Skip to main content
OpenTrials
Completed

NCT Number: NCT01944176

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, BKK, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin, placebo

Drug

Other names: Bestatin, B1-6-12

Primary outcomes

  1. Sputum cytokines

    Time frame: Up to 4 weeks

Secondary outcomes

  1. FEV1

    Time frame: Up to 4 weeks

  2. Sputum neutrophils

    Time frame: Up to 4 weeks

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 17, 2013
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.