Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study on Long-Term Safety and Effectiveness of Liposomal Ciclosporin A for Patients with Bronchiolitis Obliterans Syndrome After Lung Transplantation

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 condition called Bronchiolitis Obliterans Syndrome (BOS), which can occur in patients who have received a single or double lung transplant. The study is investigating the long-term safety and effectiveness of a treatment called Liposomal Ciclosporin A (L-CsA). This treatment is administered as a powder for nebulizer solution, which means it is inhaled through a device that turns the medication into a mist.

The purpose of the study is to assess how well L-CsA works and how safe it is for patients with BOS. Participants in the study will receive L-CsA in addition to their standard care, which may include medications like tacrolimus, mycophenolate mofetil (MMF), azathioprine, and prednisone. Some patients may also receive azithromycin for additional support. The study will monitor various health indicators, such as lung function and overall health, over a period of time to determine the treatment's impact.

Throughout the study, participants will be regularly assessed to track any changes in their condition and to ensure their safety. The study aims to provide valuable information on the potential benefits and risks of using L-CsA for treating BOS in lung transplant recipients. This research is part of a follow-up to previous studies known as BOSTON 1 and BOSTON 2, which also explored the use of L-CsA in similar patient groups.

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

    Participation begins after completing all visits in either the BOSTON-1 or BOSTON-2 studies. It is necessary to have not withdrawn consent or stopped the study drug early.

    A maintenance regimen of immunosuppressive agents is required. This includes tacrolimus, a second agent like mycophenolate mofetil (MMF) or azathioprine, and a systemic corticosteroid such as prednisone. Azithromycin may also be used for prophylaxis or treatment of Bronchiolitis Obliterans Syndrome (BOS).

  2. Step 2

    Medication administration

    The study involves the use of Liposomal Ciclosporin A, administered as a powder for nebuliser solution.

    The medication is taken through inhalation.

  3. Step 3

    Monitoring and assessments

    Regular monitoring includes checking for adverse events, assessing acute tolerability, and evaluating clinical laboratory parameters.

    Vital signs, physical examinations, and renal function are also monitored.

  4. Step 4

    Efficacy evaluations

    The study measures changes in lung function, specifically the forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC).

    Progression of BOS is assessed by changes in FEV1, BOS grade, need for re-transplantation, or death from respiratory failure.

  5. Step 5

    Quality of life and hospitalization

    Quality of life is evaluated using the Euro Quality of Life Questionnaire (EQ-5D-5L).

    The number of hospitalization days is recorded.

  6. Step 6

    End of study

    The study is estimated to conclude by March 31, 2025.

    Final assessments will be conducted to evaluate the long-term safety and efficacy of the treatment.

Who can join the trial?

4 criteria

  • Patients who have completed all visits through the End of Treatment Visit in either BOSTON-1 or BOSTON-2, did not withdraw informed consent, and did not stop taking the study medication early.
  • Patients should be on a maintenance regimen of **immunosuppressive agents**. These are medications that help prevent the body from rejecting a transplanted organ. The regimen includes tacrolimus, a second agent like mycophenolate mofetil (MMF) or azathioprine, and a systemic corticosteroid like prednisone. Azithromycin can also be used for prevention or treatment of **Bronchiolitis Obliterans Syndrome (BOS)**.
  • Patients must be able to understand the purposes and risks of the clinical trial, have given written informed consent, agree to follow the trial requirements and visit schedules, and be able to inhale medication in aerosol form.
  • Women who can have children must have a negative pregnancy test within 7 days before the first visit and must agree to use a reliable method of birth control until the end of the study.

Who cannot join the trial?

5 criteria

  • Patients who have not had a single or double lung transplant.
  • Patients who do not have **Bronchiolitis Obliterans Syndrome (BOS)**, a condition that affects the small airways in the lungs.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the clinical trial group being studied.
  • Patients who are not considered part of the vulnerable population selected for the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • L-CsA

    is a medication being studied for its long-term safety and effectiveness in treating a condition called BOS, which can occur in patients who have received a lung transplant. This medication is being tested to see how well it works over an extended period and to ensure it is safe for patients to use.

  • SoC

    stands for "Standard of Care," which refers to the usual treatment that patients receive for their condition. In this study, L-CsA is being used in combination with the standard treatments to see if it provides additional benefits for patients with BOS.

What is already known about the treatment

L-CsA – This medication is administered orally and is currently being studied for its long-term safety and effectiveness in treating Bronchiolitis Obliterans Syndrome (BOS) in patients who have undergone single or double lung transplants. It is in the clinical trial phase, specifically in follow-up studies after initial trials. The main therapeutic use of L-CsA is to manage BOS, a condition that affects the small airways in the lungs. At the molecular level, L-CsA works by inhibiting calcineurin, which reduces the activity of T-cells, thereby decreasing inflammation and immune response. It is classified as an immunosuppressant.

Investigated diseases

Bronchiolitis Obliterans Syndrome – This condition occurs in patients who have undergone a single or double lung transplantation. It is characterized by inflammation and scarring in the small airways of the lungs, leading to a progressive decline in lung function. Over time, the airways become obstructed, making it difficult for air to move in and out of the lungs. Patients may experience symptoms such as coughing, shortness of breath, and wheezing. The progression of the disease can vary, but it often leads to a gradual worsening of respiratory function. It is considered a chronic and irreversible condition that requires ongoing management.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512448-41-00Protocol codeBT–L-CsA–303–FUEstimated enrolment164 patientsSponsorZambon S.p.A.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.