Study Stopped
Study never opened
Evaluation of Lovastatin in Severe Persistent Asthma
2 other identifiers
interventional
N/A
0 countries
N/A
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 smooth muscle
- 2.to examine whether lovastatin will have favorable changes in asthma symptoms of patients with moderate or severe asthma.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2008
CompletedFirst Posted
Study publicly available on registry
June 4, 2008
CompletedJune 21, 2013
June 1, 2013
May 23, 2008
June 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in airway smooth muscle biology and inflammatory measures
12 Weeks
Secondary Outcomes (1)
Changes in asthma control, lung function and quality of life from the baseline visit to the end of the follow-up period
13 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORLovastin
ACTIVE COMPARATORInterventions
Lovastatin 20 mg extended release (or placebo) by mouth once daily for weeks 1-4. Liver function test will be checked at week 4 follow up visit. If LFTs are not \> 3 times the upper limit of normal, then the subject will have the dose of extended release lovastatin increased to 60 mg once a day for weeks 4-12
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Blanca Camoretti-Mercado, Ph.D.
University of Chicago
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2008
First Posted
June 4, 2008
Last Updated
June 21, 2013
Record last verified: 2013-06