This purpose of this clinical trial is to determine if a statin drug, Simvastatin, added to inhaled corticosteroids and bronchodilators can reduce systemic and airway inflammation, improve lung function and symptoms, and reduce acute exacerbations in patients with severe asthma who are already on controller inhaler therapy. This proposed investigator-initiated, single-center, early Phase II, cross-over, randomized clinical trial, titled "Randomized Trial of Simvastatin for the Treatment of Severe Asthma", will be conducted at the University of California, Davis Medical Center (UCDMC) in Sacramento, CA. This trial will evaluate Simvastatin for treatment of asthma in subjects with severe asthma (as defined by the American Thoracic Society (ATS)), who are already taking inhaler controller therapy. The investigators plan to enroll 24 patients with severe allergic asthma. The investigators hypothesize that treatment with Simvastatin 40 mg (administered once daily) will not only improve indicators of airway and systemic allergic/Th2 inflammation, but will also reduce acute exacerbations and improve lung function. All patients will be on standard controller therapy including appropriate doses of inhaled corticosteroids and long-acting bronchodilators.
See above.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Simvastatin is used to lower cholesterol, however, it also possess anti-inflammatory and immunomodulatory properties that may also alleviate allergic airway inflammation in asthma.
A placebo pill will be given to the placebo group. There will be no detectible differences between study drug pill and placebo pill.
CTSC Clinical Research Center
Sacramento, California, United States
Th2 gene expression in nasal epithelial cells.
IL13, eotaxin-1,-2,-3, STAT6) by RT-PCR.
Time frame: Before and after 12 weeks of drug or placebo intervention.
Exhaled nitric oxide (ENO)
ENO will be measured using our NIOX-Mino portable NO analyzer.
Time frame: Before and after 12 weeks of drug or placebo intervention.
Acute Exacerbations
Assessed as a rate per month.
Time frame: Before and after 12 weeks of drug or placebo intervention.
Lung function
FEV1, FVC, and FEV/FVC ratio.
Time frame: Before and after 12 weeks of drug or placebo intervention.
Asthma symptom control score
Asthma Control Test score (5 question survey).
Time frame: Before and after 12 weeks of drug or placebo intervention.
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