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RECRUITING

NCT06872892

PHASE3

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Official title: A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of BI 1291583 2.5 mg Administered Once Daily for up to 76 Weeks in Patients With Bronchiectasis (The AIRTIVITY™ Study)

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1755

Start Date

2025-06-09

Completion Date

2027-12-20

Last Updated

2026-10-28

Healthy Volunteers

Conditions

Bronchiectasis

Interventions

DRUG

BI 1291583

DRUG

Placebo matching BI 1291583

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.

Locations (478)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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

Phoenix, Arizona, United States

University of Arizona

Tucson, Arizona, United States

Newport Native MD, Inc

Newport Beach, California, United States

Paradigm Clinical Research - Redding

Redding, California, United States

University of California Davis

Sacramento, California, United States

University of California San Francisco

San Francisco, California, United States

Ventura County Medical Center

Ventura, California, United States

National Jewish Health

Denver, Colorado, United States

Yale University School of Medicine

North Haven, Connecticut, United States

Georgetown University

Washington D.C., District of Columbia, United States

Central Florida Pulmonary Group

Altamonte Springs, Florida, United States

Meris Clinical Research-Brandon-69466

Brandon, Florida, United States

St. Francis Medical Institute

Clearwater, Florida, United States

North Florida/South Georgia Veterans Health System

Gainesville, Florida, United States

University of Florida College of Medicine

Jacksonville, Florida, United States

Mayo Clinic - Florida

Jacksonville, Florida, United States

University of Miami

Miami, Florida, United States

Essence MD Research

Naples, Florida, United States

Vantage Clinical Trials - Tampa

Tampa, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

Emory University

Atlanta, Georgia, United States

Augusta University

Augusta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

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

Towson, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

UMASS Memorial Medical Center

Worcester, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic, Rochester

Rochester, Minnesota, United States

HealthPartners Specialty Center 401 Building

Saint Paul, Minnesota, United States

University Of Mississippi Medical Center

Jackson, Mississippi, United States

The Lung Research Center, LLC

Chesterfield, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

New York Medical College - Hawthorne

Hawthorne, New York, United States

Northwell Health

New Hyde Park, New York, United States

New York University Langone Medical Center

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

New York Presbyterian Hospital -Columbia University

New York, New York, United States

NewYork-Presbyterian/Weill Cornell Medical Center

New York, New York, United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Stern Research Partners, LLC

Huntersville, North Carolina, United States

Pinehurst Medical Clinic, Inc. - East

Pinehurst, North Carolina, United States

Akron Children's Hospital

Akron, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

ProMedica Physicians Pulmonary and Sleep Medicine - Toledo

Toledo, Ohio, United States

Oregon Health and Sciences University

Portland, Oregon, United States

Clinical Research Associates of Central PA

DuBois, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Jefferson Health Honickman Center

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Clinical Research of Rock Hill

Rock Hill, South Carolina, United States

Horizon Clinical Research Group

Cypress, Texas, United States

Baylor University Medical Center

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

El Paso Pulmonary Association

El Paso, Texas, United States

University of Texas Medical Branch at Galveston

Galveston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Metroplex Pulmonary & Sleep Center

McKinney, Texas, United States

Methodist Heart and Lung Institute

San Antonio, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Element Research Group

San Antonio, Texas, United States

University of Texas Health Science Center at Tyler

Tyler, Texas, United States

Intermountain Healthcare

Murray, Utah, United States

University of Vermont

Burlington, Vermont, United States

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

Virginia Commonwealth University Health Systems

Richmond, Virginia, United States

University of Washington

Seattle, Washington, United States

Providence Medical Research Center

Spokane, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Centro Dr. Lazaro Langer S.R.L

Alberdi Sur, Argentina

CEC- Centro de Especialidades Cardiovasculares

Bahía Blanca, Argentina

Fundacion NIBA Neurologia Infantil Buenos Aires

CABA, Argentina

Centro de Investigacion Clinica Belgrano

CABA, Argentina

Mautalen- Salud e Investigacion

CABA, Argentina

Equipo Ciencia

CABA, Argentina

Hospital Aleman

Capital Federal, Argentina

APRILLUS-Asistencia e Investigacion

Ciudad Autonoma Buenos Aires, Argentina

Instituto Ave Pulmo - Fundacion Enfisema

Mar del Plata, Argentina

Centro Respiratorio de Quilmes

Quilmes, Argentina

Instituto de Especialidades de la Salud Rosario

Rosario, Argentina

Ibamedica

Santa Fe, Argentina

Canberra Hospital

Garran, Australian Capital Territory, Australia

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Macquarie University

North Ryde, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Heart of Australia Research Institute

Chelmer, Queensland, Australia

Lung Research Queensland

Chermside, Queensland, Australia

The Prince Charles Hospital

Chermside, Queensland, Australia

Greenslopes Private Hospital

Greenslopes, Queensland, Australia

Mater Hospital Brisbane

South Brisbane, Queensland, Australia

And 378 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (478)