New inhaled treatment aims to halt deadly lung scarring

NCT ID NCT06329401

Summary

This study is testing whether an inhaled version of a medication called pirfenidone (AP01) can slow the progression of progressive pulmonary fibrosis (PPF), a serious lung scarring disease. About 375 participants will be randomly assigned to receive either a high dose, a low dose, or a placebo (inactive substance) for 52 weeks, in addition to their standard care. The main goal is to see if the inhaled treatment can better preserve lung function, measured by breathing tests, compared to the placebo.

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes NO responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • A.O.U. Policlinico G. Rodolico

    RECRUITING

    Catania, Sicily, 95123, Italy

  • A.O.U. delle Marche - Ospedale di Torrette

    RECRUITING

    Torrette, Ancona, 60126, Italy

  • APHP - Hopital Bicetre

    RECRUITING

    Le Kremlin-Bicêtre, 94270, France

  • Accellacare

    RECRUITING

    Wilmington, North Carolina, 28401, United States

  • Alfred Health

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • AppleTreeClinics Network

    RECRUITING

    Lodz, Łódź Voivodeship, 90-349, Poland

  • Azienda Ospedaliera dei Colli - Ospedale Monaldi

    RECRUITING

    Naples, Campania, 80131, Italy

  • Azienda Sanitaria Universitaria Giuliano Isontina

    RECRUITING

    Venezia, Giulia, 34149, Italy

  • Bay of Plenty Clinical School

    RECRUITING

    Tauranga, South Tauranga, 3112, New Zealand

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Baylor Scott & White Research Institute, Baylor University Medical Center

    RECRUITING

    Dallas, Texas, 75246, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Birmingham Heartlands Hospital

    RECRUITING

    Birmingham, Heartlands, B95SS, United Kingdom

  • C-TRIC Altnagelvin Hospital

    RECRUITING

    Londonderry, Northern Ireland, BT46, United Kingdom

  • CHU Angers

    RECRUITING

    Angers, 49933, France

  • CHU Tours

    RECRUITING

    Tours, Indre et Loire, 37000, France

  • CHU de Liège

    RECRUITING

    Liège, 4000, Belgium

  • CHU de Rennes

    RECRUITING

    Rennes, Cedex NA, 35033, France

  • CIC Mauricie

    RECRUITING

    Trois-Rivières, Quebec, G8T7A1, Canada

  • CIMER Centro Integral de Medicina Respiratoria

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • CINME

    RECRUITING

    Buenos Aires, Buenos Aires, C1056AB, Argentina

  • Canberra Hospital

    RECRUITING

    Canberra, 2605, Australia

  • Cedars-Sinai

    RECRUITING

    Los Angeles, California, 90048, United States

  • Centro Respiratorio Quilmes

    RECRUITING

    Quilmes, Buenos Aires, B1878, Argentina

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinica Monte Grande

    RECRUITING

    Monte Grande, Buenos Aires, 1842, Argentina

  • Clinical Site Partners

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Clinical Site Partners, LCC

    RECRUITING

    Leesburg, Florida, 34748, United States

  • Clinical Trials Center of Middle Tennessee

    RECRUITING

    Franklin, Tennessee, 37067, United States

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Cukurova University Medical Faculty

    RECRUITING

    Adana, 01240, Turkey (Türkiye)

  • Department of Pneumology of the University Hospital No 1

    RECRUITING

    Lodz, 90-153, Poland

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Dunedin Hospital

    RECRUITING

    Dunedin, Dunedine, 9016, New Zealand

  • Dynamic Drug Advancement

    RECRUITING

    Ajax, Ontario, L1S2J5, Canada

  • Ege University Medical Faculty Hospital

    RECRUITING

    Bornova, İzmir, 35100, Turkey (Türkiye)

  • El Paso Pulmonary Association

    RECRUITING

    El Paso, Texas, 79902, United States

  • Endeavor Health

    RECRUITING

    Evanston, Illinois, 60201, United States

  • Erasmus University Medical Center

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia

    RECRUITING

    Pavia, Lombardy, 27100, Italy

  • Fundacion Respirar

    RECRUITING

    Buenos Aires, Buenos Aires, 1427, Argentina

  • Greenlane Clinical Centre

    RECRUITING

    Auckland, Auckland, 1051, New Zealand

  • HUMANITAS Research Hospital

    RECRUITING

    Rozzano, Milano, 20089, Italy

  • Hannibal Regional Healthcare System

    RECRUITING

    Hannibal, Missouri, 63401, United States

  • Health New Zealand

    RECRUITING

    Christchurch, Canterbury, 8011, New Zealand

  • Health Sciences University, Gulhane Faculty of Medicine

    RECRUITING

    Ankara, 06010, Turkey (Türkiye)

