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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
25
32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d.
32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given three times daily (tid) with a concluding single dose on 11d.
Unnamed facility
Mannheim, Baden-Wurttemberg, Germany
Vital signs: evaluated by heart rate, blood pressure, clinical laboratory
Time frame: Within 28 days after first treatment
Electrocardiogram: evaluated by shape and time intervals
Time frame: Within 28 days after first treatment
Pulmonary function test evaluated by FEV1
Time frame: Within 28 days after first treatment
Pulse oximetry by peripheral oxygen concentration
Time frame: Within 12 days after first treatment
Determination of ciprofloxacin concentration in blood
Time frame: Within 14 days after first treatment
Determination of ciprofloxacin concentration in urine
Time frame: Within 14 days after first treatment
Determination of ciprofloxacin concentration in sputum
Time frame: Within 14 days after first treatment
Determination of ciprofloxacin concentration in oral rinsing fluid
Time frame: Within 7 days after first treatment
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48.75 mg ciprofloxacin betaine corresponding to 75 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d.
Placebo inhalation powder will be given as an initial single dose inhalation on 00d.During the multiple dose phase placebo will be given twice/three-times daily with a concluding single dose on day 11d.