A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
NCT ID: NCT06329401
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
375 participants
INTERVENTIONAL
2024-04-03
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AP01 High Dose BID
Pirfenidone Solution for Inhalation
AP01
Oral inhalation solution
AP01 Low Dose BID
Pirfenidone Solution for Inhalation
AP01
Oral inhalation solution
Placebo BID
Placebo solution for inhalation
Placebo
Placebo oral inhalation solution
Interventions
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AP01
Oral inhalation solution
Placebo
Placebo oral inhalation solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In subjects with interstitial lung disease (ILD) of known or unknown etiology other than idiopathic pulmonary fibrosis (IPF) who have radiological evidence of pulmonary fibrosis, PPF is defined as:
Physiological evidence of disease progression with at least 1 of the following criteria despite treatment with approved or unapproved medications commonly used in practice (per Investigator):
1. Relative decline in FVC ≥10% predicted within the previous 24 months based on documented historical spirometry assessments
2. Relative decline in FVC ≥5% to \<10% predicted within the previous 24 months based on documented historical spirometry assessments with at least 1 of the 2 following criteria:
* Worsening respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) OR
* Radiological (HRCT) evidence of disease progression per a local or central radiologist (from historical HRCT taken up to 24 months prior to Screening Visit 1), for example:
* Increased extent or severity of traction bronchiectasis and bronchiolectasis
* New ground-glass opacity with traction bronchiectasis
* New fine reticulation
* Increased extent or increased coarseness of reticular abnormality
* New or increased honeycombing
* Increased lobar volume loss
3. Worsening of respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) AND radiological (HRCT) evidence of disease progression per a local or central radiologist
* Meeting all of the following criteria during the Screening Period:
a. FVC ≥45% of predicted normal at Screening Visit 1, b. Forced expiratory volume at 1 second (FEV1)/FVC ≥0.7 or ≥age-adjusted lower limit of normal at Screening Visit 1, c. Diffusing capacity of lung for carbon monoxide (DLCO) ≥30% of predicted, corrected for hemoglobin at Screening Visit 1, d. Acceptability: Participants can perform acceptable spirometry (i.e., meet American Thoracic Society (ATS)/ European Respiratory Society (ERS) acceptability criteria at both Screening Visits).
• For subjects already on nintedanib (up to 30% of subjects): Must have been on nintedanib for at least 6 months prior to Screening with or without dose adjustments and/or drug interruptions during that period. For subjects who have discontinued nintedanib prior to Screening: Must have been off of nintedanib for a minimum of 12 weeks.
Exclusion Criteria
* Elevated liver enzymes and liver injury at Screening defined as:
1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ˃ 3 times the upper limit of normal (ULN)
2. Bilirubin \>2.0 x ULN
* Renal disease with a creatinine clearance \< 30 mL/min, calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula. Retesting is allowed once.
* Diagnosis of idiopathic pulmonary fibrosis (IPF) based on the ATS diagnostic algorithm for IPF. UIP that is not idiopathic, for example related to rheumatoid arthritis (RA), familial interstitial lung disease (ILD), or other is not exclusionary.
* Greater extent of emphysema than of fibrotic ILD on HRCT. Note: CT results must be confirmed through the central over read process.
* Significant clinical worsening of PPF between Screening
* Participants who cannot meet protocol-specified Baseline stability criteria. FVC Baseline stability is defined as the FVC assessments at Visit 3 being within ±12% of the mean of the FVC assessments obtained at the 2 preceding visits. At Visit 3, if the pre-dose FVC is outside of ±12% range, the participant will not be randomized and will be considered a screen failure.
18 Years
ALL
No
Sponsors
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DevPro Biopharma
INDUSTRY
Avalyn Pharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Avalyn Pharma, Inc.
Role: STUDY_DIRECTOR
Avalyn Pharma Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Pulmonary Associates, PA
Phoenix, Arizona, United States
University of Southern California
Los Angeles, California, United States
Cedars-Sinai
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
Newport Native MD, Inc.
