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

Asthma Clinical Trial

— Simvastatin  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01266434
• Other study ID #: si481/2010
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2010
• Last updated: March 15, 2016
• Start date: January 2011
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Simvastatin
10 mg once daily for 8 weeks
• B1-6-12
1 tablet once daily for 8 weeks

Locations

Country	Name	City	State
Thailand	Division of Respiratory Disease and TB, Siriraj Hospital	Bangkoknoi	BKK

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sputum eosinophils	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)	8 weeks	No
Secondary	Phosphorylated p38 MAPK in sputum cells	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.	8 weeks	No