The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids on p38 MAPK in Asthma (Simvastatin)

March 15, 2016 updated by: Kittipong Maneechotesuwan, Mahidol University
To test whether simvastatin has an additional anti-inflammatory effects on p38 MAPK, a signaling molecule for inflammation in inhaled steroid-treated asthmatics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

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
      • Bangkoknoi, BKK, Thailand, 10700
        • Division of Respiratory Disease and TB, Siriraj Hospital

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mild-to-moderate persistent asthmatics
  • FEV1 = OR > 50% of predicted

Exclusion Criteria:

  • Previous history of renal disease or serum creatinine is more than 2 mg/dl.
  • Previous history of liver disease.
  • Pregnancy or lactation.
  • Are already receiving or are known to be allergic to statins or to have developed myositis.
  • Have an asthma exacerbation requiring treatment with oral corticosteroids during the 3 months prior to the commencement of study entry.
  • Being treated with immunosuppressive agents.
  • Unwilling to cooperate the study.

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: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: simvastatin
Drug: Simvastatin
10 mg once daily for 8 weeks
Other Names:
  • Zocor
PLACEBO_COMPARATOR: B1-6-12
Drug: Simvastatin
10 mg once daily for 8 weeks
Other Names:
  • Zocor
Drug: B1-6-12
1 tablet once daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sputum eosinophils
Time Frame: 8 weeks
To determine the additive effect of simvastatin on airway inflammation in ICS-treated patients with persistent asthma by measuring eosinophil counts in induced sputum and on lung function (FEV1)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phosphorylated p38 MAPK in sputum cells
Time Frame: 8 weeks
  1. To determine the additional effects of simvastatin in combination with inhaled corticosteroids on the expression of phosphorylated p38 MAPK and phosphorylated activating transcription factor (ATF)2 in induced sputum cells from asthmatic patients.
  2. To confirm the above in vivo results in the in vitro model using monocyte-derived dendritic cells.
  3. To determine the effects of simvastatin and/or corticosteroids on Th2 cytokine production by peripheral blood CD4+ T-lymphocytes in vitro.
8 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

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

January 1, 2011

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

December 22, 2010

First Submitted That Met QC Criteria

December 23, 2010

First Posted (ESTIMATE)

December 24, 2010

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

  • si481/2010

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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