Trial of Simvastatin for the Treatment of Severe Asthma
Status:
Withdrawn
Trial end date:
2017-08-22
Target enrollment:
Participant gender:
Summary
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.