Page Title
Clinical Trial Finder
Anti-Infective Completed with Results
Azithromycin in patients with CF who are culture negative for Pseudomonas aeruginosa (AZ 0004 (Randomized))
This study evaluated the effect of azithromycin in children with CF who are not infected with Pseudomonas aeruginosa.
Earlier studies of azithromycin in people with CF who had chronic P. aeruginosa had resulted in the drug being recommended as a chronic treatment for these individuals. This study was conducted to find out whether azithromycin could provide benefits to CF patients who are not infected with P. aeruginosa. Participants in this study were randomized to receive either azithromycin or placebo three times a week for 24 weeks.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
6 Years to 18 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
50% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Eligible subjects must be negative for P aeruginosa for one year prior to screening (documented by at least 2 negative cultures)
Study Results
-
What We Learned:
Study results show that while there was no improvement in lung function in the treatment group compared to the placebo group; treatment with azithromycin did improve other measures including the rate of pulmonary exacerbations. Treatment with azithromycin did not increase the risk of adverse events.
-
Primary Findings:
Effectiveness:
This study was conducted between February 2007 and July 2009. A total of 260 patients were randomized to receive either azithromycin (N=131) or placebo (N= 129); the vast majority of participants completed the study (126 in each treatment group). The researchers found that treatment with azithromycin for 24 weeks, compared with placebo, did not result in improved pulmonary function, as measured by the change in FEV1 (the volume of air that can be forced out in one second after taking a deep breath).
Analyses of exploratory end points demonstrated that when compared with the placebo group, the azithromycin group had a 50 percent reduction in pulmonary exacerbations, 27 percent reduction in the initiation of new oral antibiotics (other than azithromycin), 1.3 lbs. weight gain, and a 0.34-unit increase in body mass index. There were no differences in treatment groups in the use of intravenous or inhaled antibiotics or hospitalizations.
Safety:
Participants in the azithromycin group had no increased risk of adverse events, but had less cough and less productive cough compared with placebo participants.
-
Citation:
JAMA 2010;303(17):1707-1715
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
24 weeks -
Number of Study Visits:
5
Additional Information
-
Phase: ?more info
Phase Three -
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:
50% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Eligible subjects must be negative for P aeruginosa for one year prior to screening (documented by at least 2 negative cultures)
Related Topics
Sign up for clinical trial alerts
Get email updates about clinical trials that matter to you.
Check the Drug Development Pipeline
We’re attacking CF from every angle. Learn about the status of CF drugs in development.
Learn More