drugset / Trial / NCT01944176

The Effects of Simvastatin on Th17 Cytokines and Th17 Polarizing Cytokine in COPD Patients

NCT01944176 ↗

Phase 3 Completed 24 enrolled Mahidol University
RandomizedCrossoverQuadruple-blindTreatment

Summary

Airway inflammation is partly driven by Th17 and Th17-polarizing cytokines that is steroid-resistant. Statins could suppress IL-17 cytokines in other diseases such as atherosclerosis and multiple sclerosis in mouse model. The investigators hypothesize that statins might provide anti-inflammatory benefit of suppressing IL-17 cytokines in COPD patients.

Timeline

Start
2013-09
Primary completion
2014-08
Completion
2014-08

Outcome

Met primary endpoint

paper Simvastatin reversed the IL-17A/IL-10 imbalance in the airways PMID 26043025 ↗

paper At 4 weeks, there was a significant reduction in sputum IL-17A, IL-22, IL-6, and CXCL8 concentrations PMID 26043025 ↗

paper whereas IL-10 concentrations, IDO messenger RNA expression (fold change), and IDO activity (kynurenine to tryptophan ratio) were markedly increased during simvastatin treatment compared with placebo PMID 26043025 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Simvastatin Small molecule 20 mg Oral