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Anti-Infective Completed with Results
Phase 3 study of inhaled vancomycin in adults and children 6 years and older with cystic fibrosis (Savara SAV005-04)
This study evaluated the effectiveness of the inhaled drug vancomycin hydrochloride inhalation powder (AeroVanc) in adults and children 6 years and older with CF and positive cultures for methicillin-resistant Staphylococcus aureus (MRSA).
This was a two-part study. In the first part of the study, participants were randomly assigned to receive inhaled vancomycin (30mg) or placebo twice daily during 3 dosing cycles over a 24-week period. A dosing cycle is defined as 28 days of treatment followed by 28 days of observation. In the second part of the study, all participants received inhaled vancomycin (30mg twice daily) during 3 dosing cycles over a second 24-week period to evaluate long-term safety of inhaled vancomycin.
Eligibility
See other primary eligibility criteria for more information.
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Age:
6 Years to 21 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
30 to 90%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Subjects with a P. aeruginosa co-infection must either be stable on a regular suppression regimen of inhaled antibiotics or must be, in the opinion of the investigator, stable despite the lack of such treatment.
Study Results
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What We Learned:
This study did not meet the primary endpoint of change in lung function, as measured by mean absolute change from baseline in FEV1 percent predicted, analyzed sequentially at Week 4 (end of Cycle 1), Week 12 (end of Cycle 2), and at Week 20 (end of Cycle 3). The mean change from baseline in FEV1 percent predicted compared to placebo was 1.4 at week 4 (p=0.33), 1.3 at week 12 (p=0.33), and 3.0 at week 20 (p=0.07). Additionally, treatment with inhaled vancomycin did not result in a reduction in the frequency of pulmonary exacerbations when compared with placebo. Inhaled vancomycin was generally well-tolerated.
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Primary Findings:
Effectiveness:
The primary efficacy endpoint was change in lung function, as measured by mean absolute change from baseline in FEV1 percent predicted, analyzed sequentially at Week 4 (end of Cycle 1), Week 12 (end of Cycle 2), and at Week 20 (end of Cycle 3). This study did not meet the primary endpoint. The mean change from baseline in FEV1 percent predicted compared to placebo was 1.4 at week 4 (p=0.33), 1.3 at week 12 (p=0.33), and 3.0 at week 20 (p=0.07).
Additionally, treatment with inhaled vancomycin did not result in a reduction in the frequency of pulmonary exacerbations when compared with placebo. The exacerbation rate per year was 2.3 for both groups (risk ratio 1.0, 95% CI 0.7, 1.4).
Safety:
Inhaled vancomycin was generally well-tolerated.
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Citation:
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
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
12 months -
Number of Study Visits:
13
Additional Information
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Phase: ?more info
Phase Three -
Study Sponsor: ?more info
Savara -
Study Drugs:
Eligibility
See other primary eligibility criteria for more information.
-
Age:
6 Years to 21 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
30 to 90%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Subjects with a P. aeruginosa co-infection must either be stable on a regular suppression regimen of inhaled antibiotics or must be, in the opinion of the investigator, stable despite the lack of such treatment.
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