New inhaled therapy aims to slow lung scarring in progressive fibrosis

NCT ID NCT06329401

Ongoing Disease control Sponsor: Avalyn Pharma Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an inhaled form of pirfenidone (AP01) in 375 adults with progressive pulmonary fibrosis (PPF), a condition where lung scarring worsens over time. Participants receive either a high dose, low dose, or placebo twice daily for 52 weeks, alongside their usual care. The main goal is to see if AP01 can preserve lung function, measured by forced vital capacity (FVC).

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Conditions

The condition(s) this trial relates to.

hypersensitivity pneumonitis interstitial lung disease pulmonary fibrosis pulmonary systemic sclerosis rheumatoid arthritis-associated interstitial lung disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HYPERSENSITIVITY PNEUMONITIS 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 INTERSTITIAL LUNG DISEASE WITH SYSTEMIC SCLEROSIS PROGRESSIVE PULMONARY FIBROSIS PULMONARY FIBROSIS PULMONARY FIBROSIS SECONDARY TO SYSTEMIC SCLEROSIS PULMONARY FIBROSIS, INTERSTITIAL LUNG DISEASE

Contacts and locations

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Locations

A.O.U. Policlinico G. Rodolico

Catania, Sicily, 95123, Italy
A.O.U. delle Marche - Ospedale di Torrette

Torrette, Ancona, 60126, Italy
APHP - Hopital Bicetre

Le Kremlin-Bicêtre, 94270, France
Accellacare

Wilmington, North Carolina, 28401, United States
Alfred Health

Melbourne, Victoria, 3004, Australia
AppleTreeClinics Network

Lodz, Łódź Voivodeship, 90-349, Poland
Azienda Ospedaliera dei Colli - Ospedale Monaldi

Naples, Campania, 80131, Italy
Azienda Sanitaria Universitaria Giuliano Isontina

Venezia, Giulia, 34149, Italy
Bay of Plenty Clinical School

Tauranga, South Tauranga, 3112, New Zealand
Baylor College of Medicine

Houston, Texas, 77030, United States
Baylor Scott & White Research Institute, Baylor University Medical Center

Dallas, Texas, 75246, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Birmingham Heartlands Hospital

Birmingham, Heartlands, B95SS, United Kingdom
C-TRIC Altnagelvin Hospital

Londonderry, Northern Ireland, BT46, United Kingdom
CHU Angers

Angers, 49933, France
CHU Tours

Tours, Indre et Loire, 37000, France
CHU de Liège

Liège, 4000, Belgium
CHU de Rennes

Rennes, Cedex NA, 35033, France
CIC Mauricie

Trois-Rivières, Quebec, G8T7A1, Canada
CIMER Centro Integral de Medicina Respiratoria

San Miguel de Tucumán, Tucumán Province, 4000, Argentina
CINME

Buenos Aires, Buenos Aires, C1056AB, Argentina
Canberra Hospital

Canberra, 2605, Australia
Cedars-Sinai

Los Angeles, California, 90048, United States
Centro Respiratorio Quilmes

Quilmes, Buenos Aires, B1878, Argentina
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Clinica Monte Grande

Monte Grande, Buenos Aires, 1842, Argentina
Clinical Site Partners

Winter Park, Florida, 32789, United States
Clinical Site Partners, LCC

Leesburg, Florida, 34748, United States
Clinical Trials Center of Middle Tennessee

Franklin, Tennessee, 37067, United States
Columbia University

New York, New York, 10032, United States
Cukurova University Medical Faculty

Adana, 01240, Turkey (Türkiye)
Department of Pneumology of the University Hospital No 1

Lodz, 90-153, Poland
Duke University

Durham, North Carolina, 27710, United States
Dunedin Hospital

Dunedin, Dunedine, 9016, New Zealand
Dynamic Drug Advancement

Ajax, Ontario, L1S2J5, Canada
Ege University Medical Faculty Hospital

Bornova, İzmir, 35100, Turkey (Türkiye)
El Paso Pulmonary Association

El Paso, Texas, 79902, United States
Endeavor Health

Evanston, Illinois, 60201, United States
Erasmus University Medical Center

Rotterdam, 3015 GD, Netherlands
Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia

