Resumen

Este estudio está abierto a adultos y adolescentes de entre 12 y menos de 18 años con bronquiectasias. Podrán participar las personas que produzcan esputo y hayan tenido reagudizaciones (también llamadas exacerbaciones). El objetivo del estudio es determinar si un medicamento llamado BI 1291583 ayuda a las personas con bronquiectasias. Los participantes son asignados aleatoriamente, es decir, por azar, a uno de 2 grupos. Un grupo toma comprimidos de BI 1291583 y el otro grupo toma comprimidos de placebo. Un comprimido de placebo tiene el mismo aspecto que el de BI 1291583, pero no contiene ningún principio activo. Los participantes toman 1 comprimido una vez al día durante hasta 1 año y 6 meses. Los participantes permanecen en el estudio durante hasta 1 año y 8 meses. Durante este tiempo, realizan hasta 10 visitas al centro del estudio y reciben aproximadamente 13 llamadas telefónicas del personal del centro. Los participantes completan periódicamente un diario en un teléfono inteligente sobre sus síntomas de bronquiectasias, y los médicos del estudio comprueban regularmente si hay cambios. Los médicos del estudio documentan cuándo los participantes experimentan reagudizaciones. El número de reagudizaciones se compara entre los participantes que reciben BI 1291583 y los que reciben placebo. Los médicos del estudio también controlan periódicamente la salud de los participantes y registran cualquier efecto no deseado.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

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