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Looking for participantsPhase3

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

Sponsor: Boehringer Ingelheim

NCT ID: NCT06872892

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
BI 1291583 (drug), Placebo matching BI 1291583 (drug)
How long the study runs
Study runs about 30 months (dates as stated)
About the drug or intervention
BI 1291583 — drug: BI 1291583 · Placebo matching BI 1291583 — drug: Placebo matching BI 1291583
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
12 Years and over
Who
All
Number of participants
1,755
Started
2025-06-09
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for bronchiectasis
  • • Phase3 - 1,755 participants
  • • This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis

Who can take part?

  • • Ages 12 Years and over
  • • Diagnosed with bronchiectasis

Where?

  • • Belfast - Belfast City Hospital
  • • Birmingham - Heartlands Hospital
  • • Blackpool - Blackpool Victoria Hospital
  • • Bradford - Bradford Royal Infirmary
  • • +19 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Bronchiectasis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 12 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFR

Treatment history

Treatments you must have had:

  • ✓ had either:
  • ✓ occurred since initiation of antibiotics or CFTR-MT

What the study is looking for

  • ✓Signed and dated written agreement to take part and assent, if applicable, prior to admission to the study, in accordance...
  • ✓Age of participants when signing the agreement to take part/assent ≥12 years.
  • ✓\-- Adolescents need to weigh at least 35 kg at Visit 1.
  • ✓Participants whose past CT scan image records are not available will undergo a chest CT scan during Screening....
  • ✓Adult participants should be able to produce sputum for Pseudomonas aeruginosa assessment during the screening period.

Who cannot take part

  • ✗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
  • ✗Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to randomisation or...
  • ✗Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C liver impairment).
See the full 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. 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 Is This Study? (23 UK sites)

Belfast City Hospital

Belfast BT9 7AB, United Kingdom

COMPLETED

Heartlands Hospital

Birmingham B9 5SS, United Kingdom

Recruiting
Site contact (verified)

Blackpool Victoria Hospital

Blackpool FY3 8NR, United Kingdom

Recruiting
Site contact (verified)

Bradford Royal Infirmary

Bradford BD9 6RJ, United Kingdom

Recruiting
Site contact (verified)

Velocity Clinical Research, Bristol

Bristol BS8 2RA, United Kingdom

Recruiting
Site contact (verified)

Royal Papworth Hospital

Cambridge CB2 0AY, United Kingdom

Recruiting
Site contact (verified)

University Hospital Llandough

Cardiff CF64 2XX, United Kingdom

Recruiting
Site contact (verified)

Ninewells Hospital & Medical School

Dundee, Scotland DD1 9SY, United Kingdom

Recruiting
Site contact (verified)

University Hospital Hairmyres

East Kilbride G75 8RG, United Kingdom

COMPLETED

Royal Infirmary of Edinburgh

Edinburgh EH16 4SA, United Kingdom

Recruiting
Site contact (verified)

Royal Hospital for Children and Young People

Edinburgh EH16 4TJ, United Kingdom

Recruiting
Site contact (verified)

Western General Hospital

Edinburgh EH4 2XU, United Kingdom

Recruiting
Site contact (verified)

Freeman Hospital

High Heaton NE7 7DN, United Kingdom

Recruiting
Site contact (verified)

Royal Lancaster Infirmary

Lancaster LA1 4RP, United Kingdom

Recruiting
Site contact (verified)

St James's University Hospital

Leeds LS9 7TF, United Kingdom

Recruiting
Site contact (verified)

Liverpool Heart & Chest Hospital

Liverpool L14 3PE, United Kingdom

Recruiting
Site contact (verified)

King's College Hospital

London SE5 9RS, United Kingdom

Recruiting
Site contact (verified)

Royal Brompton Hospital

London SW3 6NP, United Kingdom

Recruiting
Site contact (verified)

Craigavon Area Hospital

Portadown BT63 5QQ, United Kingdom

Recruiting
Site contact (verified)

Northern General Hospital

Sheffield S5 7AU, United Kingdom

Recruiting
Site contact (verified)

Southampton General Hospital

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)

Royal Stoke University Hospital

Stoke-on-Trent ST4 6QG, United Kingdom

Recruiting
Site contact (verified)

Torbay Hospital

Torquay TQ2 7AA, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Boehringer Ingelheim

Sponsor contact

CONTACT

1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09