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Phase 2 Study of Inhaled AGMB-447 and Salbutamol Sulfate in Adults with Idiopathic Pulmonary Fibrosis to Evaluate Lung Function, Safety and Tolerability

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What is this trial about?

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

Idiopathic Pulmonary Fibrosis is a rare disease where the tissue that supports the tiny air sacs in the lungs becomes thick and stiff, making breathing difficult. People in the study may keep using their usual inhaled medicine such as salbutamol to help open the airways. The trial is testing a new inhaled powder called AGMB-447 and comparing it with a placebo, which looks the same but does not contain the active drug.

The purpose of the study is to evaluate the effect of AGMB-447 on lung function in participants with IPF compared with placebo. Participants will be randomly assigned to receive either the study drug or the placebo, inhaled using a small machine that turns the powder into a mist, for about 24 weeks. During the study they will come to the clinic several times for safety checks and to have a test that measures how much air they can blow out in one breath, called FVC. The researchers will look at how the drug changes this measurement and will watch for any side effects.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Randomization

    You are entered into the study and assigned at random to receive either the investigational medicine AGMB‑447 or a matching placebo. The assignment is double‑blind, meaning neither you nor the study staff know which product you receive.

  2. Step 2

    Baseline Assessments

    Before starting the study medication, you undergo a series of examinations, including a measurement of lung capacity called forced vital capacity (FVC), basic health checks, and collection of medical information.

    These assessments establish your starting point for later comparison.

  3. Step 3

    Receiving Study Medication

    You are given a sealed container of powder for a nebuliser. The product is labeled either Inspiria (AGMB‑447) or Placebo of Inspiria (AGMB‑447).

    The dose supplied is the amount prepared by the study pharmacy; the protocol lists the dose as 0 mg, which reflects the study’s standardized packaging rather than a therapeutic amount you must measure.

  4. Step 4

    Daily Inhalation Procedure

    You use a nebuliser device to inhale the powder according to the study schedule, typically once each day.

    The inhalation is performed by placing the powder into the nebuliser, adding the recommended amount of sterile water, and breathing the mist for the time indicated in the instruction booklet.

    You keep a diary to record each inhalation and any symptoms you experience.

  5. Step 5

    Rescue Medication Use

    If you experience sudden shortness of breath, you may use the background medication salbutamol inhalation at a dose of 800 µg (micrograms).

    Salbutamol is a fast‑acting bronchodilator that helps open the airways temporarily.

  6. Step 6

    Scheduled Clinic Visits

    You attend study visits at approximately weeks 4, 12, and 24 after starting the medication.

    During each visit, the study team repeats the lung function test (FVC), checks vital signs, reviews your diary, and asks about any side effects.

    Blood samples may be taken to monitor safety.

  7. Step 7

    End of Treatment Assessment

    At week 24, the final treatment visit is performed.

    The primary goal is to compare the change in FVC from the baseline measurement to this time point.

    All study medication is stopped after this assessment.

  8. Step 8

    Post‑Treatment Follow‑Up

    Approximately four weeks after the last dose, you return for a safety follow‑up visit.

    The visit includes a brief physical examination and a final review of any lingering side effects.

Who can join the trial?

7 criteria

  • Be at least 40 years old when signing the informed consent form (ICF).
  • Have a diagnosis of idiopathic pulmonary fibrosis (IPF) that was made no more than 7 years ago and confirmed by a specialist review of a chest scan called a high‑resolution CT (HRCT).
  • Show lung function test results that meet all of the following:
    • Forced vital capacity (FVC) at least 45% of the normal predicted value, measured with a test called spirometry.
    • FEV1/FVC ratio greater than 0.7 (or within the normal lower limit), also measured with spirometry.
    • Diffusing capacity for carbon monoxide (DLCO) corrected for hemoglobin at least 25% of the normal predicted value, which assesses how well oxygen moves from the lungs into the blood.
    • Be taking the usual standard of care treatment for IPF at a stable dose for at least 8 weeks before the screening visit and during the screening period, or not be on any antifibrotic medication and be stable (no new treatment) for at least 4 weeks before screening (including people who have never used these medicines or cannot tolerate them).
    • Be a woman who is of non‑childbearing potential or be a man who agrees to follow the study’s requirements for contraception (birth control).

