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Recruiting Phase 3 NCT06872892

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

Phase 3 – large-scale trial before approval
Conditions: Bronchiectasis

Sponsor: Boehringer Ingelheim

trial.available_in: БГ
Overview
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.
Who can participate
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. * 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 43
Argentina (1)
Centro Dr. Lazaro Langer S.R.L
Alberdi Sur
Australia (1)
Canberra Hospital
Garran , Australian Capital Territory
Belgium (1)
Cliniques Universitaires Saint-Luc
Brussels
Brazil (1)
Serviços Medicos Respirar Sul Fluminense
Barra Mansa
Bulgaria (1)
MHAT Rahila Angelova AD
Pernik
ACTIVE_NOT_RECRUITING
Canada (1)
University of Calgary
Calgary , Alberta
Chile (1)
Centro de Estudios Clínicos CEC
Santiago
China (1)
China-Japan Friendship Hospital
Beijing
Croatia (1)
Clinical Hospital Centar Sestre Milosrdnice
Zagreb
ACTIVE_NOT_RECRUITING
Czech Republic (1)
MediTrial s.r.o.
Jindřichův Hradec
ACTIVE_NOT_RECRUITING
Denmark (1)
Aalborg Sygehus Syd
Aalborg
Egypt (1)
CRC-Alexandria University
Alexandria
NOT_YET_RECRUITING
Finland (1)
Helsinki University Hospital
Helsinki
France (1)
CHU Amiens-Picardie
Amiens
NOT_YET_RECRUITING
Hong Kong (1)
Prince of Wales Hospital-Hong Kong-20715
Hong Kong
Hungary (1)
Koranyi National Institute For Pulmonolgy
Budapest
India (1)
Jawahar Lal Nehru Medical College
Ajmer
NOT_YET_RECRUITING
Ireland (1)
Cork University Hospital
Cork
Israel (1)
Lady Davis Carmel Medical Center
Haifa
Italy (1)
Azienda Ospedaliero Universitaria delle Marche
Ancona
NOT_YET_RECRUITING
Japan (1)
Nagoya University Hospital
Aichi, Nagoya
Kazakhstan (1)
Multidisciplinary City Hospital №1 of the Akimat of Astana
Astana
NOT_YET_RECRUITING
Latvia (1)
Med.Center OLVI Health Center Assotiation,Private Practice
Daugavpils
ACTIVE_NOT_RECRUITING
Lithuania (1)
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas
Malaysia (1)
Hospital Sultanah Bahiyah
Alor Setar, Kedah
Mexico (1)
Centro de Investigacion Integral MEDIVEST S.C
Chihuahua City
Netherlands (1)
Noordwest Ziekenhuisgroep
Alkmaar
New Zealand (1)
NZ Respiratory and Sleep Institute
Greenlane East , Auckland
Philippines (1)
Iloilo Doctors Hospital
Iloilo City
Poland (1)
Respiratory Medicine Centre, private prac., Bialystok
Bialystok
Puerto Rico (1)
San Juan Bautista School of Medicine
Caguas
NOT_YET_RECRUITING
Romania (1)
Marius Nasta Institute of Pneumophthisiology
Bucharest
Singapore (1)
National University Hospital-Singapore-42005
Singapore
Slovakia (1)
Univ. Hospital Martin
Martin
South Africa (1)
Iatros International
Bloemfontein
South Korea (1)
Hallym University Sacred Heart Hospital
Anyang
Spain (1)
Complejo Hospitalario Universitario A Coruña
A Coruña
Sweden (1)
Universitetssjukhuset, Örebro
Örebro
Taiwan (1)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Thailand (1)
Ramathibodi Hospital
Bangkok
Turkey (1)
Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi
Ankara
NOT_YET_RECRUITING
United Kingdom (1)
Belfast City Hospital
Belfast
NOT_YET_RECRUITING
United States (1)
University of Alabama at Birmingham
Birmingham , Alabama
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Healthy volunteers
No
Start date
09.06.2025
Completion date
12.10.2028
Registry ID
NCT06872892
Source
anzctr
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