Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

This is a study to determine the safety and tolerability of 28 days of daily dosing of 560 mg of Arikayce™ versus placebo and daily dosing of 70 mg and 140 mg of Arikayce™ versus placebo in patients who have Cystic fibrosis (CF) and chronic infection due to pseudomonas aeruginosa.

Key facts

Study ID

NCT00558844

Run by

Insmed Incorporated

People needed

41

Starts

2008-01-01

Expected to finish

2009-06-01

Last updated by the study team

2019-06-04

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Los Angeles, California, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Jackson, Mississippi, United States
• Study site — St Louis, Missouri, United States
• Study site — Morristown, New Jersey, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Rochester, New York, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Sioux Falls, South Dakota, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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