Currently Enrolling Studies

 If you are interested in participating in any of the following studies, please contact us at (336) 713-8550. 

   
GENOTYPE-PHENOTYPE INTERACTION IN SEVERE ASTHMA
  
Description
The purpose of this project is to study subjects with severe asthma to try and understand why and how severe disease develops. This is an observational study only; there are no therapeutic interventions being studied. This study will explore the relationships between clinical symptoms/signs of asthma severity, candidate genes that may influence disease severity and inflammatory substances and cells (in the lungs) that may lead to irreversible changes in the lungs and hence, severe asthma.

Major Requirements
·         Be a non-smoking asthmatic 
  



Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS)

Description
To identify subpopulations with the potential to benefit from new treatments and to identify clearly defined and measurable endpoints, for which treatment effects can be accurately and efficiently assessed in a shorter time frame than is typically required, are both important aspects of efficient drug development programs targeted at COPD. SPIROMICS offers the opportunity to address these critical issues by ascertaining potentially important biomarkers and other surrogate endpoints while simultaneously identifying homogeneous subtypes of COPD. If successfully executed, this research initiative will significantly inform the development of new therapies for COPD.

Major Requirements
·         Have COPD



Vitamin D add-on therapy enhances corticosteroid responsiveness in Asthma (VIDA)

Description
The effect of Vitamin D on the cells of the immune system presents a plausible explanation for the wide range of diseases in which Vitamin D has been reported to modulate, including asthma. Vitamin D has the potential to both directly and indirectly regulate the function multiple cell types that ultimately determines the outcome of an immune response.

Major Requirements
·         Have asthma
·         Have low Vitamin D levels



A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Rduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) with Eosinophilic Asthma. (Cephalon)

Description
Some individuals have a type of asthma made worse by an unusual increase in white blood cells in their lungs which may cause chronic airway inflammation. These cells are called eosinophils and may be caused by high levels of a normal protein called interleukin 5 (IL 5).  Researchers believe that reslizumab blocks the action of the IL 5 protein and therefore lowers the level of these white blood cells in the lungs.  The study doctor will give reslizumab to some people in this study in addition to their regular asthma medicines to determine if it is safe and will decrease their asthma symptoms even further.  

Major Requirements
·         Have asthma
·         Be between 12 and 75
·         Have a blood eosinophil of 400ug or higher
·         Using moderate to high dose steroids



A randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy, safety, and tolerability of SAR231893/REGN668 administered subcutaneously (SC) once weekly for 12 weeks in patients with persistent eosinophilic asthma who are partially controlled/uncontrolled by inhaled corticosteroid (ICS) plus long-acting beta 2 agonist (LABA) therapy. (Sanofi-Aventis) 

Description
The purpose of this study is to evaluate the safety and effectiveness of SAR231893/REGN668 compared to placebo (substance which contains no active drug) in subjects with asthma whose symptoms are not controlled by their daily asthma medication (Advair® or Symbicort®). 

If you qualify to participate in the study, you will use Advair® and receive study drug (SAR231891/REGN668 or placebo) for 4 weeks. You will then stop Advair® and use fluticasone (the steroid part of Advair®) with the study drug.

Your participation in this study may last up to about 5 months and will include 15 study visits and 3 follow-up telephone calls.  This study includes a screening period of up to 2 weeks (to see if you qualify to participate in the study), a 12 week study drug period, and a 6-week of follow-up period, during which your health will be followed and you will not be taking the study drug.

Major Requirements
·         Have asthma
·         Eosinophil level of 350 or higher
·         Using Advair® or Symbicort®

Quick Reference

Center for Genomics and Personalized Medicine Research

Local Phone 336-713-7500
Toll Free 866-487-2344
Fax 336-713-7566

Center for Genomics and Personalized Medicine Research
Wake Forest School of Medicine
Medical Center Blvd.
Winston-Salem, NC  27157
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Last Updated: 05-29-2014
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