check_circleStudy Completed
Infection, Pulmonary Disease, Chronic Obstructive
Bayer Identifier:
14972
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study in COPD (chronic obstructive pulmonary disease) subjects to investigate safety, tolerability, and pharmacokinetics of ciprofloxacin after single dose inhalations of 50 mg and 75 mg ciprofloxacin inhalation powder
Trial purpose
The purpose of this study is to compare the safety and pharmacokinetics of ciprofloxacin after inhalation of single 52.5 and 48.75 mg doses in COPD patients. In this study the 48.75 mg dose will be administered for the first time using a new high dose strength (i.e. one capsule containing 75 mg powder = 48.75 mg ciprofloxacin) formulation. Safety investigations will focus on local tolerability in the lung and evaluate whether the patient can inhale the higher amount of powder compared to the lower dose strength. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. Results from this study will be used to decide whether the new dose strength is suitable for larger clinical trials planned for the COPD patients population.
Key Participants Requirements
Sex
BothAge
40 - 75 YearsTrial summary
Enrollment Goal
12Trial Dates
July 2010 - September 2010Phase
Phase 1Could I Receive a placebo
NoProducts
Ciprofloxacin DPI (BAYQ3939)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Krankenhaus Großhansdorf | Großhansdorf, 22927, Germany |
Primary Outcome
- Determination of ciprofloxacin pharmacokinetics derived from drug concentrations in blood, urine and sputumdate_rangeTime Frame:Within 24 hours after treatmentenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Adverse events collectiondate_rangeTime Frame:Within 30 daysenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Crossover AssignmentTrial Arms
2