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

StatusRecruiting
PhasePhase 3
Started2025-06-09
View on ClinicalTrials.gov ↗

Amendment history

2026-09-02
Study Status, Contacts/Locations v40
Trial sites expanded: 471 → 478 locations
2026-08-19
Study Status, Contacts/Locations v39
Study sites470→471
2026-08-05
Study Status, Contacts/Locations v38
Primary completion moved earlier: 2028-09-14 → 2027-06-15
Completion moved earlier: 2028-10-12 → 2027-12-20
Study sites470 entries, revised
DCC V - Plovdiv - St. Archbishop Luka EOOD
2026-07-27
Study Status, Contacts/Locations v37
Trial sites reduced: 488 → 470 locations
2026-07-08
Study Status, Contacts/Locations v36
Trial sites reduced: 494 → 488 locations
Show 5 earlier versions
2026-06-23
Study Status, Contacts/Locations v35
Study sites494 entries, revised
HôpitalHopital Pasteur A.O.Azienda Ospedaliera dei Colli Momentum clinical Research TaurangaRotorua
2026-06-09
Study Status, Contacts/Locations v34
Study sites494 entries, revised
PremierVantage MedicalClinical AssociatesTrials - Tampa
2026-05-27
Study Status, Eligibility, Contacts/Locations v33
Eligibility criteria+13 characters
[...] 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 [...] ening period. History of documented pulmonary exacerbations (assessed and recorded by the investigator) requiring antibiotic treatment. In the 12 months before Visi [...]
Study sitesdetails revised at 9 of 494 sites
2026-05-12
Study Status, Contacts/Locations v32
Study sitesdetails revised at 27 of 494 sites
2026-04-28
Study Status, Contacts/Locations v31
Study sites495→494
2026-04-14
Study Status, Contacts/Locations v30
Trial sites reduced: 498 → 495 locations
2026-04-01
Study Status, Contacts/Locations v29
Study sites497→498
2026-03-17
Study Status, Contacts/Locations v28
Study sites497 entries, revised
Instituto Ave Pulmo - Fundacion Enfisema AOUAzienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Fondazione Policlinico Universitario A.Agostino Gemelli IRCCS
2026-03-04
Study Status, Contacts/Locations v27
Study sites498→497
2026-02-17
Study Status, Contacts/Locations, IPDSharing, References v26
Study sites499→498
2026-02-04
Study Status, Contacts/Locations v25
Study sites503→499
2026-01-20
Study Status, Contacts/Locations v24
Study sites501→503
2026-01-07
Study Status, Contacts/Locations v23
Study sites505→501
2025-12-19
Study Status, Contacts/Locations v22
Study sites511→505
2025-12-11
Study Status, Contacts/Locations v21
Study sites508→511
2025-11-25
Study Status, Contacts/Locations v20
Study sites512→508
2025-11-14
Study Status v19
Primary completion date2027-07-05→2028-09-14
Completion date2027-08-02→2028-10-12
2025-11-11
Study Status, Contacts/Locations v18
Primary completion date2028-09-14→2027-07-05
Completion date2028-10-12→2027-08-02
Study sites511→512
2025-10-29
Study Status, Contacts/Locations v17
Study sites513→511
2025-10-20
Study Identification, Study Status, Study Description, Study Design, Outcome Measures, Eligibility v16
Enrollment target1680→1755
Eligibility criteria+254 characters
[...] ipant information. Signed and dated written informed consent and assent, if applicable, prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation. Age of participants when signing the informed consent/assent ≥1812 (years. -- Adolescents need to weigh at least the35 legalkg ageat ofVisit consent in countries where it is greater than 18 years) years1. Clinical history consistent with bronchiectasis (e.g. coug [...] ) and investigator confirmed diagnosis of bronchiectasis by Computed Tomography (CT) scan where bronchiectasis has been documented by a radiologi [...] [...]
Secondary endpoints6 entries, revised
Time to first adjudicated pulmonary exacerbation up to Week 76 Absolute change from baseline in Quality of Life Questionnai [...] ectasis (QOL-B) respiratory symptoms domain score at Week 52 (participants ≥ 16 years) Time to first pulmonary exacerbation up to Week 76 AnnualizedAnnualised rate of severe adjudicated pulmonary exacerbations up to Week 76 Time to first adjudicated severe pulmonary exacerbation up to Week 76
Primary endpoints1 entry, revised
AnnualizedAnnualised rate of adjudicated pulmonary exacerbations (number of events per person year) up to Week 76
Study titlerevised
The AIRTIVITY®™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis
2025-10-15
Study Status, Contacts/Locations v15
Study sites511→513
2025-10-05
Study Status, Contacts/Locations v14
Study sites511 entries, revised
Meris Clinical Research-TampaBrandon-7033369466 OdenseSSM UniversityHealth Cardinal Glennon Children's Hospital Hospital Universitari Vall d'D Hebron Hospital Universitario La Paz Chang Gung Memorial Hospital( Linkou)
2025-09-17
Study Status, Contacts/Locations v13
Study sites503→511
2025-09-02
Study Status, Contacts/Locations v12
Study sites485→503
2025-08-22
Study Status, Contacts/Locations v11
Study sites477→485
2025-08-05
Study Status, Arms and Interventions, Contacts/Locations v10
Study sites477 entries, revised
SaintSt. Francis Sleep, Allergy and LungMedical Institute, Huzhou LLCCentral Hospital Velocity Clinical Research Germany GmbH-, Ahrensburg-69816 Velocity Clinical Research Germany GmbH-, Lübeck-69809 Kaohsiung Medical University Chung-Ho Memorial Hospital
2025-07-25
Study Status, Contacts/Locations v9
Study sites462→477
2025-07-08
Study Status, Contacts/Locations v8
Study sites441→462
2025-06-27
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v7
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-06-16→confirmed 2025-06-09
Study sites414→441
2025-06-10
Study Status, Contacts/Locations v6
Study sites394→414
2025-05-13
Study Status, Contacts/Locations v5
Study sites384→394
2025-04-30
Study Status, Contacts/Locations v4
Study sites375→384
2025-04-17
Study Status, Contacts/Locations v3
Study sites321→375
2025-04-01
Study Status, Contacts/Locations v2
Study sites301→321
2025-03-25
Study Status, Contacts/Locations v1
Study sites0→301
2025-03-07
Original filing
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.
Trial Details
NCT Number NCT06872892
Lead Sponsor Boehringer Ingelheim
Conditions Bronchiectasis
Enrollment 1,755 participants
Start Date 2025-06-09
Primary Completion 2027-06-15 (estimated)
Study Completion 2027-12-20 (estimated)
Updated on ClinicalTrials.gov 2026-10-01