Status:
COMPLETED
Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) Bronchiectasis
Lead Sponsor:
Bayer
Conditions:
Bronchiectasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 obje...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT01818544
Start Date
April 1 2013
End Date
June 1 2014
Last Update
July 9 2015
Active Locations (33)
Enter a location and click search to find clinical trials sorted by distance.
1
Nice, France, 06000
2
Perpignan, France, 66025
3
Donaustauf, Bavaria, Germany, 93093
4
Rüdersdorf, Brandenburg, Germany, 15562