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

NCT01818544 | Completed Phase 2

• 2 other identifiers: 163592012-004491-18
• Study Type: interventional
• Target: 94
• Locations: 5 countries
• Sites: 33

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.

Conditions

Bronchiectasis

Keywords

Elastase Inhibition

Outcome Measures

Primary Outcomes (7)

• 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)

• Change From Baseline in Systolic Blood Pressure At Days 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

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

• Change From Baseline in Heart Rate At Days 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

  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

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

• Number of Subjects With Drug Related Adverse Events as a Measure of Safety And Tolerability

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

Secondary Outcomes (15)

• 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

• 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

• 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

• 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

• Change From Baseline in 24 Hours Sputum Weight at Day 28

  Baseline (Day 1), Day 28

Study Arms (2)

BAY85-8501

EXPERIMENTAL

Drug: BAY85-8501

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BAY85-8501 DRUG

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

BAY85-8501

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (33)

Unknown Facility

Nice, 06000, France

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Perpignan, 66025, France

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Donaustauf, Bavaria, 93093, Germany

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Rüdersdorf, Brandenburg, 15562, Germany

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Hamburg, Hamburg, 20354, Germany

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Hanover, Lower Saxony, 30167, Germany

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Leipzig, Saxony, 04103, Germany

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Großhansdorf, Schleswig-Holstein, 22927, Germany

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Kiel, Schleswig-Holstein, 24105, Germany

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Lübeck, Schleswig-Holstein, 23538, Germany

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Jena, Thuringia, 07740, Germany

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Orbassano, Torino, 10043, Italy

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Genova, 16132, Italy

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Milan, 20142, Italy

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Napoli, 80131, Italy

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Padua, 35128, Italy

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Siena, 53100, Italy

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Badalona, Barcelona, 08916, Spain

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Salt, Girona, 17190, Spain

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Madrid, Madrid, 28046, Spain

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Majadahonda, Madrid, 28222, Spain

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Southampton, Hampshire, SO16 6YD, United Kingdom

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Cottingham, Humberside, HU16 5JQ, United Kingdom

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Leicester, Leicestershire, LE3 9QP, United Kingdom

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Liverpool, Merseyside, L9 7JU, United Kingdom

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Sheffield, South Yorkshire, S5 7AU, United Kingdom

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Dundee, Tayside, DD2 1UB, United Kingdom

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Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

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South Shields, Tyne and Wear, NE34 0PL, United Kingdom

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Wolverhampton, West Midlands, WV10 0QP, United Kingdom

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Bradford, West Yorkshire, BD9 6RJ, United Kingdom

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Glasgow, G42 9TY, United Kingdom

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London, EC1M 6BQ, United Kingdom

Location

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2013
• First Posted: March 26, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 9, 2015

Record last verified: 2015-07

Locations

IT (6); ES (4); DE (9); FR (2); GB (12)