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Study Name: Study of Arikace in People with CF with Chronic Lung Infection Due to Pseudomonas Aeruginosa
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Insmed
Study Phase: 3
Recruitment Status: Not Yet Recruiting
Study Drug(s): Arikace
Number of Participants Being Recruited: 300
Single / Multi-Center: Multi-Center
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 placebo. Eligible study participants will be required to visit the clinic 8 times (including the Screening visit) over a period of approximately 3 months. No overnight stays at the clinic will be required.
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 If a specific trial listing for this trial is available, a link to the specific listing will be present in the "More Information" section below.
Sponsor Contact Information: Gupta, Renu
(732) 997-4526
Trial Specific Link on
Clinical Research Terms Glossary: Click here
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