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

Primary Purpose

Bronchiectasis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

BAY85-8501

Placebo

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Elastase Inhibition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BAY85-8501

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

NCT ID

NCT01818544

First Posted

March 8, 2013

Last Updated

July 8, 2015

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01818544

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchiectasis

Keywords

Elastase Inhibition

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

94 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BAY85-8501

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

BAY85-8501

Intervention Description

BAY85-8501 (1.0 mg, 2 tablets each 0.5 mg) will be administered orally once daily in the morning

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo (1.0 mg, 2 tablets each 0.5 mg) will be administered orally once daily in the morning

Primary Outcome Measure Information:

Title

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)

Title

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

Title

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

Title

Change From Baseline in Heart Rate At Days 7, 14, 21, 28, 56

Time Frame

Baseline (Day 1), Day 7, 14, 21, 28, 56

Title

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

Title

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

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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

Title

Change From Baseline in 24 Hours Sputum Weight at Day 28

Time Frame

Baseline (Day 1), Day 28

Title

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