NIPH Clinical Trials Search

The AIRTIVITY Study: A study to find out whether BI 1291583 helps people with bronchiectasis

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Bronchiectasis
Date of first enrollment	01/08/2025
Target sample size	1680
Countries of recruitment	Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,China,Japan,Croatia,Japan,Czech Republic,Japan,Denmark,Japan,Egypt,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Hong Kong,Japan,Hungary,Japan,India,Japan,Israel,Japan,Italy,Japan,Kazakhstan,Japan,Latvia,Japan,Lithuania,Japan,Malaysia,Japan,Mexico,Japan,Netherlands,Japan,New Zealand,Japan,Philippines,Japan
Study type	Interventional
Intervention(s)	Drug: BI 1291583 Other: Placebo Route: oral

Outcome(s)

Primary Outcome

Annualized rate of pulmonary exacerbations (number of events per person year) up to Week 76 [Time Frame: up to 76 weeks]

Secondary Outcome

Absolute change from baseline in post-bronchodilator Forced Expiratory Volume in the first second (FEV1) %pred at Week 52 Absolute change from baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) respiratory symptoms domain score at Week 52 Time to first pulmonary exacerbation up to Week 76 Absolute change from baseline in post-bronchodilator Forced Vital Capacity (FVC) %pred at Week 52 Annualized rate of severe pulmonary exacerbations up to Week 76 Time to first severe pulmonary exacerbation up to Week 76

Key inclusion & exclusion criteria

Age minimum	>= 12age old
Age maximum	Not applicable
Gender	Both
Include criteria	Male or female participants. Women of childbearing potential, defined as WOCBP, must be willing and able to use highly effective methods of birth control in accordance with International Council for Harmonisation M3 R2. These methods must result in a low failure rate of less than one percent per year when used consistently and correctly and must include at least one barrier method. A list of acceptable contraception methods is provided in the participant information. Signed and dated written informed consent and assent, if applicable, must be obtained prior to admission to the study, in accordance with Good Clinical Practice and local legislation. Age of participants at the time of signing informed consent or assent must be 12 years or older. Adolescents must weigh at least 35 kg at Visit 1. Clinical history consistent with bronchiectasis, such as cough, chronic sputum production, or recurrent respiratory infections, and investigator confirmed diagnosis of bronchiectasis by computed tomography scan. Bronchiectasis must be documented by a radiologist. Participants whose historical computed tomography scan images are not available will undergo a chest computed tomography scan during screening. Historical scans must not be older than five years. Adult participants must be able to produce sputum for Pseudomonas aeruginosa assessment during the screening period. History of documented pulmonary exacerbations requiring antibiotic treatment. During the twelve months prior to Visit 1, participants must have had either at least two exacerbations, or at least one exacerbation and a Saint George Respiratory Questionnaire Symptoms score greater than forty at the screening Visit 1 for adults only, or at least one exacerbation with high symptom burden according to the investigator judgement for adolescents only. For participants receiving stable oral or inhaled antibiotics as chronic treatment for bronchiectasis or receiving Cystic Fibrosis Transmembrane Conductance Regulator modulator therapy, at least one exacerbation must have occurred since initiation of stable antibiotics or modulator therapy.
Exclude criteria	Any new or newly diagnosed condition of primary or secondary immunodeficiency within one year prior to randomization. Allergic bronchopulmonary aspergillosis that is being treated or requires treatment. Tuberculosis or non tuberculous mycobacterial infection that is being treated or requires treatment. Any findings from the medical examination or laboratory values assessed at Screening Visit 1 or during the screening period that, in the opinion of the investigator, may put the participant at risk by participating in the trial. Any clinically relevant acute respiratory infection or ongoing pulmonary exacerbation at screening or during the screening period, unless fully recovered prior to Visit 2 in the opinion of the investigator. 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, defined as major according to the investigator assessment, performed within six weeks prior to randomization or planned during the trial period. Any documented active or suspected malignancy, or history of malignancy within five years prior to screening, except for adequately treated in situ non melanoma skin cancer or in situ carcinoma of the uterine cervix. Evidence or medical history of moderate or severe liver disease corresponding to Child Pugh class B or class C hepatic impairment. Estimated glomerular filtration rate below thirty milliliters per minute at Visit 1, calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula for adults or the Chronic Kidney Disease in Children formula for adolescents. Previous treatment with a dipeptidyl peptidase one inhibitor, also known as a cathepsin C inhibitor. Participants who were randomized and received placebo only in studies involving this inhibitor are allowed. Additional exclusion criteria apply.