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Study on Long-Term Safety and Efficacy of BI 1291583 in Patients with Bronchiectasis

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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 long-term safety and effectiveness of a medication called BI 1291583 in people with a lung condition known as bronchiectasis. Bronchiectasis is a disease where the airways in the lungs become widened and scarred, leading to symptoms like coughing and difficulty breathing. The study involves taking oral doses of BI 1291583, which is a tablet form of medication, to see how it affects patients over time.

Participants in this study will receive either the medication BI 1291583 or a placebo, which looks like the medication but does not contain the active ingredient. The purpose of the study is to evaluate the safety of the medication by monitoring any side effects that occur during the trial. The study will also look at how the medication affects the time it takes for a lung flare-up, known as a pulmonary exacerbation, to occur and how often these flare-ups happen.

The study will last for up to 12 months, during which participants will take the medication daily. The trial is designed to be a roll-over study, meaning it includes people who have already participated in a previous study with BI 1291583. This approach helps researchers understand the long-term effects of the medication in a real-world setting. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the medication's impact on their condition.

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, you will be required to provide a signed and dated written informed consent. This is to ensure that you understand the study and agree to participate according to the guidelines of Good Clinical Practice and local legislation.

  2. Step 2

    Medication administration

    You will be assigned to take an oral medication called BI 1291583. The dosage will be either 1 mg, 2.5 mg, or 5 mg, depending on the group you are placed in. This medication is taken once daily.

    In some cases, you may receive a placebo, which looks like the medication but does not contain the active substance. This is to help compare the effects of the medication.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, your health will be closely monitored. This includes regular check-ups to assess any side effects or changes in your condition.

    The main focus is to evaluate the safety of the medication by observing any treatment-emergent adverse events, which are any new or worsening health issues that occur during the trial.

  4. Step 4

    Tracking exacerbations

    The study will also track the time to your first pulmonary exacerbation, which is a worsening of your lung condition, from the start of the medication until the end of the trial.

    The rate of these exacerbations will be recorded to understand how often they occur during the study period.

  5. Step 5

    Completion of the trial

    The trial is expected to continue until March 30, 2026. Upon completion, you will have a final assessment to evaluate your overall health and any effects of the medication.

Who can join the trial?

3 criteria

  • Patients who have completed the treatment period in the Phase II trial (identified as 1397-0012 or 1397-0013) as planned.
  • Both male and female patients can participate. Women who can have children must be ready and able to use highly effective birth control methods that have a low failure rate (less than 1% per year) when used correctly, along with one barrier method like a condom. Men must use male contraception (such as a condom) or practice sexual abstinence if their partner is a woman who can have children.
  • Patients must provide a signed and dated written informed consent before joining the trial, following Good Clinical Practice (GCP) and local laws.

Who cannot join the trial?

3 criteria

  • Patients with a history of **Bronchiectasis** cannot participate.
  • Patients who have experienced any **treatment-emergent adverse events (TEAEs)** during previous treatments are excluded. TEAEs are side effects or reactions that occur after starting a new treatment.
  • Patients who are part of a **vulnerable population** are not eligible. This term refers to groups of people who may be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
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Investigated drugs

BI 1291583 is an experimental medication being tested for its safety and effectiveness in treating patients with bronchiectasis. Bronchiectasis is a lung condition where the airways become widened and scarred, leading to mucus build-up and frequent lung infections. This medication is taken orally, which means it is swallowed in the form of a pill or liquid. The goal of using BI 1291583 in this trial is to see if it can help reduce symptoms and improve lung function in people with this condition. The study is also focused on monitoring any side effects that patients might experience while taking this medication over a long period. This helps researchers understand how safe the medication is for long-term use.

What is already known about the treatment

ClairleafTM – ClairleafTM is an oral medication taken once daily, designed to help people with bronchiectasis, a condition where the airways in the lungs become damaged and widened. Currently, it is being studied in clinical trials to ensure its long-term safety and effectiveness. The main goal of the trial is to monitor any side effects that patients might experience while using the medication. ClairleafTM works by targeting specific pathways in the body to reduce inflammation and improve lung function, making it easier for patients to breathe. It belongs to a class of drugs that focus on respiratory health.

Investigated diseases

Bronchiectasis – Bronchiectasis is a chronic condition where the walls of the bronchi, the large air passages from the trachea to the lungs, become permanently widened. This widening is often due to inflammation and infection, leading to a cycle of damage and further infection. As the disease progresses, the airways lose their ability to clear out mucus, resulting in frequent lung infections and blockages. Patients often experience a persistent cough, production of large amounts of sputum, and shortness of breath. Over time, the repeated infections and inflammation can cause further damage to the lung tissue. The condition can lead to a decline in lung function and increased respiratory symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503290-38-00Protocol code1397-0017Estimated enrolment226 patientsSponsorBoehringer Ingelheim Espana S.A.

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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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