Evaluation of Lovastatin in Severe Persistent Asthma

This study has been withdrawn prior to enrollment.
(Study never opened)
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00689806
First received: May 23, 2008
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Severe Persistent Asthma
Drug: Lovastatin
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Lovastatin in Severe Persistent Asthma

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Changes in airway smooth muscle biology and inflammatory measures [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689806

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

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00689806     History of Changes
Other Study ID Numbers: 15427A, UL1RR024999
Study First Received: May 23, 2008
Last Updated: June 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Lovastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014