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Trial of Simvastatin for the Treatment of Severe Asthma

NCT ID: NCT02433535

Last Updated: 2017-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-08-22

Brief Summary

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This purpose of this clinical trial is to determine if a statin drug, Simvastatin, added to inhaled corticosteroids and bronchodilators can reduce systemic and airway inflammation, improve lung function and symptoms, and reduce acute exacerbations in patients with severe asthma who are already on controller inhaler therapy.

This proposed investigator-initiated, single-center, early Phase II, cross-over, randomized clinical trial, titled "Randomized Trial of Simvastatin for the Treatment of Severe Asthma", will be conducted at the University of California, Davis Medical Center (UCDMC) in Sacramento, CA. This trial will evaluate Simvastatin for treatment of asthma in subjects with severe asthma (as defined by the American Thoracic Society (ATS)), who are already taking inhaler controller therapy. The investigators plan to enroll 24 patients with severe allergic asthma.

The investigators hypothesize that treatment with Simvastatin 40 mg (administered once daily) will not only improve indicators of airway and systemic allergic/Th2 inflammation, but will also reduce acute exacerbations and improve lung function. All patients will be on standard controller therapy including appropriate doses of inhaled corticosteroids and long-acting bronchodilators.

Detailed Description

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See above.

Conditions

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Severe Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Simvastatin

Simvastatin 40 mg daily will be given for 12 weeks.

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

Simvastatin is used to lower cholesterol, however, it also possess anti-inflammatory and immunomodulatory properties that may also alleviate allergic airway inflammation in asthma.

Placebo

A placebo capsule will be given daily for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

A placebo pill will be given to the placebo group. There will be no detectible differences between study drug pill and placebo pill.

Interventions

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Simvastatin

Simvastatin is used to lower cholesterol, however, it also possess anti-inflammatory and immunomodulatory properties that may also alleviate allergic airway inflammation in asthma.

Intervention Type DRUG

Placebo

A placebo pill will be given to the placebo group. There will be no detectible differences between study drug pill and placebo pill.

Intervention Type OTHER

Other Intervention Names

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Zocor

Eligibility Criteria

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Inclusion Criteria

1. statin-naïve adults \>18 years old with the ATS definition of severe asthma,
2. on ICS and LABA,
3. confirmation of allergic asthma (serum IgE \>100 kU/L, positive radioallergosorbent test (RAST) panel, and/or peripheral blood absolute eosinophil count of ≥700/mm3),
4. clinically stable for 4 weeks.

Exclusion Criteria

1. baseline FEV1 \<30% predicted,
2. current smokers or ex-smokers with \>5 pack-years of smoking history,
3. pregnant women, nursing/lactating mothers, or women of childbearing potential who are actively attempting to become pregnant,
4. nasal or sinus surgery or trauma within 3 months of study participation,
5. ischemic heart disease,
6. liver disease, and
7. the concurrent use of the following medications (amiodarone, verapamil, diltiazem, gemfibrozil, cyclosporine, antifungal azoles (itraconazole, ketoconazole, or voriconazole), and danazol.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CTSC Clinical Research Center

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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522110-3

Identifier Type: OTHER

Identifier Source: secondary_id

522110

Identifier Type: -

Identifier Source: org_study_id