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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01944176
Enrollment
24
Registered
2013-09-17
Start date
2013-09-30
Completion date
2014-08-31
Last updated
2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

COPD, Statins, Cytokines

Brief 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.

Interventions

DRUGsimvastatin, placebo

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Stable COPD without an exacerbation within 3 months prior to study entry * mild, moderate and severe COPD with or without treatments, regardless of COPD medications

Exclusion criteria

* Concomitant other chronic lung diseases including with TB and malignancy * HIV * Being on immunosuppressive drugs and systemic corticosteroids * Dyslipidemic patients with recent cardiovascular or cerebrovascular disease within 6 month prior to study entry * Cognitive impairment * Currently on macrolides, azole anti-fungal agents, amiodarone and amlodipine

Design outcomes

Primary

MeasureTime frame
Sputum cytokinesUp to 4 weeks

Secondary

MeasureTime frame
FEV1Up to 4 weeks
Sputum neutrophilsUp to 4 weeks

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026