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 (drug), Placebo (other)
- How long the study runs
- Study runs about 38 months (dates as stated)
- About the drug or intervention
- AP01 — drug: Oral inhalation solution · Placebo — other: Placebo oral inhalation solution
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 375
- Started
- 2024-04-03
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for pulmonary fibrosis
- • Phase2 - 375 participants
- • A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with pulmonary fibrosis
Where?
- • Cottingham - Hull University Teaching Hospital NHS Trust
- • Birmingham - Birmingham Heartlands Hospital
- • Glenfield - Leicester Biomedical Research Centre - Respiratory Theme
- • London - St George's University Hospitals NHS Foundation Trust
- • +11 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.
More detail
This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 (pirfenidone solution for inhalation) versus placebo on top of standard of care in participants with PPF over 52 weeks. Up to 300 eligible participants will be randomized to 1 of 3 treatment arms: AP01 high dose, AP01 low dose, or placebo.
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
Treatment history
Treatments you must have had:
- ✓ been on nintedanib for at least 6 months
What the study is looking for
- ✓Participant meets criteria for PPF, as follows:
- ✓In subjects with interstitial lung disease (ILD) of known or unknown etiology other than idiopathic lung...
- ✓Physiological evidence of disease progression with at least 1 of the following criteria despite treatment with...
- ✓Relative decline in FVC ≥10% predicted within the previous 24 months based on documented historical spirometry...
- ✓Relative decline in FVC ≥5% to \<10% predicted within the previous 24 months based on documented historical...
Who cannot take part
- ✗Current treatment with oral pirfenidone or treatment with oral pirfenidone within 3 months prior to Screening.
- ✗Elevated liver enzymes and liver injury at Screening defined as:
- ✗Alanine aminotransferase (liver enzymes) or aspartate aminotransferase (liver enzymes) ˃ 3 times the upper limit of normal (ULN)
- ✗liver blood test \>2.0 x ULN
- ✗kidney disease with a creatinine clearance \< 30 mL/min, calculated according to the Chronic Kidney Disease...
See the full criteria
Where Is This Study? (15 UK sites)
Hull University Teaching Hospital NHS Trust
Cottingham HU16 5JQ, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903Birmingham Heartlands Hospital
Birmingham B95SS, United Kingdom
Leicester Biomedical Research Centre - Respiratory Theme
Glenfield LE3 9QP, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351St George's University Hospitals NHS Foundation Trust
London sw17 0QT, United Kingdom
ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme
Birmingham B15 2GW, United Kingdom
C-TRIC Altnagelvin Hospital
Londonderry BT46, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford OX3 7LE, United Kingdom
Royal Devon
Exeter EX2 5DW, United Kingdom
The Royal Wolverhampton NHS Trust, New Cross Hospital, Research and Development
Wolverhampton WV10 0QP, United Kingdom
St James University Hospital - LTHT
Leeds LS9 7TF, United Kingdom
Royal Papworth Hospital
Cambridge CB2 0BB, United Kingdom
Royal Brompton Hospital
London SW3 6HP, United Kingdom
Manchester University NHS Foundation Trust
Manchester M23 9LT, United Kingdom
Nottingham University NHS Trust
Nottingham NG5 1PB, United Kingdom
University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital
Stoke-on-Trent ST4 6QG, United Kingdom
