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Study to evaluate the efficacy and safety of liposomal amphotericin B for patients with simple pulmonary aspergilloma

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What is this trial about?

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

This study focuses on individuals with simple pulmonary aspergilloma, which is a condition where a ball of fungus grows inside a cavity in the lungs. The purpose of the study is to evaluate the efficacy and safety of liposomal amphotericin B, a specialized form of an antifungal medication, when delivered directly into the airways. This method of delivery is known as intrabronchial instillation, which means the medicine is placed into the breathing tubes of the lungs.

During the course of the study, participants will receive the treatment and undergo assessments to monitor changes in the size of the fungal mass. The study will also look for signs of hemoptysis, which is the medical term for coughing up blood, and any other side effects that may occur during the process. Researchers will also monitor for any progression to more serious forms of chronic pulmonary aspergillosis, a broader type of long-term fungal lung infection.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>treatment administration</b>

    The liposomal amphotericin b (an antifungal medication) is administered via intrabronchial instillation. this means the medicine is placed directly into the lungs through the airways.

    The dose used is 50 mg of the dispersion for infusion.

  2. Step 2

    <b>monitoring and assessment</b>

    The size of the aspergilloma (a fungal ball in the lung) is measured to determine the percentage of change from the starting point.

    The response to treatment is evaluated at the week 8 visit. the response is categorized as a complete response (100% reduction in size), a partial response (reduction of 50% or more), or an insufficient response (less than 50% reduction or no change).

    Side effects are monitored and categorized by severity as mild, moderate, or severe.

    The copd assessment test (a questionnaire used to check the status of chronic obstructive pulmonary disease, a lung condition) is used to measure changes in symptoms.

    The progression of the disease is monitored to check for any increase in the size of the aspergilloma or if the condition changes into other forms of pulmonary aspergillosis (a type of lung infection caused by fungus).

    The occurrence of hemoptysis (coughing up blood) is recorded and categorized by its severity.

Who can join the trial?

9 criteria

  • You must have been diagnosed with a simple pulmonary aspergilloma, which is a fungal ball (a clump of fungus) located inside a small pocket or cavity in the lung.
  • Your diagnosis must follow specific medical guidelines and show that you have a single cavity in the lung containing the fungus, without having a weakened immune system (a state where your body's natural defenses are low).
  • A doctor must confirm the diagnosis using a chest CT scan, which is a detailed X-ray image of the inside of your chest, showing a round mass and a specific air pattern around it.
  • The infection must be confirmed through one of several tests, such as finding Aspergillus antigens (proteins from the fungus) or antibodies (proteins your body makes to fight infection) in your blood or in fluid taken from your lungs.
  • The fluid used for testing, called bronchoalveolar lavage fluid, is collected by washing a small area of the lung with liquid to collect cells and germs for testing.
  • You must test negative for pulmonary tuberculosis, which is a serious infectious disease caused by bacteria that primarily affects the lungs.
  • You must be between 18 and 80 years old.
  • Surgical resection, which is the medical procedure to surgically remove the fungal ball, must be impossible, not recommended for your situation, or something you have chosen not to do.
  • You must not be currently taking systemic antifungal treatment, which refers to antifungal medicine taken throughout the entire body (usually as a pill or injection), or you must have declined this treatment or found it ineffective in the past.

Who cannot join the trial?

17 criteria

  • Failure to sign the informed consent, which is the official document where you agree to take part in the study.
  • Refusal to take part in the study.
  • Coagulation abnormalities, which means your blood does not clot normally. This includes:
  • Severe thrombocytopenia, which is a very low level of platelets (the cells in your blood that help stop bleeding).
  • An elevated INR, which is a blood test measurement that shows how long it takes for your blood to clot.
  • An allergy or hypersensitivity to Amphotericin B or other similar antifungal drugs (medicines used to treat fungal infections).
  • The need for systemic antifungal therapy, which means taking antifungal medicine that travels through your entire body, or currently being on such medicine.
  • The need for surgical resection, which means the medical recommendation to remove the pulmonary aspergilloma (a fungal ball in the lung) through surgery.
  • Severe hemoptysis, which is coughing up large amounts of blood that requires bronchial artery embolisation (a procedure to block blood vessels to stop bleeding) or surgery.
  • Being pregnant.
  • Having more than one mycetoma, which is another name for a fungal ball, visible on a chest CT scan (a special type of X-ray imaging).
  • Severe impairment in lung function, specifically an FEV1 (the amount of air you can blow out in one second) that is less than 30 percent of normal.
  • Any reason that prevents a bronchoscopy, which is a procedure where a doctor uses a thin tube to look inside your lungs. This includes:
  • Being hemodynamically unstable, which means your blood pressure or heart rate is not steady or normal.
  • Hypoxaemia, which means having low levels of oxygen in your blood.
  • Known chronic type II respiratory failure, which is a long-term condition where the lungs cannot remove enough carbon dioxide from the body.
  • A recent myocardial infarction, which is the medical term for a heart attack that happened less than 3 months ago.
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Investigated drugs

Amphotericin B is an antifungal medication used to treat infections caused by fungi. In this study, it is delivered directly into the lungs to help treat a fungal growth known as an aspergilloma.

What is already known about the treatment

Amphotericin B - This medication is a specialized antifungal drug delivered as a liquid dispersion directly into the lungs through a breathing tube. It is a well-established treatment used to combat serious fungal infections, and in this study, it is being tested for its ability to treat fungal balls in the lungs. On a molecular level, the drug works by attaching to the cell membranes of fungi, creating tiny holes that cause the fungal cells to leak and eventually die. It belongs to a class of drugs known as polyenes, which are specifically designed to target and destroy fungal organisms.

Investigated diseases

Simple aspergilloma - This condition occurs when a ball of fungus grows inside a pre-existing cavity in the lungs. The fungus typically grows in an area where lung tissue has been damaged or hollowed out. As the fungal mass develops, it can occupy the space within the lung cavity. Over time, the lesion may change in size. In some cases, the condition can progress into more extensive forms of fungal lung disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523501-15-00Protocol codeBRO-LAMBEstimated enrolment20 patientsSponsorPauls Stradins Clinical University Hospital

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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.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).