A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06329401
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 375 participants
Conditions and interventions
Conditions
- Pulmonary Fibrosis
- Progressive Pulmonary Fibrosis
- Pulmonary Fibrosis Secondary to Systemic Sclerosis
- Pulmonary Fibrosis, Interstitial Lung Disease
- Interstitial Lung Disease
- Interstitial Lung Disease Due to Connective Tissue Disease (Disorder)
- Interstitial Lung Disease in Patients With Rheumatoid Arthritis
- Interstitial Lung Disease With Progressive Fibrotic Phenotype in Diseases Classified Elsewhere
- Hypersensitivity Pneumonitis
- Interstitial Lung Disease With Systemic Sclerosis
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
- Jul 1, 2026
2024 – 2027
United States locations
- U.S. sites
- 61
- U.S. states
- 25
- U.S. cities
- 49
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35205 | — |
| Mayo Clinic- Scottsdale | Scottsdale | Arizona | 85259 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Cedars-Sinai | Los Angeles | California | 90048 | — |
| UCLA | Los Angeles | California | 90095 | — |
| Newport Native MD, Inc. | Newport Beach | California | 92663 | — |
| Paradigm Clinical Research - Redding | Redding | California | 96001 | — |
| University of California - San Francisco | San Francisco | California | 94143 | — |
| University of Colorado, Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| UCONN Health | Farmington | Connecticut | 06030 | — |
| Yale University | New Haven | Connecticut | 06519 | — |
| Clinical Site Partners, LCC | Leesburg | Florida | 34748 | — |
| Renstar Medical Research | Ocala | Florida | 34470 | — |
| Clinical Site Partners | Winter Park | Florida | 32789 | — |
| Piedmont Healthcare, Inc. | Atlanta | Georgia | 30309 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Endeavor Health | Evanston | Illinois | 60201 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Johns Hopkins University | Baltimore | Maryland | 21224 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | — |
| Hannibal Regional Healthcare System | Hannibal | Missouri | 63401 | — |
| Northern Westchester Hospital | Mount Kisco | New York | 10549 | — |
| Northwell Health - Mount Kisco | Mount Kisco | New York | 10549 | — |
| NYU Langone Health | New York | New York | 10017 | — |
| Weill Cornell | New York | New York | 10021 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Columbia University | New York | New York | 10032 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| Piedmont HealthCare, PA | Statesville | North Carolina | 28625 | — |
| Accellacare | Wilmington | North Carolina | 28401 | — |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| The Oregon Clinic Pulmonary West | Beaverton | Oregon | 97008 | — |
| Summit Health | Bend | Oregon | 97701 | — |
| The Oregon Clinic Pulmonary East | Portland | Oregon | 97220 | — |
| The Oregon Clinic Pulmonary West | Portland | Oregon | 97225 | — |
| The Pennsylvania State University | Hershey | Pennsylvania | 17033 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Temple University | Philadelphia | Pennsylvania | 19140 | — |
| Lowcountry Lung and Critical Care | Charleston | South Carolina | 29406 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Clinical Trials Center of Middle Tennessee | Franklin | Tennessee | 37067 | — |
| Vanderbilt Lung Institute | Nashville | Tennessee | 37204 | — |
| Baylor Scott & White Research Institute, Baylor University Medical Center | Dallas | Texas | 75246 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| El Paso Pulmonary Association | El Paso | Texas | 79902 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| The University of Texas Health Science Center | Houston | Texas | 77030 | — |
| Metroplex Pulmonary and Sleep Center, PA | McKinney | Texas | 75069 | — |
| Intermountain Medical Center | Murray | Utah | 84157 | — |
| University of Utah Health | Salt Lake City | Utah | 84108 | — |
| Inova Healthcare | Falls Church | Virginia | 22042 | — |
| University of Washington | Seattle | Washington | 98195 | — |
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 Jul 1, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06329401 live on ClinicalTrials.gov.