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

Bayer94 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Bronchiectasis

Interventions

BAY85-8501DRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (33)

Unnamed facility

Nice, France

Outcomes