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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
19
32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin PulmoSphere inhalation powder will be given as an initial single-dose inhalation (day 0).During the multiple-dose phase (day 2 to day 11), the same dose will be given twice daily, with a concluding single dose (on day 12)
48,75 mg ciprofloxacin betaine corresponding to 75 mg Ciprofloxacin PulmoSphere inhalation powder will be given as an initial single-dose inhalation (day 0).During the multiple-dose phase (day 2 to day 11), the same dose will be given twice daily, with a concluding single dose (on day 12)
Placebo inhalation powder will be given as an initial single-dose inhalation (day 0).During the multiple-dose phase (day 2 to day 11), placebo will be given twice daily, with a concluding single dose (on day 12)
Unnamed facility
Hanover, Lower Saxony, Germany
Vital signs
Time frame: Within 28 days after first treatment
Electrocardiogram (ECG)
Time frame: Within 28 days after first treatment
Pulmonary function test
Time frame: Within 28 days after first treatment
Pulse-oximetry
Time frame: Within 12 days after first treatment
Ciprofloxacin concentrations in blood
Time frame: Within 14 days after first treatment
Ciprofloxacin concentrations in urine
Time frame: Within 14 days after first treatment
Ciprofloxacin concentrations in sputum
Time frame: Within 14 days after first treatment
Ciprofloxacin concentrations in mouth fluid
Time frame: Within 7 days after first treatment
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