This study is open to adults aged 18 years and older with cystic fibrosis bronchiectasis. The purpose of this study is to find out whether a medicine called BI 1291583 is tolerated by people with cystic fibrosis bronchiectasis. Participants are put randomly into 2 groups. One group takes BI 1291583 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1291583 tablets but do not contain any medicine. Participants in both groups take 1 tablet once a day for 12 weeks. Participants have twice the chance of being placed in the BI 1291583 group than in the placebo group. Participants are in the study for about 6 months. During this time, they visit the study site 7 times. At the visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 1291583.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
22
Once daily oral administration of 5 milligram (mg) tablets of BI 1291583 for 12 weeks.
Once daily oral administration of tablets of placebo matching BI 1291583 for 12 weeks.
University of Kansas Medical Center
Kansas City, Kansas, United States
Northwell Health Physician Partners
New York, New York, United States
UZ Leuven
Leuven, Belgium
Charite Universitätsmedizin Berlin KöR
Berlin, Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Jena
Jena, Germany
Azienda Ospedaliera Meyer
Florence, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
Amsterdam UMC, location VUMC
Amsterdam, Netherlands
...and 2 more locations
Occurrence of Any Treatment Emergent Adverse Events
Occurrence of any treatment emergent adverse events is expressed as percentages of participants with treatment emergent adverse events. Percentages are rounded to one decimal place.
Time frame: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Relative Change From Baseline in NE Activity, in Sputum, at Week 8 After First Drug Administration
Relative change from baseline in neutrophil elastase (NE) activity, in sputum, at Week 8 after first drug administration is reported. Relative change from baseline at Week 8 in neutrophil elastase was calculated as below: Relative fluorescence unit (RFU) at Week 8-Relative fluorescence unit at baseline)\*100%/Relative fluorescence unit at baseline.
Time frame: Before the first drug administration (baseline: mean value of screening and Week 0 prior to the first treatment intake) and Week 8 after first study drug administration.
Area Under the Curve of BI 1291583 in Plasma Over a Uniform Dosing Interval Tau=6h After the First Dose (AUC0-6)
Area under the curve of BI 1291583 in plasma over a uniform dosing interval tau=6h after the first dose (AUC0-6) is reported.
Time frame: Before drug administration and 1 hour (h), 3.5h, 6h after administration of the first dose of BI 1291583 at Day 1.
Area Under the Curve of BI 1291583 in Plasma Over a Uniform Dosing Interval Tau=6h at Steady State (AUC0-6,ss)
Area under the curve of BI 1291583 in plasma over a uniform dosing interval tau=6h at steady state (AUC0-6,ss) is reported.
Time frame: Before drug administration at Day 85 and 1 hour (h), 3.5h, 6h after administration of BI 1291583 at Day 85.
Maximum Measured Concentration of BI 1291583 in Plasma After the First Dose
Maximum measured concentration of BI 1291583 in plasma after the first dose is reported.
Time frame: Before drug administration and 1 hour (h), 3.5h, 6h, and 8h after administration of the first dose of BI 1291583 at Day 1.
Maximum Measured Concentration of BI 1291583 in Plasma at Steady State
Maximum measured concentration of BI 1291583 in plasma at steady state is reported.
Time frame: Before drug administration at Day 85 and 1 hour (h), 3.5h, 6h after administration of BI 1291583 at Day 85.
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