Non-cystic Fibrosis Bronchiectasis
Conditions
Brief summary
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.
Interventions
DRUGBI 1323495
BI 1323495
DRUGPlacebo
Placebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18 years to 80 years (inclusive) at the time of informed consent signature, male and female (not of childbearing potential) subjects --For 'female not of childbearing potential' at least one of the following criteria must be fulfilled: * Permanently sterile (permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy; tubal ligation is not a method of permanent sterilisation) * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea without an alternative medical cause (in questionable cases a blood sample with Follicle Stimulating Hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory). * Men must be vasectomised with documented absence of sperm or use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after the last administration of trial medication if their sexual partner is a woman of childbearing potential (WOCBP) * Clinical history consistent with non cystic fibrosis bronchiectasis (nCFB) (cough, chronic sputum production and/or recurrent respiratory infections) and proven and documented diagnosis of bronchiectasis by computed tomography (CT) scan including dilated airways compatible with bronchiectasis at initial diagnosis. Bronchiectasis of various etiologies will be allowed, with
Exclusion criteria
as below. * Vaccination against Streptococcus pneumoniae in accordance with national vaccination recommendations * Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation. * FEV1 ≥ 30 % predicted (post-bronchodilator) at Screening Visit 1. * Stable (i.e., no dose change) regimen of standard nCFB treatment (including - but not limited to - hypertonic inhalation solutions, mucolytics, Long Acting Muscarinic Agonists (LAMA)/ Long Acting Beta Agonists (LABA) / inhaled corticosteriods (iCS), oral antibiotic maintenance regimen, and physiotherapy), if applicable, administered at least for 4 weeks prior to Screening Visit 1 and throughout the run-in period. * Regular daily sputum producers with a history of chronic expectoration who are able to provide a typical bronchiectasis sputum sample at Screening Visit 1. * Sputum neutrophil elastase positive based on point of care test (NEATstik® score ≥ 6) assessment at Visit 2a and Visit 2b. * Subjects genotyped as UDP-Glucuronosyltransferase-2B17 (UGT2B17) extensive metabolizers prior to randomisation, i.e., carrying at least one functional allele of the UGT2B17 gene (\*1/\*1 or \*1/\*2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Drug-related Adverse Events (AEs) | 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. | Number of participants with drug-related adverse events (AEs) is presented. Participants with treatment-emergent drug-related Adverse Events (AEs) is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. | 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). |
| Change From Baseline to Week 12 (at Week 2, Week 4, Week 8, Week 12) in Neutrophil Cell Count in Sputum | 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. | 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 |
| Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) | 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. | 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). |
| Change From Baseline to Week 12 in Absolute Post-bronchodilator Forced Expiratory Volume in One Second, FEV1 | At baseline Day -2 before the first dose and at at Week 2, Week 8, Week 12 during treatment. | 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). |
Countries
Germany
Participant flow
Recruitment details
This was a randomised, double blind, placebo-controlled, parallel group design, to compare safety and tolerability of different doses of BI 1323495 with placebo and to assess pharmacodynamics of BI 1323495 in sputum and in blood as well as early signs of clinical efficacy of BI 1323495 in patients with non-cystic fibrosis bronchiectasis (nCFB).
Pre-assignment details
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participants by arm
| Arm | Count |
|---|---|
| Part A: Placebo Bid This arm comprises all placebo treated participants in trial part A. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered for 12 weeks, twice a day (bid) an oral dose of film-coated tablets of matching placebo (the matching placebo was mannitol, microcrystalline cellulose, and magnesium stearate) together with about 240 milliliter (mL) of water. The doses were taken after 15-30 minutes (min) of food intake including a fat component. Evening and morning dose were taken with a 12 hours (h) time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour. | 2 |
| Part A: 30 mg BI 1323495 Bid 3 film-coated tablets of 10 milligram (mg) BI 1323495 were administered orally twice daily (bid) (total dose: 60 mg) together with about 240 milliliter of water over 12 weeks. The doses were taken after 15-30 min of food intake including a fat component. Evening and morning dose were taken with a 12 h time interval approximately at the same time each day during the treatment phase, within a time window of +/- 1 hour. | 5 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated by sponsor | 2 | 4 |
Baseline characteristics
| Characteristic | Part A: Placebo Bid | Total | Part A: 30 mg BI 1323495 Bid |
|---|---|---|---|
| Absolute neutrophil elastase (NE) activity in sputum | 19115.0 Relative fluorescence unit (RFU) STANDARD_DEVIATION 598.2 | 16778.6 Relative fluorescence unit (RFU) STANDARD_DEVIATION 7952.8 | 15610.4 Relative fluorescence unit (RFU) STANDARD_DEVIATION 9991.7 |
| Absolute post-bronchodilator forced expiratory volume in one second, FEV1 | 3052.5 Milliliter (mL) STANDARD_DEVIATION 475.9 | 2427.3 Milliliter (mL) STANDARD_DEVIATION 588.3 | 2177.2 Milliliter (mL) STANDARD_DEVIATION 434.5 |
| Age, Continuous | 52.0 Years STANDARD_DEVIATION 8.5 | 57.1 Years STANDARD_DEVIATION 6.6 | 59.2 Years STANDARD_DEVIATION 5.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 7 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| NE activity in whole blood after stimulation with zymosan, normalized to neutrophil counts | 5354.8 RFU/(10^9 cells/L) STANDARD_DEVIATION 3506.7 | 6728.9 RFU/(10^9 cells/L) STANDARD_DEVIATION 2710.9 | 7278.5 RFU/(10^9 cells/L) STANDARD_DEVIATION 2574.4 |
| Neutrophil cell count in sputum | 338.9 Neutrophils*10^9/Liter STANDARD_DEVIATION 40.7 | 327.6 Neutrophils*10^9/Liter STANDARD_DEVIATION 98 | 322.0 Neutrophils*10^9/Liter STANDARD_DEVIATION 123.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 5 |
| other Total, other adverse events | 0 / 2 | 2 / 5 |
| serious Total, serious adverse events | 0 / 2 | 0 / 5 |
Outcome results
Primary
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.