  • Hospital Gregorio Marañon

    RECRUITING

    Madrid, Madrid, 28007, Spain

  • Hospital Italiano de Buenos Aires

    RECRUITING

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1199ABH, Argentina

  • Hospital Universitario Central de Asturias

    RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Marqués de Valdecilla

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Puerta del Mar - Leon-Jimenez

    RECRUITING

    Cadiz, 11009, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, Málaga, 29010, Spain

  • Hospital Universitario Virgen de las Nieves

    RECRUITING

    Granada, Andalusia, 18014, Spain

  • Hospital Universitario Virgen del Rocío

    RECRUITING

    Seville, Sevilla, 41013, Spain

  • Hospital Universitary de Bellvitge

    RECRUITING

    Barcelona, 08908, Spain

  • Hospital de Sant Pau y la Santa Creu

    RECRUITING

    Barcelona, Barcelona, 08025, Spain

  • Hull University Teaching Hospital NHS Trust

    RECRUITING

    Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

  • Hôpital Haut-Lévêque

    RECRUITING

    Pessac, 33604, France

  • Hôpital Paris St Jozeph

    RECRUITING

    Paris, 75014, France

  • ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme

    RECRUITING

    Birmingham, Midlands, B15 2GW, United Kingdom

  • IRCCS AOU di Bologna - Policlinico Sant' Orsola

    RECRUITING

    Bologna, Emilia-Romagna, 40138, Italy

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Inova Healthcare

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval

    RECRUITING

    Québec, Quebec, G1V4G5, Canada

  • Institute for Respiratory Health

    RECRUITING

    Nedlands, Perth West Australia, 6009, Australia

  • Instituto Ave Pulmo, Fundacion Enfisema

    RECRUITING

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Instituto de Medicina Respiratoria

    RECRUITING

    Córdoba, Córdoba Province, 5003, Argentina

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84157, United States

  • Investigaciones En Patologias Respiratorias

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • John Hunter Hospital

    RECRUITING

    New Lambton, New South Wales, 2305, Australia

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • Leicester Biomedical Research Centre - Respiratory Theme

    RECRUITING

    Glenfield, Leicester, LE3 9QP, United Kingdom

  • Louis Pradel Hospital

    RECRUITING

    Lyon, Lyon, 69677, France

  • Lowcountry Lung and Critical Care

    RECRUITING

    Charleston, South Carolina, 29406, United States

  • Loyola University Medical Center

    RECRUITING

    Maywood, Illinois, 60153, United States

  • Lung Research Victoria

    RECRUITING

    Footscray, Victoria, 3011, Australia

  • Macquarie University Clinical Trials Unit

    RECRUITING

    Sydney, New South Wales, 2109, Australia

  • Manchester University NHS Foundation Trust

    RECRUITING

    Manchester, M23 9LT, United Kingdom

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic- Scottsdale

    RECRUITING

    Scottsdale, Arizona, 85259, United States

    Contact Phone: •••-•••-••••

    Contact

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, Lower Saxony, 30625, Germany

  • Metroplex Pulmonary and Sleep Center, PA

    RECRUITING

    McKinney, Texas, 75069, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Muenchen Klinik Bogenhausen - Klinik für Pneumologie und Pneumologische Onkologie

    RECRUITING

    München, Bavaria, 81925, Germany

  • NYU Langone Health

    RECRUITING

    New York, New York, 10017, United States

  • National Jewish Health

    RECRUITING

    Denver, Colorado, 80206, United States

  • Nepean Lung & Sleep

    RECRUITING

    Kingswood, New South Wales, 2745, Australia

  • Newport Native MD, Inc.

    RECRUITING

    Newport Beach, California, 92663, United States

  • Northwell Health - Mount Kisco

    RECRUITING

    Mount Kisco, New York, 10549, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Nottingham University NHS Trust

    RECRUITING

    Nottingham, NG5 1PB, United Kingdom

  • Ospedale San Giuseppe

    RECRUITING

    Milan, Milano, 20123, Italy

  • Oxford University Hospitals NHS Foundation Trust

    RECRUITING

    Oxford, Oxon, OX3 7LE, United Kingdom

  • PRYWATNY GABINET LEKARSKI GINEKOLOGIA I POŁOZNICTWO ULTRASONOGRAFIA Prof. Dr hab. Med. Jacek Suzin

    RECRUITING

    Lodz, 90-602, Poland

  • Paradigm Clinical Research - Redding

    RECRUITING

    Redding, California, 96001, United States

  • Piedmont HealthCare, PA

    RECRUITING

    Statesville, North Carolina, 28625, United States

  • Piedmont Healthcare, Inc.

