Asthma
Conditions
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
Interventions
DRUGsimvastatin
10 mg per oral once daily for 8 weeks
DRUGB1-6-12
1 table per day for 8 weeks
Sponsors
Mahidol University
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
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sputum eosinophil | 8 WEEKS |
Secondary
| Measure | Time frame |
|---|---|
| FEV1 | 8 WEEKS |
| PC20 | 8 weeks |
Countries
Thailand
Outcome results
None listed