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

March 15, 2016 updated by: Kittipong Maneechotesuwan, Mahidol University

The Effects of Simvastatin on Th17 Cytokines and Th17 Polarizing Cytokines 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • BKK
      • Bangkok-noi, BKK, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Simvastatin
simvastatin 20 mg/d is randomized to treat COPD patients for 4 weeks
Drug: simvastatin, placebo
Other Names:
  • Bestatin
  • B1-6-12
Placebo Comparator: B1-6-12
B1-6-12 one tablet a day is randomized to give to COPD patients for 4 weeks
Drug: simvastatin, placebo
Other Names:
  • Bestatin
  • B1-6-12

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sputum cytokines
Time Frame: Up to 4 weeks
Up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
FEV1
Time Frame: Up to 4 weeks
Up to 4 weeks
Sputum neutrophils
Time Frame: Up to 4 weeks
Up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Kittipong Maneechotesuwan, MD., PhD., Faculty of Medicine Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

September 10, 2013

First Submitted That Met QC Criteria

September 12, 2013

First Posted (Estimate)

September 17, 2013

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si323/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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