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Long-Term Safety Study of Inhaled Pirfenidone for Patients with Progressive or 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 two lung diseases: Progressive Pulmonary Fibrosis (PPF) and Idiopathic Pulmonary Fibrosis (IPF). These are conditions where the lungs become scarred over time, making it difficult to breathe. The treatment being tested is a medication called Pirfenidone Solution for Inhalation, which is designed to be inhaled using a device known as the eFlow Nebulizer System. This study aims to understand the long-term safety and how well patients can tolerate this inhaled medication.

Participants in this study will have previously taken part in other studies involving inhaled antifibrotic treatments. The study will observe participants over an extended period to monitor any side effects or changes in their condition. The goal is to gather information on how the treatment affects the progression of the lung diseases and to ensure it is safe for long-term use.

Throughout the study, researchers will keep track of any new health issues that arise, changes in lung function, and any serious health events. This information will help determine if the inhaled medication is a viable long-term treatment option for people with PPF and IPF. Participants will use the inhalation device as instructed and attend regular study visits to provide feedback and undergo health assessments.

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, you will be required to provide written informed consent. This means you agree to participate in the study after understanding all the details and requirements.

    You must have previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for conditions such as idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF).

  2. Step 2

    Medication administration

    You will receive a medication called Pirfenidone Solution for Inhalation. This medication is administered through inhalation, which means you will breathe it in using a device called a nebulizer.

    The dosage, frequency, and duration of administration will be determined by the study team and communicated to you during the trial.

  3. Step 3

    Safety and monitoring

    The main objective of the study is to evaluate the long-term safety and tolerability of the medication. This means the study will monitor how your body responds to the medication over time.

    You will be required to attend regular study visits to check for any treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs). These are any new or worsening medical issues that occur during the study.

  4. Step 4

    Regular assessments

    Your lung function will be assessed regularly by measuring your forced vital capacity (FVC). This is a test that measures how much air you can exhale after taking a deep breath.

    These assessments will occur at intervals of 6 months to track any changes from the baseline measurement.

  5. Step 5

    End of study

    The study is estimated to end by December 31, 2031. You will be informed about the final steps and any follow-up required after the study concludes.

    Throughout the study, you are expected to comply with all study visits and requirements as outlined by the study team.

Who can join the trial?

6 criteria

  • Provide written informed consent, which means you agree to participate in the study after being fully informed about it.
  • Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either Idiopathic Pulmonary Fibrosis (IPF) or Progressive Pulmonary Fibrosis (PPF). This means you have been part of a similar study before and completed it.
  • Be a male or a female of childbearing potential. If you are a female who can have children, or a male, you must agree to use highly effective birth control methods during the study and for 90 days after the last dose of the study drug. This includes methods like condoms, certain birth control pills, or having a partner who has had a vasectomy.
  • Agree not to donate eggs or sperm during the study and for 90 days after the last dose of the study drug.
  • Be willing to attend all study visits and follow all study requirements.
  • Be at least 18 years old at the start of the study.

Who cannot join the trial?

2 criteria

  • Patients with a history of progressive pulmonary fibrosis (PPF) cannot participate. This is a condition where the lungs become scarred over time.
  • Patients with idiopathic pulmonary fibrosis (IPF) are excluded. This is a type of lung disease that results in scarring (fibrosis) of the lungs for an unknown reason.
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Investigated drugs

Avalyn nebulized antifibrotic medications are being studied in this clinical trial. These medications are designed to help manage and treat lung conditions by reducing the formation of scar tissue in the lungs. The goal is to improve breathing and lung function over time. Participants in the trial will use these medications in a form that is inhaled through a nebulizer, which turns the medication into a mist that can be easily breathed into the lungs. This method allows the medication to directly reach the lungs, where it can work to prevent or slow down the scarring process.

What is already known about the treatment

Avalyn nebulized antifibrotic medications – This medication is administered through inhalation using a nebulizer, which turns the liquid medicine into a mist that can be easily breathed into the lungs. Currently, it is being studied in clinical trials to assess its long-term safety and tolerability for patients with progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF). These conditions involve scarring of the lung tissue, making it difficult to breathe. The medication works by targeting and reducing the fibrotic process at the molecular level, which helps to slow down the progression of lung scarring. It is classified as an antifibrotic agent, which means it is designed to prevent or reduce fibrosis, or tissue scarring.

Investigated diseases

  • Progressive Pulmonary Fibrosis

    Progressive pulmonary fibrosis is a condition characterized by the gradual scarring of lung tissue, which leads to a decline in lung function over time. The scarring, or fibrosis, makes it increasingly difficult for the lungs to transport oxygen into the bloodstream. As the disease progresses, individuals may experience worsening shortness of breath, a persistent dry cough, and fatigue. The progression of fibrosis can vary among individuals, with some experiencing a rapid decline in lung function. Over time, the reduced lung capacity can significantly impact daily activities and quality of life. The exact cause of the fibrosis is often unknown, and it can occur as part of other lung diseases.

  • Idiopathic Pulmonary Fibrosis

    Idiopathic pulmonary fibrosis is a specific type of chronic lung disease where the lung tissue becomes thickened, stiff, and scarred without a known cause. This scarring, known as fibrosis, progressively worsens, leading to a decline in lung function. Individuals with this condition often experience symptoms such as shortness of breath, especially during physical activity, and a persistent dry cough. As the disease advances, the ability to breathe deeply and efficiently is compromised, affecting oxygen levels in the blood. The progression of idiopathic pulmonary fibrosis can vary, with some individuals experiencing a slow decline and others a more rapid progression. The term "idiopathic" indicates that the cause of the fibrosis is unknown.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518289-28-00Protocol codeAP-LTE-008Estimated enrolment341 patientsSponsorAvalyn Pharma Inc.

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