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Evaluation of Lovastatin in Severe Persistent Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00689806
Recruitment Status : Withdrawn (Study never opened)
First Posted : June 4, 2008
Last Update Posted : June 21, 2013
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Severe Persistent Asthma Drug: Lovastatin Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Lovastatin in Severe Persistent Asthma

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Lovastatin

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo by mouth once daily for weeks 1-4.

Active Comparator: Lovastin Drug: Lovastatin
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

Primary Outcome Measures :
  1. Changes in airway smooth muscle biology and inflammatory measures [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Changes in asthma control, lung function and quality of life from the baseline visit to the end of the follow-up period [ Time Frame: 13 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00689806

Sponsors and Collaborators
University of Chicago
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Principal Investigator: Blanca Camoretti-Mercado, Ph.D. University of Chicago

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Responsible Party: University of Chicago Identifier: NCT00689806    
Other Study ID Numbers: 15427A
UL1RR024999 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Keywords provided by University of Chicago:
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
L 647318
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors