Evaluation of Lovastatin in Severe Persistent Asthma

NCT ID: NCT00689806

Last Updated: 2013-06-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL

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.

Conditions

Severe Persistent Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo by mouth once daily for weeks 1-4.

Lovastin

Group Type: ACTIVE_COMPARATOR

Lovastatin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Placebo

Placebo by mouth once daily for weeks 1-4.

Intervention Type: DRUG

Eligibility 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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Blanca Camoretti-Mercado, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Other Identifiers

UL1RR024999

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15427A

Identifier Type: -

Identifier Source: org_study_id