check_circleStudy Completed
Bronchiectasis
Bayer Identifier:
16359
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Safety and Efficacy of Oral BAY85-8501 in Patients with non-CF (cystic fibrosis) Bronchiectasis
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.
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
94Trial Dates
April 2013 - June 2014Phase
Phase 2Could I Receive a placebo
YesProducts
BAY85-8501Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Hospital Universitario "La Paz" | Madrid, 28046, Spain |
Completed | Southampton General Hospital | Southampton, SO16 6YD, United Kingdom |
Completed | Victoria Infirmary | Glasgow, G42 9TY, United Kingdom |
Completed | William Harvey Research Centre | London, EC1M 6BQ, United Kingdom |
Completed | Northern General Hospital | Sheffield, S5 7AU, United Kingdom |
Completed | New Cross Hospital | Wolverhampton, WV10 0QP, United Kingdom |
Completed | Castle Hill Hospital | Cottingham, HU16 5JQ, United Kingdom |
Completed | Glenfield Hospital | Leicester, LE3 9QP, United Kingdom |
Completed | Bradford Royal Infirmary | Bradford, BD9 6RJ, United Kingdom |
Completed | University Hospital Aintree | Liverpool, L9 7JU, United Kingdom |
Terminated | Krankenhaus Großhansdorf | Großhansdorf, 22927, Germany |
Completed | Universitätsklinikum Leipzig AöR | Leipzig, 04103, Germany |
Completed | IFG Institut für Gesundheitsförderung GmbH | Rüdersdorf, 15562, Germany |
Completed | Hospital Universitario Clinica Puerta de Hierro | Majadahonda, 28222, Spain |
Terminated | Hospital Universitari Germans Trias i Pujol | Badalona, 08916, Spain |
Completed | Hospital Santa Caterina | Salt, 17190, Spain |
Terminated | Krankenhaus Donaustauf | Donaustauf, 93093, Germany |
Completed | Universitätsklinikum Schleswig-Holstein / AÖR | Lübeck, 23538, Germany |
Completed | Klinikum der Friedrich-Schiller-Universität Jena | Jena, 07740, Germany |
Completed | Krankenhaus Großhansdorf | Großhansdorf, 22927, Germany |
Completed | Klinikum der Christian-Albrechts-Universität | Kiel, 24105, Germany |
Terminated | Pneumologische Praxis Hannover Nordstadt | Hannover, 30167, Germany |
Terminated | Centre d'allergologie et de pneumologie respiratoire | PERPIGNAN, 66025, France |
Terminated | Cabinet médical - Cronstadt - Nice | NICE, 06000, France |
Completed | IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca Cancro | Genova, 16132, Italy |
Completed | A.O. San Paolo Polo Universitario | Milano, 20142, Italy |
Completed | A.O.U. San Luigi Gonzaga | Orbassano, 10043, Italy |
Completed | A.O. di Padova | Padova, 35128, Italy |
Completed | A.O.R.N. Dei Colli | Napoli, 80131, Italy |
Completed | A.O.U. Senese | Siena, 53100, Italy |
Completed | Hamburger Institut für Therapieforschung GmbH | Hamburg, 20354, Germany |
Completed | Freeman Hospital | Newcastle Upon Tyne, NE7 7DN, United Kingdom |
Completed | Ninewells Hospital | Dundee, DD2 1UB, United Kingdom |
Completed | South Tyneside District Hospital | South Shields, NE34 0PL, United Kingdom |
Primary Outcome
- Number Of Subjects Who Need To Discontinue Study Medication Due To Findings In Physical Examinationdate_rangeTime Frame:From start of study treatment up to follow up visit (28 days after last dose)enhanced_encryptionYesSafety Issue:
- Change From Baseline in Systolic Blood Pressure At Days 7, 14, 21, 28, 56date_rangeTime Frame:Baseline (Day 1), Day 7, 14, 21, 28, 56enhanced_encryptionYesSafety Issue:
- Change From Baseline in Diastolic Blood Pressure At Days 7, 14, 21, 28, 56date_rangeTime Frame:Baseline (Day 1), Day 7, 14, 21, 28, 56enhanced_encryptionYesSafety Issue:
