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

Asthma research study

What is the primary objective of this study?

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

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Asthma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Simvastatin10 mg once daily for 8 weeks

Drug:B1-6-121 tablet once daily for 8 weeks

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

simvastatin

B1-6-12

Study Status

Completed

Start Date: January 2011

Completed Date: March 2016

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Sputum eosinophils

Secondary Outcome: Phosphorylated p38 MAPK in sputum cells

Study sponsors, principal investigator, and references

Principal Investigator: Kittipong - Maneechotesuwan, MD., PhD.

Lead Sponsor: Mahidol University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01266434

Discuss Simvastatin