The purpose of this study is to characterize variability and extent of the deposition of ciprofloxacin in the respiratory tract of healthy subjects in comparison to patients with chronic lung diseases after inhalation of a single 50 mg dry powder dose containing 32 mg active substance. In addition the safety and pharmacokinetics of ciprofloxacin will be evaluated. In this study the radiolabeled substance will be administered and scintigraphy imaging techniques will be used to demonstrate the lung deposition visually. In the healthy subjects an additional pharmacokinetic method is used to calculate lung deposition indirectly based on pharmacokinetic data derived from plasma. For this purpose they will inhale at a separate occasion another dose of ciprofloxacin after having ingested activated charcoal. The latter serves to bind ciprofloxacin which is swallowed down during the inhalation maneuver in the gastrointestinal (GI) tract, thus preventing its uptake into the blood (charcoal block). Safety investigations will focus on local tolerability in the lung. 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 show how the drug is distributed in the human lung.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by healthy subjects
50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by healthy subjects under charcoal block
50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by COPD patients
50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by bronchiectasis patients
Unnamed facility
Gauting, Bavaria, Germany
Ciprofloxacin pharmacokinetics including lung deposition
Firstly, scintigraphic imaging, a non-invasive method using a radioactive (99mTc-) label tagged to the formulation, will be used to describe the distribution and deposition of a single inhaled dose of Ciprofloxacin Dry Powder Inhalation (DPI) in the lung quantitatively. Secondly, based on blood sampling over a period of 24 hours after inhalation non-compartmental pharmacokinetic parameters of ciprofloxacin will be calculated to determine the systemic exposure to drug following inhalation of a single 32.5 mg Ciprofloxacin dose.
Time frame: Within 24 hours after treatment
Adverse Events collection
Time frame: Within 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.