A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmo… (NCT06329401) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
United States, Argentina, Australia375 participantsStarted 2024-04-03
Plain-language summary
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 participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Relative decline in FVC ≥10% predicted within the previous 24 months based on documented historical spirometry assessments
. Relative decline in FVC ≥5% to \<10% predicted within the previous 24 months based on documented historical spirometry assessments with at least 1 of the 2 following criteria:
. Worsening of respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) AND radiological (HRCT) evidence of disease progression per a local or central radiologist
Exclusion criteria
. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ˃ 3 times the upper limit of normal (ULN)
. Bilirubin \>2.0 x ULN
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 2, which means it's still in relatively early testing — what does that mean for how much we'd know about AP01's safety and long-term effects compared to treatments I might already be eligible for?
2The trial is listed as 'active, not recruiting,' which suggests they've stopped enrolling new participants — does this mean this specific trial is no longer an option for me, and are there similar trials studying inhaled treatments for progressive pulmonary fibrosis that I could still join?
3AP01 is inhaled rather than taken as a pill, like some existing antifibrotic drugs — how might that difference in delivery affect my daily routine, and is that something worth factoring into my treatment decisions?
4Since this trial covers several different underlying causes of pulmonary fibrosis, including conditions like rheumatoid arthritis and systemic sclerosis, does my specific diagnosis make me a better or worse fit for what this study is trying to learn?
5Given that this is a placebo-controlled trial where I might receive a lower dose, a higher dose, or no active drug at all, how would we monitor whether my lung function is holding stable or declining during the study period, and what would happen if things got worse?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the effect of AP01 high dose twice a day (BID) or AP01 low dose twice a day (BID) compared to placebo twice a day (BID)