Trial Condition(s):
Bronchiectasis
Evaluation of cipro inhale in patients with non-cystic fibrosis bronchiectasis
Bayer Identifier:
12965
ClinicalTrials.gov Identifier:
Not Available
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 | |
|---|---|
Locations Investigative Site Großhansdorf, Germany, 22927 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frankfurt, Germany, 60596 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Witten, Germany, 58452 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Koblenz, Germany, 56068 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 13507 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rüdersdorf, Germany, 15562 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newcastle Upon Tyne, United Kingdom, NE7 7DN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cambridge, United Kingdom, CB3 8RE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bristol, United Kingdom, BS2 8HW | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Norwich, United Kingdom, NR4 7UY | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Payson, United States, 84651 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Farmington, United States, 06030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site La Jolla, United States, 92037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mineola, United States, 11501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Palma de Mallorca, Spain, 07010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Uppsala, Sweden, 751 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Woollongabba, Australia, 4102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Prahran, Australia, 3181 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site South Brisbane, Australia, 4101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Löwenstein, Germany, 74245 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bad Berka, Germany, 99437 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30167 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gelnhausen, Germany, 63571 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 14059 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Geesthacht, Germany, 21502 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Belfast, United Kingdom, BT12 7AB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Liverpool, United Kingdom, L9 7JU | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Edinburgh, United Kingdom, EH16 4SA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Little Rock, United States, 72205 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Washington, United States, 20007-2197 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tyler, United States, 75708-3154 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Naples, United States, 34109-0446 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Denver , United States, 80206 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77204 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Michigan City, United States, 46360 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Badajoz, Spain, 06080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Adelaide, Australia, 5065 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Adelaide, Australia, 5000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Australia, 3084 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Concord, Australia, 2139 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nedlands, Australia, 6009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 10961 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 12203 | 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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