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Randomized placebo-controlled double-blind multicenter study to assess the efficacy safety and tolerability of Arikace in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa

To evaluate the efficacy safety and tolerability of Arikace treatment for 28 days with a 56 day follow-up period in CF subjects Time to pulmonary exacerbation change in pulmonary function change in sputum quantitative microbiology hospitalization need for anti-pseudomonal antibiotics patient reported symptomsoutcomes and time off workschool will be assessed Amikacin pharmacokinetics will be assessed in a subset of subjects Safety and tolerability will be evaluated throughout the 28 day treatment period and the 56 day follow-up period

FieldValue
Modified
2019-06-26
Release Date
2018-03-08
Identifier
037a6edc-9a42-4c1b-ad5b-299e5959fd5c
License
Public Access Level
Public