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RecruitingNCT06872892Updated Oct 28, 2026

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

A Phase 3 interventional study of BI 1291583 and Placebo matching BI 1291583 in Bronchiectasis, sponsored by Boehringer Ingelheim. Recruiting at 478 sites in 46 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 5 months later.
Updated Oct 28, 2026Site recruiting status changed15 sites added+1 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
1,755
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

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.

02

Conditions studied

  • Bronchiectasis

Browse trials for

03

In context

Bronchiectasis

404 studies on the registry are indexed under Bronchiectasis; 125 are open to participants now.

This study's planned enrollment of 1,755 is above the median of 60 across 263 interventional studies indexed under Bronchiectasis.

Browse Bronchiectasis studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 62 are open to participants now.

Of its 167 completed or terminated interventional studies of FDA-regulated products, 123 (74%) have results posted.

Browse Boehringer Ingelheim studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female participants. Woman of (WOCBP) must be ready and able to use highly effective methods of 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 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

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 (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 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 ( score B or C hepatic impairment).
  • estimated (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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,755 participants (estimated)

Study arms

  • Experimental
    Treatment arm

    Drug: BI 1291583

  • Placebo comparator
    Placebo arm

    Drug: Placebo matching BI 1291583

Interventions

  • DrugBI 1291583

    BI 1291583

    Also known as: Verducatib

  • DrugPlacebo matching BI 1291583

    Placebo matching BI 1291583

06

What researchers measure

Primary outcomes

  1. Annualised rate of adjudicated pulmonary exacerbations (number of events per person year) up to Week 76

    Time frame: up to 76 weeks

Secondary outcomes

  1. Time to first adjudicated pulmonary exacerbation up to Week 76

    Time frame: up to 76 weeks

  2. Absolute change from baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) respiratory symptoms domain score at Week 52 (participants ≥ 16 years)

    The QOL-B is a patient reported outcome (PRO) measure assessing symptoms, functioning and health-related quality of life of patients with bronchiectasis. It consists of 37 items covering the following domains: respiratory symptoms, physical functioning, vitality, role functioning, health perception, emotional functioning, social functioning, and treatment burden. All items are rated on a 4-point response scale ranging from 'a lot' to 'not at all' with the recall period 'the previous week'. Domain scores are generated ranging from 0 to 100, with higher scores indicating less symptom burden, better functioning, and higher health-related quality of life respectively.

    Time frame: at baseline, at week 52

  3. Absolute change from baseline in post-bronchodilator Forced Expiratory Volume in the first second (FEV1) %pred at Week 52

    Time frame: at baseline, at week 52

  4. Absolute change from baseline in post-bronchodilator Forced Vital Capacity (FVC) %pred at Week 52

    Time frame: at baseline, at week 52

  5. Annualised rate of severe adjudicated pulmonary exacerbations up to Week 76

    Time frame: up to 76 weeks

  6. Time to first adjudicated severe pulmonary exacerbation up to Week 76

    Time frame: up to 76 weeks

07

Study locations

244 of 478 sites recruiting

Showing the first 100 of 478 sites across 46 countries. Choose a country and city above to see the rest.

08

References and documents

Publications

  • Chalmers JD, Shteinberg M, Chotirmall SH, Sauter W, Flume PA, Jain R, Morimoto K, O'Donnell AE, Ringshausen FC, Watz H, Xu JF, Rauch J, Eleftheraki A, Engel AT, Chang AB, Nielsen KG, Benitez G, Gupta A, Mall MA, McShane PJ. Phase III AIRTIVITY study design: verducatib (BI 1291583) in people with bronchiectasis. ERJ Open Res. 2026 Sep 1;12(5):01068-2025. doi: 10.1183/23120541.01068-2025. eCollection 2026 Sep. PubMed 42820152 ↗

Related links

Individual participant data

Plan to share: Yes — Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

Access criteria: For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Data sharing details ↗ · www.clinicalstudies.boehringer-ingelheim.com