Pavia, Lombardy, 27100, Italy
Fundacion Respirar

Buenos Aires, Buenos Aires, 1427, Argentina
Greenlane Clinical Centre

Auckland, Auckland, 1051, New Zealand
HUMANITAS Research Hospital

Rozzano, Milano, 20089, Italy
Hannibal Regional Healthcare System

Hannibal, Missouri, 63401, United States
Health New Zealand

Christchurch, Canterbury, 8011, New Zealand
Health Sciences University, Gulhane Faculty of Medicine

Ankara, 06010, Turkey (Türkiye)
Hospital Gregorio Marañon

Madrid, Madrid, 28007, Spain
Hospital Italiano de Buenos Aires

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1199ABH, Argentina
Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain
Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain
Hospital Universitario Puerta del Mar - Leon-Jimenez

Cadiz, 11009, Spain
Hospital Universitario Ramon y Cajal

Madrid, Madrid, 28034, Spain
Hospital Universitario Virgen de la Victoria

Málaga, Málaga, 29010, Spain
Hospital Universitario Virgen de las Nieves

Granada, Andalusia, 18014, Spain
Hospital Universitario Virgen del Rocío

Seville, Sevilla, 41013, Spain
Hospital Universitary de Bellvitge

Barcelona, 08908, Spain
Hospital de Sant Pau y la Santa Creu

Barcelona, Barcelona, 08025, Spain
Hull University Teaching Hospital NHS Trust

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom
Hôpital Haut-Lévêque

Pessac, 33604, France
Hôpital Paris St Jozeph

Paris, 75014, France
ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme

Birmingham, Midlands, B15 2GW, United Kingdom
IRCCS AOU di Bologna - Policlinico Sant' Orsola

Bologna, Emilia-Romagna, 40138, Italy
Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States
Inova Healthcare

Falls Church, Virginia, 22042, United States
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval

Québec, Quebec, G1V4G5, Canada
Institute for Respiratory Health

Nedlands, Perth West Australia, 6009, Australia
Instituto Ave Pulmo, Fundacion Enfisema

Mar del Plata, Buenos Aires, 7600, Argentina
Instituto de Medicina Respiratoria

Córdoba, Córdoba Province, 5003, Argentina
Intermountain Medical Center

Murray, Utah, 84157, United States
Investigaciones En Patologias Respiratorias

San Miguel de Tucumán, Tucumán Province, 4000, Argentina
John Hunter Hospital

New Lambton, New South Wales, 2305, Australia
Johns Hopkins University

Baltimore, Maryland, 21224, United States
Leicester Biomedical Research Centre - Respiratory Theme

Glenfield, Leicester, LE3 9QP, United Kingdom
Louis Pradel Hospital

Lyon, Lyon, 69677, France
Lowcountry Lung and Critical Care

Charleston, South Carolina, 29406, United States
Loyola University Medical Center

Maywood, Illinois, 60153, United States
Lung Research Victoria

Footscray, Victoria, 3011, Australia
Macquarie University Clinical Trials Unit

Sydney, New South Wales, 2109, Australia
Manchester University NHS Foundation Trust

Manchester, M23 9LT, United Kingdom
Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States
Mayo Clinic- Scottsdale

Scottsdale, Arizona, 85259, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany
Metroplex Pulmonary and Sleep Center, PA

McKinney, Texas, 75069, United States
Montefiore Medical Center

The Bronx, New York, 10467, United States
Muenchen Klinik Bogenhausen - Klinik für Pneumologie und Pneumologische Onkologie

München, Bavaria, 81925, Germany
NYU Langone Health

New York, New York, 10017, United States
National Jewish Health

Denver, Colorado, 80206, United States
Nepean Lung & Sleep

Kingswood, New South Wales, 2745, Australia
Newport Native MD, Inc.

Newport Beach, California, 92663, United States
Northwell Health - Mount Kisco

Mount Kisco, New York, 10549, United States
Northwestern University

Chicago, Illinois, 60611, United States
Nottingham University NHS Trust

Nottingham, NG5 1PB, United Kingdom
Ospedale San Giuseppe

Milan, Milano, 20123, Italy
Oxford University Hospitals NHS Foundation Trust

Oxford, Oxon, OX3 7LE, United Kingdom
PRYWATNY GABINET LEKARSKI GINEKOLOGIA I POŁOZNICTWO ULTRASONOGRAFIA Prof. Dr hab. Med. Jacek Suzin

Lodz, 90-602, Poland
Paradigm Clinical Research - Redding

Redding, California, 96001, United States
Piedmont HealthCare, PA

Statesville, North Carolina, 28625, United States
Piedmont Healthcare, Inc.

