Trial of Simvastatin for the Treatment of Severe Asthma

NCT02433535 | Withdrawn Phase 2 DMC

• 2 other identifiers: 522110522110-3
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Asthma

Keywords

severe asthma; simvastatin; allergic airway inflammation

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (3)

• Acute Exacerbations

  Before and after 12 weeks of drug or placebo intervention.

• Lung function

  Before and after 12 weeks of drug or placebo intervention.

• Asthma symptom control score

  Before and after 12 weeks of drug or placebo intervention.

Study Arms (2)

Simvastatin

EXPERIMENTAL

Simvastatin 40 mg daily will be given for 12 weeks.

Drug: Simvastatin

Placebo

PLACEBO COMPARATOR

A placebo capsule will be given daily for 12 weeks.

Other: Placebo

Interventions

Simvastatin 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.

Also known as: Zocor

Simvastatin

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

CTSC Clinical Research Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 5, 2015
• Study Start: December 1, 2013
• Primary Completion: August 22, 2017
• Study Completion: August 22, 2017
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

US (1)