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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01266434
First received: December 22, 2010
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Asthma Steroids
Drug Information available for: Simvastatin
U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Sputum eosinophils [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 70
Study Start Date: January 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Associate Professor Kittipong Maneechotesuwan, Department of Internal Medcine
ClinicalTrials.gov Identifier: NCT01266434     History of Changes
Other Study ID Numbers: si481/2010
Study First Received: December 22, 2010
Last Updated: July 21, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by 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
Anti-Inflammatory Agents
 Simvastatin
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013