Atlanta, Georgia, 30309, United States
Pneumologisches Studienzentrum München-West

Munich, Bavaria, 81241, Germany
Renstar Medical Research

Ocala, Florida, 34470, United States
Research Institute McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada
RoMed Klinikum Rosenheim

Rosenheim, Bavaria, 83022, Germany
Robert Schuman Hospital UNEOS

Metz, Lorraine, 57000, France
Royal Brompton Hospital

London, SW3 6HP, United Kingdom
Royal Devon

Exeter, South West, EX2 5DW, United Kingdom
Royal Papworth Hospital

Cambridge, CB2 0BB, United Kingdom
Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia
Ruhrlandklinik Essen, Klinik fuer Pneumologie

Essen, North Rhine-Westphalia, 45239, Germany
Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States
St Antoniusziekenhuis

Nieuwegein, Utrecht, 3435, Netherlands
St George's University Hospitals NHS Foundation Trust

London, London, sw17 0QT, United Kingdom
St James University Hospital - LTHT

Leeds, West Yorkshire, LS9 7TF, United Kingdom
St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada
Studienzentrum Dr. Claus Keller

Frankfurt, Main Hessia, 60389, Germany
Summit Health

Bend, Oregon, 97701, United States
Temple University

Philadelphia, Pennsylvania, 19140, United States
The Oregon Clinic Pulmonary East

Portland, Oregon, 97220, United States
The Oregon Clinic Pulmonary West

Portland, Oregon, 97225, United States
The Pennsylvania State University

Hershey, Pennsylvania, 17033, United States
The Royal Wolverhampton NHS Trust, New Cross Hospital, Research and Development

Wolverhampton, West Midlands, WV10 0QP, United Kingdom
The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States
The University of Texas Health Science Center

Houston, Texas, 77030, United States
Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States
UCLA

Los Angeles, California, 90095, United States
UCONN Health

Farmington, Connecticut, 06030, United States
UT Southwestern Medical Center

Dallas, Texas, 75390, United States
UZ Leuven

Leuven, 3000, Belgium
Uniklinikum Leipzig Medizinische Klinik II - Bereich

Leipzig, Saxony, 04103, Germany
University Hospital in Krakow

Krakow, Krakow, 30-688, Poland
University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital

Stoke-on-Trent, ST4 6QG, United Kingdom
University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States
University of California - San Francisco

San Francisco, California, 94143, United States
University of Cincinnati

Cincinnati, Ohio, 45267, United States
University of Colorado, Anschutz Medical Campus

Aurora, Colorado, 80045, United States
University of Maryland

Baltimore, Maryland, 21201, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of Minnesota

Minneapolis, Minnesota, 55455, United States
University of Montpellier

Montpellier, Montpellier, 34295, France
University of Southern California

Los Angeles, California, 90033, United States
University of Utah Health

Salt Lake City, Utah, 84108, United States
University of Washington

Seattle, Washington, 98195, United States
Università degli Studi di Napoli Federico II - Ospedale Monaldi

Naples, Campania, 80131, Italy
Universitätsmedizin Mainz - Zentrum für Thoraxerkrankungen

Mainz, Rhineland-Palatinate, 55131, Germany
Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada
Vanderbilt Lung Institute

Nashville, Tennessee, 37204, United States
Vitamed Galaj I Cichomski sp.j.

Bydgoszcz, Bydgoszc, 85-079, Poland
Vivantes Klinikum Neukölln - Klinik für Innere Medizin - Pneumologie und Infektiologie

Berlin, State of Berlin, 12351, Germany
Wallace Street Specialist Centre/Lung Research QLD Pty Ltd

Brisbane, Queensland, 4032, Australia
Weill Cornell

New York, New York, 10021, United States
Westmead Hospital

Westmead, New South Wales, 2145, Australia
Yale University

New Haven, Connecticut, 06519, United States