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Taking people in United StatesPhase 3

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

Key facts

Where
Akron, Ann Arbor, Atlanta, Augusta, Baltimore, Birmingham, Boston, Brandon, Burlington, Chapel Hill, Charleston, Chesterfield, Cincinnati, Clearwater, Cleveland, Cypress, Dallas, Denver, DuBois, El Paso, Falls Church, Gainesville, Galveston, Hawthorne, Houston, Huntersville, Indianapolis, Iowa City, Jackson, Jacksonville, Kansas City, Lebanon, Madison, McKinney, Miami, Milwaukee, Murray, Naples, New Brunswick, New Hyde Park, New York, Newport Beach, North Haven, Omaha, Philadelphia, Pinehurst, Portland, Redding, Richmond, Rochester, Rock Hill, Sacramento, Saint Paul, San Antonio, San Francisco, Seattle, Spokane, St Louis, Tampa, Towson, Tucson, Tyler, Ventura, Washington D.C., Weston, and Worcester, United StatesSee the 74 sites
Phase
Phase 3

Where in United States

  • Akron Children's HospitalAkron, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of MichiganAnn Arbor, United StatesContact: Boehringer IngelheimNo longer taking part
  • Emory UniversityAtlanta, United StatesContact: Boehringer IngelheimNo longer taking part
  • Augusta UniversityAugusta, United StatesContact: Boehringer IngelheimNo longer taking part
  • Johns Hopkins HospitalBaltimore, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of Alabama at BirminghamBirmingham, United StatesContact: Boehringer IngelheimTaking people
  • Massachusetts General HospitalBoston, United StatesContact: Boehringer IngelheimNo longer taking part
  • Meris Clinical Research-Brandon-69466Brandon, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of VermontBurlington, United StatesContact: Boehringer IngelheimNo longer taking part
  • The University of North Carolina at Chapel HillChapel Hill, United StatesContact: Boehringer IngelheimNo longer taking part
  • Medical University of South CarolinaCharleston, United StatesContact: Boehringer IngelheimNo longer taking part
  • The Lung Research Center, LLCChesterfield, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of CincinnatiCincinnati, United StatesContact: Boehringer IngelheimNo longer taking part
  • St Francis Medical InstituteClearwater, United StatesContact: Boehringer IngelheimNo longer taking part
  • University Hospitals Cleveland Medical Center*Cleveland, United StatesContact: Boehringer IngelheimNo longer taking part
  • Horizon Clinical Research GroupCypress, United StatesContact: Boehringer IngelheimNo longer taking part
  • Baylor University Medical CenterDallas, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of Texas Southwestern Medical CenterDallas, United StatesContact: Boehringer IngelheimNo longer taking part
  • National Jewish HealthDenver, United StatesContact: Boehringer IngelheimNo longer taking part
  • Clinical Research Associates of Central PADuBois, United StatesContact: Boehringer IngelheimNo longer taking part
  • El Paso Pulmonary AssociationEl Paso, United StatesContact: Boehringer IngelheimNo longer taking part
  • Inova Fairfax Medical CampusFalls Church, United StatesContact: Boehringer IngelheimNo longer taking part
  • North Florida/South Georgia Veterans Health SystemGainesville, United StatesContact: Boehringer IngelheimNo longer taking part
  • University Of Texas Medical Branch At GalvestonGalveston, United StatesContact: Boehringer IngelheimTaking people
  • New York Medical College - HawthorneHawthorne, United StatesContact: Boehringer IngelheimNo longer taking part
  • Baylor College of MedicineHouston, United StatesContact: Boehringer IngelheimNo longer taking part
  • Stern Research Partners, LLCHuntersville, United StatesContact: Boehringer IngelheimNo longer taking part
  • Indiana UniversityIndianapolis, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of Iowa Hospitals and ClinicsIowa City, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of Mississippi Medical CenterJackson, United StatesContact: Boehringer IngelheimNo longer taking part
  • Mayo Clinic FloridaJacksonville, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of Florida - College of MedicineJacksonville, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of Kansas Medical CenterKansas City, United StatesContact: Boehringer IngelheimNo longer taking part
  • Dartmouth Hitchcock Medical CenterLebanon, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of WisconsinMadison, United StatesContact: Boehringer IngelheimNo longer taking part
  • Metroplex Pulmonary & Sleep CenterMcKinney, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of MiamiMiami, United StatesContact: Boehringer IngelheimNo longer taking part
  • Froedtert and the Medical College of WisconsinMilwaukee, United StatesContact: Boehringer IngelheimNo longer taking part
