Status:
WITHDRAWN
Evaluation of Lovastatin in Severe Persistent Asthma
Lead Sponsor:
University of Chicago
Conditions:
Severe Persistent Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This study has two purposes: 1. to determine whether lovastatin, a commonly used medication to lower cholesterol in the blood, can produce beneficial changes in airway inflammation and in the airway ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00689806
Last Update
June 21 2013
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