Long-term safety study of inhaled AP01 for lung scarring diseases
Follows people with pulmonary fibrosis who previously took inhaled AP01 in earlier studies.
Plain-language title generated from the registry record
Registry title: An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Key facts
- Where
- Atlanta, Aurora, Baltimore, Bend, Birmingham, Charleston, Cincinnati, El Paso, Falls Church, Farmington, Hannibal, Houston, Kansas City, Los Angeles, Murray, Nashville, New Haven, New York, Newport Beach, Ocala, Philadelphia, Portland, Rochester, Salt Lake City, Seattle, Statesville, and Winston-Salem, United StatesSee the 32 sites
- Phase
- Phase 2
Where in United States
- Piedmont Healthcare, IncAtlanta, United StatesTaking people
- University of Colorado Anschutz Medical CampusAurora, United StatesTaking people
- Johns Hopkins Asthma and Allergy CenterBaltimore, United StatesTaking people
- University of MarylandBaltimore, United StatesTaking people
- Summit HealthBend, United StatesTaking people
- University of Alabama at BirminghamBirmingham, United StatesTaking people
- Lowcountry Lung and Critical Care, PACharleston, United StatesTaking people
- Medical University of South CarolinaCharleston, United StatesTaking people
- University of CincinnatiCincinnati, United StatesTaking people
- El Paso Pulmonary Association, P.A.El Paso, United StatesTaking people
- Inova HealthcareFalls Church, United StatesTaking people
- UConn HealthFarmington, United StatesTaking people
- Hannibal Regional Healthcare System, Inc.Hannibal, United StatesTaking people
- Baylor College of MedicineHouston, United StatesTaking people
- The University of Kansas Medical CenterKansas City, United StatesTaking people
- University of Southern CaliforniaLos Angeles, United StatesTaking people
- Intermountain Medical CenterMurray, United StatesTaking people
- Vanderbilt University Medical CenterNashville, United StatesTaking people
- Yale UniversityNew Haven, United StatesTaking people
- Columbia UniversityNew York, United StatesTaking people
- Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
- Weill CornellNew York, United StatesTaking people
- Newport Native Md, Inc.Newport Beach, United StatesTaking people
- Renstar Medical ResearchOcala, United StatesTaking people
- Temple University HospitalPhiladelphia, United StatesTaking people
- Thomas Jefferson UniversityPhiladelphia, United StatesTaking people
- The Oregon Clinic Pulmonary EastPortland, United StatesTaking people
- Mayo Clinic - RochesterRochester, United StatesTaking people
- University of UtahSalt Lake City, United StatesTaking people
- University of WashingtonSeattle, United StatesTaking people
- Piedmont HealthCare, PAStatesville, United StatesTaking people
- Southeastern Research CenterWinston-Salem, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Avalyn Pharma Inc.
- Trial code
- NCT06951217
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
A Multinational, Long-Term, Safety and Tolerability, Open-Label Extension Study of Subjects Who Have Participated in Avalyn Pharma Studies of Inhaled Antifibrotic Agents (AP-LTE-008 [SAIL])
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.
Inclusion: Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either idiopathic pulmonary fibrosis (IPF) (IPF subjects are excluded from the US and Canada) or progressive pulmonary fibrosis (PPF) and with the approval of the Study Physician; 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); Male subjects and female subjects of childbearing potential (FOCBP) agree to use highly effective contraception measures from the time of first dose of study drug (for the male subject) or the signing of the informed consent form (ICF) (for the female subject), during the study, and until 90 days after the last dose of study drug. Subjects agree not to donate eggs or sperm during the same period.
Exclusion: 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; Participation in a concurrent clinical study or in a clinical study in which any other investigational drug product aside from the Avalyn nebulized antifibrotic medication from their lead-in study was administered within the previous 30 days, or 5 half-lives of the previously administered investigational product, whichever is shorter. Subjects may be enrolled in registries; 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); History of hypersensitivity and/or allergic reaction to pirfenidone or the excipients to be used in this study; Subjects who experienced an acute exacerbation of IPF (IPF subjects are excluded from the US and Canada) or of PPF within 3 months of Day 1 (Screening/Baseline Visit).