Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) Bronchiectasis
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bronchiectasis
Intervention: BAY85-8501 (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Summary
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Number Of Subjects Who Need To Discontinue Study Medication Due To Findings In Physical ExaminationChange 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
Secondary outcome: Change From Baseline in Pulmonary Function Test Forced Expired Volume in 1 Second (FEV1) At Days 7, 14, 21, 28, 56Change 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Nice 06000, France
Perpignan 66025, France
Hamburg 20354, Germany
Genova 16132, Italy
Milano 20142, Italy
Napoli 80131, Italy
Padova 35128, Italy
Siena 53100, Italy
Madrid 28046, Spain
Glasgow G42 9TY, United Kingdom
London EC1M 6BQ, United Kingdom
Badalona, Barcelona 08916, Spain
Donaustauf, Bayern 93093, Germany
Rüdersdorf, Brandenburg 15562, Germany
Salt, Girona 17190, Spain
Southampton, Hampshire SO16 6YD, United Kingdom
Cottingham, Humberside HU16 5JQ, United Kingdom
Leicester, Leicestershire LE3 9QP, United Kingdom
Majadahonda, Madrid 28222, Spain
Liverpool, Merseyside L9 7JU, United Kingdom
Hannover, Niedersachsen 30167, Germany
Leipzig, Sachsen 04103, Germany
Großhansdorf, Schleswig-Holstein 22927, Germany
Kiel, Schleswig-Holstein 24105, Germany
Lübeck, Schleswig-Holstein 23538, Germany
Sheffield, South Yorkshire S5 7AU, United Kingdom
Dundee, Tayside DD2 1UB, United Kingdom
Jena, Thüringen 07740, Germany
Orbassano, Torino 10043, Italy
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
Additional Information
Click here and search for drug information provided by the FDA. Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Starting date: April 2013
Last updated: July 8, 2015
|