Trial Condition(s):
Bronchiectasis
Evaluation of cipro inhale in patients with non-cystic fibrosis bronchiectasis
Bayer Identifier:
12965
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Krankenhaus Großhansdorf Großhansdorf, Germany, 22927 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Johannes-Gutenberg-Universität Mainz Mainz, Germany, 55131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IFS Interdisziplinäres Facharztzentrum Frankfurt, Germany, 60596 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis für Lungenheilkunde Witten, Germany, 58452 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gemeinschaftspraxis Drs. Korker, Schmidt & Schaeben Koblenz, Germany, 56068 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gemeinschaftspraxis Harald Sudhoff, Drs. med. Thomas Hering, Berlin, Germany, 13507 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IFG Institut für Gesundheitsförderung GmbH Rüdersdorf, Germany, 15562 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Freeman Hospital Newcastle Upon Tyne, United Kingdom, NE7 7DN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Papworth Hospital Cambridge, United Kingdom, CB3 8RE | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bristol Royal Infirmary Bristol, United Kingdom, BS2 8HW | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Norfolk and Norwich University Hospital Norwich, United Kingdom, NR4 7UY | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Central Utah Clinic, PC Payson, United States, 84651 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Connecticut Health Center Farmington, United States, 06030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scripps Clinic - Torrey Pines La Jolla, United States, 92037 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Winthrop-University Hospital Mineola, United States, 11501 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitari Son Espases Palma de Mallorca, Spain, 07010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akademiska Sjukhuset Uppsala, Sweden, 751 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Princess Alexandra Hospital Woollongabba, Australia, 4102 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Alfred Hospital Prahran, Australia, 3181 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Brisbane Mater Misericordiae Hospital South Brisbane, Australia, 4101 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken der Medizinischen Hochschule Hannover Hannover, Germany, 30625 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinik Löwenstein gGmbH Löwenstein, Germany, 74245 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zentralklinik Bad Berka GmbH Bad Berka, Germany, 99437 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Drs. Volgmann/Weber Hannover, Germany, 30167 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. W. Schröder-Babo Gelnhausen, Germany, 63571 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. A. de Roux Berlin, Germany, 14059 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lungenzentrum Geesthacht Geesthacht, Germany, 21502 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Belfast City Hospital Belfast, United Kingdom, BT12 7AB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Hospital Aintree Liverpool, United Kingdom, L9 7JU | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Infirmary of Edinburgh Edinburgh, United Kingdom, EH16 4SA | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Arkansas for Medical Sciences Little Rock, United States, 72205 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Georgetown University Hospital Washington, United States, 20007-2197 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Texas Health Center/Tyler Tyler, United States, 75708-3154 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Naples Institute for Clinical Research Naples, United States, 34109-0446 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Jewish Health Denver , United States, 80206 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Chest Associates Houston, United States, 77204 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations LaPorte County Institute for Clinical Research, Inc. Michigan City, United States, 46360 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela, Spain, 15706 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Infanta Cristina de Badajoz Badajoz, Spain, 06080 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Burnside War Memorial Hospital Adelaide, Australia, 5065 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Adelaide Hospital Adelaide, Australia, 5000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Austin and Repatriation Centre Heidelberg, Australia, 3084 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Concord Repatriation General Hospital Concord, Australia, 2139 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sir Charles Gairdner Hospital Nedlands, Australia, 6009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. L.-H. von Versen Berlin, Germany, 10961 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. Th. Schultz Berlin, Germany, 12203 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Randomized, placebo-controlled, double-blind, multi-center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Change from baseline in total bacterial load in the sputum at end of treatment (Day 29)Timeframe: Baseline and 29 days
Secondary Outcome
- Change from baseline in forced expiratory volume in 1 second (FEV1)Timeframe: Baseline and up to end of study (planned at Day 84)
- Change from baseline in forced vital capacity (FVC)Timeframe: Baseline and up to end of study (planned at Day 84)
- Time to exacerbation with antibiotic interventionTimeframe: Up to end of study (planned at Day 84)
- Effect of ciprofloxacin inhale treatment on health-related quality of life (HRQoL) as measured by the Saint George's Respiratory Questionnaire (SGRQ)Timeframe: Up to end of study (planned at Day 84)
- Effect of ciprofloxacin inhale treatment on health-related quality of life (HRQoL) as measured by Chronic Respiratory Questionnaire – Self Administered Standardized (CRQ-SAS)Timeframe: Up to end of study (planned at Day 84)
- Change from baseline in high sensitive C-reactive protein (hsCRP)Timeframe: Baseline and up to Day 42
- Change from baseline in absolute neutrophil count (ANC)Timeframe: Baseline and up to Day 42
- 24-hour sputum volumeTimeframe: Up to end of study (planned at Day 84)
- 24-hour sputum color (percentage of participants with non-clear sputum)Timeframe: Up to end of study (planned at Day 84)
- Microbiological response of Cipro Inhale per participantTimeframe: Up to end of study (planned at Day 84)
- Microbiological response of Cipro Inhale per pathogenTimeframe: Up to end of study (planned at Day 84)
- Emergence of new potential respiratory pathogensTimeframe: Up to end of study (planned at Day 84)
- Emergence of resistance among baseline pathogensTimeframe: Up to end of study (planned at Day 84)
Additional Information
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