The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids in Asthma
- Registration Number
- NCT00792337
- Lead Sponsor
- Mahidol University
- Brief Summary
We hypothesize that simvastatin in combination with ICS might have synergistic anti-inflammatory effects on airway inflammation in asthmatic patients
- Detailed 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description simvastatin simvastatin simvastatin in combination with budesonide B1-6-12 B1-6-12 Budesonide in combination with B1-6-12
- Primary Outcome Measures
Name Time Method Sputum eosinophil 8 WEEKS
- Secondary Outcome Measures
Name Time Method FEV1 8 WEEKS PC20 8 weeks
Trial Locations
- Locations (1)
Kittipong Maneechotesuwan
🇹ðŸ‡Bangkoknoi, Bangkok, Thailand