check_circleStudy Completed

Infection, Pulmonary Disease, Chronic Obstructive

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

Both

Age

40 - 75 Years

Trial summary

Enrollment Goal
12
Trial Dates
July 2010 - September 2010
Phase
Phase 1
Could I Receive a placebo
No
Products
Ciprofloxacin DPI (BAYQ3939)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Krankenhaus GroßhansdorfGroßhansdorf, 22927, Germany

Primary Outcome

  • Determination of ciprofloxacin pharmacokinetics derived from drug concentrations in blood, urine and sputum
    date_rangeTime Frame:
    Within 24 hours after treatment
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    Safety Issue:
    No

Secondary Outcome

  • Adverse events collection
    date_rangeTime Frame:
    Within 30 days
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    Safety Issue:
    Yes

Trial design

Randomized, double-blind, cross-over study in COPD subjects to investigate safety, tolerability, and pharmacokinetics of ciprofloxacin after single dose inhalations of 50 mg and 75 mg ciprofloxacin inhalation powder
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Crossover Assignment
Trial Arms
2