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2025 (actual). Primary completion is estimated for Jun 2027, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2025
First posted
Mar 12, 2025
StartActual
Jun 9, 2025
Primary completionEst.
Jun 15, 2027
CompletionEst.
Dec 20, 2027
Last update
Oct 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
15 sites added, 8 sites removed. 9 sites changed recruiting status (7 now completed, 1 now active, not recruiting, …)
Show 9 sites
  • CEC- Centro de Especialidades Cardiovasculares · Bahía Blanca, ArgentinaRecruiting→Completed
  • Kangdong Sacred Heart Hospital · Seoul, South KoreaCompleted→Active, not recruiting
  • Enhancing Care Foundation NPC · Mount Edgecombe, South AfricaRecruiting→Completed
  • Emory University · Atlanta, United StatesRecruiting→Completed
  • Dartmouth-Hitchcock Medical Center · Lebanon, United StatesRecruiting→Completed
  • Akron Children's Hospital · Akron, United StatesRecruiting→Completed
  • Oregon Health and Sciences University · Portland, United StatesRecruiting→Completed
  • Ospedale Pediatrico Bambino Gesù · Roma, ItalyNot yet recruiting→Recruiting
  • Hospital Sultanah Bahiyah · Alor Setar, Kedah, MalaysiaActive, not recruiting→Completed
Show 15 added (7 India, 2 Bulgaria, 1 China, 1 Germany, 1 Spain, 1 United States, 1 Argentina, 1 France)
  • Sichuan Provincial People's Hospital · Chengdu, China
  • Christliches Klinikum Halle (Saale) GmbH · Halle, Germany
  • Jawahar Lal Nehru Medical College · Ajmer, India
  • M. S. Ramaiah Institute of Health Science · Bengaluru, India
  • Narayana Health - Mazumdar Shaw Medical Center · Bengaluru, India
  • B. P. Poddar Hospital and Medical Research Limited · Kolkata, India
  • Siddhi Hospital, C/o Dr. Mutha Hospital · Nashik, India
  • Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences · Rohtak, India
  • Government Hospital for Chest and Communicable Diseases (GHCCD) · Visakhapatnam, India
  • Hospital Universitario de Navarra · Pamplona, Spain
  • Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse · Rousse, Bulgaria
  • Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Vraca /Sbalpfz Vratsa EOOD · Vratsa, Bulgaria
  • New York Presbyterian Hospital -Columbia University · New York, United States
  • Hospital Aleman · Capital Federal, Argentina
  • HOP Haut-Leveque · Pessac, France
Show 8 removed
  • People's Hospital of Sichuan Province · Chengdu, China
  • Krankenhaus Martha-Maria Halle-Dölau gGmbH · Halle, Germany
  • Complejo Hospitalario de Navarra · Pamplona, Spain
  • SHATPPD "Dr. Dimitar Gramatikov" · Rousse, Bulgaria
  • Sbalpfz-Vratsa · Vratsa, Bulgaria
  • Columbia University Medical Center-New York Presbyterian Hospital · New York, United States
  • Hospital Aleman · CABA, Argentina
  • HOP Haut-Lévêque · Pessac, France
across 3 updates, Oct 1, 2026 – Oct 28, 2026
Site contacts
Changed at 6 sites. See the sites
Show 6 sites
  • CEC- Centro de Especialidades Cardiovasculares · Bahía Blanca, ArgentinaContact removed a•••@bitrialsupport.com · •••7801
  • Enhancing Care Foundation NPC · Mount Edgecombe, South AfricaContact removed s•••@bitrialsupport.com · •••8886
  • Emory University · Atlanta, United StatesContact removed u•••@bitrialsupport.com · •••2368
  • Dartmouth-Hitchcock Medical Center · Lebanon, United StatesContact removed u•••@bitrialsupport.com · •••2368
  • Akron Children's Hospital · Akron, United StatesContact removed u•••@bitrialsupport.com · •••2368
  • Oregon Health and Sciences University · Portland, United StatesContact removed u•••@bitrialsupport.com · •••2368
across 3 updates, Oct 1, 2026 – Oct 28, 2026
Show all 3 updates
  1. Oct 28, 2026
    3 sites added, 3 sites removed. 6 sites changed recruiting status (5 now completed, 1 now recruiting)
    Show 6 sites
    • Emory University · Atlanta, United StatesRecruiting→Completed
