Trial Condition(s):

Bronchiectasis

Evaluation of cipro inhale in patients with non-cystic fibrosis bronchiectasis

Bayer Identifier:

12965

ClinicalTrials.gov Identifier:

NCT00930982

EudraCT Number:

2009-009869-34

EU CT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to find out if bacterial load in the airways can be reduced after inhalation of ciprofloxacin for 28 days.

Inclusion Criteria
- Patients with a proven and documented diagnosis of non-cystic fibrosis idiopathic or post pneumonic bronchiectasis 
 - Stable pulmonary status and stable regimen of standard treatment at least for the past 30 days
Exclusion Criteria
- Forced Expiratory Volume 1 < 35% or > 80% 
 - Allergic bronchopulmonary aspergillosis 
 - Immunodeficiency disease requiring immunoglobulin replacement
 - Inflammatory bowel disease

Trial Summary

Enrollment Goal
124
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Ciprofloxacin DPI (BAYQ3939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Krankenhaus Großhansdorf

Großhansdorf, Germany, 22927

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Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55131

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IFS Interdisziplinäres Facharztzentrum

Frankfurt, Germany, 60596

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Praxis für Lungenheilkunde

Witten, Germany, 58452

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Gemeinschaftspraxis Drs. Korker, Schmidt & Schaeben

Koblenz, Germany, 56068

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Gemeinschaftspraxis Harald Sudhoff, Drs. med. Thomas Hering,

Berlin, Germany, 13507

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IFG Institut für Gesundheitsförderung GmbH

Rüdersdorf, Germany, 15562

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Freeman Hospital

Newcastle Upon Tyne, United Kingdom, NE7 7DN

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Papworth Hospital

Cambridge, United Kingdom, CB3 8RE

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Bristol Royal Infirmary

Bristol, United Kingdom, BS2 8HW

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Norfolk and Norwich University Hospital

Norwich, United Kingdom, NR4 7UY

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Central Utah Clinic, PC

Payson, United States, 84651

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University of Connecticut Health Center

Farmington, United States, 06030

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Scripps Clinic - Torrey Pines

La Jolla, United States, 92037

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Winthrop-University Hospital

Mineola, United States, 11501

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Hospital Universitari Son Espases

Palma de Mallorca, Spain, 07010

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Akademiska Sjukhuset

Uppsala, Sweden, 751 85

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Princess Alexandra Hospital

Woollongabba, Australia, 4102

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The Alfred Hospital

Prahran, Australia, 3181

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Brisbane Mater Misericordiae Hospital

South Brisbane, Australia, 4101

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Kliniken der Medizinischen Hochschule Hannover

Hannover, Germany, 30625

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Klinik Löwenstein gGmbH

Löwenstein, Germany, 74245

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Zentralklinik Bad Berka GmbH

Bad Berka, Germany, 99437

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Praxis Drs. Volgmann/Weber

Hannover, Germany, 30167

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Praxis Hr. Dr. W. Schröder-Babo

Gelnhausen, Germany, 63571

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Praxis Hr. Dr. A. de Roux

Berlin, Germany, 14059

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Lungenzentrum Geesthacht

Geesthacht, Germany, 21502

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Belfast City Hospital

Belfast, United Kingdom, BT12 7AB

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University Hospital Aintree

Liverpool, United Kingdom, L9 7JU

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Royal Infirmary of Edinburgh

Edinburgh, United Kingdom, EH16 4SA

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University of Arkansas for Medical Sciences

Little Rock, United States, 72205

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Georgetown University Hospital

Washington, United States, 20007-2197

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University of Texas Health Center/Tyler

Tyler, United States, 75708-3154

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Naples Institute for Clinical Research

Naples, United States, 34109-0446

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National Jewish Health

Denver , United States, 80206

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Medical Chest Associates

Houston, United States, 77204

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LaPorte County Institute for Clinical Research, Inc.

Michigan City, United States, 46360

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Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

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Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain, 15706

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Hospital Universitario Infanta Cristina de Badajoz

Badajoz, Spain, 06080

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Burnside War Memorial Hospital

Adelaide, Australia, 5065

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Royal Adelaide Hospital

Adelaide, Australia, 5000

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Austin and Repatriation Centre

Heidelberg, Australia, 3084

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Concord Repatriation General Hospital

Concord, Australia, 2139

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Sir Charles Gairdner Hospital

Nedlands, Australia, 6009

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Praxis Hr. Dr. L.-H. von Versen

Berlin, Germany, 10961

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Praxis Hr. Dr. Th. Schultz

Berlin, Germany, 12203

Trial Design