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

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

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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Number Of Subjects Who Need To Discontinue Study Medication Due To Findings In Physical Examination

Secondary Outcome

 Change From Baseline in Pulmonary Function Test Forced Expired Volume in 1 Second (FEV1) At Days 7, 14, 21, 28, 56

Condition

Bronchiectasis

Intervention

BAY85-8501

Study Arms / Comparison Groups

 BAY85-8501

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

94

Start Date

April 2013

Completion Date

June 2014

Primary Completion Date

June 2014

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Bayer Study Director, , 

Location Countries

France

Location Countries

France

NCT ID

NCT01818544

Organization ID

16359

Secondary IDs

2012-004491-18

Responsible Party

Sponsor

Study Sponsor

Bayer

Study Sponsor

Bayer Study Director, Study Director, Bayer

Verification Date

July 2015