The Effects of Simvastatin on Th17 Cytokines and Th17 Polarizing Cytokine in COPD Patients
Phase 3
Completed
- Conditions
- COPD
- Interventions
- Drug: simvastatin, placebo
- Registration Number
- NCT01944176
- Lead Sponsor
- Mahidol University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description B1-6-12 simvastatin, placebo B1-6-12 one tablet a day is randomized to give to COPD patients for 4 weeks Simvastatin simvastatin, placebo simvastatin 20 mg/d is randomized to treat COPD patients for 4 weeks
- Primary Outcome Measures
Name Time Method Sputum cytokines Up to 4 weeks
- Secondary Outcome Measures
Name Time Method FEV1 Up to 4 weeks Sputum neutrophils Up to 4 weeks
Trial Locations
- Locations (1)
Faculty of Medicine Siriraj Hospital, Mahidol University
🇹🇭Bangkok-noi, BKK, Thailand