🏛️ Verified NIH Record • Updated 2026-07-01
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis (NCT06329401)
A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Participants With PPF
🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Avalyn Pharma Inc.
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (154 Sites)
Showing the first 25 of 154 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- Mayo Clinic- Scottsdale — Scottsdale, Arizona
- University of Southern California — Los Angeles, California
- Cedars-Sinai — Los Angeles, California
- UCLA — Los Angeles, California
- Newport Native MD, Inc. — Newport Beach, California
- Paradigm Clinical Research - Redding — Redding, California
- University of California - San Francisco — San Francisco, California
- University of Colorado, Anschutz Medical Campus — Aurora, Colorado
- National Jewish Health — Denver, Colorado
- UCONN Health — Farmington, Connecticut
- Yale University — New Haven, Connecticut
- Clinical Site Partners, LCC — Leesburg, Florida
- Renstar Medical Research — Ocala, Florida
- Clinical Site Partners — Winter Park, Florida
- Piedmont Healthcare, Inc. — Atlanta, Georgia
- Northwestern University — Chicago, Illinois
- Endeavor Health — Evanston, Illinois
- Loyola University Medical Center — Maywood, Illinois
- The University of Kansas Medical Center — Kansas City, Kansas
- University of Maryland — Baltimore, Maryland
- Johns Hopkins University — Baltimore, Maryland
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- University of Minnesota — Minneapolis, Minnesota
💰 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 § 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.
More studies in Pulmonary Fibrosis
- Analysis of Specimens From Individuals With Pulmonary Fibrosis — Bethesda, Maryland
- Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis (IPF) — Pittsburgh, Pennsylvania
- Assessing the Efficacy of Sirolimus in Patients With COVID-19 Pneumonia for Prevention of Post-COVID Fibrosis — Chicago, Illinois
- Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis — Birmingham, Alabama
- Genetic Polymorphisms in Idiopathic Pulmonary Fibrosis (IPF) — Pittsburgh, Pennsylvania
Explore by condition: All Pulmonary Fibrosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.