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Study Comparing Itraconazole and Nebulised Amphotericin B with Itraconazole Alone for Patients with Chronic Pulmonary Aspergillosis

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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 the treatment of Chronic Pulmonary Aspergillosis, a lung condition caused by a type of fungus called Aspergillus. The study aims to compare the effectiveness of two treatment approaches over a six-month period. One group of patients will receive a combination of two medications: itraconazole, which is taken orally, and AmBisome, which is inhaled. The other group will receive only itraconazole. The purpose of the study is to determine which treatment is more effective in improving the health of patients with this condition.

Participants in the study will be monitored for six months while receiving their assigned treatment. During this time, doctors will assess both clinical and radiological improvements, which means they will look for signs of better health and changes in lung images. After the treatment period, there will be a follow-up for 24 months to observe any long-term effects or relapses. The study will also evaluate the quality of life of participants using a questionnaire and track any major health events or hospital visits related to respiratory symptoms.

The study is designed for patients who are not severely immunocompromised, meaning their immune systems are not significantly weakened. It excludes those with a single aspergilloma, which is a specific type of fungal growth in the lungs. The trial is conducted in a single-blind manner, meaning that the patients do not know which treatment group they are in, but the researchers do. This helps ensure that the results are unbiased and reliable.

The research process

The trial runs in 6 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 randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment option.

  2. Step 2

    Treatment initiation

    If assigned to the first group, you will receive a combination of itraconazole and nebulized AmBisome. Itraconazole is taken orally in the form of 100 mg capsules. The dosage and frequency will be determined by the study team.

    If assigned to the second group, you will receive itraconazole alone, taken orally in the form of 100 mg capsules. The dosage and frequency will be determined by the study team.

  3. Step 3

    Treatment duration

    The treatment will last for a period of six months. During this time, you will be required to take the medication as prescribed and attend regular follow-up visits.

  4. Step 4

    Follow-up visits

    You will have scheduled visits at the clinic to monitor your progress. These visits will occur at regular intervals, including at three months and six months into the treatment.

    During these visits, your clinical and radiological progress will be assessed to determine the effectiveness of the treatment.

  5. Step 5

    End of treatment

    At the end of the six-month treatment period, your condition will be evaluated to assess the overall therapeutic efficacy, which includes both clinical improvement and radiological improvement.

  6. Step 6

    Post-treatment follow-up

    After completing the treatment, there will be a follow-up period of 24 months. During this time, you will have periodic assessments to monitor for any relapse or major events related to your condition.

    You will also be asked to complete questionnaires to evaluate your quality of life and any changes in your condition.

Who can join the trial?

9 criteria

  • Patient with an Aspergillus bronchopulmonary infection, which can be cavitary, fibrotic, necrotizing (also known as Semi Invasive Aspergillosis), or nodular, and confirmed by a compatible chest CT scan.
  • Must meet one of the following criteria:
    • Positive detection of anti-Aspergillus IgG and/or precipitating anti-Aspergillus antibodies, based on the laboratory's positivity threshold.
    • Positive direct examination or culture of Aspergillus from lung samples (such as sputum or endoscopic aspiration).
    • Presence of aspergillar hyphae/filaments in tissue samples.
    • Men or women aged 18 years or older.
    • Women of childbearing age must have a negative blood pregnancy test, use highly effective contraception, and agree to continue it for at least the first 12 months of the study.
    • Patient must be legally free and not under any custody, guardianship, or similar measures.
    • Patient must be affiliated with the national health care system.
    • Patient must provide free and informed consent by signing a consent form.

Who cannot join the trial?

3 criteria

  • Patients with a **single aspergilloma** cannot participate. An aspergilloma is a clump of fungus that can form in the lungs.
  • Patients who are **severely immunocompromised** are not eligible. Being immunocompromised means having a weakened immune system, which makes it harder for the body to fight infections.
  • Patients who are part of a **vulnerable population** are excluded. This generally refers to groups who may be at higher risk of harm or exploitation.
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Investigated drugs

  • Itraconazole

    is a medication used to treat fungal infections. In this clinical trial, it is being used to help manage Chronic Pulmonary Aspergillosis, a lung condition caused by a type of fungus. The medication works by stopping the growth of the fungus, helping to reduce symptoms and improve lung function over a six-month treatment period.

  • Ambisome®

    is a form of amphotericin B that is given through a nebulizer, which means it is inhaled directly into the lungs. This medication is also used to treat fungal infections and is being tested in combination with itraconazole in this trial. The goal is to see if using both medications together is more effective in treating Chronic Pulmonary Aspergillosis than using itraconazole alone. Ambisome® works by attacking the fungus in the lungs, helping to clear the infection and improve breathing.

What is already known about the treatment

  • Itraconazole

    Itraconazole is an oral medication used to treat fungal infections, specifically chronic pulmonary aspergillosis. It is currently well-established in medical practice and literature for its antifungal properties. The main therapeutic indication for itraconazole is to manage and treat fungal infections in the lungs. At the molecular level, itraconazole works by inhibiting the synthesis of ergosterol, a vital component of fungal cell membranes, thereby disrupting the growth and survival of the fungus. It belongs to the pharmacological class of azole antifungals.

  • Ambisome®

    Ambisome® is a nebulized medication, meaning it is inhaled directly into the lungs, used in combination with itraconazole to treat chronic pulmonary aspergillosis. It is recognized in medical literature for its role in treating severe fungal infections. The main therapeutic indication is to enhance the treatment of lung infections caused by fungi. At the molecular level, Ambisome® works by binding to ergosterol in the fungal cell membrane, creating pores that lead to cell death. It is classified as a polyene antifungal.

Investigated diseases

Chronic Pulmonary Aspergillosis – Chronic Pulmonary Aspergillosis is a long-term fungal infection of the lungs caused by the Aspergillus species. It typically occurs in individuals with pre-existing lung conditions or mild immune system compromise. The disease progresses slowly, with symptoms that may include persistent cough, weight loss, fatigue, and shortness of breath. Over time, the infection can lead to the formation of cavities in the lungs, which may contain fungal balls known as aspergillomas. The condition can cause significant lung damage if not managed, leading to further respiratory complications. The progression of the disease varies, with periods of stability and potential exacerbations.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517004-11-00Protocol codeCPAAARIEstimated enrolment224 patientsSponsorCentre Hospitalier Universitaire De Poitiers

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