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

Mahidol University

Status and phase: Completed; Phase 3

Conditions: COPD

Treatments: Drug: simvastatin, placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01944176

Si323/2013

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Simvastatin

Experimental group

Description:

simvastatin 20 mg/d is randomized to treat COPD patients for 4 weeks

Treatment:

Drug: simvastatin, placebo

B1-6-12

Placebo Comparator group

Description:

B1-6-12 one tablet a day is randomized to give to COPD patients for 4 weeks

Treatment:

Drug: simvastatin, placebo