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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004491-18 | EudraCT Number |
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The primary objective of this study is to assess the safety and tolerability of 28 day oral administration of BAY85-8501 versus placebo in subjects with non-CF Bronchiectasis (BE).
The secondary objectives are to examine the effect of BAY85-8501 on pulmonary function, biomarkers of inflammation and tissue damage, and the impact on overall health and perceived well-being and to evaluate the pharmacokinetics of BAY85-8501.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY85-8501 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY85-8501 | Drug | BAY85-8501 (1.0 mg, 2 tablets each 0.5 mg) will be administered orally once daily in the morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number Of Subjects Who Need To Discontinue Study Medication Due To Findings In Physical Examination | From start of study treatment up to follow up visit (28 days after last dose) | |
| Change From Baseline in Systolic Blood Pressure At Days 7, 14, 21, 28, 56 | Baseline (Day 1), Day 7, 14, 21, 28, 56 | |
| Change From Baseline in Diastolic Blood Pressure At Days 7, 14, 21, 28, 56 | Baseline (Day 1), Day 7, 14, 21, 28, 56 | |
| Change From Baseline in Heart Rate At Days 7, 14, 21, 28, 56 | Baseline (Day 1), Day 7, 14, 21, 28, 56 | |
| Number of Subjects With new Abnormal (Pathologic) Electrocardiogram (ECG) Findings From Baseline to Day 28 | Baseline (Day 1), Day 7, 14, 21, 28 | |
| Number of Subjects who Show Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TB) Abnormalities in Their Safety Lab Assessment | Baseline (Day 1), Day 7, 14, 21, 28, 56 | |
| Number of Subjects With Drug Related Adverse Events as a Measure of Safety And Tolerability | Baseline (Day 1), Day 7, 14, 21, 28, 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pulmonary Function Test Forced Expired Volume in 1 Second (FEV1) At Days 7, 14, 21, 28, 56 | Baseline (Day 1), Day 7, 14, 21, 28, 56 | |
| Change From Baseline in Pulmonary Function Test Forced Vital Capacity (FVC) at Days 7, 14, 21, 28, 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nice | 06000 | France | ||||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| Placebo | Drug | Placebo (1.0 mg, 2 tablets each 0.5 mg) will be administered orally once daily in the morning |
|
| Baseline (Day 1), Day 7, 14, 21, 28, 56 |
| Change From Baseline in Pulmonary Function Test Forced Expiratory Flow Over the Middle Half of Subject's Forced Vital Capacity (FVC) (FEF2575) at Days 7, 14, 21, 28, 56 | Baseline (Day 1), Day 7, 14, 21, 28, 56 |
| Change From Baseline in Total Score on St. George's Respiratory Questionnaire (SGRQ) at Day 28 and 56 | Baseline (Day 1), Day 28 and 56 |
| Change From Baseline in 24 Hours Sputum Weight at Day 28 | Baseline (Day 1), Day 28 |
| Change From Baseline of Biomarkers in Sputum at Days 14, 28, 56: Alpha1 Antitrypsin Human Neutrophil Elastase (A1AHNE) Complex, Interleukin-8(IL-8) | Baseline (Day 1), Day 14, 28 and 56 |
| Change From Baseline of Biomarkers in Sputum at Days 14, 28, 56: Neutrophil cell Count | Baseline (Day 1), Day 14, 28 and 56 |
| Change From Baseline of Human Neutrophil Elastase (NE) Activity in Sputum at Days 14, 28, 56 | Baseline (Day 1), Day 14, 28 and 56 |
| Change From Baseline of Human Neutrophil Elastase (NE) Concentration in Sputum at Days 14, 28, 56 | Baseline (Day 1), Day 14, 28 and 56 |
| Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: C-reactive Protein | Baseline (Day 1), Day 14, 28 and 56 |
| Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: Interleukin-8 (IL8) | Baseline (Day 1), Day 14, 28 and 56 |
| Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: Neutrophil cell Count | Baseline (Day 1), Day 14, 28 and 56 |
| Change From Baseline of Biomarkers in Urine At Days 14, 28, 56: Creatinine | Baseline (Day 1), Day 14, 28 and 56 |
| Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Desmosine | Baseline (Day 1), Day 14, 28 and 56 |
| Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Normalized Desmosine Value to Creatinine | Baseline (Day 1), Day 14, 28 and 56 |
| Perpignan |
| 66025 |
| France |
| Donaustauf | Bavaria | 93093 | Germany |
| Rüdersdorf | Brandenburg | 15562 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 20354 | Germany |
| Hanover | Lower Saxony | 30167 | Germany |
| Leipzig | Saxony | 04103 | Germany |
| Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| Kiel | Schleswig-Holstein | 24105 | Germany |
| Lübeck | Schleswig-Holstein | 23538 | Germany |
| Jena | Thuringia | 07740 | Germany |
| Orbassano | Torino | 10043 | Italy |
| Genova | 16132 | Italy |
| Milan | 20142 | Italy |
| Naples | 80131 | Italy |
| Padova | 35128 | Italy |
| Siena | 53100 | Italy |
| Badalona | Barcelona | 08916 | Spain |
| Salt | Girona | 17190 | Spain |
| Madrid | Madrid | 28046 | Spain |
| Majadahonda | Madrid | 28222 | Spain |
| Southampton | Hampshire | SO16 6YD | United Kingdom |
| Cottingham | Humberside | HU16 5JQ | United Kingdom |
| Leicester | Leicestershire | LE3 9QP | United Kingdom |
| Liverpool | Merseyside | L9 7JU | United Kingdom |
| Sheffield | South Yorkshire | S5 7AU | United Kingdom |
| Dundee | Tayside | DD2 1UB | United Kingdom |
| Newcastle upon Tyne | Tyne and Wear | NE7 7DN | United Kingdom |
| South Shields | Tyne and Wear | NE34 0PL | United Kingdom |
| Wolverhampton | West Midlands | WV10 0QP | United Kingdom |
| Bradford | West Yorkshire | BD9 6RJ | United Kingdom |
| Glasgow | G42 9TY | United Kingdom |
| London | EC1M 6BQ | United Kingdom |
| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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