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Study of BI 1291583 tablets taken once daily for 76 weeks in adults with bronchiectasis

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This clinical trial focuses on evaluating a new medication called BI 1291583 for people with bronchiectasis, a condition where the airways in the lungs become permanently widened, damaged, and scarred. People with bronchiectasis often experience persistent cough, excess mucus production, and frequent chest infections. The study aims to determine if the medication is effective in reducing the number of lung-related flare-ups compared to placebo.

The study medication comes in the form of film-coated tablets that are taken by mouth once daily. The treatment period lasts up to 76 weeks, during which participants will receive either BI 1291583 at a dose of 2.5 mg or a matching placebo. This is part of what is called a Phase III study, which is one of the final stages of testing a new medication before it can be approved for general use.

Throughout the study, participants will be monitored for improvements in their condition, particularly focusing on how often they experience pulmonary exacerbations (sudden worsening of respiratory symptoms that require antibiotic treatment). The study will also track changes in breathing tests and how the treatment affects participants' quality of life related to their respiratory symptoms.

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

    Initial evaluation

    You will undergo evaluation to confirm your bronchiectasis diagnosis through CT scan (if your previous scan is older than 5 years)

    Your ability to produce sputum will be assessed

    Your medical history will be reviewed, particularly focusing on previous pulmonary exacerbations (lung infection episodes requiring antibiotics)

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either BI 1291583 or placebo

    The medication will be in the form of film-coated tablets

    The dosage will be 2.5 mg taken once daily

  3. Step 3

    Treatment period

    The treatment duration will be up to 76 weeks (approximately 1.5 years)

    You will take the assigned medication orally once per day

    Regular assessments will monitor your lung function and respiratory symptoms

    Your quality of life related to respiratory symptoms will be evaluated

    Any pulmonary exacerbations during the study period will be documented

  4. Step 4

    Key evaluations

    Your lung function will be measured at week 52 using tests called FEV1 (amount of air you can forcefully exhale in one second) and FVC (total amount of air you can exhale)

    Your respiratory symptoms and quality of life will be assessed using standardized questionnaires

    The frequency and severity of any lung infections will be monitored throughout the study

  5. Step 5

    Study completion

    The study will evaluate how the medication affects the rate of lung infections over the 76-week period

    Final assessments will be conducted to compare your condition with the initial measurements

Who can join the trial?

11 criteria

  • Must be at least 18 years old when signing the consent form
  • Both men and women can participate. Women who can become pregnant must use highly effective birth control methods with less than 1% failure rate, plus one barrier method
  • Must provide written informed consent to participate in the study
  • Must have symptoms typical for bronchiectasis, such as:
    • Cough
    • Ongoing mucus production
    • Repeated chest infections
    • Must have bronchiectasis confirmed by CT scan (a detailed X-ray of the chest). The CT scan must be from the last 5 years or a new one will need to be done
    • Must be able to produce sputum (mucus coughed up from lungs) for testing
    • Must have a history of pulmonary exacerbations (flare-ups of lung symptoms) that required antibiotics, specifically either:
      • At least 2 flare-ups in the past 12 months, or
      • At least 1 flare-up and a high symptom score (above 40) on a special breathing questionnaire
      • For patients already taking regular antibiotics or specific genetic therapy (CFTR-MT), at least one flare-up must have occurred since starting this treatment

Who cannot join the trial?

16 criteria

  • Age below 18 years old or above 80 years old
  • Pregnant or breastfeeding women
  • History of severe allergic reactions to medications
  • Active lung infection at the time of screening
  • Major surgery within 3 months before the study
  • Current participation in other clinical trials
  • Significant liver problems (as shown in blood tests)
  • Severe kidney disease requiring dialysis (a process of removing waste from blood when kidneys don't work properly)
  • Active tuberculosis (a serious bacterial infection primarily affecting the lungs)
  • Inability to perform breathing tests
  • Known or suspected lung cancer
  • History of organ transplantation
  • Serious heart conditions
  • Unable to take oral medications
  • Mental conditions that could interfere with study participation
  • Alcohol or drug abuse within the past year
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Investigated drugs

Based on the provided trial information, I can only identify one medication: BI 1291583 is an investigational medication being studied for treating bronchiectasis, a condition where the airways in the lungs become damaged and widened. This medication is being tested to see if it can reduce the number of times patients experience worsening of their bronchiectasis symptoms (called pulmonary exacerbations). It is taken once daily as an oral medication. Note: The trial also includes a placebo, which has been excluded as per the instructions.

What is already known about the treatment

BI 1291583 - An investigational medication administered orally once daily that is currently being studied in Phase III clinical trials for the treatment of bronchiectasis, a chronic respiratory condition where the airways become abnormally widened. The drug is being evaluated for its efficacy in reducing the frequency of pulmonary exacerbations (sudden worsening of respiratory symptoms) in patients with bronchiectasis. While the exact mechanism of action is still under investigation as part of the AIRTIVITY® clinical trial program, this compound is being tested at a 2.5 mg daily dose and is being compared to placebo to determine its safety, tolerability, and effectiveness in managing bronchiectasis symptoms.

Investigated diseases

Bronchiectasis - A chronic lung condition where the airways become abnormally widened and damaged, leading to mucus build-up in these areas. The condition causes the walls of the airways to become thickened from chronic inflammation and infection. People with bronchiectasis often experience persistent coughing that brings up thick mucus, recurrent chest infections, and breathlessness. The damaged airways lose their ability to clear mucus effectively, creating a cycle of infection and inflammation. Over time, this condition can affect larger portions of the lungs as more airways become damaged and dilated.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518589-29-00Protocol code1397-0014Estimated enrolment1 755 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.

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).