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Clinical Trials in Ireland / NCT06872892
Recruiting Phase 3

The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis

NCT06872892 · tracked via the Priya Life Science Ireland tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 3
Started
2025-06-09
Last updated
2026-09-03

Condition(s) studied

Bronchiectasis

Investigational drug(s) / intervention(s)

BI 1291583Placebo matching BI 1291583

BI 1291583: BI 1291583

Placebo matching BI 1291583: Placebo matching BI 1291583

Study summary

This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations).

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

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (470)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
Dignity Health, St. Joseph's Hospital and Medical Center Phoenix Arizona Not Yet Recruiting
University of Arizona Tucson Arizona Active Not Recruiting
Newport Native MD, Inc Newport Beach California Active Not Recruiting
Paradigm Clinical Research - Redding Redding California Active Not Recruiting
University of California Davis Sacramento California Active Not Recruiting
University of California San Francisco San Francisco California Active Not Recruiting
Ventura County Medical Center Ventura California Completed
National Jewish Health Denver Colorado Active Not Recruiting
Yale University School of Medicine North Haven Connecticut Active Not Recruiting
Georgetown University Washington D.C. District of Columbia Active Not Recruiting
Central Florida Pulmonary Group Altamonte Springs Florida Not Yet Recruiting
Meris Clinical Research-Brandon-69466 Brandon Florida Active Not Recruiting
St. Francis Medical Institute Clearwater Florida Completed
North Florida/South Georgia Veterans Health System Gainesville Florida Completed
University of Florida College of Medicine Jacksonville Florida Completed
Mayo Clinic - Florida Jacksonville Florida Active Not Recruiting
University of Miami Miami Florida Active Not Recruiting
Essence MD Research Naples Florida Active Not Recruiting
Vantage Clinical Trials - Tampa Tampa Florida Active Not Recruiting
Cleveland Clinic Florida Weston Florida Active Not Recruiting
Emory University Atlanta Georgia Recruiting
Augusta University Augusta Georgia Recruiting
Northwestern University Chicago Illinois Not Yet Recruiting
Indiana University Indianapolis Indiana Completed
University of Iowa Hospitals and Clinics Iowa City Iowa Completed
University of Kansas Medical Center Kansas City Kansas Active Not Recruiting
Johns Hopkins Hospital Baltimore Maryland Recruiting
University of Maryland St. Joseph Medical Group Pulmonary Care and Sleep Medicine Towson Maryland Completed
Massachusetts General Hospital Boston Massachusetts Active Not Recruiting
UMASS Memorial Medical Center Worcester Massachusetts Active Not Recruiting
University of Michigan Ann Arbor Michigan Active Not Recruiting
Mayo Clinic, Rochester Rochester Minnesota Active Not Recruiting
HealthPartners Specialty Center 401 Building Saint Paul Minnesota Active Not Recruiting
University Of Mississippi Medical Center Jackson Mississippi Active Not Recruiting
The Lung Research Center, LLC Chesterfield Missouri Completed
Washington University School of Medicine St Louis Missouri Active Not Recruiting
Washington University School of Medicine St Louis Missouri Completed
University of Nebraska Medical Center Omaha Nebraska Active Not Recruiting
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire Recruiting

+ 430 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06872892 on ClinicalTrials.gov ↗ ← All trials in Ireland