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 Information
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
Administrative Informations
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