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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01266434
First Posted: December 24, 2010
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kittipong Maneechotesuwan, Mahidol University
  Purpose
To test whether simvastatin has an additional anti-inflammatory effects on p38 MAPK, a signaling molecule for inflammation in inhaled steroid-treated asthmatics.

Condition Intervention Phase
Asthma Drug: Simvastatin Drug: B1-6-12 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids on p38 MAPK in Asthma

Resource links provided by NLM:


Further study details as provided by Kittipong Maneechotesuwan, Mahidol University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Enrollment: 44
Study Start Date: January 2011
Study Completion Date: March 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: simvastatin Drug: Simvastatin
10 mg once daily for 8 weeks
Other Name: Zocor
Placebo Comparator: B1-6-12 Drug: Simvastatin
10 mg once daily for 8 weeks
Other Name: Zocor
Drug: B1-6-12
1 tablet once daily for 8 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266434


Locations
Thailand
Division of Respiratory Disease and TB, Siriraj Hospital
Bangkoknoi, BKK, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Kittipong - Maneechotesuwan, MD., PhD. Faculty of Medicine Siriraj Hospital
  More Information

Responsible Party: Kittipong Maneechotesuwan, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01266434     History of Changes
Other Study ID Numbers: si481/2010
First Submitted: December 22, 2010
First Posted: December 24, 2010
Last Update Posted: March 16, 2016
Last Verified: March 2016

Keywords provided by Kittipong Maneechotesuwan, Mahidol University:
moderate persistent asthma
Inhaled corticosteroids

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Simvastatin
Anti-Inflammatory Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors