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New inhaled therapy aims to slow lung scarring in progressive fibrosis

NCT ID NCT06329401

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

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).

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 375 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant meets criteria for PPF, as follows: * 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: * Current treatment with oral pirfenidone or treatment with oral pirfenidone within 3 months prior to Screening. * 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.

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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

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

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549, 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

    Beaverton, Oregon, 97008, 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

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