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

Mahidol University

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Simvastatin; Drug: B1-6-12

Study type: Interventional

Funder types: Other

Identifiers

NCT01266434

si481/2010

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

simvastatin

Experimental group

Treatment:

Drug: Simvastatin

B1-6-12

Placebo Comparator group

Treatment:

Drug: B1-6-12

Drug: Simvastatin