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Study Name: Safety Study of Azithromycin in Cystic Fibrosis Patients Negative for P. aeruginosa
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Rose, Lynn

Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Study Phase: Other
Recruitment Status: Trial Completed
Study Drug(s): Azithromycin
Number of Participants Being Recruited: 180
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This clinical trial was an open label extension of the azithromycin trial in children with CF who were not infected with P. aeruginosa. This study evaluated the safety of an additional 6 months of azithromycin treatment in participants who completed the placebo-controlled part of the study.
ELIGIBILITY
Age: 6 Years - 18 Years
FEV1: >= 30 Percent Predicted
P. aeruginosa status: Not applicable
B. cepacia status: Negative
Other Primary Eligibility Requirements:

Only subjects who complete the 6 month randomized portion of this trial are eligible for this open label extension.
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: Hocevar-Trnka, Jasna
(206) 884-7527
jasna.hocevar-trnka@seattlechildrens.org
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct/show/NCT00431964?order=1
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

One hundred forty-six subjects were enrolled in this 24-week open-label, follow on study to the randomized, placebo-controlled trial of azithromycin in children 7-18 years of age with CF uninfected with P. aeruginosa. The study assessed the durability of response to azithromycin and continued safety of tolerability of prolonged usage.
Two treatment groups were assessed: subjects initially on azithromycin who stayed on azithromycin vs subjects initially on placebo who received azithromycin.
Durability of treatment response to azithromycin was observed in the azithromycin-azithromycin group as measured by rate of pulmonary exacerbation and continued weight gain.

Secondary Efficacy:

No significant improvements in lung function were observed with either of 2 treatment groups.

Safety:

Compared with the preceding placebo-controlled study, there were no new safety concerns for adverse events, laboratory abnormalities, or emergent pathogens. Continued safety and tolerability were observed.

Citation:

Pediatr Pulmonol 2012;47(7):641-8

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