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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 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

Secondary outcome:

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

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

Page last updated: August 23, 2015

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