This study is open to adults with non-cystic fibrosis bronchiectasis. The main purpose of this study is to find out how a medicine called BI 1323495 is tolerated by people with non-cystic bronchiectasis. The study tests 2 different doses of BI 1323495. Some of the participants get placebo. It is decided by chance who gets BI 1323495 and who gets placebo. Participants take BI 1323495 or placebo as tablets twice a day for 3 months. Placebo tablets look like BI 1323495 tablets but do not contain any medicine. Participants can also continue taking standard medicines for noncystic bronchiectasis throughout the study. Participants are in the study for about 4 months. During this time, the participants visit the study site about 11 times and get about 2 phone calls. At the visits, doctors check the health of the participants and note any health problems that could have been caused by BI 1323495.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
7
BI 1323495
Placebo
IKF Pneumologie GmbH & Co. KG
Frankfurt, Germany
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, Germany
KLB Gesundheitsforschung Lübeck GmbH
Lübeck, Germany
Number of Subjects With Drug-related Adverse Events (AEs)
Number of participants with drug-related adverse events (AEs) is presented. Participants with treatment-emergent drug-related Adverse Events (AEs) is reported.
Time frame: From drug administration until 12:00 AM on day after last administration of study drug + 7 days residual effect period (REP) or 12:00 AM on day after last contact date, which ever occurs first. Up to 13 weeks.
Change From Baseline to Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98 in Absolute Neutrophil Elastase (NE) Activity in Sputum
The change from baseline to Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98 in absolute neutrophil elastase (NE) activity in sputum is reported. The baseline value was calculated as the mean of the baseline values (at day -6, -2, day 1 predose). RFU is the standard output of a florescence reader. RFU (ex 360 nm, em460 nm).
Time frame: At baseline Day -6, Day -2, Day 1 before the first dose and at Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98.
Change From Baseline to Week 12 (at Week 2, Week 4, Week 8, Week 12) in Neutrophil Cell Count in Sputum
The change from baseline to week 12 (at Week 2, Week 4, Week 8, Week 12) in absolute neutrophil cell count in sputum is reported. The baseline value was calculated as the mean of the baseline values (at day -6, -2, day 1 predose). RFU: Relative fluorescence unit
Time frame: At baseline Day -6, Day -2, Day 1 before the first dose and at at Week 2, Week 4, Week 8, Week 12 during treatment.
Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts)
The change of NE activity from baseline to Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98 in whole blood after stimulation with zymosan (normalized to neutrophil counts) is reported. Relative fluorescence unit (RFU) is the standard output of a florescence reader. RFU (ex 360 nm, em460 nm).
Time frame: At baseline Day 1, 2.5 hours (hrs) before the first dose and at Day 15, Day 29, Day 57, Day 78, Day 82 and Day 98.
Change From Baseline to Week 12 in Absolute Post-bronchodilator Forced Expiratory Volume in One Second, FEV1
The change from baseline to week 12 (at Week 2, Week 8, Week 12) in absolute post-bronchodilator forced expiratory volume in one second (FEV1).
Time frame: At baseline Day -2 before the first dose and at at Week 2, Week 8, Week 12 during treatment.
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