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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Simvastatin; Drug: B1-6-12

• Registration Number: NCT01266434
• Lead Sponsor: Mahidol University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-22
• Study First Submitted QC: 2010-12-23
• Study First Posted: 2010-12-24
• Study Start: 2011-01
• Primary Completion: 2016-02
• Status Verified: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
simvastatin	Simvastatin	-
B1-6-12	Simvastatin	-
B1-6-12	B1-6-12	-

Primary Outcome Measures

Name	Time	Method
Sputum eosinophils	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

Name	Time	Method
Phosphorylated p38 MAPK in sputum cells	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.

Trial Locations

Locations (1)

Division of Respiratory Disease and TB, Siriraj Hospital; 🇹🇭 Bangkoknoi, BKK, Thailand