    • Dartmouth-Hitchcock Medical Center · Lebanon, United StatesRecruiting→Completed
    • Akron Children's Hospital · Akron, United StatesRecruiting→Completed
    • Oregon Health and Sciences University · Portland, United StatesRecruiting→Completed
    • Ospedale Pediatrico Bambino Gesù · Roma, ItalyNot yet recruiting→Recruiting
    • Hospital Sultanah Bahiyah · Alor Setar, Kedah, MalaysiaActive, not recruiting→Completed
    Show 3 added (1 United States, 1 Argentina, 1 France)
    • New York Presbyterian Hospital -Columbia University · New York, United States
    • Hospital Aleman · Capital Federal, Argentina
    • HOP Haut-Leveque · Pessac, France
    Show 3 removed
    • Columbia University Medical Center-New York Presbyterian Hospital · New York, United States
    • Hospital Aleman · CABA, Argentina
    • HOP Haut-Lévêque · Pessac, France
    Site contacts Changed at 4 sites. See the sites
    Show 4 sites
    • Emory University · Atlanta, United StatesContact removed u•••@bitrialsupport.com · •••2368
    • Dartmouth-Hitchcock Medical Center · Lebanon, United StatesContact removed u•••@bitrialsupport.com · •••2368
    • Akron Children's Hospital · Akron, United StatesContact removed u•••@bitrialsupport.com · •••2368
    • Oregon Health and Sciences University · Portland, United StatesContact removed u•••@bitrialsupport.com · •••2368
  2. Oct 14, 2026
    2 sites added, 2 sites removed. Enhancing Care Foundation NPC is now Completed
    Show 2 added (2 Bulgaria)
    • Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse · Rousse, Bulgaria
    • Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Vraca /Sbalpfz Vratsa EOOD · Vratsa, Bulgaria
    Show 2 removed
    • SHATPPD "Dr. Dimitar Gramatikov" · Rousse, Bulgaria
    • Sbalpfz-Vratsa · Vratsa, Bulgaria
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Enhancing Care Foundation NPC · Mount Edgecombe, South AfricaContact removed s•••@bitrialsupport.com · •••8886
    + 1 other change: verification date
  3. Oct 1, 2026
    10 sites added, 3 sites removed. 2 sites changed recruiting status (1 now completed, 1 now active, not recruiting)
    Show 2 sites
    • CEC- Centro de Especialidades Cardiovasculares · Bahía Blanca, ArgentinaRecruiting→Completed
    • Kangdong Sacred Heart Hospital · Seoul, South KoreaCompleted→Active, not recruiting
    Show 10 added (7 India, 1 China, 1 Germany, 1 Spain)
    • Sichuan Provincial People's Hospital · Chengdu, China
    • Christliches Klinikum Halle (Saale) GmbH · Halle, Germany
    • Jawahar Lal Nehru Medical College · Ajmer, India
    • M. S. Ramaiah Institute of Health Science · Bengaluru, India
    • Narayana Health - Mazumdar Shaw Medical Center · Bengaluru, India
    • B. P. Poddar Hospital and Medical Research Limited · Kolkata, India
    • Siddhi Hospital, C/o Dr. Mutha Hospital · Nashik, India
    • Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences · Rohtak, India
    • Government Hospital for Chest and Communicable Diseases (GHCCD) · Visakhapatnam, India
    • Hospital Universitario de Navarra · Pamplona, Spain
    Show 3 removed
    • People's Hospital of Sichuan Province · Chengdu, China
    • Krankenhaus Martha-Maria Halle-Dölau gGmbH · Halle, Germany
    • Complejo Hospitalario de Navarra · Pamplona, Spain
    Site contacts Changed at 1 site. See the sites
    Show the site
    • CEC- Centro de Especialidades Cardiovasculares · Bahía Blanca, ArgentinaContact removed a•••@bitrialsupport.com · •••7801

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06872892
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Mar 12, 2025
Start date
Jun 9, 2025
Primary completion
Jun 15, 2027 (estimated)
Completion
Dec 20, 2027 (estimated)
Last update
Oct 28, 2026

Study contacts

Boehringer Ingelheim
Contact
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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