A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY85-8501 in Patients With Non-Cystic Fibrosis Bronchiectasis

BAY85-8501

Placebo

Number Of Subjects Who Need To Discontinue Study Medication Due To Findings In Physical Examination

Change From Baseline in Systolic Blood Pressure At Days 7, 14, 21, 28, 56

Change From Baseline in Diastolic Blood Pressure At Days 7, 14, 21, 28, 56

Change From Baseline in Heart Rate At Days 7, 14, 21, 28, 56

Number of Subjects With new Abnormal (Pathologic) Electrocardiogram (ECG) Findings From Baseline to Day 28

Number of Subjects who Show Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TB) Abnormalities in Their Safety Lab Assessment

Number of Subjects With Drug Related Adverse Events as a Measure of Safety And Tolerability

Change From Baseline in Pulmonary Function Test Forced Expired Volume in 1 Second (FEV1) At Days 7, 14, 21, 28, 56

Change From Baseline in Pulmonary Function Test Forced Vital Capacity (FVC) at Days 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

Change From Baseline in Total Score on St. George's Respiratory Questionnaire (SGRQ) at Day 28 and 56

Change From Baseline in 24 Hours Sputum Weight at 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)

Change From Baseline of Biomarkers in Sputum at Days 14, 28, 56: Neutrophil cell Count

Change From Baseline of Human Neutrophil Elastase (NE) Activity in Sputum at Days 14, 28, 56

Change From Baseline of Human Neutrophil Elastase (NE) Concentration in Sputum at Days 14, 28, 56

Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: C-reactive Protein

Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: Interleukin-8 (IL8)

Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: Neutrophil cell Count

Change From Baseline of Biomarkers in Urine At Days 14, 28, 56: Creatinine

Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Desmosine

Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Normalized Desmosine Value to Creatinine