Trial of Simvastatin for the Treatment of Severe Asthma

Severe Asthma Clinical Trial

Official title:

Randomized Trial of Simvastatin for the Treatment of Severe Asthma

Clinical Trial Details — Status: Withdrawn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• Status: Withdrawn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
• 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• Status: Withdrawn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.

Related Conditions & MeSH terms

• Asthma
• Severe Asthma

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.