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NCT06872892

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

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1755 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-09

Study Completion Date

2027-08-02

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchiectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Intervention Type DRUG

Placebo matching BI 1291583

Intervention Type DRUG

Other Intervention Names

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Verducatib

Eligibility Criteria

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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, as well as one barrier method. 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 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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Ho Chi Minh City, , Vietnam

Site Status NOT_YET_RECRUITING

Countries

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Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1317-2315

Identifier Type: REGISTRY

Identifier Source: secondary_id

1397-0014

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Treatment arm

BI 1291583

Placebo arm

Placebo matching BI 1291583

Interventions

BI 1291583

Placebo matching BI 1291583

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Boehringer Ingelheim

Responsible Party

Locations

Affiliated Hospital, Xuzhou Medical college

Northern Jiangsu People's Hospital

Yixing People'S Hospital

Specialty Hospital Medico

Clinical Hospital Centar Sestre Milosrdnice

Clinical Hospital Centre Zagreb

MediTrial s.r.o.

Motol University Hospital

The First Pulmonary Private Practice

Aalborg Sygehus Syd

Aarhus University Hospital

Hvidovre Hospital

Copenhagen University Hospital, Rigshospitalet

Vejle University Hospital

CRC-Alexandria University

Ain Shams University Clinical Research Center (MASRI)

Air Force Specialized Hospital

Kasr Al Aini, Cairo University

Helsinki University Hospital

University of Alabama at Birmingham

Providence Medical Group Alaska

Dignity Health, St. Joseph's Hospital and Medical Center

University of Arizona

Newport Native MD, Inc

Paradigm Clinical Research - Redding

University of California Davis

Ventura County Medical Center

National Jewish Health

Yale University School of Medicine

Georgetown University

Central Florida Pulmonary Group

Meris Clinical Research-Brandon-69466

St. Francis Medical Institute

North Florida/South Georgia Veterans Health System

University of Florida College of Medicine

Mayo Clinic - Florida

University of Miami

Essence MD Research

Premier Medical Associates

Cleveland Clinic Florida

Emory University

Augusta University

Northwestern University

Indiana University

University of Iowa Hospitals and Clinics

University of Kansas Medical Center

Johns Hopkins Hospital

University of Maryland St. Joseph Medical Group Pulmonary Care and Sleep Medicine

Massachusetts General Hospital

UMASS Memorial Medical Center

University of Michigan Health System

Mayo Clinic, Rochester

Health Partners Specialty

University Of Mississippi Medical Center

The Lung Research Center, LLC

SSM Health Cardinal Glennon Children's Hospital

Washington University School of Medicine