 52 weeks in patients with PPF. A placebo is a medication with no active ingredients. It looks like the real thing but is not. During the research study, you will continue your current PPF treatment regimen; study drug will be added to your current treatment regimen.

The active component of AP01 is pirfenidone. The Therapeutic Goods Administration (TGA) has approved pirfenidone in capsule and tablet form under the name Ameda, Astron, Esbriet etc for the treatment of idiopathic pulmonary fibrosis (IPF) in Australia. However, pirfenidone in solution for inhalation is not approved by the TGA for the treatment of PPF, therefore its use in this research study is considered experimental. The eFlow® nebulizer device is not approved in Australia by TGA and is considered an investigational device.

Open-label extension study (OLE): If you complete all of your study visits, you may have the option to enrol into a separate open-label extension study (OLE). For that study you would receive AP01 regardless of your treatment during this research study. If you are currently on treatment for PPF, your doctor will let you know if you can continue treatment in order to be in the research study. You will be given a separate participant information sheet and consent form regarding this at the time

To find out if this trial is suitable for you, please register below, or contact our Clinical Trials Team on 6151 0888 or email clinicaltrials@resphealth.uwa.edu.au.

• The trial will run for 52 weeks
• 12 clinic visits at Nedlands, plus one phone visit
• A full health check by our doctors and nurses
• Reimbursement for travel expenses
• Personalised health care with our doctors and nurses