Trial Condition(s):

Bronchiectasis

Safety and Efficacy of Oral BAY85-8501 in Patients with non-CF (cystic fibrosis) Bronchiectasis

Bayer Identifier:

16359

ClinicalTrials.gov Identifier:

NCT01818544

EudraCT Number:

2012-004491-18

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
94
Trial Dates
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Phase
2
Could I receive a placebo?
Yes
Products
BAY85-8501
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Hospital Universitario "La Paz"

Madrid, Spain, 28046

Status
Completed
 
Locations

Southampton General Hospital

Southampton, United Kingdom, SO16 6YD

Status
Completed
 
Locations

Victoria Infirmary

Glasgow, United Kingdom, G42 9TY

Status
Completed
 
Locations

William Harvey Research Centre

London, United Kingdom, EC1M 6BQ

Status
Completed
 
Locations

Northern General Hospital

Sheffield, United Kingdom, S5 7AU

Status
Completed
 
Locations

New Cross Hospital

Wolverhampton, United Kingdom, WV10 0QP

Status
Completed
 
Locations

Castle Hill Hospital

Cottingham, United Kingdom, HU16 5JQ

Status
Completed
 
Locations

Glenfield Hospital

Leicester, United Kingdom, LE3 9QP

Status
Completed
 
Locations

Bradford Royal Infirmary

Bradford, United Kingdom, BD9 6RJ

Status
Completed
 
Locations

University Hospital Aintree

Liverpool, United Kingdom, L9 7JU

Status
Completed
 
Locations

Krankenhaus Großhansdorf

Großhansdorf, Germany, 22927

Status
Terminated
 
Locations

Universitätsklinikum Leipzig AöR

Leipzig, Germany, 04103

Status
Completed
 
Locations

IFG Institut für Gesundheitsförderung GmbH

Rüdersdorf, Germany, 15562

Status
Completed
 
Locations

Hospital Universitario Clinica Puerta de Hierro

Majadahonda, Spain, 28222

Status
Completed
 
Locations

Hospital Universitari Germans Trias i Pujol

Badalona, Spain, 08916

Status
Terminated
 
Locations

Hospital Santa Caterina

Salt, Spain, 17190

Status
Completed
 
Locations

Krankenhaus Donaustauf

Donaustauf, Germany, 93093

Status
Terminated
 
Locations

Universitätsklinikum Schleswig-Holstein / AÖR

Lübeck, Germany, 23538

Status
Completed
 
Locations

Klinikum der Friedrich-Schiller-Universität Jena

Jena, Germany, 07740

Status
Completed
 
Locations

Krankenhaus Großhansdorf

Großhansdorf, Germany, 22927

Status
Completed
 
Locations

Klinikum der Christian-Albrechts-Universität

Kiel, Germany, 24105

Status
Completed
 
Locations

Pneumologische Praxis Hannover Nordstadt

Hannover, Germany, 30167

Status
Terminated
 
Locations

Centre d'allergologie et de pneumologie respiratoire

PERPIGNAN, France, 66025

Status
Terminated
 
Locations

Cabinet médical - Cronstadt - Nice

NICE, France, 06000

Status
Terminated
 
Locations

IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca Cancro

Genova, Italy, 16132

Status
Completed
 
Locations

A.O. San Paolo Polo Universitario

Milano, Italy, 20142

Status
Completed
 
Locations

A.O.U. San Luigi Gonzaga

Orbassano, Italy, 10043

Status
Completed
 
Locations

A.O. di Padova

Padova, Italy, 35128

Status
Completed
 
Locations

A.O.R.N. Dei Colli

Napoli, Italy, 80131

Status
Completed
 
Locations

A.O.U. Senese

Siena, Italy, 53100

Status
Completed
 
Locations

Hamburger Institut für Therapieforschung GmbH

Hamburg, Germany, 20354

Status
Completed
 
Locations

Freeman Hospital

Newcastle Upon Tyne, United Kingdom, NE7 7DN

Status
Completed
 
Locations

Ninewells Hospital

Dundee, United Kingdom, DD2 1UB

Status
Completed
 
Locations

South Tyneside District Hospital

South Shields, United Kingdom, NE34 0PL

Status
Completed
 

Trial Design