Conditions: Long-term Safety of TIP
Keywords: CF, Open-label, TIP, phase IV, extension study
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 45
Healthy volunteers: no

Brief summary:
The purpose of this extension study is to collect additional 48 weeks of safety data from patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting second year safety data through this study is to obtain long-term (2 years) safety data of TIP.

Detailed description:

Arms:
arm 1: TIP 112 mg/b.i.d

Interventions: intervention 1: TBM100
Intervention descriptions: intervention 1: Tobramycin inhalation powder (TIP) 112mg/b.i.d

Protocol document: