At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- AP01 (combination product)
- How long the study runs
- Study runs about 80 months (dates as stated)
- About the drug or intervention
- AP01 — combination product: AP01 will be administered open-label via the eFlow Nebulizer System
- Patient visit burden
- "Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day." (as stated by sponsor)
In plain English
This extension study, run by Avalyn Pharma Inc., is for people who took part in an earlier Avalyn study of an inhaled antifibrotic medicine for progressive pulmonary fibrosis (PPF) or idiopathic pulmonary fibrosis (IPF). It lets them keep receiving the study medicine after finishing the treatment period of their previous study. Note that people with IPF are excluded in the United States and Canada.
Who can take part
- You finished the final visit of the treatment period of a previous Avalyn study of an inhaled antifibrotic medicine, at the full dose (either the real medicine or a placebo), and the study doctor agrees you can take part.
- Men, and women who could become pregnant, must use highly effective contraception from the first dose (for men) or from signing the consent form (for women), during the study, and for 90 days after the last dose. You must also agree not to donate eggs or sperm during this time.
Who may not be able to
- You did not take part in a previous Avalyn inhaled antifibrotic study, or you were permanently stopped from that study for any reason. If you stopped the study medicine but kept going to visits, you cannot take part.
- You had an asthma or chronic obstructive pulmonary disease (COPD) flare-up needing steroid tablets or injections in the 3 months before the first study day.
- You had a sudden worsening of IPF or PPF in the 3 months before the first study day.
- You took part in another clinical study, or received a different investigational medicine, in the past 30 days or within 5 half-lives of that medicine (whichever is shorter). Taking part in registries is allowed.
- You have had a bad allergic reaction to pirfenidone or to any of the other ingredients used in this study.
What taking part involves
- • Continuing an inhaled (nebulised) antifibrotic study medicine from your previous Avalyn study.
- • Using highly effective contraception during the study and for 90 days after the last dose, if this applies to you.
Time commitment: Number of visits and study length are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 340
- Started
- 2025-04-17
- Last checked
- 2026-02
Plain English Summary
What is this study?
- • Testing a new treatment for progressive pulmonary fibrosis
- • Phase2 - 340 participants
- • This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with progressive pulmonary fibrosis
Where?
- • Cottingham - Hull University Teaching Hospital
- • Oxford - Oxford University Hospitals NHS Foundation Trust
- • Birmingham - ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme
- • Cambridge - Royal Papworth Hospital NHS Foundation Trust
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01. Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day.
More detail
All participants will receive 100 mg inhaled pirfenidone inhalation solution (AP01) taken twice daily using the eFlow Nebulizer System. The study will consist of a Screening/Baseline Visit, an open-label Treatment Period, and a Follow-up/End of Study (EOS) phone call. During the open-label Treatment Period, subjects will receive study drug (AP01 from their lead-in study). Subjects will complete an EOS follow-up phone call approximately 2 weeks after their last dose of study drug. A paper dosing diary will be used to monitor adherence along with returns of any unused investigational product.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Previous participation is defined as: Having completed the final visit of the Treatment Period on the full dose of...
Who cannot take part
- ✗Subjects who experienced an exacerbation of asthma or of chronic obstructive lung disease (COPD) requiring oral...
- ✗Subjects who experienced an acute exacerbation of IPF (IPF subjects are excluded from the US and Canada) or of PPF...
- ✗History of hypersensitivity and/or allergic reaction to pirfenidone or the excipients to be used in this study.
See the full criteria
Where Is This Study? (6 UK sites)
Hull University Teaching Hospital
Cottingham HU16 5JQ, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford OX3 7LE, United Kingdom
ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme
Birmingham B15 2GW, United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Cambridge CB2 0AY, United Kingdom
Leicester Biomedical Research Centre
Leicester, United Kingdom
St. George's University Hospitals NHS Foundation Trust
London SW17 0RE, United Kingdom
How to Get in Touch
Dr. Felix Woodhead, MB BChir,PhD
Sponsor contactCONTACT
