check_circleStudy Completed

Bronchiectasis

Bayer Identifier:

16359

ClinicalTrials.gov Identifier:

NCT01818544

EudraCT Number:

2012-004491-18

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
94
Trial Dates
April 2013 - June 2014
Phase
Phase 2
Could I Receive a placebo
Yes
Products
BAY85-8501
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hospital Universitario "La Paz"Madrid, 28046, Spain
Completed
Southampton General HospitalSouthampton, SO16 6YD, United Kingdom
Completed
Victoria InfirmaryGlasgow, G42 9TY, United Kingdom
Completed
William Harvey Research CentreLondon, EC1M 6BQ, United Kingdom
Completed
Northern General HospitalSheffield, S5 7AU, United Kingdom
Completed
New Cross HospitalWolverhampton, WV10 0QP, United Kingdom
Completed
Castle Hill HospitalCottingham, HU16 5JQ, United Kingdom
Completed
Glenfield HospitalLeicester, LE3 9QP, United Kingdom
Completed
Bradford Royal InfirmaryBradford, BD9 6RJ, United Kingdom
Completed
University Hospital AintreeLiverpool, L9 7JU, United Kingdom
Terminated
Krankenhaus GroßhansdorfGroßhansdorf, 22927, Germany
Completed
Universitätsklinikum Leipzig AöRLeipzig, 04103, Germany
Completed
IFG Institut für Gesundheitsförderung GmbHRüdersdorf, 15562, Germany
Completed
Hospital Universitario Clinica Puerta de HierroMajadahonda, 28222, Spain
Terminated
Hospital Universitari Germans Trias i PujolBadalona, 08916, Spain
Completed
Hospital Santa CaterinaSalt, 17190, Spain
Terminated
Krankenhaus DonaustaufDonaustauf, 93093, Germany
Completed
Universitätsklinikum Schleswig-Holstein / AÖRLübeck, 23538, Germany
Completed
Klinikum der Friedrich-Schiller-Universität JenaJena, 07740, Germany
Completed
Krankenhaus GroßhansdorfGroßhansdorf, 22927, Germany
Completed
Klinikum der Christian-Albrechts-UniversitätKiel, 24105, Germany
Terminated
Pneumologische Praxis Hannover NordstadtHannover, 30167, Germany
Terminated
Centre d'allergologie et de pneumologie respiratoirePERPIGNAN, 66025, France
Terminated
Cabinet médical - Cronstadt - NiceNICE, 06000, France
Completed
IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca CancroGenova, 16132, Italy
Completed
A.O. San Paolo Polo UniversitarioMilano, 20142, Italy
Completed
A.O.U. San Luigi GonzagaOrbassano, 10043, Italy
Completed
A.O. di PadovaPadova, 35128, Italy
Completed
A.O.R.N. Dei ColliNapoli, 80131, Italy
Completed
A.O.U. SeneseSiena, 53100, Italy
Completed
Hamburger Institut für Therapieforschung GmbHHamburg, 20354, Germany
Completed
Freeman HospitalNewcastle Upon Tyne, NE7 7DN, United Kingdom
Completed
Ninewells HospitalDundee, DD2 1UB, United Kingdom
Completed
South Tyneside District HospitalSouth Shields, NE34 0PL, United Kingdom

Primary Outcome

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

Secondary Outcome

  • Change From Baseline in Pulmonary Function Test Forced Expired Volume in 1 Second (FEV1) At Days 7, 14, 21, 28, 56
    date_rangeTime Frame:
    Baseline (Day 1), Day 7, 14, 21, 28, 56
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Pulmonary Function Test Forced Vital Capacity (FVC) at Days 7, 14, 21, 28, 56
    date_rangeTime Frame:
    Baseline (Day 1), Day 7, 14, 21, 28, 56
    enhanced_encryption
    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
    date_rangeTime Frame:
    Baseline (Day 1), Day 7, 14, 21, 28, 56
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Total Score on St. George's Respiratory Questionnaire (SGRQ) at Day 28 and 56
    date_rangeTime Frame:
    Baseline (Day 1), Day 28 and 56
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in 24 Hours Sputum Weight at Day 28
    date_rangeTime Frame:
    Baseline (Day 1), Day 28
    enhanced_encryption
    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)
    date_rangeTime Frame:
    Baseline (Day 1), Day 14, 28 and 56
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline of Biomarkers in Sputum at Days 14, 28, 56: Neutrophil cell Count
    date_rangeTime Frame:
    Baseline (Day 1), Day 14, 28 and 56
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline of Human Neutrophil Elastase (NE) Activity in Sputum at Days 14, 28, 56
    date_rangeTime Frame:
    Baseline (Day 1), Day 14, 28 and 56
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline of Human Neutrophil Elastase (NE) Concentration in Sputum at Days 14, 28, 56
    date_rangeTime Frame:
    Baseline (Day 1), Day 14, 28 and 56
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: C-reactive Protein
    date_rangeTime Frame:
    Baseline (Day 1), Day 14, 28 and 56
    enhanced_encryption
    Safety Issue:
    No
  • 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 56
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: Neutrophil cell Count
    date_rangeTime Frame:
    Baseline (Day 1), Day 14, 28 and 56
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline of Biomarkers in Urine At Days 14, 28, 56: Creatinine
    date_rangeTime Frame:
    Baseline (Day 1), Day 14, 28 and 56
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Desmosine
    date_rangeTime Frame:
    Baseline (Day 1), Day 14, 28 and 56
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Normalized Desmosine Value to Creatinine
    date_rangeTime Frame:
    Baseline (Day 1), Day 14, 28 and 56
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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