NCT02433535

Trial of Simvastatin for the Treatment of Severe Asthma

Randomized Trial of Simvastatin for the Treatment of Severe Asthma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

See above.

Conditions

• Severe Asthma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-08-22
• Completion: 2017-08-22
• First posted: 2015-05-05
• Last updated: 2017-09-26

Locations

1 site across 1 country: United States