Trial Condition(s):
Bronchiectasis
Safety and Efficacy of Oral BAY85-8501 in Patients with non-CF (cystic fibrosis) Bronchiectasis
Bayer Identifier:
16359
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Proven and documented diagnosis of non-CF (cystic fibrosis) idiopathic or post-infectious BE (bronchiectasis) by computed tomography (CT) scan [conventional high resolution CT is considered the standard], including 2 or more lobes and dilated airways compatible with BE at initial diagnosis - Stable pulmonary status as indicated by the forced, expired volume in 1 second (FEV1) percent predicted ≥30% and <90% (post-bronchodilator) - Stable (i.e., no dose change) regimen of standard BE treatment administered at least for 4 weeks prior to screening - Cough on most days
Exclusion Criteria
- Forced, expired volume in 1 second <30% or ≥90% predicted (post-bronchodilator) - Recent significant hemoptysis (≥300 mL or requiring blood transfusion) in the preceding 4 weeks before screening (and during the screening period) - Known cystic fibrosis and/or documented chronic bronchial asthma - Active allergic bronchopulmonary aspergillosis (ABPA) - Diagnosis of common variable immunodeficiency (CVID) - Systemic or inhaled antibiotic treatment within 4 weeks prior to screening - Treatment of an exacerbation within 4 weeks prior to screening - Systemic corticosteroids at >10 mg/day prednisolone equivalent for >2 weeks within 4 weeks prior to screening
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Hospital Universitario "La Paz" Madrid, Spain, 28046 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southampton General Hospital Southampton, United Kingdom, SO16 6YD | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Victoria Infirmary Glasgow, United Kingdom, G42 9TY | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations William Harvey Research Centre London, United Kingdom, EC1M 6BQ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Northern General Hospital Sheffield, United Kingdom, S5 7AU | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations New Cross Hospital Wolverhampton, United Kingdom, WV10 0QP | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Castle Hill Hospital Cottingham, United Kingdom, HU16 5JQ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Glenfield Hospital Leicester, United Kingdom, LE3 9QP | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bradford Royal Infirmary Bradford, United Kingdom, BD9 6RJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Hospital Aintree Liverpool, United Kingdom, L9 7JU | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenhaus Großhansdorf Großhansdorf, Germany, 22927 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Leipzig AöR Leipzig, Germany, 04103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IFG Institut für Gesundheitsförderung GmbH Rüdersdorf, Germany, 15562 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Clinica Puerta de Hierro Majadahonda, Spain, 28222 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitari Germans Trias i Pujol Badalona, Spain, 08916 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Santa Caterina Salt, Spain, 17190 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenhaus Donaustauf Donaustauf, Germany, 93093 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Schleswig-Holstein / AÖR Lübeck, Germany, 23538 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Friedrich-Schiller-Universität Jena Jena, Germany, 07740 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenhaus Großhansdorf Großhansdorf, Germany, 22927 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Christian-Albrechts-Universität Kiel, Germany, 24105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pneumologische Praxis Hannover Nordstadt Hannover, Germany, 30167 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre d'allergologie et de pneumologie respiratoire PERPIGNAN, France, 66025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet médical - Cronstadt - Nice NICE, France, 06000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca Cancro Genova, Italy, 16132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. San Paolo Polo Universitario Milano, Italy, 20142 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. San Luigi Gonzaga Orbassano, Italy, 10043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Padova Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.R.N. Dei Colli Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Senese Siena, Italy, 53100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hamburger Institut für Therapieforschung GmbH Hamburg, Germany, 20354 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Freeman Hospital Newcastle Upon Tyne, United Kingdom, NE7 7DN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ninewells Hospital Dundee, United Kingdom, DD2 1UB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations South Tyneside District Hospital South Shields, United Kingdom, NE34 0PL | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Number Of Subjects Who Need To Discontinue Study Medication Due To Findings In Physical ExaminationTimeframe: 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, 56Timeframe: Baseline (Day 1), Day 7, 14, 21, 28, 56
- Change From Baseline in Diastolic Blood Pressure At Days 7, 14, 21, 28, 56Timeframe: Baseline (Day 1), Day 7, 14, 21, 28, 56
- Change From Baseline in Heart Rate At Days 7, 14, 21, 28, 56Timeframe: Baseline (Day 1), Day 7, 14, 21, 28, 56
- Number of Subjects With new Abnormal (Pathologic) Electrocardiogram (ECG) Findings From Baseline to Day 28Timeframe: 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 AssessmentTimeframe: Baseline (Day 1), Day 7, 14, 21, 28, 56
- Number of Subjects With Drug Related Adverse Events as a Measure of Safety And TolerabilityTimeframe: Baseline (Day 1), Day 7, 14, 21, 28, 56
Secondary Outcome
- Change From Baseline in Pulmonary Function Test Forced Expired Volume in 1 Second (FEV1) At Days 7, 14, 21, 28, 56Timeframe: 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, 56Timeframe: 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, 56Timeframe: 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 56Timeframe: Baseline (Day 1), Day 28 and 56
- Change From Baseline in 24 Hours Sputum Weight at Day 28Timeframe: 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)Timeframe: Baseline (Day 1), Day 14, 28 and 56
- Change From Baseline of Biomarkers in Sputum at Days 14, 28, 56: Neutrophil cell CountTimeframe: Baseline (Day 1), Day 14, 28 and 56
- Change From Baseline of Human Neutrophil Elastase (NE) Activity in Sputum at Days 14, 28, 56Timeframe: Baseline (Day 1), Day 14, 28 and 56
- Change From Baseline of Human Neutrophil Elastase (NE) Concentration in Sputum at Days 14, 28, 56Timeframe: Baseline (Day 1), Day 14, 28 and 56
- Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: C-reactive ProteinTimeframe: Baseline (Day 1), Day 14, 28 and 56
- Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: Interleukin-8 (IL8)Timeframe: Baseline (Day 1), Day 14, 28 and 56
- Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: Neutrophil cell CountTimeframe: Baseline (Day 1), Day 14, 28 and 56
- Change From Baseline of Biomarkers in Urine At Days 14, 28, 56: CreatinineTimeframe: Baseline (Day 1), Day 14, 28 and 56
- Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: DesmosineTimeframe: Baseline (Day 1), Day 14, 28 and 56
- Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Normalized Desmosine Value to CreatinineTimeframe: Baseline (Day 1), Day 14, 28 and 56
Additional Information
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