RECRUITING

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

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Conditions

Bronchiectasis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2025-06-09
Study Completion:2028-10-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06872892

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Signed and dated written informed consent and assent, if applicable, prior to admission to the study, in accordance with GCP and local legislation.
  3. * Age of participants when signing the informed consent/assent ≥12 years.
  4. * 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.
  5. * Adult participants should be able to produce sputum for Pseudomonas aeruginosa assessment during the screening period.
  6. * History of documented pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, participants must have had either:
  7. * at least 2 exacerbations, or
  8. * at least 1 exacerbation and an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of \>40 at screening Visit 1 (adults only)
  9. * 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.
  1. * Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation.
  2. * Allergic bronchopulmonary aspergillosis being treated or requiring treatment.
  3. * Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment
  4. * 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.
  5. * 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.
  6. * 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.
  7. * Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to randomisation or scheduled during trial period.
  8. * 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.
  9. * Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment).
  10. * 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.
  11. * 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.

Contacts and Locations

Study Contact

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

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
Providence Medical Group Alaska
Anchorage, Alaska, 99508
United States
Dignity Health, St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
United States
University of Arizona
Tucson, Arizona, 85724
United States
Newport Native MD, Inc
Newport Beach, California, 92663
United States
Paradigm Clinical Research - Redding
Redding, California, 96001
United States
University of California Davis
Sacramento, California, 95816
United States
Ventura County Medical Center
Ventura, California, 93003
United States
National Jewish Health
Denver, Colorado, 80206
United States
Yale University School of Medicine
New Haven, Connecticut, 06519
United States
Georgetown University
Washington D.C., District of Columbia, 20007
United States
Central Florida Pulmonary Group
Altamonte Springs, Florida, 32701
United States
Meris Clinical Research-Brandon-69466
Brandon, Florida, 33511
United States
St. Francis Medical Institute
Clearwater, Florida, 33765
United States
Malcom Randall VA Medical Center
Gainesville, Florida, 32608
United States
University of Florida College of Medicine
Jacksonville, Florida, 32209
United States
Mayo Clinic - Florida
Jacksonville, Florida, 32224
United States
University of Miami
Miami, Florida, 33136
United States
Essence MD Research
Naples, Florida, 34102
United States
Premier Medical Associates
The Villages, Florida, 32159
United States
Cleveland Clinic Florida
Weston, Florida, 33331
United States
Emory University
Atlanta, Georgia, 30342
United States
Augusta University
Augusta, Georgia, 30912
United States
Northwestern University
Chicago, Illinois, 60611
United States
Indiana University
Indianapolis, Indiana, 46202
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Johns Hopkins University
Baltimore, Maryland, 21218
United States
University of Maryland St. Joseph Medical Group Pulmonary Care and Sleep Medicine
Towson, Maryland, 21286
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655
United States
University of Michigan Health System
Ann Arbor, Michigan, 48109-5314
United States
Mayo Clinic, Rochester
Rochester, Minnesota, 55902
United States
Health Partners Specialty
Saint Paul, Minnesota, 55130
United States
University Of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
The Lung Research Center, LLC
Chesterfield, Missouri, 63017
United States
SSM Health Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
United States
Washington University School of Medicine
St Louis, Missouri, 63110
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
United States
New York Medical College - Hawthorne
Hawthorne, New York, 10532
United States
Northwell Health
New Hyde Park, New York, 11040
United States
NYU Langone Health
New York, New York, 10017
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032
United States
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, 10065
United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Stern Research Partners, LLC
Huntersville, North Carolina, 28078
United States
Pinehurst Medical Clinic, Inc. - East
Pinehurst, North Carolina, 28374
United States
Akron Children's Hospital
Akron, Ohio, 44308
United States
University of Cincinnati
Cincinnati, Ohio, 45219
United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106
United States
ProMedica Physicians Pulmonary and Sleep Medicine - Toledo
Toledo, Ohio, 43606
United States
Summit Health
Bend, Oregon, 97701
United States
Oregon Health and Sciences University
Portland, Oregon, 97239
United States
Clinical Research Associates of Central PA
DuBois, Pennsylvania, 15801
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Jefferson Health Honickman Center
Philadelphia, Pennsylvania, 19107
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
United States
Horizon Clinical Research Group
Cypress, Texas, 77429
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
El Paso Pulmonary Association
El Paso, Texas, 79902
United States
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
United States
Metroplex Pulmonary & Sleep Center
McKinney, Texas, 75069
United States
Methodist Heart and Lung Institute
San Antonio, Texas, 78229
United States
UT Health San Antonio
San Antonio, Texas, 78229
United States
Element Research Group
San Antonio, Texas, 78258
United States
University of Texas Health Science Center at Tyler
Tyler, Texas, 75708
United States
Intermountain Healthcare
Murray, Utah, 84107
United States
University of Vermont
Colchester, Vermont, 05446
United States
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
United States
Virginia Commonwealth University Health Systems
Richmond, Virginia, 23219
United States
University of Washington
Seattle, Washington, 98195
United States
Providence Medical Research Center
Spokane, Washington, 99204
United States
University of Wisconsin
Madison, Wisconsin, 53792
United States
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Boehringer Ingelheim

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-09
Study Completion Date2028-10-12

Study Record Updates

Study Start Date2025-06-09
Study Completion Date2028-10-12

Terms related to this study

Additional Relevant MeSH Terms

  • Bronchiectasis