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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01266434

Acronym

Simvastatin

Enrollment

Registered

2010-12-24

Start date

2011-01-31

Completion date

2016-03-31

Last updated

2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

moderate persistent asthma, Inhaled corticosteroids

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.

Interventions

DRUGSimvastatin

10 mg once daily for 8 weeks

DRUGB1-6-12

1 tablet once daily for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026