Conditions: Pulmonary Infections Pseudomonas Aeruginosa in Cystic Fibrosis
Keywords: Tobramycin Inhalation powder Cystic fibrosis Lung disease Anti-bacterial agents
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 157
Healthy volunteers: no

Brief summary:
This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.

Detailed description:

Arms:
arm 1: Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.

Interventions: intervention 1: TBM100
Intervention descriptions: intervention 1: Tobramycin inhalation powder was assigned as four capsules at 28mg dosage strength. It was inhaled b.i.d in the morning and in the evening via the T-326 Inhaler.

Protocol document: