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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02433535
Other study ID # 522110
Secondary ID 522110-3
Status Withdrawn
Phase Phase 2
First received April 29, 2015
Last updated September 22, 2017
Start date December 2013
Est. completion date August 22, 2017

Study information

Verified date September 2017
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

See above.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 22, 2017
Est. primary completion date August 22, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States CTSC Clinical Research Center Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Th2 gene expression in nasal epithelial cells. IL13, eotaxin-1,-2,-3, STAT6) by RT-PCR. Before and after 12 weeks of drug or placebo intervention.
Primary Exhaled nitric oxide (ENO) ENO will be measured using our NIOX-Mino portable NO analyzer. Before and after 12 weeks of drug or placebo intervention.
Secondary Acute Exacerbations Assessed as a rate per month. Before and after 12 weeks of drug or placebo intervention.
Secondary Lung function FEV1, FVC, and FEV/FVC ratio. Before and after 12 weeks of drug or placebo intervention.
Secondary Asthma symptom control score Asthma Control Test score (5 question survey). Before and after 12 weeks of drug or placebo intervention.
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