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Study of Inhaled Pirfenidone for Patients with Progressive Pulmonary Fibrosis

Fast replyInvestigationalNo 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 lung condition known as Progressive Pulmonary Fibrosis (PPF). PPF is a disease where the lungs become scarred over time, making it difficult to breathe. The study will evaluate a treatment called Pirfenidone Solution for Inhalation, also referred to as AP01. This treatment is administered through a device called the eFlow Nebuliser System, which helps deliver the medication directly into the lungs in the form of a mist.

The purpose of the study is to assess the safety and effectiveness of AP01 in people with PPF. Participants in the study will be randomly assigned to receive either the AP01 treatment or a placebo, which looks like the treatment but does not contain the active medication. The study will last for 52 weeks, during which participants will have regular check-ups to monitor their lung function and overall health.

Throughout the study, the main focus will be on changes in lung function, specifically measuring something called forced vital capacity (FVC), which is a way to assess how well the lungs are working. Additionally, the study will look at the quality of life of participants and any changes in lung scarring using a special imaging method called high-resolution computed tomography (HRCT). The goal is to understand how AP01 might help improve breathing and slow down the progression of lung scarring in people with PPF.

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, eligibility is confirmed based on specific criteria related to age, lung function, and previous treatments.

    Participants must be at least 18 years old and meet certain lung function criteria, such as a forced vital capacity (FVC) of at least 45% of the predicted normal value.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to receive either the Pirfenidone Solution for Inhalation or a placebo.

    The study is double-blind, meaning neither the participants nor the researchers know who receives the actual medication or the placebo.

  3. Step 3

    Medication administration

    The Pirfenidone Solution for Inhalation is administered through inhalation.

    The treatment period lasts for 52 weeks, during which the medication or placebo is taken as directed.

  4. Step 4

    Monitoring and assessments

    Participants undergo regular assessments to monitor lung function and overall health.

    Key assessments include measuring changes in forced vital capacity (FVC) and quality of life using specific questionnaires.

  5. Step 5

    End of study evaluation

    At the end of the 52-week period, a final evaluation is conducted to assess the effects of the treatment on lung function and disease progression.

    The primary focus is on the change in FVC from the start of the study to the end.

Who can join the trial?

9 criteria

  • Must be a male or female who is at least 18 years old.
  • Must have a condition called **Progressive Pulmonary Fibrosis (PPF)**, which is a lung disease that gets worse over time.
  • During the screening period, must meet the following lung function criteria:
    • **Forced Vital Capacity (FVC)**: This is a test that measures how much air you can exhale after taking a deep breath. It must be at least 45% of what is considered normal.
    • **Forced Expiratory Volume in 1 second (FEV1)/FVC**: This is a ratio that compares the amount of air you can forcefully exhale in one second to the total amount you can exhale. It must be at least 0.7.
    • **Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)**: This test measures how well your lungs can transfer gas from the air you breathe to your blood. It must be at least 30% of what is considered normal, adjusted for hemoglobin levels.
    • Must be able to perform acceptable **spirometry**, which is a test to measure lung function, according to specific guidelines.
    • If currently taking a medication called **nintedanib** (up to 30% of participants):
      • Must have been taking nintedanib for 6 to 12 months before the screening and have shown signs of PPF during this time.
      • Must not have changed the dose of nintedanib for at least 12 weeks before the screening.
      • If previously stopped taking nintedanib:
        • Must have stopped taking nintedanib for at least 12 weeks before the screening.

Who cannot join the trial?

8 criteria

  • Patients with any other lung disease that is not **Progressive Pulmonary Fibrosis** cannot participate.
  • Patients who have had a lung transplant are not eligible.
  • Patients who are currently participating in another clinical trial are excluded.
  • Patients with a history of severe allergic reactions to the study medication or its ingredients cannot join.
  • Patients with unstable heart conditions, such as recent heart attacks, are not allowed to participate.
  • Patients with severe liver or kidney disease are excluded from the study.
  • Patients who are pregnant or breastfeeding cannot take part in the trial.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.
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Investigated drugs

Pirfenidone Solution for Inhalation (AP01) is being studied for its potential to help people with Progressive Pulmonary Fibrosis (PPF). This medication is designed to be inhaled, which means it is breathed directly into the lungs. The goal of using this medication is to see if it can improve lung function over a period of 52 weeks. The study is focused on understanding how effective and safe this treatment is for individuals with this lung condition.

What is already known about the treatment

Pirfenidone Solution for Inhalation (AP01) – This medication is administered through inhalation, allowing direct delivery to the lungs. It is currently being studied in a Phase 2b clinical trial to assess its safety and effectiveness for treating Progressive Pulmonary Fibrosis. The main therapeutic indication is to improve lung function in individuals with this condition. At the molecular level, Pirfenidone works by reducing the production of certain proteins that cause inflammation and scarring in the lungs. It is classified as an antifibrotic agent, which means it helps to prevent or reduce the formation of fibrous tissue.

Investigated diseases

Progressive Pulmonary Fibrosis – Progressive Pulmonary Fibrosis is a chronic lung disease characterized by the gradual scarring of lung tissue, which leads to a decline in lung function over time. The disease causes the lung tissue to become thick and stiff, making it difficult for the lungs to work properly. As the fibrosis progresses, individuals may experience increasing shortness of breath, a persistent dry cough, and fatigue. The scarring process can vary in speed and severity among individuals, but it generally leads to a continuous decline in the ability to breathe deeply. The condition is considered rare and can significantly impact the quality of life due to its progressive nature.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508429-29-00Protocol codeAP01-007Estimated enrolment379 patientsSponsorAvalyn Pharma Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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