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BI 1291583 for people with bronchiectasis

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 (The AIRTIVITY™ Study)

Phase 3 Interventional Boehringer Ingelheim · NCT06872892

This study will test whether a once-daily pill called BI 1291583 can reduce flare-ups in people aged 12 and older who have bronchiectasis and produce sputum.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1755 (estimated)
Ages12 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Locations494 sites (Birmingham, Alabama and 493 other locations)
Trial IDNCT06872892 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are people aged 12 or older with CT-confirmed bronchiectasis who produce sputum, have had prior exacerbations, can consent (or assent) and meet weight and contraceptive requirements for adolescents and women of childbearing potential.

Not a fit: People who do not produce sputum, have no history of exacerbations, are pregnant, or have medical exclusions listed by the trial are unlikely to receive benefit from this study.

Why it matters

Potential benefit: If effective, BI 1291583 could lower the number or severity of bronchiectasis flare-ups and improve symptoms and quality of life.

How similar studies have performed: Earlier phase studies of BI 1291583 and other investigational agents for bronchiectasis have shown some promising signals but require confirmation in larger phase 3 trials.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 493 other locations

+444 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bronchiectasis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.