Progressive Pulmonary Fibrosis study: AP01
Official title An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
ClinicalTrials.gov ID: NCT06951217
What this study is testing
What is AP01?
An investigational inhaled pirfenidone solution being studied as a potential treatment for progressive pulmonary fibrosis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether staying on the inhaled antifibrotic medicine is safe and how well it works for progressive lung fibrosis.
- Who it's for
- You may be able to join if you finished a previous Avalyn inhaled antifibrotic study and have progressive pulmonary fibrosis.
- What's involved
- You will keep using the inhaled medicine at home and go to the clinic for check‑ups. Everyone knows they are getting the real medicine.
- Time commitment
- The study runs until the final visit, with a clinic visit on the same day as your last dose and later follow‑up visits.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for people with either idiopathic pulmonary fibrosis (IPF) (IPF...
- Male people and female people of childbearing potential (FOCBP) agree to use highly effective contraception measures from the time of first dose of...
You likely can't join if
- Have not previously participated in an Avalyn-sponsored inhaled antifibrotic lead-in study or if the subject was permanently discontinued from the...
- people who experienced an exacerbation of asthma or of chronic obstructive pulmonary disease (COPD) requiring oral or systemic corticosteroids within...
- people who experienced an acute exacerbation of IPF (IPF people are excluded from the US and Canada) or of PPF within 3 months of Day 1...
- Participation in a concurrent clinical study or in a clinical study in which any other investigational drug product aside from the Avalyn nebulized...
- History of hypersensitivity and/or allergic reaction to pirfenidone or the excipients to be used in this study.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Aurora, Colorado, United States
- Farmington, Connecticut, United States
- New Haven, Connecticut, United States
- Ocala, Florida, United States
- Atlanta, Georgia, United States
- Kansas City, Kansas, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- Hannibal, Missouri, United States
- New York, New York, United States
- Statesville, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Cincinnati, Ohio, United States
- Bend, Oregon, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
+ 54 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Los Angeles, California, United States; Newport Beach, California, United States; Aurora, Colorado, United States; Farmington, Connecticut, United States; New Haven, Connecticut, United States and 68 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.