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New inhaled therapy aims to slow lung scarring in IPF

NCT ID NCT07194382

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 11, 2026 · Updated 2 times

Summary

This study tests an inhaled version of the drug nintedanib (called AP02) in people with idiopathic pulmonary fibrosis (IPF), a disease that scars the lungs and makes breathing hard. About 160 adults aged 40 and older who are not currently on IPF treatment will take either a low or high dose of AP02 or a placebo twice daily for 12 weeks using a nebulizer. The goal is to see if AP02 improves lung function and is safe and well-tolerated.

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 160 people

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

Started

Mar 2026

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

40 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: * Male or female patients aged ≥40 years at the time of signing the written informed consent form * Diagnosis of idiopathic pulmonary fibrosis (IPF) as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/ Asociación Latinoamericana de Tórax IPF guidelines within 5 years * Combination of High-Resolution Computerized Tomography (HRCT) pattern, and if available, surgical lung biopsy pattern consistent with diagnosis of IPF * In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation * Forced vital capacity (FVC) ≥45% predicted of normal * Lung diffusion test (DLCO) corrected for hemoglobin (Hgb) ≥30% and ≤80% predicted of normal. * Women and men of childbearing potential must use highly effective contraception measures until 90 days after the last dose of study drug. Exclusion Criteria: * Current treatment with oral nintedanib, oral pirfenidone, or previous treatment with oral nintedanib or oral pirfenidone within 3 months prior to screening. Participants who have taken both oral nintedanib and pirfenidone together as a treatment will not be able to join the study. * Forced expiratory volume (FEV) in the first second/FVC (FEV1/FVC) ratio ≥0.7 based on pre-bronchodilator value * Participants with a history of serious cardiovascular disease, bleeding problems or significant liver or kidney disease (as defined in the study protocol) * History of diverticular disease or abdominal surgery within 4 weeks prior to screening visit * History of cancer within the past 5 years (except for certain types explained in the protocol) * Participants who have smoked within the past 3 months prior to screening, who are not willing to stop smoking during the study, or who currently use illegal drugs or drugs of abuse * Female participants who are pregnant or nursing * Use of any investigational drugs including those for IPF within the past 30 days prior to screening Further inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis

As listed by the trial registrant

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

Idiopathic pulmonary fibrosis (IPF)

How to take part

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

  1. The places running it

    24 sites in 6 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

  • CIC Mauricie

    RECRUITING

    Trois-Rivières, Quebec, G8T 7A1, Canada

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    RECRUITING

    Montreal, Quebec, Canada

  • Centre for Lung Health - Vancouver General Hospital

    RECRUITING

    Vancouver, British Columbia, Canada

  • Christchurch Hospital

    RECRUITING

    Christchurch, Cantebury, New Zealand

  • Dynamic Drug Advancement

    RECRUITING

    Ajax, Ontario, L1S2J5, Canada

  • Greenlane Clinical Centre

    RECRUITING

    Auckland, New Zealand

  • Hospital Clínic de Barcelona

    RECRUITING

    Barcelona, Spain

  • Hospital General de Granollers, Barcelona

    RECRUITING

    Granollers, Barcelona, Spain

  • Hospital Germans Trias i Pujol/Hospital Can Ruti

    RECRUITING

    Badalona, Barcelona, Spain

  • Hospital HM Sanchinarro

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Marqués de Valdecilla

    RECRUITING

    Santander, Cantabria, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, Spain

  • Hull University Hospitals NHS Trust

    RECRUITING

    Cottingham, East Riding of Yorkshire, United Kingdom

  • Leicester Biomedical Research Centre

    RECRUITING

    Leicester, Leicestershire, United Kingdom

  • Ludwig Engel Centre for Respiratory Research

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Nepean Lung and Sleep

    RECRUITING

    Kingswood, New South Wales, 2747, Australia

  • Newfoundland and Labrador Health Services

    RECRUITING

    St. John's, Newfoundland and Labrador, Canada

  • Pneumologisches Studienzentrum München-West

    RECRUITING

    Munich, Bavaria, Germany

  • Queen Elizabeth

    RECRUITING

    Halifax, Nova Scotia, Canada

  • Royal Devon University Hospital

    RECRUITING

    Exeter, Devon, United Kingdom

  • Royal Prince Alfred Hospital

    RECRUITING

    Camperdown, New South Wales, Australia

  • Studienzentrum Dr. Keller

    RECRUITING

    Frankfurt am Main, Hesse, Germany

  • University Hospitals Birmingham NHS Foundation Trust

    RECRUITING

    Birmingham, West Midlands, United Kingdom

  • Waikato Hospital

    RECRUITING

    Hamilton, Waikato Region, New Zealand

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