- Change From Baseline in Heart Rate At Days 7, 14, 21, 28, 56date_rangeTime Frame:Baseline (Day 1), Day 7, 14, 21, 28, 56enhanced_encryptionYesSafety Issue:
- Number of Subjects With new Abnormal (Pathologic) Electrocardiogram (ECG) Findings From Baseline to Day 28date_rangeTime Frame:Baseline (Day 1), Day 7, 14, 21, 28enhanced_encryptionYesSafety Issue:
- Number of Subjects who Show Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TB) Abnormalities in Their Safety Lab Assessmentdate_rangeTime Frame:Baseline (Day 1), Day 7, 14, 21, 28, 56enhanced_encryptionYesSafety Issue:
- Number of Subjects With Drug Related Adverse Events as a Measure of Safety And Tolerabilitydate_rangeTime Frame:Baseline (Day 1), Day 7, 14, 21, 28, 56enhanced_encryptionYesSafety Issue:
Secondary Outcome
- Change From Baseline in Pulmonary Function Test Forced Expired Volume in 1 Second (FEV1) At Days 7, 14, 21, 28, 56date_rangeTime Frame:Baseline (Day 1), Day 7, 14, 21, 28, 56enhanced_encryptionNoSafety Issue:
- Change From Baseline in Pulmonary Function Test Forced Vital Capacity (FVC) at Days 7, 14, 21, 28, 56date_rangeTime Frame:Baseline (Day 1), Day 7, 14, 21, 28, 56enhanced_encryptionNoSafety Issue:
- 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, 56date_rangeTime Frame:Baseline (Day 1), Day 7, 14, 21, 28, 56enhanced_encryptionNoSafety Issue:
- Change From Baseline in Total Score on St. George's Respiratory Questionnaire (SGRQ) at Day 28 and 56date_rangeTime Frame:Baseline (Day 1), Day 28 and 56enhanced_encryptionNoSafety Issue:
- Change From Baseline in 24 Hours Sputum Weight at Day 28date_rangeTime Frame:Baseline (Day 1), Day 28enhanced_encryptionNoSafety Issue:
- Change From Baseline of Biomarkers in Sputum at Days 14, 28, 56: Alpha1 Antitrypsin Human Neutrophil Elastase (A1AHNE) Complex, Interleukin-8(IL-8)date_rangeTime Frame:Baseline (Day 1), Day 14, 28 and 56enhanced_encryptionNoSafety Issue:
- Change From Baseline of Biomarkers in Sputum at Days 14, 28, 56: Neutrophil cell Countdate_rangeTime Frame:Baseline (Day 1), Day 14, 28 and 56enhanced_encryptionNoSafety Issue:
- Change From Baseline of Human Neutrophil Elastase (NE) Activity in Sputum at Days 14, 28, 56date_rangeTime Frame:Baseline (Day 1), Day 14, 28 and 56enhanced_encryptionNoSafety Issue:
- Change From Baseline of Human Neutrophil Elastase (NE) Concentration in Sputum at Days 14, 28, 56date_rangeTime Frame:Baseline (Day 1), Day 14, 28 and 56enhanced_encryptionNoSafety Issue:
- Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: C-reactive Proteindate_rangeTime Frame:Baseline (Day 1), Day 14, 28 and 56enhanced_encryptionNoSafety Issue:
- Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: Interleukin-8 (IL8)date_rangeTime Frame:Baseline (Day 1), Day 14, 28 and 56enhanced_encryptionNoSafety Issue:
- Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: Neutrophil cell Countdate_rangeTime Frame:Baseline (Day 1), Day 14, 28 and 56enhanced_encryptionNoSafety Issue:
- Change From Baseline of Biomarkers in Urine At Days 14, 28, 56: Creatininedate_rangeTime Frame:Baseline (Day 1), Day 14, 28 and 56enhanced_encryptionNoSafety Issue:
- Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Desmosinedate_rangeTime Frame:Baseline (Day 1), Day 14, 28 and 56enhanced_encryptionNoSafety Issue:
- Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Normalized Desmosine Value to Creatininedate_rangeTime Frame:Baseline (Day 1), Day 14, 28 and 56enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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