Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis
NCT ID: NCT00930982
Last Updated: 2014-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2009-06-30
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ciprofloxacin Inhale (BAYQ3939)
32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Ciprofloxacin (Cipro, BAYQ3939)
Inhalation of 32,5mg Ciprofloxacin inhaled twice a day
Placebo
Inhalation of matching placebo twice a day
Placebo
Inhalation of matching placebo twice a day
Interventions
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Ciprofloxacin (Cipro, BAYQ3939)
Inhalation of 32,5mg Ciprofloxacin inhaled twice a day
Placebo
Inhalation of matching placebo twice a day
Eligibility Criteria
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Inclusion Criteria
* Stable pulmonary status and stable regimen of standard treatment at least for the past 30 days
Exclusion Criteria
* Allergic bronchopulmonary aspergillosis
* Immunodeficiency disease requiring immunoglobulin replacement
* Inflammatory bowel disease
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Little Rock, Arkansas, United States
La Jolla, California, United States
Denver, Colorado, United States
Farmington, Connecticut, United States
Washington D.C., District of Columbia, United States
Naples, Florida, United States
Michigan City, Indiana, United States
Mineola, New York, United States
Houston, Texas, United States
Tyler, Texas, United States
Payson, Utah, United States
Concord, New South Wales, Australia
South Brisbane, Queensland, Australia
Woollongabba, Queensland, Australia
Adelaide, South Australia, Australia
Adelaide, South Australia, Australia
Heidelberg, Victoria, Australia
Prahran, Victoria, Australia
Nedlands, Western Australia, Australia
Löwenstein, Baden-Wurttemberg, Germany
Rüdersdorf, Brandenburg, Germany
Frankfurt am Main, Hesse, Germany
Gelnhausen, Hesse, Germany
Hanover, Lower Saxony, Germany
Hanover, Lower Saxony, Germany
Witten, North Rhine-Westphalia, Germany
Koblenz, Rhineland-Palatinate, Germany
Mainz, Rhineland-Palatinate, Germany
Geesthacht, Schleswig-Holstein, Germany
Großhansdorf, Schleswig-Holstein, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Bad Berka, Thuringia, Germany
Santiago de Compostela, A Coruña, Spain
Badajoz, Badajoz, Spain
Barcelona, Barcelona, Spain
Palma de Mallorca, Illes Baleares, Spain
Uppsala, , Sweden
Bristol, Avon, United Kingdom
Cambridge, Cambridgeshire, United Kingdom
Liverpool, Merseyside, United Kingdom
Belfast, North Ireland, United Kingdom
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Edinburgh, , United Kingdom
Norwich, , United Kingdom
Countries
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References
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Wilson R, Welte T, Polverino E, De Soyza A, Greville H, O'Donnell A, Alder J, Reimnitz P, Hampel B. Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study. Eur Respir J. 2013 May;41(5):1107-15. doi: 10.1183/09031936.00071312. Epub 2012 Sep 27.
Related Links
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Click here and search for Bayer products information provided by EMA
Other Identifiers
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2009-009869-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12965
Identifier Type: -
Identifier Source: org_study_id