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Clinical Trial Finder
Anti-Inflammatory Completed with Results
Multiple Dose Safety Study of SB-656933 in People with Cystic Fibrosis (GSK CF2110399)
SB-656933 is a novel, once daily oral anti-inflammatory agent for the maintenance treatment of CF. Inflammatory cells in the lung are thought to contribute significantly to lung disease in CF. This study looked at the safety, tolerability and pharmacodynamics of SB-656933 following 28 days of daily administration of SB-656933 in patients with CF.
Eligibility
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Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40 to 110%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Study Results
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What We Learned:
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Primary Findings:
Effectiveness:
There were no changes in lung function or respiratory symptoms. In the 50 mg treatment group sputum neutrophils and elastase were reduced compared to baseline and free DNA reduced compared to placebo. Blood levels of fibrinogen, CRP, and CXCL8 were increased in the same group.
Safety:
This multinational Phase 2 safety and tolerability study randomized one hundred forty-six adult subjects with CF to receive either SB-656933 20 mg or 50mgs or placebo once daily for 28 days. SB-656933 was generally well tolerated with a similar number of adverse events reported in all treatment groups. The most frequent AE and drug-related AE reported across all groups was headache.
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Citation:
J Cyst Fibros 2013;12(3):241-248
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:
8 weeks -
Number of Study Visits:
7
Additional Information
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Phase: ?more info
Phase Two -
Study Sponsor: ?more info
GSK -
Study Drugs:
Eligibility
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40 to 110%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
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