Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) Bronchiectasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01818544
First received: March 8, 2013
Last updated: July 8, 2015
Last verified: July 2015
  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.


Condition Intervention Phase
Bronchiectasis
Drug: BAY85-8501
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number Of Subjects Who Need To Discontinue Study Medication Due To Findings In Physical Examination [ Time Frame: From start of study treatment up to follow up visit (28 days after last dose) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Systolic Blood Pressure At Days 7, 14, 21, 28, 56 [ Time Frame: Baseline (Day 1), Day 7, 14, 21, 28, 56 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Diastolic Blood Pressure At Days 7, 14, 21, 28, 56 [ Time Frame: Baseline (Day 1), Day 7, 14, 21, 28, 56 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Heart Rate At Days 7, 14, 21, 28, 56 [ Time Frame: Baseline (Day 1), Day 7, 14, 21, 28, 56 ] [ Designated as safety issue: Yes ]
  • Number of Subjects With new Abnormal (Pathologic) Electrocardiogram (ECG) Findings From Baseline to Day 28 [ Time Frame: Baseline (Day 1), Day 7, 14, 21, 28 ] [ Designated as safety issue: Yes ]
  • Number of Subjects who Show Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TB) Abnormalities in Their Safety Lab Assessment [ Time Frame: Baseline (Day 1), Day 7, 14, 21, 28, 56 ] [ Designated as safety issue: Yes ]
  • Number of Subjects With Drug Related Adverse Events as a Measure of Safety And Tolerability [ Time Frame: Baseline (Day 1), Day 7, 14, 21, 28, 56 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change From Baseline in Pulmonary Function Test Forced Expired Volume in 1 Second (FEV1) At Days 7, 14, 21, 28, 56 [ Time Frame: Baseline (Day 1), Day 7, 14, 21, 28, 56 ] [ Designated as safety issue: No ]
  • Change From Baseline in Pulmonary Function Test Forced Vital Capacity (FVC) at Days 7, 14, 21, 28, 56 [ Time Frame: Baseline (Day 1), Day 7, 14, 21, 28, 56 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Baseline (Day 1), Day 7, 14, 21, 28, 56 ] [ Designated as safety issue: No ]
  • Change From Baseline in Total Score on St. George's Respiratory Questionnaire (SGRQ) at Day 28 and 56 [ Time Frame: Baseline (Day 1), Day 28 and 56 ] [ Designated as safety issue: No ]
  • Change From Baseline in 24 Hours Sputum Weight at Day 28 [ Time Frame: Baseline (Day 1), Day 28 ] [ Designated as safety issue: No ]
  • Change From Baseline of Biomarkers in Sputum at Days 14, 28, 56: Alpha1 Antitrypsin Human Neutrophil Elastase (A1AHNE) Complex, Interleukin-8(IL-8) [ Time Frame: Baseline (Day 1), Day 14, 28 and 56 ] [ Designated as safety issue: No ]
  • Change From Baseline of Biomarkers in Sputum at Days 14, 28, 56: Neutrophil cell Count [ Time Frame: Baseline (Day 1), Day 14, 28 and 56 ] [ Designated as safety issue: No ]
  • Change From Baseline of Human Neutrophil Elastase (NE) Activity in Sputum at Days 14, 28, 56 [ Time Frame: Baseline (Day 1), Day 14, 28 and 56 ] [ Designated as safety issue: No ]
  • Change From Baseline of Human Neutrophil Elastase (NE) Concentration in Sputum at Days 14, 28, 56 [ Time Frame: Baseline (Day 1), Day 14, 28 and 56 ] [ Designated as safety issue: No ]
  • Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: C-reactive Protein [ Time Frame: Baseline (Day 1), Day 14, 28 and 56 ] [ Designated as safety issue: No ]
  • Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: Interleukin-8 (IL8) [ Time Frame: Baseline (Day 1), Day 14, 28 and 56 ] [ Designated as safety issue: No ]
  • Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: Neutrophil cell Count [ Time Frame: Baseline (Day 1), Day 14, 28 and 56 ] [ Designated as safety issue: No ]
  • Change From Baseline of Biomarkers in Urine At Days 14, 28, 56: Creatinine [ Time Frame: Baseline (Day 1), Day 14, 28 and 56 ] [ Designated as safety issue: No ]
  • Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Desmosine [ Time Frame: Baseline (Day 1), Day 14, 28 and 56 ] [ Designated as safety issue: No ]
  • Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Normalized Desmosine Value to Creatinine [ Time Frame: Baseline (Day 1), Day 14, 28 and 56 ] [ Designated as safety issue: No ]

Enrollment: 94
Study Start Date: April 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BAY85-8501 Drug: BAY85-8501
BAY85-8501 (1.0 mg, 2 tablets each 0.5 mg) will be administered orally once daily in the morning
Placebo Comparator: Placebo Drug: Placebo
Placebo (1.0 mg, 2 tablets each 0.5 mg) will be administered orally once daily in the morning

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01818544

Locations
France
Nice, France, 06000
Perpignan, France, 66025
Germany
Donaustauf, Bayern, Germany, 93093
Rüdersdorf, Brandenburg, Germany, 15562
Hannover, Niedersachsen, Germany, 30167
Leipzig, Sachsen, Germany, 04103
Großhansdorf, Schleswig-Holstein, Germany, 22927
Kiel, Schleswig-Holstein, Germany, 24105
Lübeck, Schleswig-Holstein, Germany, 23538
Jena, Thüringen, Germany, 07740
Hamburg, Germany, 20354
Italy
Orbassano, Torino, Italy, 10043
Genova, Italy, 16132
Milano, Italy, 20142
Napoli, Italy, 80131
Padova, Italy, 35128
Siena, Italy, 53100
Spain
Badalona, Barcelona, Spain, 08916
Salt, Girona, Spain, 17190
Majadahonda, Madrid, Spain, 28222
Madrid, Spain, 28046
United Kingdom
Southampton, Hampshire, United Kingdom, SO16 6YD
Cottingham, Humberside, United Kingdom, HU16 5JQ
Leicester, Leicestershire, United Kingdom, LE3 9QP
Liverpool, Merseyside, United Kingdom, L9 7JU
Sheffield, South Yorkshire, United Kingdom, S5 7AU
Dundee, Tayside, United Kingdom, DD2 1UB
Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
South Shields, Tyne and Wear, United Kingdom, NE34 0PL
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Bradford, West Yorkshire, United Kingdom, BD9 6RJ
Glasgow, United Kingdom, G42 9TY
London, United Kingdom, EC1M 6BQ
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01818544     History of Changes
Other Study ID Numbers: 16359, 2012-004491-18
Study First Received: March 8, 2013
Last Updated: July 8, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bayer:
Elastase Inhibition

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 31, 2015