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Completed

NCT Number: NCT01818544

Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (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.

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nice, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY85-8501

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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)

  2. 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

  3. 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

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

    Time frame: Baseline (Day 1), Day 7, 14, 21, 28, 56

  5. 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

  6. 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

  7. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Change From Baseline in 24 Hours Sputum Weight at Day 28

    Time frame: Baseline (Day 1), Day 28

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. Change From Baseline of Biomarkers in Urine At Days 14, 28, 56: Creatinine

    Time frame: Baseline (Day 1), Day 14, 28 and 56

  14. Change From Baseline of Biomarkers in Urine at Days 14, 28, 56: Desmosine

    Time frame: Baseline (Day 1), Day 14, 28 and 56

  15. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 26, 2013
Registry last updated
Jul 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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