Conditions: Cystic Fibrosis
Keywords: Ciprofloxacin cystic fibrosis sweat test pulmonary function test
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 288
Healthy volunteers: no

Brief summary:
To evaluate the change in forced expiratory volume (FEV1) from baseline to Day 28-30 between Cipro Inhale-treated and placebo-treated subjects after a 4-week treatment period.

Detailed description:
Safety issues are addressed in the Adverse Events section.

Arms:
arm 1: 32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days arm 2: 48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days arm 3: Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days arm 4: Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days

Interventions: intervention 1: Ciprofloxacin (Cipro Inhale, BAYQ3939) intervention 2: Placebo intervention 3: Ciprofloxacin (Cipro Inhale, BAYQ3939) intervention 4: Placebo
Intervention descriptions: intervention 1: 32.5 mg ciprofloxacin DPI corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days intervention 2: 50 mg matching placebo powder formulation twice a day for 28 days intervention 3: 48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2) intervention 4: 75 mg matching placebo powder formulation twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2)

Protocol document: