Conditions: Cystic Fibrosis
Keywords: tobramycin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 517
Healthy volunteers: no

Brief summary:
This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler

Detailed description:

Arms:
arm 1: Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles. arm 2: Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.

Interventions: intervention 1: Tobramycin Inhalation Powder intervention 2: Tobramycin Solution for Inhalation
Intervention descriptions: intervention 1: Tobramycin Inhalation Powder (TIP) capsules for inhalation. intervention 2: Tobramycin solution for inhalation (TOBI), supplied as 300 mg/5mL ampoules administered with a nebulizer

Protocol document: