Evaluation of Lovastatin in Severe Persistent Asthma

This is an interventional treatment trial for Severe Persistent Asthma focused on measuring Asthma Read More

Inclusion Criteria:

• Age > 18 years to <65 years
• Severe persistent asthma (per 2002 National Asthma Education and Prevention Program guidelines)
• Treatment with daily fluticasone (500 ug BID) and salmeterol (50 ug BID) during the past 4 or more weeks
• Pre-bronchodilator FEV1 <80% predicted
• Post-bronchodilator improvement in FEV1 of at least 12% and 200 mL or a PC20 to methacholine of <8 mg/mL
• Evidence of inadequate asthma control in the past 2 weeks: use of rescue inhaler > 4 days and >8 occasions in the past 2 weeks, daytime asthma symptoms > 4 days in the past 2 weeks, or 1 or more nocturnal awakening in the past 2 weeks
• No evidence of alternate diagnosis (e.g., sarcoidosis, eosinophilic pneumonia) on bronchoscopy performed as part of routine care in the Refractory Obstructive Lung Disorders clinic.
• Completed research bronchoscopy while on current dose of daily fluticasone and salmeterol within 4 weeks of meeting other inclusion criteria. Note: many patients in the ROLD clinic require a bronchoscopy to confirm the diagnosis of asthma and exclude other diagnosis (e.g., sarcoidosis). These patients are asked to participate in a research protocol (separate from this proposal) that allows investigators to collect additional samples (endobronchial biopsies, bronchoalveolar lavage fluid, endobronchial brushings) at the end of the clinical portion of the bronchoscopy {IRB protocol # 15361A entitled, "Airway inflammation in refractory obstructive lung disease (ROLD): understanding markers of inflammation and remodeling"}. This protocol was recently submitted to the IRB in March 2007.

Exclusion Criteria:

• Pregnancy or lactation
• Severe metabolic disease
• Other respiratory or inflammatory disorders (sarcoidosis, emphysema)
• Hypokalemia, dehydration
• Uncontrolled seizure disorder ( 2 or more seizures in last year)
• Major surgery, trauma
• Pre-existing liver disease (AST or ALT >10% above the upper limit of normal)
• Elevated CK (>50% above the upper limit of normal)
• History of alcohol abuse
• Current smokers or ex-smokers with > 10 pack-years of smoking
• Partial ileal bypass surgery
• Concurrent treatment with drugs known to be have potential interactions or associated with rhabdomyolysis (Cimetadine, danazole, delavaridine, diltiazem, fenofiibrate, nefazodone, niacin, protease inhibitors, quinipristoline/dalfopristin, ranolazine, rifampin, telbivudine, telithromycin)
• HIV patients taking protease inhibitors
• History of allergy or intolerance to statin
• Use of 1 or more doses of any cholesterol lowering medication in the previous 12 weeks
• Clinical indication for treatment with statins