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Clinical trials identifierNCT01316276
Study codesTR02-110, CLEAR-110
Study titleLong Term Safety and Tolerability of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection Due to Pseudomonas Aeruginosa
Drug (brand name)Amikacin (Arikace™)
Drug administrationInhalation
Eligible CF patientsAged at least 6 years
Controlled study?No
Randomised study?No
Blinded study?No
Extension study?Yes (Feeder study: CLEAR-108/TR02-108)
Study timeframeStudy timeframe    The study was conducted between October 2012 and July 2015


What does this mean for me?This once daily nebulised antibiotic appears safe and effectiveness and appears to be maintained over 2 years when used as a treatment against chronic Pseudomonas infection
Study:This Phase 3 study was an open-label two-year extension study conducted in 50 sites across 17 countries.
Aim:The aim was to assess the long term safety and efficacy of inhaled amikacin in CF patients with chronic P. aeruginosa infection who were previously treated with inhaled amikacin or inhaled tobramycin in the feeder study.
Participants:206 participants were enrolled. There were 32 participants from 11 ECFS-CTN sites in Spain, Germany, UK, Denmark, Belgium, the Netherlands and Italy.
Treatment:Participants received amikacin for up to 12 treatment cycles. Each cycle had 28 days of once daily treatment with amikacin 590 mg, then 28 days without study treatment
Safety:Most patients (84.5%) had at least one adverse event after start of treatment with amikacin. Most side effects involved the respiratory system and were expected, given that the patients all have CF. The most common adverse event was CF exacerbation due to infection.
Efficacy:Lung function (measured by FEV1) improved from study start (baseline) to the end of the study by around 3.5%. The density of P. aeruginosa in sputum changed little over the study. The mean change was 0.02 (standard deviation 2.56) log colony forming unit per gram of sputum. 
Overall, inhaled amikacin was generally safe and well tolerated, with no unexpected adverse events in this 2 year extension study.
Data source:The summary of data provided here is from the presentation of study results at the at the North American Cystic Fibrosis Conference in Phoenix (AZ, USA) in October 2015 (available here: and from