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New inhaled drug for lung scarring moves to Long-Term safety check

NCT ID NCT06951217

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 3 times

Summary

This study looks at the long-term safety of an inhaled drug (AP01) for people with progressive lung scarring (pulmonary fibrosis). It is for those who already completed an earlier Avalyn Pharma study. About 340 participants will receive the drug and be monitored for side effects like breathing issues or liver problems. The goal is to see if the drug is safe to use over time.

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 340 people

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

Started

Apr 2025

Expected to finish

Dec 2031

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: * Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either idiopathic pulmonary fibrosis (IPF) (IPF subjects are excluded from the US and Canada) or progressive pulmonary fibrosis (PPF) and with the approval of the Study Physician. Previous participation is defined as: Having completed the final visit of the Treatment Period on the full dose of study drug (either active or placebo). * Male subjects and female subjects of childbearing potential (FOCBP) agree to use highly effective contraception measures from the time of first dose of study drug (for the male subject) or the signing of the informed consent form (ICF) (for the female subject), during the study, and until 90 days after the last dose of study drug. Subjects agree not to donate eggs or sperm during the same period. Exclusion Criteria: * Have not previously participated in an Avalyn-sponsored inhaled antifibrotic lead-in study or if the subject was permanently discontinued from the lead-in study for any reason. Subjects who discontinued study drug but continued to attend study visits are ineligible. * Subjects who experienced an exacerbation of asthma or of chronic obstructive pulmonary disease (COPD) requiring oral or systemic corticosteroids within 3 months of Day 1 (Screening/Baseline Visit). * Subjects who experienced an acute exacerbation of IPF (IPF subjects are excluded from the US and Canada) or of PPF within 3 months of Day 1 (Screening/Baseline Visit). * Participation in a concurrent clinical study or in a clinical study in which any other investigational drug product aside from the Avalyn nebulized antifibrotic medication from their lead-in study was administered within the previous 30 days, or 5 half-lives of the previously administered investigational product, whichever is shorter. Subjects may be enrolled in registries. * History of hypersensitivity and/or allergic reaction to pirfenidone or the excipients to be used in this study.

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis pulmonary fibrosis

As listed by the trial registrant

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

Idiopathic pulmonary fibrosis (IPF) Progressive pulmonary fibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    70 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bay of Plenty Clinical Trials Unit

    RECRUITING

    Tauranga, Tauranga, 3112, New Zealand

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • CIC Mauricie

    RECRUITING

    Trois-Rivières, Quebec, G8T 7A1, Canada

  • CINME

    RECRUITING

    Buenos Aires, C1056ABI, Argentina

  • Centre Hospitalier Universitaire d'Angers

    RECRUITING

    Angers, 49933, France

  • Centre for Lung Health

    RECRUITING

    Vancouver, Vancouver, V5Z1M9, Canada

  • Centro Respiratorio Quilmes

    RECRUITING

    Buenos Aires, B1878, Argentina

  • Christchurch Hospital

    RECRUITING

    Christchurch, Canterbury, 8011, New Zealand

  • Clinica Monte Grande

    RECRUITING

    Buenos Aires, 1842, Argentina

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Department of Pneumology of the University Hospital No 1

    RECRUITING

    Lodz, 90315, Poland

  • Dunedin Hospital

    ACTIVE_NOT_RECRUITING

    Dunedin, 9016, New Zealand

  • Dynamic Drug Advancement

    RECRUITING

    Ajax, Ontario, Canada

  • El Paso Pulmonary Association, P.A.

    RECRUITING

    El Paso, Texas, 79902, United States

  • Fakultni Thomayerove nemocnice

    RECRUITING

    Praha Klanovice, Czechia

  • Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia

    RECRUITING

    Pavia, Lombardy, 27100, Italy

  • Fundación Respirar

    RECRUITING

    Buenos Aires, 1427, Argentina

  • Greenlane Clinical Centre

    RECRUITING

    Auckland, Auckland, New Zealand

  • HUMANITAS Research Hospital

    RECRUITING

    Milan, 20089, Italy

  • Hannibal Regional Healthcare System, Inc.

    RECRUITING

    Hannibal, Missouri, 63401, United States

  • Hospital Gregorio Marañon

    RECRUITING

    Madrid, Madrid, Spain

  • Hospital Italiano de Buenos Aires

    RECRUITING

    Buenos Aires, C1199ABH, Argentina

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitario Virgen de las Nieves

    RECRUITING

    Granada, Andalusia, 18014, Spain

  • Hull University Teaching Hospital

    RECRUITING

    Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

  • ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme

    RECRUITING

    Birmingham, West Midlands, B15 2GW, United Kingdom

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Inova Healthcare

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Instituto Ave Pulmo, Fundacion Enfisema

    RECRUITING

    Buenos Aires, 7600, Argentina

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • Investigaciones En Patologias Respiratorias

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, T4000IAP, Argentina

  • John Hunter Hospital

    RECRUITING

    New Lambton Heights, Australia

  • Johns Hopkins Asthma and Allergy Center

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • Leicester Biomedical Research Centre

    RECRUITING

    Leicester, United Kingdom

  • Lowcountry Lung and Critical Care, PA

    RECRUITING

    Charleston, South Carolina, 29406, United States

  • Lung & Sleep Victoria

    RECRUITING

    Footscray, Australia

  • Macquarie University Clinical Trials Unit

    RECRUITING

    Macquarie Park, New South Wales, 2113, Australia

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55901, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, Lower Saxony, 30625, Germany

  • Nepean Lung & Sleep

    RECRUITING

    Kingston, Australia

  • Ospedale San Giuseppe/ MultiMedica SPA

    RECRUITING

    Milan, 20123, Italy

  • Piedmont HealthCare, PA

    RECRUITING

    Statesville, North Carolina, 28625, United States

  • Piedmont Healthcare, Inc.

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Renstar Medical Research

    RECRUITING

    Ocala, Florida, 34470, United States

  • Research Institute McGill University Health Center

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Respiratory Clinical Trials PTY Ltd

    RECRUITING

    Kent Town, Australia

  • Royal Papworth Hospital NHS Foundation Trust

    RECRUITING

    Cambridge, CB2 0AY, United Kingdom

  • Royal Prince Alfred Hospital

    RECRUITING

    Camperdown, Australia

  • Southeastern Research Center

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • St Antonius Hospital

    RECRUITING

    Nieuwegein, Netherlands

  • St. George's University Hospitals NHS Foundation Trust

    RECRUITING

    London, SW17 0RE, United Kingdom

  • Studienzentrum Dr. Claus Keller

    RECRUITING

    Frankfurt, 60389, Germany

  • Summit Health

    RECRUITING

    Bend, Oregon, 97701, United States

  • Temple University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • The Prince Charles Hospital (TPCH)

    RECRUITING

    Chermside, Australia

  • The Queen Elizabeth Hospital

    ACTIVE_NOT_RECRUITING

    Woodville South, South Australia, 5011, Australia

  • The University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Univ of Western Australia / Institute for Respiratory Health

    RECRUITING

    Nedlands, Australia

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35205, United States

  • 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 Montpellier

    RECRUITING

    Montrevel-en-Bresse, Montpellier, 34090, France

  • University of Southern California

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84108, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, 80211, Poland

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37204, United States

  • Waikato Hospital

    RECRUITING

    Hamilton, New Zealand

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia

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