Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

PHASE1CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

Ciprofloxacin (PulmoSphere, BAYQ3939)

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)

DRUG

Ciprofloxacin (PulmoSphere, BAYQ3939)

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)

DRUG

Placebo

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)

Trial Locations (1)

30625

Hanover

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Bayer

INDUSTRY