non-cystic fibrosis bronchiectasis (nCFB)
Conditions
Interventions
Drug: BI 1291583 (1mg, 2.5mg, 5mg)
Other: Placebo
Route: oral
Sponsors
Imazu Susumu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients: Women of childbearing potential (WOCBP) adhering to contraception requirements may be included as soon as regulatory criteria are fulfilled. At start of the trial this is only considered possible for WOCBP in the USA, Canada, Mexico and Turkey. WOCBP and men able to father a child must be ready and able to use highly effective methods of birth control per International Council for Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, preferably with low user dependency, and one barrier method in addition. A list of contraception methods meeting these criteria and instructions on the duration of their use are provided in the patient information. Men participating in this clinical trial must use male contraception (condom or sexual abstinence) if their sexual partner is a WOCBP. 2.Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation. 3. Age of patients when signing the informed consent >=18 and =40 at screening visit For patients on stable oral or inhaled antibiotics as chronic treatment for bronchiectasis, at least one exacerbation must have occurred since initiation of stable antibiotics. 6. Current sputum producers with a history of chronic expectoration who are able to provide a spontaneous (not induced) sputum sample at Screening Visit 1.
Exclusion criteria
Exclusion criteria: 1. Aspartate Aminotransferase (AST) and / or Alanine Aminotransferase (ALT) >3.0 x upper limit of normal (ULN) at Visit 1, or moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment). 2. Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula =10% - Reactive arthritis (Reiter's syndrome); keratoderma blennorrhagicum - Pityriasis rubra pilaris - Atopic dermatitis affecting palms and soles; or body surface area for atopic dermatitis >= 10% - Active extensive verruca vulgaris, as per investigator's discretion - Active fungal infection of hand and/or feet not adequately treated, or not responsive to antifungal therapy, as per investigator's discretion. 7. Acute respiratory infection or any other acute infection requiring systemic or inhaled therapy within 4 weeks prior Visit 1 and throughout screening. 8. Any evidence of a concomitant disease, such as Papillon-Lefevre Syndrome, relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal disorders, or patients who are immunocompromised with a higher risk of invasive pneumococcal disease or other invasive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis), that in the opinion of the investigator, may put the patient at risk by participating in the study. 9. Received any live attenuated vaccine within 4 weeks prior to Visit 2. 10. Medical conditions associated with periodontal disease (to be evaluated by a periodontist or dentist): - Any tooth that can potentially cause pain or infection as noted in the oral exam unless they are corrected before the study (e.g. pulp necrosis). - Severe periodontal disease defined as with pocket depth measurements >= 6 mm on 2 or more teeth. Class-3 mobility or Class-3 furcation involvement. - Scheduled tooth extraction during the study period. 11. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first pulmonary exacerbation up to 48 weeks after first drug administration (Time Frame: Up to week 48) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of pulmonary exacerbations (number of events per person-time) up to week 48 after first drug administration [ Time Frame: Up to week 48 ] 2. Absolute change from baseline in Quality of Life Questionnaire - Bronchiectasis (QOLB) respiratory symptoms domain score at week 24 after first drug administration [ Time Frame: At baseline and at week 24 ] 3. Relative change from baseline in neutrophil elastase (NE) activity in sputum at week 12 after first drug administration [ Time Frame: At baseline and at week 12 ] 4. Absolute change from baseline in St. George's Respiratory Questionnaire (SGRQ) Symptoms score at week 24 after first drug administration [ Time Frame: At baseline and at week 24 ] 5. Absolute change from baseline in percent predicted post-bronchodilator forced expiratory volume in one second (FEV1%pred) at week 24 after first drug administration [ Time Frame: At baseline and at week 24 ] 6. Occurrence of an exacerbation by week 24 after first drug administration [ Time Frame: Up to week 24 ] | — |
Countries
Australia, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Greece, Hungary, Israel, Itary, Japan, Latvia, Mexico, Netherlands, Poland, Portugal, Rep. of Korea, Spain, Turkey, United Kingdom, USA
Contacts
Public ContactShizuko Kawahara
Boehringer Ingelheim
Outcome results
None listed