About the study
Disease target: Progressive pulmonary fibrosis (PPF) or idiopathic pulmonary fibrosis (IPF)
Recruitment target: The total number of subjects is dependent on the number of subjects is dependent on the number of subjects who choose to roll over from each lead-in study and are eligible for AP-LTE-008.
Duration: Subjects will begin dosing on Day 1 (screening/baseline visit) of the study and may continue with treatment until the Avalyn nebulised antifibrotic medication from their lead-in study is approved for marketing authorisation and is commercially available in the county/region of the subject’s residence, the investigator deems treatment should discontinue, the subject meets withdrawal criteria, or until the study is terminated.
Study Locations
NSW
- Westmead Hospital
- Nepean Lung and Sleep
- Royal Prince Alfred Hospital
- Macquarie University Clinical Trials Unit
QLD
- The Prince Charles Hospital
- Lung Research Queensland
VIC
- Alfred Hospital
- Lung and Sleep Victoria
SA
- The Queen Elizabeth Hospital
- Respiratory Clinical Trials
ACT
- Canberra Hospital
WA
- Institute for Respiratory Health
New Zealand
- Christchurch Hospital
- Dunedin Hospital
- Bay of Plenty Clinical Trials Unit
- Waikato Hospital
What is involved?
Study AP-LTE-008 is a multinational, multicentre, open-label, long-term extension study to evaluate the long-term safety, tolerability, and efficacy of Avalyn nebulized antifibrotic medications, including AP01 (pirfenidone inhalation solution), in addition to standard of care in subjects who previously participated in an Avalyn lead-in study and if eligible to do so, choose to continue dosing of study drug for their condition (progressive pulmonary fibrosis [PPF] or idiopathic pulmonary fibrosis [IPF]).
Subjects are eligible if they have completed the protocol-required final visit of the Treatment Period while on the full dose of study drug (either active or placebo) in the lead-in study.
The study visits will be a continuation from the lead-in study, with the first study visit of AP-LTE-008 on the same day as the last study visit of the lead-in study. The study will consist of a Screening/Baseline Visit (Day 1), an open-label Treatment Period, and a Follow-up/End of Study (EOS) phone call.
Investigational medicinal product, comparator and randomisation
AP01 100 mg (two 4 mL blow-fill-seal [BFS] ampoules of 12.5 mg/mL pirfenidone) will be administered two times a day (BID) via the eFlow nebulizer (inhaled).
Can I participate?
Inclusion Criteria
- Provide written informed consent per the Institutional Review Board/Ethics Committee (IRB/EC).
- Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either IPF or PPF and with the approval of the Investigator. Previous participation is defined as: Having completed the final visit of the Treatment Period on the full dose of study drug (either active or placebo).
Exclusion Criteria
- Have not previously participated in an Avalyn-sponsored inhaled antifibrotic lead-in study or if the subject was permanently discontinued from the lead-in study for any reason. Subjects who discontinued study drug but continued to attend study visits are ineligible.
- Subjects who experienced an exacerbation of asthma or of chronic obstructive pulmonary disease (COPD) requiring oral or systemic corticosteroids within 3 months of Day 1 (Screening/Baseline Visit).
- Subjects who experienced an acute exacerbation of IPF or of PPF within 3 months of Day 1 (Screening/Baseline Visit).
- Any conditions or abnormalities (including electrocardiogram [ECG] or laboratory abnormalities) which, in the opinion of the Investigator may compromise the safety of the subject or interfere with the subject participating in or completing the study.
- SAIL Study Trial Summary SAIL-Avalyn-20Jul25-1.pdf
For further information or if you would like to take part in this research study, please complete our Patient Trial Enquiry Form or email enquiries@pactnetwork.com.au.
This study is sponsored by Avalyn Pharma.
ClinicalTrials.gov: NCT06951217.