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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (23 UK sites)
Belfast City Hospital
Belfast BT9 7AB, United Kingdom
Heartlands Hospital
Birmingham B9 5SS, United Kingdom
Blackpool Victoria Hospital
Blackpool FY3 8NR, United Kingdom
Bradford Royal Infirmary
Bradford BD9 6RJ, United Kingdom
Velocity Clinical Research, Bristol
Bristol BS8 2RA, United Kingdom
Royal Papworth Hospital
Cambridge CB2 0AY, United Kingdom
University Hospital Llandough
Cardiff CF64 2XX, United Kingdom
Ninewells Hospital & Medical School
Dundee, Scotland DD1 9SY, United Kingdom
University Hospital Hairmyres
East Kilbride G75 8RG, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh EH16 4SA, United Kingdom
Royal Hospital for Children and Young People
Edinburgh EH16 4TJ, United Kingdom
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
Freeman Hospital
High Heaton NE7 7DN, United Kingdom
Royal Lancaster Infirmary
Lancaster LA1 4RP, United Kingdom
St James's University Hospital
Leeds LS9 7TF, United Kingdom
Liverpool Heart & Chest Hospital
Liverpool L14 3PE, United Kingdom
King's College Hospital
London SE5 9RS, United Kingdom
Royal Brompton Hospital
London SW3 6NP, United Kingdom
Craigavon Area Hospital
Portadown BT63 5QQ, United Kingdom
Northern General Hospital
Sheffield S5 7AU, United Kingdom
Southampton General Hospital
Southampton SO16 6YD, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent ST4 6QG, United Kingdom
Torbay Hospital
Torquay TQ2 7AA, United Kingdom
How to Get in Touch
Boehringer Ingelheim
Sponsor contactCONTACT
