check_circleStudy Completed
Disease, Pulmonary
Bayer Identifier:
13013
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study to evaluate the safety and pharmacokinetics of inhaled ciprofloxacin in patients with mild to moderate 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 mild to moderate COPD (stage I-II according to GOLD Criteria).
Key Participants Requirements
Sex
BothAge
35 YearsTrial summary
Enrollment Goal
25Trial Dates
April 2009 - September 2009Phase
Phase 1Could I Receive a placebo
YesProducts
Ciprofloxacin DPI (BAYQ3939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | CRS Clinical-Research-Services Mannheim GmbH | Mannheim, 68167, Germany |
Primary Outcome
- Vital signs: evaluated by heart rate, blood pressure, clinical laboratorydate_rangeTime Frame:Within 28 days after first treatmentenhanced_encryptionyesSafety Issue:
- Electrocardiogram: evaluated by shape and time intervalsdate_rangeTime Frame:Within 28 days after first treatmentenhanced_encryptionyesSafety Issue:
- Pulmonary function test evaluated by FEV1date_rangeTime Frame:Within 28 days after first treatmentenhanced_encryptionyesSafety Issue:
- Pulse oximetry by peripheral oxygen concentrationdate_rangeTime Frame:Within 12 days after first treatmentenhanced_encryptionyesSafety Issue:
Secondary Outcome
- Determination of ciprofloxacin concentration in blooddate_rangeTime Frame:Within 14 days after first treatmentenhanced_encryptionnoSafety Issue:
- Determination of ciprofloxacin concentration in urinedate_rangeTime Frame:Within 14 days after first treatmentenhanced_encryptionnoSafety Issue:
- Determination of ciprofloxacin concentration in sputumdate_rangeTime Frame:Within 14 days after first treatmentenhanced_encryptionnoSafety Issue:
- Determination of ciprofloxacin concentration in oral rinsing 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
4