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Study Name: Amikacin for Inhalation (Transave)
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Insmed
Study Phase: 2
Recruitment Status: Trial Completed
Study Drug(s): Arikace
Number of Participants Being Recruited: 46
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This study looked at a new way inhaled antibiotics can be made for people who have CF and a lung infection caused by pseudomonas aeruginosa. The antibiotic drug (Amikacin) has been made by wrapping it within microscopic bubbles called liposomes. It is thought that the lipsome will help the antibiotic get into the mucus to kill pseudomonas aeruginosa, and also slow down how quickly the Amikacin leaves the lung. The PARI eFlow electronic nebulizer was used in this study to give the Amikacin.
ELIGIBILITY
Age: >= 6 Years
FEV1: >= 40 Percent Predicted
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: Gupta, Renu
(732) 997-4526
rgupta@transaveinc.com
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00558844?term=cystic+fibrosis&rank=5
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

This placebo-controlled Phase 2 study enrolled 46 Adult CF subjects in the U.S. to evaluate the safety, tolerability, pharmacokinetics, and efficacy of three dose levels of Arikaceâ?¢ (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 and showed that patients in the 560 mg Arikace dose group showed improvement in lung function over baseline while patients on placebo declined over time.

Secondary Efficacy:

More patients receiving Arikace vs those receiving placebo showed improvement in patient reported respiratory symptoms, reduction in Pseudomonas aeruginosa density, and prolonged time to pulmonary exacerbation.

Safety:

Acute tolerability was similar across all groups and the treatment was well tolerated. Adverse effects were consistent with those expected in a population of CF patients receiving inhalation medications.
The summary of data provided here is from an abstract presented at the Cystic Fibrosis Foundation North American CF Conference (2009) and from a poster presented at the 2010 NACFC. These data may be preliminary and have not been peer-reviewed.

Citation:

Thorax 2013;DOI 10.1136/thoraxjnl-2012-202230 [Epub ahead of print]

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