The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids 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

NCT00792337

004(II)/51

Details and patient eligibility

About

We hypothesize that simvastatin in combination with ICS might have synergistic anti-inflammatory effects on airway inflammation in asthmatic patients

Full description

To determine the additive effect of simvastatin on airway inflammation in ICS-treated patients with persistent asthma by measuring eosinophil counts in induced sputum

Enrollment: 53 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• He or she has FEV1 > 60% of predicted
• He or she requires less than 1000 mcg daily of beclomethasone or equivalent

Exclusion criteria

• He or she had previous history of renal disease or serum creatinine more than 2 mg/dL
• He or she had previous history of liver disease
• She is pregnant or during lactation
• He or she has already received statins or is allergic to statins or has developed myositis.
• He or she has an asthma exacerbation and requires treatment with oral corticosteroids during the 3 months prior to the commencement of study entry.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

53 participants in 2 patient groups, including a placebo group

simvastatin

Active Comparator group

Description:

simvastatin in combination with budesonide

Treatment:

Drug: simvastatin

B1-6-12

Placebo Comparator group

Description:

Budesonide in combination with B1-6-12

Treatment:

Drug: B1-6-12