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Study on Pirfenidone Inhalation Solution for Patients with Progressive Fibrosing Interstitial Lung Diseases, Including Idiopathic Pulmonary Fibrosis

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a group of lung diseases known as Interstitial Lung Diseases (ILD), which includes a specific condition called Idiopathic Pulmonary Fibrosis (IPF). These diseases cause scarring of the lung tissue, leading to breathing difficulties. The treatment being tested in this study is called Pirfenidone Solution for Inhalation, also known by its code name AP01. This medication is delivered directly to the lungs using a device called a nebulizer, which turns the solution into a mist that can be inhaled.

The purpose of the study is to allow patients to continue or start using AP01 for treating their lung conditions until it receives regulatory approval or the study ends. The study will also monitor the safety of patients while they are on this treatment. Participants in the study may include those who have previously been part of an Avalyn AP01 study or those with no other treatment options for their lung disease. The study aims to provide access to this treatment for patients who cannot use other medications like oral pirfenidone or nintedanib due to various reasons, such as intolerance or lack of availability.

Throughout the study, participants will use the Pirfenidone Solution for Inhalation as directed and will be monitored for any side effects or changes in their condition. The study will continue until the treatment is approved by regulatory authorities or until the study is concluded. The safety of the participants is a key focus, and any adverse events or issues will be carefully tracked and evaluated.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must have been a prior participant in an Avalyn AP01 study or have no other treatment options for interstitial lung diseases (ILDs), including idiopathic pulmonary fibrosis (IPF).

    The patient must be over 18 years old and able to understand and sign a written informed consent form.

  2. Step 2

    Treatment initiation

    The patient will begin treatment with pirfenidone solution for inhalation. This medication is administered through inhalation, which means it is breathed in through the lungs.

    The treatment is intended to continue until regulatory approval is obtained or the study is terminated.

  3. Step 3

    Treatment adherence

    The patient must adhere to the study treatment and protocol, including any restrictions on other medications.

    Females of childbearing potential must use an effective contraceptive method during the study and for 30 days after the last dose of AP01.

  4. Step 4

    Monitoring and evaluation

    The study aims to evaluate the safety outcomes of patients while on AP01 therapy.

    The patient will be monitored for any treatment-emergent adverse events or deaths.

  5. Step 5

    Study duration

    The estimated end date for the study is December 31, 2025.

    The patient will continue treatment until the study concludes or regulatory approval is obtained.

Who can join the trial?

9 criteria

  • Must have participated in a previous Avalyn AP01 study, except if you were a healthy volunteer.
  • If you have no other treatment options for **Interstitial Lung Diseases (ILD)**, including **Idiopathic Pulmonary Fibrosis (IPF)**, you may be eligible. This includes conditions like fibrosing phenotype ILD, lung issues from scleroderma, rheumatoid lung, and silicosis. Approval from the study sponsor is needed if you were in a non-Avalyn study before.
  • Must have a diagnosed **chronic progressive fibrotic ILD**, including IPF, with no other treatment options. This means:
    • You are not eligible for oral medications like pirfenidone and nintedanib due to restrictions or lack of approval.
    • You cannot tolerate oral pirfenidone and nintedanib if you have tried them before.
    • You are not eligible for any other ongoing AP01 clinical study.
    • Must be over 18 years old at the time of screening.
    • Must be able to understand and sign a written informed consent form before joining the study. This form follows international guidelines and local laws.
    • Must understand the importance of following the study treatment and rules, and be willing to comply with all study requirements, including restrictions on other medications during the study.
    • Females who can have children must use an effective birth control method during the study and for 30 days after the last dose of AP01.

Who cannot join the trial?

8 criteria

  • Patients who have a different lung disease that is not part of the study.
  • Patients who are not within the age range specified for the study.
  • Patients who are not able to follow the study procedures or take the study medication.
  • Patients who have a medical condition that the study doctors think might make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial that might interfere with this study.
  • Patients who have a history of allergic reactions to the study medication.
  • Patients who have a serious illness that might affect their ability to participate in the study.
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Investigated drugs

Pirfenidone Solution for Inhalation (AP01) is a medication being studied for its potential to treat progressive, fibrosing interstitial lung diseases, including idiopathic pulmonary fibrosis. This medication is administered through inhalation, allowing it to directly target the lungs. The trial aims to provide patients with access to this therapy and to assess its safety for long-term use.

What is already known about the treatment

Pirfenidone – This medication is administered as a solution for inhalation, allowing it to be directly delivered to the lungs. It is currently being studied in clinical trials for its effectiveness in treating progressive, fibrosing interstitial lung diseases, including idiopathic pulmonary fibrosis. Pirfenidone works by reducing the production of certain proteins and molecules that lead to inflammation and scarring in the lungs. It is classified as an antifibrotic agent, which means it helps to slow down or prevent the formation of fibrous tissue.

Investigated diseases

  • Interstitial Lung Diseases

    Interstitial lung diseases (ILD) are a group of disorders that cause scarring of lung tissue, leading to stiffness and difficulty in breathing. The scarring, known as fibrosis, gradually worsens over time, affecting the ability of the lungs to transfer oxygen into the bloodstream. Symptoms often include a persistent dry cough and shortness of breath, especially during or after physical activity. The progression of ILD can vary significantly among individuals, with some experiencing rapid deterioration while others have a slower course. Environmental factors, such as exposure to certain toxins, and genetic predispositions can contribute to the development of these diseases.

  • Idiopathic Pulmonary Fibrosis

    Idiopathic pulmonary fibrosis (IPF) is a specific type of interstitial lung disease characterized by the thickening and scarring of lung tissue without a known cause. This scarring makes it increasingly difficult for the lungs to function properly, leading to symptoms such as chronic dry cough and progressive shortness of breath. The disease typically affects middle-aged and older adults, and its progression can vary, with some individuals experiencing a gradual decline and others facing more rapid deterioration. The exact cause of IPF remains unknown, but it is believed to involve a combination of genetic and environmental factors. As the disease progresses, the lung tissue becomes more fibrotic, further impairing respiratory function.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515964-30-00Protocol codeAP01-005Estimated enrolment100 patientsSponsorAvalyn Pharma Inc.

sourced from the EU Clinical Trials Register and site verification

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