BI 1291583 for people with bronchiectasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled phase 3 trial enrolls adolescents (12 years and up) and adults with CT-confirmed bronchiectasis who produce sputum and have a history of exacerbations. Participants are assigned by chance to receive either BI 1291583 or a matching placebo tablet once daily and are followed for up to 1 year and 8 months, with treatment for up to 1 year and 6 months. Study procedures include up to 10 in-person visits, about 13 phone calls, and daily symptom diaries completed on a smartphone while investigators document exacerbations and safety measures. The trial compares exacerbation rates and safety outcomes between groups to determine whether BI 1291583 provides clinical benefit.

Why it matters

Who can join: the full rules

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. 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 (assessed and recorded by the investigator) 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.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Augusta University
  Augusta, Georgia, United States Recruiting
• Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting
• Rutgers Robert Wood Johnson Medical School
  New Brunswick, New Jersey, United States Recruiting
• New York Medical College - Hawthorne
  Hawthorne, New York, United States Recruiting
• University of Texas Health Science Center at San Antonio
  San Antonio, Texas, United States Recruiting

+428 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Chronic Respiratory Disease Participant Engagement

  This study tests whether adults with long-term lung conditions can get comfortable with a clinical trials unit and research team before joining future trials.

  Recruiting Richmond Pharmacology Limited · London · NCT07924462

• Breathlessness in respiratory diseases: who feels it and why

  This study tests how physiology, psychology, function, and breathing patterns relate to breathlessness in people with respiratory conditions compared with healthy controls.

  Recruiting University Hospitals, Leicester · Leicester, Leicestershire · NCT07648082

• Hypertonic saline inhalation for NTM lung disease

  This trial tests whether starting inhaled 3% hypertonic saline early helps people with non-tuberculous mycobacterial lung disease feel better and clear bacteria better, compared with starting with normal saline first.

  Recruiting Taipei Veterans General Hospital, Taiwan · Taipei · NCT07647575

• Azithromycin added to usual care to see if it lowers bronchiectasis flare-ups

  This trial tests whether taking azithromycin daily for a year reduces bronchiectasis-related flare-ups in adults with non-cystic fibrosis bronchiectasis.

  Recruiting Phase 4 Assiut University · Asyut · NCT07608328

• Bronchiectasis Phenotype Identification Model for Adults

  This study tests a baseline classifier to categorize adults with non-cystic fibrosis bronchiectasis into phenotype groups using data collected over time.

  Recruiting Assiut University · Asyut, Assiut Egypt · NCT07599969

• BASE: Aiming to test a simple, objective way to gauge bronchiectasis severity and predict flare-ups

  This study tests a new BASE framework to classify how severe non-cystic fibrosis bronchiectasis is right now and see if it can predict 12 months of worsening or flare-ups.

  Recruiting Assiut University · Asyut, Asyut Egypt · NCT07599839

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.