A Phase III, Randomised, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Bi 1291583 2.5 Mg Administered once Daily for Up to 76 Weeks in Patients with Bronchiectasis

Research Study for Lung Condition

C
Cynthia Brown, MD

Primary Investigator

Enrolling By Invitation
12 years or above
All
Phase 3
1 participants needed
1 Location

Brief description of study

The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. 

THIS STUDY IS ENROLLING BY INVITATION ONLY - Study staff will identify, screen and enroll subjects and perform visit procedures (i.e., vital signs, physical exams, pulmonary function tests, ECGs, blood draws and urine/sputum collection, administer questionnaires and investigational product, assess for adverse events and changes in medications, Chest CT [if applicable]). 

Detailed description of study

Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. 

  • Participants take 1 tablet once a day for up to 1 year and 6 months.
  • Participants are in the study for up to 1 year and 8 months.
  • During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Bronchiectasis
  • Age: 12 years or above
  • Gender: All

Inclusion criteria:

  • Male or female participants. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council of Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1 % per year when used consistently and correctly, as well as one barrier method. A list of contraception methods meeting these criteria is provided in the participant information.
  • Signed and dated written informed consent and assent, if applicable, prior to admission to the study, in accordance with GCP and local legislation.
  • Age of participants when signing the informed consent/assent ≥12 years.

    -- Adolescents need to weigh at least 35 kg at Visit 1.

  • Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by CT scan where bronchiectasis has been documented by a radiologist.

Participants whose past CT scan image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than five years.

  • Adult participants should be able to produce sputum for Pseudomonas aeruginosa assessment during the screening period.
  • History of documented pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, participants must have had either:
    • at least 2 exacerbations, or
    • at least 1 exacerbation and an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of >40 at screening Visit 1 (adults only)
    • at least 1 exacerbation and high symptom burden according to the investigator's judgement (adolescents only) For participants on oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy (CFTR-MT), at least one exacerbation must have occurred since initiation of antibiotics or CFTR-MT.

Exclusion criteria:

  • Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation.
  • Allergic bronchopulmonary aspergillosis being treated or requiring treatment.
  • Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment
  • Any findings in the medical examination and/or laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the participant at risk by participating in the trial.
  • Any clinically relevant (at the discretion of the investigator) acute respiratory infection or ongoing pulmonary exacerbation at screening visit or during the screening unless recovered in the opinion of the investigator prior to Visit 2.
  • Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study.
  • Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to randomisation or scheduled during trial period.
  • Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated in situ non-melanoma skin cancers or in situ carcinoma of uterine cervix.
  • Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment).
  • estimated Glomerular Filtration Rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (adults) or Chronic Kidney Disease Under 25 (CKiD-U25) (adolescents) <30 mL/min at Visit 1.
  • Previous treatment with a dipeptidyl peptidase-1 (DPP1) (Cathepsin C (CatC)) inhibitor. (Note: Participants that were randomised and only received placebo in studies with DPP1 (CatC) inhibitor are allowed.) Further exclusion criteria apply.

This study investigates a potential treatment for bronchiectasis, a condition where the airways in the lungs become damaged, leading to a build-up of mucus and frequent lung infections. The purpose of this study is to observe the effects of an investigational medication taken by participants to see if it can reduce the frequency of lung infections compared to a placebo.

Participants are split into two study arms: one takes the investigational medication and the other takes a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. Participants take one tablet daily and regularly visit the study site and receive phone check-ins. They also complete a diary on a smartphone to track symptoms and any changes in their health are monitored by study doctors.

  • Who can participate: Participants must be 12 years or older with a clinical history of bronchiectasis confirmed by CT scan and recent lung infections needing antibiotics. Women of childbearing potential must use effective birth control.
  • Study details: Participants will take one tablet daily and be monitored through site visits and phone calls. They will keep a symptom diary on a smartphone. A placebo is used in one study group, which looks like the investigational medication but contains no medicine.
  • Study timelines and visits: The study will last 1 year and 8 months. The study requires 10 visits.
Updated on 10 Mar 2026. Study ID: PULM-BOEHRINGER-AIRTIVITY, 30275
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only