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Clinical Trial Finder
Anti-Infective Completed with Results
Amikacin for Inhalation (Transave) (Insmed TR02-106)
This phase 2 study evaluated the safety and efficacy of a new inhaled antibiotic, Liposomal Amikacin (Arikace) to treat people with CF and chronic Pseudomonas aeruginosa lung infection.
The antibiotic drug (Amikacin) has been made by wrapping it within microscopic bubbles called liposomes. It is thought that the liposome will help the antibiotic get into the mucus to kill Pseudomonas aeruginosa, and also slow down how quickly the Amikacin leaves the lung. An electronic nebulizer was used to deliver the drug. Participants were randomized to receive one of three different doses of liposomal amikacin or placebo for 28 days.
Eligibility
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Age:
6 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Study Results
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What We Learned:
Study results show that the frequency of adverse events was similar in the treatment and placebo groups. Additionally, Liposomal Amikacin was associated with improvement in lung function and reduction in Pseudomonas aeruginosa density.
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Primary Findings:
Effectiveness:
This placebo-controlled Phase 2 study enrolled 46 adult CF subjects chronically infected with P. aeruginosa in the U.S. to evaluate the safety, tolerability, pharmacokinetics, and efficacy of three dose levels of Liposomal Amikacin (70mg, 140 mg, 560 mg) administered daily for 28 days. A similar study was conducted in Europe but included one dose cohort at 280 mg. The combined results on 105 patients total were reported together.
Statistically significant improvement in lung function (FEV1) and reduced amounts of Pseudomonas aeruginosa from respiratory cultures were observed for the two highest Liposomal Amikacin doses.
Safety:
Similar acute tolerability for the drug was observed across all dose groups and placebo. The frequency of adverse events was similar across all groups.
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Citation:
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
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Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
56 days -
Number of Study Visits:
11
Additional Information
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Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Insmed -
Study Drugs:
Eligibility
-
Age:
6 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40% or greater -
Pseudomonas Status:
Positive Respiratory Cultures Required
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
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