  • Intermountain HealthcareMurray, United StatesContact: Boehringer IngelheimNo longer taking part
  • Essence MD ResearchNaples, United StatesContact: Boehringer IngelheimNo longer taking part
  • Rutgers, Robert Wood Johnson Medical SchoolNew Brunswick, United StatesContact: Boehringer IngelheimNo longer taking part
  • Northwell HealthNew Hyde Park, United StatesContact: Boehringer IngelheimNo longer taking part
  • Icahn School of Medicine at Mount SinaiNew York, United StatesContact: Boehringer IngelheimNo longer taking part
  • New York Presbyterian Hospital/Columbia UniversityNew York, United StatesContact: Boehringer IngelheimNo longer taking part
  • New York University Langone Medical CenterNew York, United StatesContact: Boehringer IngelheimNo longer taking part
  • NewYork-Presbyterian Weill Cornell Medical CenterNew York, United StatesContact: Boehringer IngelheimNo longer taking part
  • Newport Native Md, Inc.Newport Beach, United StatesContact: Boehringer IngelheimNo longer taking part
  • Yale University School of MedicineNorth Haven, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of Nebraska Medical CenterOmaha, United StatesContact: Boehringer IngelheimNo longer taking part
  • Jefferson Health Honickman CenterPhiladelphia, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of PennsylvaniaPhiladelphia, United StatesContact: Boehringer IngelheimNo longer taking part
  • Pinehurst Medical Clinic, Inc. - EastPinehurst, United StatesContact: Boehringer IngelheimNo longer taking part
  • Oregon Health Sciences UniversityPortland, United StatesContact: Boehringer IngelheimNo longer taking part
  • Paradigm Clinical Research - ReddingRedding, United StatesContact: Boehringer IngelheimNo longer taking part
  • Virginia Commonwealth University Health SystemsRichmond, United StatesContact: Boehringer IngelheimNo longer taking part
  • Mayo Clinic - RochesterRochester, United StatesContact: Boehringer IngelheimNo longer taking part
  • Clinical Research of Rock HillRock Hill, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of California - DavisSacramento, United StatesContact: Boehringer IngelheimNo longer taking part
  • HealthPartners Specialty Center 401 BuildingSaint Paul, United StatesContact: Boehringer IngelheimNo longer taking part
  • Methodist Heart and Lung InstituteSan Antonio, United StatesContact: Boehringer IngelheimNot yet recruiting
  • Element Research GroupSan Antonio, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of Texas Health Science Center at San AntonioSan Antonio, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of California San FranciscoSan Francisco, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of WashingtonSeattle, United StatesContact: Boehringer IngelheimNo longer taking part
  • Providence Medical Research CenterSpokane, United StatesContact: Boehringer IngelheimNo longer taking part
  • Washington University School of MedicineSt Louis, United StatesContact: Boehringer IngelheimNo longer taking part
  • Vantage Clinical Trials - TampaTampa, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of Maryland St. Joseph Medical Group Pulmonary Care and Sleep MedicineTowson, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of ArizonaTucson, United StatesContact: Boehringer IngelheimNo longer taking part
  • University of Texas Health Science Center at TylerTyler, United StatesContact: Boehringer IngelheimNo longer taking part
  • Ventura County Medical CenterVentura, United StatesContact: Boehringer IngelheimNo longer taking part
  • Georgetown UniversityWashington D.C., United StatesContact: Boehringer IngelheimNo longer taking part
  • Cleveland Clinic FloridaWeston, United StatesContact: Boehringer IngelheimNo longer taking part
  • Umass Memorial Medical CenterWorcester, United StatesContact: Boehringer IngelheimNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Boehringer Ingelheim
Trial code
NCT06872892EU 2024-518589-29-00
Record updated
12 November 2026
Original 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).Read full original descriptionShow less

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)

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.

Inclusion: 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: 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; Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to randomisation or scheduled during trial period; 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; 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 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; 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); 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; 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.

ClinicalTrials.gov NCT06872892 · EU CTIS 2024-518589-29-00