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

Bronchiectasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01818544
• Other study ID #: 16359
• Secondary ID: 2012-004491-18
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2013
• Last updated: July 8, 2015
• Start date: April 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencySpain: Agencia Española de Medicamentos y Productos SanitariosUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number Of Subjects Who Need To Discontinue Study Medication Due To Findings In Physical Examination		From start of study treatment up to follow up visit (28 days after last dose)	Yes
Primary	Change From Baseline in Systolic Blood Pressure At Days 7, 14, 21, 28, 56		Baseline (Day 1), Day 7, 14, 21, 28, 56	Yes
Primary	Change From Baseline in Diastolic Blood Pressure At Days 7, 14, 21, 28, 56		Baseline (Day 1), Day 7, 14, 21, 28, 56	Yes
Primary	Change From Baseline in Heart Rate At Days 7, 14, 21, 28, 56		Baseline (Day 1), Day 7, 14, 21, 28, 56	Yes
Primary	Number of Subjects With new Abnormal (Pathologic) Electrocardiogram (ECG) Findings From Baseline to Day 28		Baseline (Day 1), Day 7, 14, 21, 28	Yes
Primary	Number of Subjects who Show Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TB) Abnormalities in Their Safety Lab Assessment		Baseline (Day 1), Day 7, 14, 21, 28, 56	Yes
Primary	Number of Subjects With Drug Related Adverse Events as a Measure of Safety And Tolerability		Baseline (Day 1), Day 7, 14, 21, 28, 56	Yes
Secondary	Change From Baseline in Pulmonary Function Test Forced Expired Volume in 1 Second (FEV1) At Days 7, 14, 21, 28, 56		Baseline (Day 1), Day 7, 14, 21, 28, 56	No
Secondary	Change From Baseline in Pulmonary Function Test Forced Vital Capacity (FVC) at Days 7, 14, 21, 28, 56		Baseline (Day 1), Day 7, 14, 21, 28, 56	No
Secondary	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		Baseline (Day 1), Day 7, 14, 21, 28, 56	No
Secondary	Change From Baseline in Total Score on St. George's Respiratory Questionnaire (SGRQ) at Day 28 and 56		Baseline (Day 1), Day 28 and 56	No
Secondary	Change From Baseline in 24 Hours Sputum Weight at Day 28		Baseline (Day 1), Day 28	No
Secondary	Change From Baseline of Biomarkers in Sputum at Days 14, 28, 56: Alpha1 Antitrypsin Human Neutrophil Elastase (A1AHNE) Complex, Interleukin-8(IL-8)		Baseline (Day 1), Day 14, 28 and 56	No
Secondary	Change From Baseline of Biomarkers in Sputum at Days 14, 28, 56: Neutrophil cell Count		Baseline (Day 1), Day 14, 28 and 56	No
Secondary	Change From Baseline of Human Neutrophil Elastase (NE) Activity in Sputum at Days 14, 28, 56		Baseline (Day 1), Day 14, 28 and 56	No
Secondary	Change From Baseline of Human Neutrophil Elastase (NE) Concentration in Sputum at Days 14, 28, 56		Baseline (Day 1), Day 14, 28 and 56	No
Secondary	Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: C-reactive Protein		Baseline (Day 1), Day 14, 28 and 56	No
Secondary	Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: Interleukin-8 (IL8)		Baseline (Day 1), Day 14, 28 and 56	No
Secondary	Change From Baseline of Biomarkers in Blood at Days 14, 28, 56: Neutrophil cell Count		Baseline (Day 1), Day 14, 28 and 56	No
Secondary	Change From Baseline of Biomarkers in Urine At Days 14, 28, 56: Creatinine		Baseline (Day 1), Day 14, 28 and 56	No
Secondary	Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Desmosine		Baseline (Day 1), Day 14, 28 and 56	No
Secondary	Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Normalized Desmosine Value to Creatinine		Baseline (Day 1), Day 14, 28 and 56	No

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