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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944176
• Other study ID #: Si323/2013
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2013
• Last updated: March 15, 2016
• Start date: September 2013
• Est. completion date: August 2014

Study information

• Verified date: March 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• simvastatin, placebo

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok-noi	BKK

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sputum cytokines		Up to 4 weeks	No
Secondary	FEV1		Up to 4 weeks	No
Secondary	Sputum neutrophils		Up to 4 weeks	No