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Study Name: Multiple Dose Safety Study of SB-656933 in People with Cystic Fibrosis
Study Type: Interventional
Intervention Category: Anti-Inflammatory
Study Sponsor: GSK
Study Phase: 2
Recruitment Status: Trial Completed
Study Drug(s): SB-656933
Number of Participants Being Recruited: 140
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
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
Age: >= 18 Years
FEV1: 40 - 110 Percent Predicted
P. aeruginosa status: Not applicable
B. cepacia status: Negative
Other Primary Eligibility Requirements:

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: Kirihara, Jean
(206) 884-7593
jean.kirihara@seattlechildrens.org
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT00903201?term=SB-656933+and+cystic+fibrosis&rank=1
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

Not applicable

Secondary Efficacy:

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.

Citation:

J Cyst Fibros 2013;12(3):241-248

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