Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis CF
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 32
Healthy volunteers: no

Brief summary:
To provide efficacy and safety data comparing two dosing schedules of Tobramycin Inhalation Powder (TIP) for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis.

Detailed description:

Arms:
arm 1: Tobramycin Inhalation Powder (112 mg) once daily during 168 days arm 2: Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140

Interventions: intervention 1: Tobramycin Inhalation Powder
Intervention descriptions: intervention 1: Tobramycin Inhalation Powder 112 mg (four 28-mg capsules) taken via inhaler once or twice a day, depending on study arm

Protocol document: