๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-26

An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL) (NCT06951217)

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])

๐ŸŸข Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Avalyn Pharma Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Alabama at Birmingham โ€” Birmingham, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (72 Sites)

Showing the first 25 of 72 sites.

  • University of Alabama at Birmingham โ€” Birmingham, Alabama
  • University of Southern California โ€” Los Angeles, California
  • University of Colorado, Anschutz Medical Campus โ€” Aurora, Colorado
  • Renstar Medical Research โ€” Ocala, Florida
  • Piedmont Healthcare, Inc. โ€” Atlanta, Georgia
  • The University of Kansas Medical Center โ€” Kansas City, Kansas
  • University of Maryland โ€” Baltimore, Maryland
  • Johns Hopkins Asthma and Allergy Center โ€” Baltimore, Maryland
  • Mayo Clinic Rochester โ€” Rochester, Minnesota
  • Hannibal Regional Healthcare System, Inc. โ€” Hannibal, Missouri
  • Icahn School of Medicine at Mount Sinai โ€” New York, New York
  • Columbia University โ€” New York, New York
  • Piedmont HealthCare, PA โ€” Statesville, North Carolina
  • Southeastern Research Center โ€” Winston-Salem, North Carolina
  • University of Cincinnati โ€” Cincinnati, Ohio
  • Summit Health โ€” Bend, Oregon
  • Thomas Jefferson University โ€” Philadelphia, Pennsylvania
  • Temple University Hospital โ€” Philadelphia, Pennsylvania
  • Lowcountry Lung and Critical Care, PA โ€” Charleston, South Carolina
  • Medical University of South Carolina โ€” Charleston, South Carolina
  • Vanderbilt University Medical Center โ€” Nashville, Tennessee
  • El Paso Pulmonary Association, P.A. โ€” El Paso, Texas
  • Baylor College of Medicine โ€” Houston, Texas
  • Intermountain Medical Center โ€” Murray, Utah
  • University of Utah โ€” Salt Lake City, Utah

๐Ÿ“ž Contact the Study Coordinator

Phone: +44 7999 885973

Email: fwoodhead@avalynpharma.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—