Who cannot join the trial?

9 criteria

  • Having a diagnosis of fibrosing interstitial lung disease (ILD) that is not idiopathic pulmonary fibrosis (IPF) – this means a scar‑type lung disease other than the specific condition being studied.
  • Having an acute IPF exacerbation (a sudden worsening of lung symptoms) within the past 6 months or during the screening period.
  • Having a lower respiratory tract infection (such as a severe bronchitis or pneumonia) that needed treatment within the past 4 weeks or during the screening period.
  • Having had major lung surgery – such as lung volume reduction surgery or a lung transplant – or any major surgery within the past 3 months, or planning such surgery during the trial (being on a transplant waiting list is allowed).
  • Having certain ongoing infections, including:
    • Active infection with human immunodeficiency virus (HIV) – the virus that can cause AIDS.
    • A current infection with tuberculosis (TB) – a bacterial disease that mainly affects the lungs.
    • Positive test for hepatitis B (either the surface antigen HBsAg or core antibody HBcAb) – a virus that can affect the liver.
    • Chronic hepatitis C (positive hepatitis C antibody and detectable hepatitis C virus RNA) – another liver‑affecting virus.
    • Having taken part in another clinical trial or received an investigational therapy (a drug or treatment that is still being tested) within 4 weeks, or within 5 half‑lives (the time it takes for half of the drug to leave the body) – whichever period is longer – before screening.
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Investigated drugs

  • SALBUTAMOL

    is an inhaled medication that helps open the airways in the lungs. In this trial it is used as a background treatment, meaning participants continue to take it as they normally would to relieve breathing difficulties while the study medication is being tested.

  • Inspiria

    is the investigational product being studied. It is a powder that is turned into a mist by a nebuliser and inhaled into the lungs. The powder contains the experimental drug AGMB‑447, which is being evaluated to see if it can improve lung function in people with idiopathic pulmonary fibrosis. Participants receive Inspiria instead of a placebo, and the study looks at how well it works and how safe it is.

What is already known about the treatment

  • SALBUTAMOL

    This medication is given by inhalation, usually from a metered‑dose inhaler, delivering a fine mist that reaches the lungs. It is an approved, widely used drug for relieving breathing problems such as asthma and chronic obstructive pulmonary disease. It works by activating beta‑2 receptors on airway muscles, causing them to relax and open the airways. It belongs to the class of short‑acting beta‑2 agonist bronchodilators.

  • AGMB‑447 (Inspiria)

    The test drug is supplied as a powder that is mixed with liquid to create a solution for a nebuliser, allowing the medicine to be inhaled directly into the lungs. It is currently an investigational product being studied in a Phase 2 trial for idiopathic pulmonary fibrosis, a rare lung‑scarring disease. The drug is thought to act on cells that cause scar tissue, helping to reduce the buildup of collagen and slow the stiffening of lung tissue. It is classified as an experimental antifibrotic agent.

Investigated diseases

Idiopathic pulmonary fibrosis - Idiopathic pulmonary fibrosis is a chronic condition in which the tissue of the lungs becomes thickened and scarred for unknown reasons. The scarring gradually stiffens the lungs, making it harder for oxygen to move into the blood. Over time, patients typically notice increasing shortness of breath, especially during activity, and a persistent dry cough. The disease progresses slowly but steadily, with lung function declining as more tissue is affected. Symptoms often worsen over months to years as the fibrotic process continues.
Trial detailsLast updated 29 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-526404-71-00Protocol codeAGMB447-01-CL-201Estimated enrolment60 patientsSponsorAgomab Spain S.L.U.

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