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Pneumologisches Studienzentrum München-West

    RECRUITING

    Munich, Bavaria, 81241, Germany

  • Renstar Medical Research

    RECRUITING

    Ocala, Florida, 34470, United States

  • Research Institute McGill University Health Center

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • RoMed Klinikum Rosenheim

    RECRUITING

    Rosenheim, Bavaria, 83022, Germany

  • Robert Schuman Hospital UNEOS

    RECRUITING

    Metz, Lorraine, 57000, France

  • Royal Brompton Hospital

    RECRUITING

    London, SW3 6HP, United Kingdom

  • Royal Devon

    RECRUITING

    Exeter, South West, EX2 5DW, United Kingdom

  • Royal Papworth Hospital

    RECRUITING

    Cambridge, CB2 0BB, United Kingdom

  • Royal Prince Alfred Hospital

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Ruhrlandklinik Essen, Klinik fuer Pneumologie

    RECRUITING

    Essen, North Rhine-Westphalia, 45239, Germany

  • Southeastern Research Center

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • St Antoniusziekenhuis

    RECRUITING

    Nieuwegein, Utrecht, 3435, Netherlands

  • St George's University Hospitals NHS Foundation Trust

    RECRUITING

    London, London, sw17 0QT, United Kingdom

  • St James University Hospital - LTHT

    RECRUITING

    Leeds, West Yorkshire, LS9 7TF, United Kingdom

  • St. Joseph's Healthcare Hamilton

    RECRUITING

    Hamilton, Ontario, L8N 4A6, Canada

  • Studienzentrum Dr. Claus Keller

    RECRUITING

    Frankfurt, Main Hessia, 60389, Germany

  • Summit Health

    RECRUITING

    Bend, Oregon, 97701, United States

  • Temple University

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • The Oregon Clinic Pulmonary East

    RECRUITING

    Portland, Oregon, 97220, United States

  • The Oregon Clinic Pulmonary West

    RECRUITING

    Portland, Oregon, 97225, United States

  • The Pennsylvania State University

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • The Royal Wolverhampton NHS Trust, New Cross Hospital, Research and Development

    RECRUITING

    Wolverhampton, West Midlands, WV10 0QP, United Kingdom

  • The University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • The University of Texas Health Science Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UCLA

    RECRUITING

    Los Angeles, California, 90095, United States

  • UCONN Health

    RECRUITING

    Farmington, Connecticut, 06030, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

    Contact Phone: •••-•••-••••

    Contact

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Uniklinikum Leipzig Medizinische Klinik II - Bereich

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • University Hospital in Krakow

    RECRUITING

    Krakow, Krakow, 30-688, Poland

  • University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital

    RECRUITING

    Stoke-on-Trent, ST4 6QG, United Kingdom

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35205, United States

  • University of California - San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

    Contact Phone: •••-•••-••••

    Contact

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Colorado, Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Maryland

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Montpellier

    RECRUITING

    Montpellier, Montpellier, 34295, France

  • University of Southern California

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Utah Health

    RECRUITING

    Salt Lake City, Utah, 84108, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • Università degli Studi di Napoli Federico II - Ospedale Monaldi

    RECRUITING

    Naples, Campania, 80131, Italy

  • Universitätsmedizin Mainz - Zentrum für Thoraxerkrankungen

    RECRUITING

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Vancouver General Hospital

    RECRUITING

    Vancouver, British Columbia, V5Z1M9, Canada

  • Vanderbilt Lung Institute

    RECRUITING

    Nashville, Tennessee, 37204, United States

  • Vitamed Galaj I Cichomski sp.j.

    RECRUITING

    Bydgoszcz, Bydgoszc, 85-079, Poland

  • Vivantes Klinikum Neukölln - Klinik für Innere Medizin - Pneumologie und Infektiologie

    RECRUITING

    Berlin, State of Berlin, 12351, Germany

  • Wallace Street Specialist Centre/Lung Research QLD Pty Ltd

    RECRUITING

    Brisbane, Queensland, 4032, Australia

  • Weill Cornell

    RECRUITING

    New York, New York, 10021, United States

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06519, United States

Conditions

Explore the condition pages connected to this study.