NCT01052298 - Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

September 30, 2009

Study Completion Date

September 30, 2009

Conditions

Disease, Pulmonary

Interventions

DRUG

Ciprofloxacin (Cipro inhale, BAYQ3939)

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.

DRUG

Ciprofloxacin (Cipro inhale, BAYQ3939)

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.

DRUG

Ciprofloxacin (Cipro inhale, BAYQ3939)

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.

DRUG

Placebo

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.

Trial Locations (1)

68167

Mannheim