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Study Name: Aztreonam Inhalation Solution (AZLI) Safety Study in Children with CF and Chronic Pseudomonas Aeruginosa
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Gilead
Study Phase: 4
Recruitment Status: Trial Completed
Study Drug(s): Cayston
Number of Participants Being Recruited: 60
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This is an open-label, multicenter study in children < 13 years of age with Cystic Fibrosis (CF) and chronic Pseudomonas Aeruginosa (PA) infection in the lower airways to look at the safety of treatment with Aztreonam Inhalation Solution (AZLI) given three times daily for three 28 day on/ 28 day off cycles. The total study duration will be approximately 7 months.
ELIGIBILITY
Age: 1 Days - 12 Years
FEV1: Not Applicable
P. aeruginosa status: Positive
B. cepacia status: Negative
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:
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT01404234?term=gilead+and+cystic+fibrosis&rank=6
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

Secondary Efficacy:

Safety:

Citation:

J Cyst Fibros ;DOI 10.1016/j.jcf.2013.08.011

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