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OpenTrials
Completed

NCT Number: NCT01266434

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

To test whether simvastatin has an additional anti-inflammatory effects on p38 MAPK, a signaling molecule for inflammation in inhaled steroid-treated asthmatics.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Division of Respiratory Disease and TB, Siriraj Hospital

Bangkoknoi, BKK, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

simvastatin

Drug

10 mg once daily for 8 weeks

Other names: Zocor

B1-6-12

Drug

1 tablet once daily for 8 weeks

Primary outcomes

  1. 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 outcomes

  1. Phosphorylated p38 MAPK in sputum cells

    Time frame: 8 weeks

    • 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.
    • To confirm the above in vivo results in the in vitro model using monocyte-derived dendritic cells.
    • To determine the effects of simvastatin and/or corticosteroids on Th2 cytokine production by peripheral blood CD4+ T-lymphocytes in vitro.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Acronym: Simvastatin

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Dec 24, 2010
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.

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