Arikace Compared to TOBI in People with CF with Chronic Pseudomonas Aeruginosa Infections
Not Yet Recruiting
Number of Participants Being Recruited:
Single / Multi-Center:
STUDY BACKGROUND INFORMATION:
People with CF can experience chronic lung infections by bacteria such as Pseudomonas aeruginosa. Finding the best way to treat the chronic lung infections is one of the primary goals of CF therapy. Arikace (liposomal amikacin for inhalation) is a sustained-release form of amikacin encapsulated inside nanoscale liposomal carriers designed to be inhaled. This Phase 3 trial will look at the effectiveness, safety and tolerability of Arikace in treating CF patients with chronic lung infection compared to a currently available antibiotic, TOBI (tobramycin) Inhalation Solution.
The trial requires 9 clinic visit times (including the Screening visit) over a period of approximately 6 months. No overnight stays at the clinic will be required.
>= 6 Years
>= 25 Percent Predicted
P. aeruginosa status:
B. cepacia status:
Other Primary Eligibility Requirements:
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.