Population: Treated set (TS): The treated set included all patients who were randomised and received at least one dose of study drug. The treatment assignment was determined based on the first actual treatment the patients received. The TS was used for safety analyses and evaluation of biomarker and clinical assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo Bid | Number of Subjects With Drug-related Adverse Events (AEs) | 0 Participants |
| Part A: 30 mg BI 1323495 Bid | Number of Subjects With Drug-related Adverse Events (AEs) | 2 Participants |
Secondary
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.
Population: Treated set (TS): The treated set included all patients who were randomised and received at least one dose of study drug. The treatment assignment was determined based on the first actual treatment the patients received. The TS was used for safety analyses and evaluation of biomarker and clinical assessments. Only patients with no missing values for absolute neutrophil elastase (NE) activity in sputum are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo Bid | 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 | Change from baseline to Day 78 | 1665.0 Relative fluorescence unit (RFU) | — |
| Part A: Placebo Bid | 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 | Change from baseline to Day 29 | 2745.0 Relative fluorescence unit (RFU) | — |
| Part A: Placebo Bid | 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 | Change from baseline to Day 15 | 3301.0 Relative fluorescence unit (RFU) | — |
| Part A: 30 mg BI 1323495 Bid | 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 | Change from baseline to Day 57 | -497.1 Relative fluorescence unit (RFU) | Standard Deviation 217.9 |
| Part A: 30 mg BI 1323495 Bid | 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 | Change from baseline to Day 82 | 383.0 Relative fluorescence unit (RFU) | — |
| Part A: 30 mg BI 1323495 Bid | 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 | Change from baseline to Day 98 | 582.3 Relative fluorescence unit (RFU) | Standard Deviation 1257.7 |
| Part A: 30 mg BI 1323495 Bid | 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 | Change from baseline to Day 15 | -156.9 Relative fluorescence unit (RFU) | Standard Deviation 2028.5 |
| Part A: 30 mg BI 1323495 Bid | 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 | Change from baseline to Day 29 | -194.4 Relative fluorescence unit (RFU) | Standard Deviation 660.6 |
Secondary
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.
Population: Treated set (TS): The treated set included all patients who were randomised and received at least one dose of study drug. The treatment assignment was determined based on the first actual treatment the patients received. The TS was used for safety analyses and evaluation of biomarker and clinical assessments. Only patients with no missing values for neutrophil cell count in sputum are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo Bid | Change From Baseline to Week 12 (at Week 2, Week 4, Week 8, Week 12) in Neutrophil Cell Count in Sputum | Time-matched change from baseline to Week 4 | 16.8 Neutrophils*10^9/Liter | — |
| Part A: Placebo Bid | Change From Baseline to Week 12 (at Week 2, Week 4, Week 8, Week 12) in Neutrophil Cell Count in Sputum | Time-matched change from baseline to Week 2 | -9.7 Neutrophils*10^9/Liter | — |
| Part A: Placebo Bid | Change From Baseline to Week 12 (at Week 2, Week 4, Week 8, Week 12) in Neutrophil Cell Count in Sputum | Time-matched change from baseline to Week 12 | -47.7 Neutrophils*10^9/Liter | — |
| Part A: 30 mg BI 1323495 Bid | Change From Baseline to Week 12 (at Week 2, Week 4, Week 8, Week 12) in Neutrophil Cell Count in Sputum | Time-matched change from baseline to Week 12 | 69.5 Neutrophils*10^9/Liter | — |
| Part A: 30 mg BI 1323495 Bid | Change From Baseline to Week 12 (at Week 2, Week 4, Week 8, Week 12) in Neutrophil Cell Count in Sputum | Time-matched change from baseline to Week 4 | -7.8 Neutrophils*10^9/Liter | Standard Deviation 11.3 |
| Part A: 30 mg BI 1323495 Bid | Change From Baseline to Week 12 (at Week 2, Week 4, Week 8, Week 12) in Neutrophil Cell Count in Sputum | Time-matched change from baseline to Week 2 | 27.1 Neutrophils*10^9/Liter | Standard Deviation 82.9 |
| Part A: 30 mg BI 1323495 Bid | Change From Baseline to Week 12 (at Week 2, Week 4, Week 8, Week 12) in Neutrophil Cell Count in Sputum | Time-matched change from baseline to Week 8 | 9.7 Neutrophils*10^9/Liter | Standard Deviation 23.4 |
Secondary
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.
Population: Treated set (TS): The treated set included all patients who were randomised and received at least one dose of study drug. The treatment assignment was determined based on the first actual treatment the patients received. The TS was used for safety analyses and evaluation of biomarker and clinical assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo Bid | Change From Baseline to Week 12 in Absolute Post-bronchodilator Forced Expiratory Volume in One Second, FEV1 | Time-matched change from baseline to Week 2 | 38 Milliliter (mL) | Standard Deviation 113.1 |
| Part A: Placebo Bid | Change From Baseline to Week 12 in Absolute Post-bronchodilator Forced Expiratory Volume in One Second, FEV1 | Time-matched change from baseline to Week 8 | -27.0 Milliliter (mL) | — |
| Part A: Placebo Bid | Change From Baseline to Week 12 in Absolute Post-bronchodilator Forced Expiratory Volume in One Second, FEV1 | Time-matched change from baseline to Week 12 | -138.0 Milliliter (mL) | — |
| Part A: 30 mg BI 1323495 Bid | Change From Baseline to Week 12 in Absolute Post-bronchodilator Forced Expiratory Volume in One Second, FEV1 | Time-matched change from baseline to Week 2 | 1.4 Milliliter (mL) | Standard Deviation 78.6 |
| Part A: 30 mg BI 1323495 Bid | Change From Baseline to Week 12 in Absolute Post-bronchodilator Forced Expiratory Volume in One Second, FEV1 | Time-matched change from baseline to Week 8 | 1.0 Milliliter (mL) | Standard Deviation 220.1 |
| Part A: 30 mg BI 1323495 Bid | Change From Baseline to Week 12 in Absolute Post-bronchodilator Forced Expiratory Volume in One Second, FEV1 | Time-matched change from baseline to Week 12 | -40.0 Milliliter (mL) | Standard Deviation 178.2 |
Secondary
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.
Population: Treated set (TS): The treated set included all patients who were randomised and received at least one dose of study drug. The treatment assignment was determined based on the first actual treatment the patients received. The TS was used for safety analyses and evaluation of biomarker and clinical assessments. Only patients with no missing values for Neutrophil Elastase (NE) activity in whole blood after stimulation with zymosan are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo Bid | Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) | Time-matched change from baseline to Day 29 / 6:00 | 238.1 RFU/(10^9 cells/L) | — |
| Part A: Placebo Bid | Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) | Time-matched change from baseline to Day 82 | -622.6 RFU/(10^9 cells/L) | Standard Deviation 1089 |
| Part A: Placebo Bid | Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) | Time-matched change from baseline to Day 29 / -2:30 | 99.2 RFU/(10^9 cells/L) | — |
| Part A: Placebo Bid | Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) | Time-matched change from baseline to Day 98 | -326.4 RFU/(10^9 cells/L) | Standard Deviation 1295 |
| Part A: Placebo Bid | Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) | Time-matched change from baseline to Day 57 | -630.3 RFU/(10^9 cells/L) | — |
| Part A: Placebo Bid | Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) | Time-matched change from baseline to Day 15 | 95.8 RFU/(10^9 cells/L) | — |
| Part A: 30 mg BI 1323495 Bid | Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) | Time-matched change from baseline to Day 57 | -5889.9 RFU/(10^9 cells/L) | Standard Deviation 786 |
| Part A: 30 mg BI 1323495 Bid | Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) | Time-matched change from baseline to Day 29 / -2:30 | -6306.0 RFU/(10^9 cells/L) | Standard Deviation 852.6 |
| Part A: 30 mg BI 1323495 Bid | Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) | Time-matched change from baseline to Day 29 / 6:00 | -6649.6 RFU/(10^9 cells/L) | Standard Deviation 1505.1 |
| Part A: 30 mg BI 1323495 Bid | Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) | Time-matched change from baseline to Day 15 | -7733.9 RFU/(10^9 cells/L) | Standard Deviation 2153.2 |
| Part A: 30 mg BI 1323495 Bid | Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) | Time-matched change from baseline to Day 82 | -5689.9 RFU/(10^9 cells/L) | Standard Deviation 3610.3 |
| Part A: 30 mg BI 1323495 Bid | Change From Baseline to Week 12 in Neutrophil Elastase (NE) Activity in Whole Blood After Stimulation With Zymosan (Normalized to Neutrophil Counts) | Time-matched change from baseline to Day 98 | 1221.1 RFU/(10^9 cells/L) | Standard Deviation 2703.8 |