check_circleStudy Completed
Pulmonary Disease, Chronic Obstructive
Bayer Identifier:
13014
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study to evaluate the safety and pharmacokinetics of inhaled ciprofloxacin in patients with moderate to severe chronic obstructive pulmonary disease (COPD)
Trial purpose
Objectives of the study are to investigate the safety, tolerability and levels of ciprofloxacin in the lung after single and multiple inhalative administration to patients with moderate to severe COPD (stage II-III according to GOLD Criteria)
Key Participants Requirements
Sex
BothAge
40 - 75 YearsTrial summary
Enrollment Goal
19Trial Dates
August 2009 - March 2010Phase
Phase 1Could I Receive a placebo
YesProducts
Ciprofloxacin DPI (BAYQ3939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Hannover, 30625, Germany |
Primary Outcome
- Vital signsdate_rangeTime Frame:Within 28 days after first treatmentenhanced_encryptionyesSafety Issue:
- Electrocardiogram (ECG)date_rangeTime Frame:Within 28 days after first treatmentenhanced_encryptionyesSafety Issue:
- Pulmonary function testdate_rangeTime Frame:Within 28 days after first treatmentenhanced_encryptionyesSafety Issue:
- Pulse-oximetrydate_rangeTime Frame:Within 12 days after first treatmentenhanced_encryptionyesSafety Issue:
Secondary Outcome
- Ciprofloxacin concentrations in blooddate_rangeTime Frame:Within 14 days after first treatmentenhanced_encryptionnoSafety Issue:
- Ciprofloxacin concentrations in urinedate_rangeTime Frame:Within 14 days after first treatmentenhanced_encryptionnoSafety Issue:
- Ciprofloxacin concentrations in sputumdate_rangeTime Frame:Within 14 days after first treatmentenhanced_encryptionnoSafety Issue:
- Ciprofloxacin concentrations in mouth fluiddate_rangeTime Frame:Within 7 days after first treatmentenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Single BlindAssignment
Parallel AssignmentTrial Arms
3