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Study Name: AZLI (Inhaled Aztreonam) for People with Cystic Fibrosis and Chronic Burkholderia Infection
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Gilead
Study Phase: 3
Recruitment Status: Trial Completed
Study Drug(s): Cayston
Number of Participants Being Recruited: 100
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
The study was 48 weeks in length. Participants took an inhalation solution three times a day, with at least 4 hours between doses. The study looked at safety and effectiveness of the study medication to treat Burkholderia lung infections in people with Cystic Fibrosis.
ELIGIBILITY
Age: >= 6 Years
FEV1: Not Applicable
P. aeruginosa status: Not applicable
B. cepacia status: Positive
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: Leitzinger, Sheila
(206) 256-4904
sheila.leitzinger@gilead.com
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT01059565?term=azli&rank=3
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

On hundred subjects with CF age >/= 6 years old with chronic Burkholderia infection were randomized to receive 24 weeks of AZLI (ztreonam for inhalation solution) 75 mg or placebo followed by 24 weeks of open label AZLI. Eighty-four subjects continued into the open label phase.
There was no difference between subjects treated with AZLI or placebo in % change in FEV1% predicted (measured by the time-adjusted area under the curve) in the 24-week randomized phase.

Secondary Efficacy:

Not applicable

Safety:

Continuous AZLI treatment was safe in CF subjects with Burkholderia. Total adverse event rates were similar in both groups.

The summary of data provided here is from an abstract presented at the European Cystic Fibrosis Society Conference (2012). These data may be preliminary and have not been peer-reviewed.

Citation:

Not Available
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