In response to the AsthmaNet RFA, we have established the Atlantic Coast Consortium for Asthma (ACC-A) to serve as a clinical site. It consists of Wake Forest University Health Sciences (SP Peters, PI, Lead Investigator, Adults), University of Virginia (WG Teague, Co-PI, Lead Investigator, Children), Emory University (A Fitzpatrick, Co-I, Site Director), and North Carolina Clinical Research (C LaForce, Co-I, Medical Director). The group of investigators assembled has extensive experience as participants and lead investigators in national asthma networks including the Asthma Clinical Research Network (ACRN) 1 and 2, the Severe Asthma Research Program (SARP), the American Lung Association's Asthma Clinical Research Centers (ALA-ACRC), The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) program, and SNP Typing for Association with Multiple Phenotypes from Existing Epidemiologic Data (STAMPEED, Genome wide Association for Asthma and Lung Function), and with a wide variety of asthma clinical trials. With this experience and extensive resources, we agree to participate in all aspects of AsthmaNet and propose two major protocols (with companion exploratory and mechanistic protocols) focusing on specific sub-sets of severe asthmatics in adults and children. Gene-Based Anti-TNF Therapy in Severe Asthma (Gene BATTS) is a randomized, double-blind, placebo-controlled genotype-stratified trial in adults designed to test the hypothesis that severe asthmatics with specific genetic variants in tumor necrosis factor (TNF) receptor genes respond better to anti-TNF than patients without these variants. Management Options for Severe Asthma in Children (MOSAIC) is a randomized, double-blinded, parallel group trial designed to determine the efficacy of 3 treatment regimes: 880 meg/day fluticasone alone, 440 meg/day fluticasone + BID salmeterol, and 440 meg/day fluticasone + BID ipratropium bromide in severe asthmatic children inadequately controlled on fluticasone 440 meg/day. Companion protocols will examine corticosteroid resistance (RASS) and a possible genetic mechanism for resistance (IMMOST) in adults, and the efficacy of inhaled S-nitrosoglutathione (N30-201) (SNORT) in children.
The Atlantic Coast Consortium for Asthma (ACC-A) and AsthmaNet have been established to perform clinical trials in adults and children with asthma, in order to define better treatment options for them. Through genetic, phenotypic (i.e. clinical), and other means, we hope to be able to identify the right asthma treatment forthe right patient, which both maximizes clinical benefit, and minimizes potential harm.
|Sheehan, William J; Mauger, David T; Paul, Ian M et al. (2016) Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma. N Engl J Med 375:619-30|
|Fitzpatrick, Anne M (2016) Severe Asthma in Children: Lessons Learned and Future Directions. J Allergy Clin Immunol Pract 4:11-9; quiz 20-1|
|Jiao, Junfang; King, Tonya S; McKenzie, Matthew et al. (2016) Vitamin D3 therapy in patients with asthma complicated by sinonasal disease: Secondary analysis of the Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma trial. J Allergy Clin Immunol 138:589-592.e2|
|Denlinger, Loren C; King, Tonya S; Cardet, Juan Carlos et al. (2016) Vitamin D Supplementation and the Risk of Colds in Patients with Asthma. Am J Respir Crit Care Med 193:634-41|
|Ortega, Victor E; Kumar, Rajesh (2015) The Effect of Ancestry and Genetic Variation on Lung Function Predictions: What Is "Normal" Lung Function in Diverse Human Populations? Curr Allergy Asthma Rep 15:16|
|Bacharier, Leonard B; Guilbert, Theresa W; Mauger, David T et al. (2015) Early Administration of Azithromycin and Prevention of Severe Lower Respiratory Tract Illnesses in Preschool Children With a History of Such Illnesses: A Randomized Clinical Trial. JAMA 314:2034-44|
|Ortega, Victor E; Meyers, Deborah A; Bleecker, Eugene R (2015) Asthma pharmacogenetics and the development of genetic profiles for personalized medicine. Pharmgenomics Pers Med 8:9-22|
|Ortega, Victor E; Meyers, Deborah A (2014) Pharmacogenetics: implications of race and ethnicity on defining genetic profiles for personalized medicine. J Allergy Clin Immunol 133:16-26|
|Sutherland, E Rand; Busse, William W; National Heart, Lung, and Blood Institute's AsthmaNet (2014) Designing clinical trials to address the needs of childhood and adult asthma: the National Heart, Lung, and Blood Institute's AsthmaNet. J Allergy Clin Immunol 133:34-8.e1|
|Castro, Mario; King, Tonya S; Kunselman, Susan J et al. (2014) Effect of vitamin D3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin D levels: the VIDA randomized clinical trial. JAMA 311:2083-91|
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