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Clinical Trial Finder
Anti-Infective Completed with Results
Safety Study of Azithromycin in Cystic Fibrosis Patients Negative for P. aeruginosa (AZ 0004 (Open-Label))
This study was an open-label extension study of the Azithromycin study in adolescents and children with CF who were not infected with P. aeruginosa. This study provided addiitonal information regarding the safety of longer term treatment.
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
See other primary eligibility criteria for more information.
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Age:
6 Years to 18 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
30% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Only subjects who complete the 6 month randomized portion of this trial are eligible for this open label extension.
Study Results
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What We Learned:
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Primary Findings:
Effectiveness:
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.
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.
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Citation:
Pediatr Pulmonol 2012;47(7):641-8
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
No -
Placebo Controlled: ?more info
No -
Length of Participation:
24 weeks -
Number of Study Visits:
3
Additional Information
-
Phase: ?more info
Not Applicable -
Study Sponsor: ?more info
Rose, Lynn -
Study Drugs:
Eligibility
See other primary eligibility criteria for more information.
-
Age:
6 Years to 18 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
30% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Only subjects who complete the 6 month randomized portion of this trial are eligible for this open label extension.
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