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

Bayer

Status and phase: Completed; Phase 2

Conditions: Bronchiectasis

Treatments: Drug: BAY85-8501; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01818544

2012-004491-18 (EudraCT Number)

16359

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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94 participants in 2 patient groups, including a placebo group

BAY85-8501

Experimental group

Treatment:

Drug: BAY85-8501

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo