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

July 8, 2015 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo (1.0 mg, 2 tablets each 0.5 mg) will be administered orally once daily in the morning
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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, 56
Time Frame: Baseline (Day 1), Day 7, 14, 21, 28, 56
Baseline (Day 1), Day 7, 14, 21, 28, 56
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
Baseline (Day 1), Day 7, 14, 21, 28, 56
Change From Baseline in Heart Rate At Days 7, 14, 21, 28, 56
Time Frame: Baseline (Day 1), Day 7, 14, 21, 28, 56
Baseline (Day 1), Day 7, 14, 21, 28, 56
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
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 Assessment
Time Frame: Baseline (Day 1), Day 7, 14, 21, 28, 56
Baseline (Day 1), Day 7, 14, 21, 28, 56
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
Baseline (Day 1), Day 7, 14, 21, 28, 56

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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, 56
Time Frame: Baseline (Day 1), Day 7, 14, 21, 28, 56
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, 56
Time Frame: Baseline (Day 1), Day 7, 14, 21, 28, 56
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 56
Time Frame: Baseline (Day 1), Day 28 and 56
Baseline (Day 1), Day 28 and 56
Change From Baseline in 24 Hours Sputum Weight at Day 28
Time Frame: Baseline (Day 1), Day 28
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)
Time Frame: Baseline (Day 1), Day 14, 28 and 56
Baseline (Day 1), Day 14, 28 and 56
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
Baseline (Day 1), Day 14, 28 and 56
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
Baseline (Day 1), Day 14, 28 and 56
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
Baseline (Day 1), Day 14, 28 and 56
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
Baseline (Day 1), Day 14, 28 and 56
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
Baseline (Day 1), Day 14, 28 and 56
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
Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Biomarkers in Urine At Days 14, 28, 56: Creatinine
Time Frame: Baseline (Day 1), Day 14, 28 and 56
Baseline (Day 1), Day 14, 28 and 56
Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Desmosine
Time Frame: Baseline (Day 1), Day 14, 28 and 56
Baseline (Day 1), Day 14, 28 and 56
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
Baseline (Day 1), Day 14, 28 and 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 8, 2013

First Submitted That Met QC Criteria

March 22, 2013

First Posted (Estimate)

March 26, 2013

Study Record Updates

Last Update Posted (Estimate)

July 9, 2015

Last Update Submitted That Met QC Criteria

July 8, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16359
  • 2012-004491-18 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe