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Study Name: Arikace Compared to TOBI in People with CF with Chronic Pseudomonas Aeruginosa Infections
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Insmed
Study Phase: 3
Recruitment Status: Trial Completed
Study Drug(s): Arikace
Number of Participants Being Recruited: 300
Single / Multi-Center: 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.
ELIGIBILITY
Age: >= 6 Years
FEV1: >= 25 Percent Predicted
P. aeruginosa status: Positive
B. cepacia status: Not applicable
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.
FOR MORE INFORMATION:
Sponsor Contact Information: Gupta, Renu
(732) 997-4526
rgupta@transaveinc.com
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT01315678?term=insmed+and+cystic+fibrosis&rank=1
Clinical Research Terms Glossary: Click here
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