Newport Beach, California, United States
Paradigm Clinical Research - Redding
Redding, California, United States
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, United States
UCONN Health
Farmington, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Clinical Site Partners, LCC
Leesburg, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Central Florida Pulmonary Group
Orlando, Florida, United States
SEC Clinical Research
Pensacola, Florida, United States
Clinical Site Partners
Winter Park, Florida, United States
Piedmont Healthcare, Inc.
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Endeavor Health
Evanston, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
University of Maryland
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Hannibal Regional Healthcare System
Hannibal, Missouri, United States
Northwell Health - Mount Kisco
Mount Kisco, New York, United States
NYU Langone Health
New York, New York, United States
Weill Cornell
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University
Durham, North Carolina, United States
Pulmonix
Greensboro, North Carolina, United States
Piedmont HealthCare, PA
Statesville, North Carolina, United States
Accellacare
Wilmington, North Carolina, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Summit Health
Bend, Oregon, United States
The Oregon Clinic Pulmonary East
Portland, Oregon, United States
The Oregon Clinic Pulmonary West
Portland, Oregon, United States
The Pennsylvania State University
Hershey, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Lowcountry Lung and Critical Care
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, United States
Vanderbilt Lung Institute
Nashville, Tennessee, United States
Baylor Scott & White Research Institute, Baylor University Medical Center
Dallas, Texas, United States
El Paso Pulmonary Association
El Paso, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
The University of Texas Health Science Center
Houston, Texas, United States
Metroplex Pulmonary and Sleep Center, PA
McKinney, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Utah Health
Salt Lake City, Utah, United States
Inova Healthcare
Falls Church, Virginia, United States
University of Washington
Seattle, Washington, United States
Fundacion Respirar
Buenos Aires, Buenos Aires, Argentina
CINME
Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto Ave Pulmo, Fundacion Enfisema
Mar del Plata, Buenos Aires, Argentina
Centro Respiratorio Quilmes
Quilmes, Buenos Aires, Argentina
Instituto de Medicina Respiratoria
Córdoba, Córdoba Province, Argentina
CIMER Centro Integral de Medicina Respiratoria
San Miguel de Tucumán, Tucumán Province, Argentina
Investigaciones En Patologias Respiratorias
San Miguel de Tucumán, Tucumán Province, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Nepean Lung & Sleep
Kingswood, New South Wales, Australia
John Hunter Hospital
New Lambton, New South Wales, Australia
Macquarie University Clinical Trials Unit
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Institute for Respiratory Health
Nedlands, Perth West Australia, Australia
Wallace Street Specialist Centre/Lung Research QLD Pty Ltd
Brisbane, Queensland, Australia
Lung Research Victoria
Footscray, Victoria, Australia
Alfred Health
Melbourne, Victoria, Australia
Canberra Hospital
Canberra, , Australia
Vancouver General Hospital
Vancouver, British Columbia, Canada
Dynamic Drug Advancement
Ajax, Ontario, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Research Institute McGill University Health Center
Montreal, Quebec, Canada
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
Québec, Quebec, Canada
CIC Mauricie
Trois-Rivières, Quebec, Canada
CHU de Rennes
Rennes, Cedex NA, France
CHU Tours
Tours, Indre et Loire, France
Robert Schuman Hospital UNEOS
Metz, Lorraine, France
Louis Pradel Hospital
Lyon, Lyon, France
University of Montpellier
Montpellier, Montpellier, France
CHU Angers
Angers, , France
APHP - Hopital Bicetre
Le Kremlin-Bicêtre, , France
Hôpital Paris St Jozeph
Paris, , France
Hôpital Haut-Lévêque
Pessac, , France
Pneumologisches Studienzentrum München-West
Munich, Bavaria, Germany
RoMed Klinikum Rosenheim
Rosenheim, Bavaria, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Studienzentrum Dr. Claus Keller
Frankfurt, Main Hessia, Germany
Ruhrlandklinik Essen, Klinik fuer Pneumologie
Essen, North Rhine-Westphalia, Germany
Universitätsmedizin Mainz - Zentrum für Thoraxerkrankungen
Mainz, Rhineland-Palatinate, Germany
Uniklinikum Leipzig Medizinische Klinik II - Bereich
Leipzig, Saxony, Germany
Vivantes Klinikum Neukölln - Klinik für Innere Medizin - Pneumologie und Infektiologie
Berlin, State of Berlin, Germany
A.O.U. delle Marche - Ospedale di Torrette
Torrette, Ancona, Italy
Azienda Ospedaliera dei Colli - Ospedale Monaldi
Naples, Campania, Italy
Università degli Studi di Napoli Federico II - Ospedale Monaldi
Napoli, Campania, Italy
IRCCS AOU di Bologna - Policlinico Sant' Orsola
Bologna, Emilia-Romagna, Italy
Azienda Sanitaria Universitaria Giuliano Isontina
Venezia, Giulia, Italy
Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia
Pavia, Lombardy, Italy
Ospedale San Giuseppe
Milan, Milano, Italy
HUMANITAS Research Hospital
Rozzano, Milano, Italy
A.O.U. Policlinico G. Rodolico
Catania, Sicily, Italy
Erasmus University Medical Center
Rotterdam, , Netherlands
Greenlane Clinical Centre
Auckland, Auckland, New Zealand
Health New Zealand
Christchurch, Canterbury, New Zealand
Dunedin Hospital
Dunedin, Dunedine, New Zealand
Bay of Plenty Clinical School
Tauranga, South Tauranga, New Zealand
Vitamed Galaj I Cichomski sp.j.
Bydgoszcz, Bydgoszc, Poland
University Hospital in Krakow
Krakow, Krakow, Poland
PRYWATNY GABINET LEKARSKI GINEKOLOGIA I POŁOZNICTWO ULTRASONOGRAFIA Prof. Dr hab. Med. Jacek Suzin
Lodz, , Poland
AppleTreeClinics Network
Lodz, Łódź Voivodeship, Poland
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain
Hospital de Sant Pau y la Santa Creu
Barcelona, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Gregorio Marañon
Madrid, Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Universitario Virgen del Rocío
Seville, Sevilla, Spain
Hospital Universitary de Bellvitge
Barcelona, , Spain
Hospital Universitario Puerta del Mar - Leon-Jimenez
Cadiz, , Spain
Ege University Medical Faculty Hospital
Bornova, İzmir, Turkey (Türkiye)
Cukurova University Medical Faculty
Adana, , Turkey (Türkiye)
Health Sciences University, Gulhane Faculty of Medicine
Ankara, , Turkey (Türkiye)
Hull University Teaching Hospital NHS Trust
Cottingham, East Yorkshire, United Kingdom
Birmingham Heartlands Hospital
Birmingham, Heartlands, United Kingdom
Leicester Biomedical Research Centre - Respiratory Theme
Glenfield, Leicester, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, London, United Kingdom
ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme
Birmingham, Midlands, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxon, United Kingdom
Royal Devon
Exeter, South West, United Kingdom
The Royal Wolverhampton NHS Trust, New Cross Hospital, Research and Development
Wolverhampton, West Midlands, United Kingdom
St James University Hospital - LTHT
Leeds, West Yorkshire, United Kingdom
Royal Papworth Hospital
Cambridge, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Manchester University NHS Foundation Trust
Manchester, , United Kingdom
Nottingham University NHS Trust
Nottingham, , United Kingdom
University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Countries
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Central Contacts
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References
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West A, Chaudhuri N, Barczyk A, Wilsher ML, Hopkins P, Glaspole I, Corte TJ, Sterclova M, Veale A, Jassem E, Wijsenbeek MS, Grainge C, Piotrowski W, Raghu G, Shaffer ML, Nair D, Freeman L, Otto K, Montgomery AB. Inhaled pirfenidone solution (AP01) for IPF: a randomised, open-label, dose-response trial. Thorax. 2023 Sep;78(9):882-889. doi: 10.1136/thorax-2022-219391. Epub 2023 Mar 22.
Related Links
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Other Identifiers
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AP01-007
Identifier Type: -
Identifier Source: org_study_id
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