ClinicalTrials.gov record
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
ClinicalTrials.gov ID: NCT06329401
Public ClinicalTrials.gov record NCT06329401. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
ClinicalTrials.gov public records Last synced May 20, 2026, 6:47 AM EDT
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Participants With PPF
Study identification
- NCT ID
- NCT06329401
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Avalyn Pharma Inc.
- Industry
- Enrollment
- 375 participants
Conditions and interventions
Conditions
- Hypersensitivity Pneumonitis
- Interstitial Lung Disease
- Interstitial Lung Disease Due to Connective Tissue Disease (Disorder)
- Interstitial Lung Disease With Progressive Fibrotic Phenotype in Diseases Classified Elsewhere
- Interstitial Lung Disease With Systemic Sclerosis
- Interstitial Lung Disease in Patients With Rheumatoid Arthritis
- Progressive Pulmonary Fibrosis
- Pulmonary Fibrosis
- Pulmonary Fibrosis Secondary to Systemic Sclerosis
- Pulmonary Fibrosis, Interstitial Lung Disease
Interventions
- AP01 Drug
- Placebo Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2, 2024
- Primary completion
- May 31, 2027
- Completion
- May 31, 2027
- Last update posted
- Apr 5, 2026
2024 – 2027
United States locations
- U.S. sites
- 59
- U.S. states
- 25
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35205 | Recruiting |
| Mayo Clinic- Scottsdale | Scottsdale | Arizona | 85259 | Recruiting |
| University of Southern California | Los Angeles | California | 90033 | Recruiting |
| Cedars-Sinai | Los Angeles | California | 90048 | Recruiting |
| UCLA | Los Angeles | California | 90095 | Recruiting |
| Newport Native MD, Inc. | Newport Beach | California | 92663 | Recruiting |
| Paradigm Clinical Research - Redding | Redding | California | 96001 | Recruiting |
| University of California - San Francisco | San Francisco | California | 94143 | Recruiting |
| University of Colorado, Anschutz Medical Campus | Aurora | Colorado | 80045 | Recruiting |
| National Jewish Health | Denver | Colorado | 80206 | Recruiting |
| UCONN Health | Farmington | Connecticut | 06030 | Recruiting |
| Yale University | New Haven | Connecticut | 06519 | Recruiting |
| Clinical Site Partners, LCC | Leesburg | Florida | 34748 | Recruiting |
| Renstar Medical Research | Ocala | Florida | 34470 | Recruiting |
| Clinical Site Partners | Winter Park | Florida | 32789 | Recruiting |
| Piedmont Healthcare, Inc. | Atlanta | Georgia | 30309 | Recruiting |
| Northwestern University | Chicago | Illinois | 60611 | Recruiting |
| Endeavor Health | Evanston | Illinois | 60201 | Recruiting |
| Loyola University Medical Center | Maywood | Illinois | 60153 | Recruiting |
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | Recruiting |
| University of Maryland | Baltimore | Maryland | 21201 | Recruiting |
| Johns Hopkins University | Baltimore | Maryland | 21224 | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Recruiting |
| University of Michigan | Ann Arbor | Michigan | 48109 | Recruiting |
| University of Minnesota | Minneapolis | Minnesota | 55455 | Recruiting |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | Recruiting |
| Hannibal Regional Healthcare System | Hannibal | Missouri | 63401 | Recruiting |
| Northwell Health - Mount Kisco | Mount Kisco | New York | 10549 | Recruiting |
| NYU Langone Health | New York | New York | 10017 | Recruiting |
| Weill Cornell | New York | New York | 10021 | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Recruiting |
| Columbia University | New York | New York | 10032 | Recruiting |
| Montefiore Medical Center | The Bronx | New York | 10467 | Recruiting |
| Duke University | Durham | North Carolina | 27710 | Recruiting |
| Piedmont HealthCare, PA | Statesville | North Carolina | 28625 | Recruiting |
| Accellacare | Wilmington | North Carolina | 28401 | Recruiting |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | Recruiting |
| University of Cincinnati | Cincinnati | Ohio | 45267 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| Summit Health | Bend | Oregon | 97701 | Recruiting |
| The Oregon Clinic Pulmonary East | Portland | Oregon | 97220 | Recruiting |
| The Oregon Clinic Pulmonary West | Portland | Oregon | 97225 | Recruiting |
| The Pennsylvania State University | Hershey | Pennsylvania | 17033 | Recruiting |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | Recruiting |
| Temple University | Philadelphia | Pennsylvania | 19140 | Recruiting |
| Lowcountry Lung and Critical Care | Charleston | South Carolina | 29406 | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Recruiting |
| Clinical Trials Center of Middle Tennessee | Franklin | Tennessee | 37067 | Recruiting |
| Vanderbilt Lung Institute | Nashville | Tennessee | 37204 | Recruiting |
| Baylor Scott & White Research Institute, Baylor University Medical Center | Dallas | Texas | 75246 | Recruiting |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting |
| El Paso Pulmonary Association | El Paso | Texas | 79902 | Recruiting |
| Baylor College of Medicine | Houston | Texas | 77030 | Recruiting |
| The University of Texas Health Science Center | Houston | Texas | 77030 | Recruiting |
| Metroplex Pulmonary and Sleep Center, PA | McKinney | Texas | 75069 | Recruiting |
| Intermountain Medical Center | Murray | Utah | 84157 | Recruiting |
| University of Utah Health | Salt Lake City | Utah | 84108 | Recruiting |
| Inova Healthcare | Falls Church | Virginia | 22042 | Recruiting |
| University of Washington | Seattle | Washington | 98195 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 93 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06329401, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 5, 2026 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06329401 live on ClinicalTrials.gov.