To address new treatment approaches through AsthmaNet, National Jewish Health will contribute expertise under the direction of Drs. Richard Martin and Stanley Szefler along with experienced investigators from the ACRN and CARE Networks, and Dr. Lisa Cicutto as leader in the Education, Training and Career Development Core and the Community Engagement Core of the Colorado Clinical and Translational Sciences Institute. To understand the relationship of asthma, vitamin D deficiency and obesity in adults, we will examine the role of vitamin D supplementation to enhance inhaled corticosteroid (ICS) response. After a run-in period of ICS, based on evidence of vitamin D deficiency and stratified for body mass index, subjects with asthma, ages 18 to 70 years, will be randomized to ICS plus vitamin D or placebo for a 6-month period in a double-blind, parallel, placebo controlled design to evaluate change in asthma control. An associated mechanistic study will examine cellular mechanisms of steroid response related to the MAP kinase-1 pathway. To improve asthma management in young children, we will evaluate three treatments: low dose ICS delivered via nebulizer/face mask, low dose ICS via metered dose inhaler/spacer/face mask, or an oral leukotriene antagonist. After a placebo run-in, children with asthma, ages 1 to less than 5 years, will be randomized to one treatment in a double-blind, parallel design for a one-year study period. We will measure symptom control and exacerbations and also determine whether therapy can be individualized based on patient characteristics including biomarkers and genetics. To evaluate a novel treatment strategy, we will examine the role of an omega3/antioxidant nutritional formula on exercise-induced bronchospasm in adolescents, ages 12 to 18 years, using a double-blind, placebo controlled, parallel design over a three month treatment period. We will also implement a Clinical Research Skills Development Core Plan and contribute expertise in quality control of physiological clinical outcomes to develop independent academic clinical investigators in asthma. The National Jewish site will contribute collaborative experience, leadership skills and commitment for recruitment of adults and children to participate in AsthmaNet trials.
To improve asthma patient outcomes for both adults and children by innovative and practical clinical trials. Also, to understand mechanisms as to the improvement in asthma status. The Denver group will furthermore contribute to the leadership of the AsthmaNet group.
| Jackson, Daniel J; Bacharier, Leonard B; Mauger, David T et al. (2018) Quintupling Inhaled Glucocorticoids to Prevent Childhood Asthma Exacerbations. N Engl J Med 378:891-901 |
| Sorkness, Christine A; King, Tonya S; Dyer, Anne-Marie et al. (2018) Adapting clinical trial design to maintain meaningful outcomes during a multicenter asthma trial in the precision medicine era. Contemp Clin Trials 77:98-103 |
| Cardet, Juan Carlos; Louisias, Margee; King, Tonya S et al. (2018) Income is an independent risk factor for worse asthma outcomes. J Allergy Clin Immunol 141:754-760.e3 |
| Morris, Claudia R; Mauger, David T; Suh, Jung H et al. (2018) Glutathione and arginine levels: Predictors for acetaminophen-associated asthma exacerbation? J Allergy Clin Immunol 142:308-311.e9 |
| Lang, Jason E; Fitzpatrick, Anne M; Mauger, David T et al. (2018) Overweight/obesity status in preschool children associates with worse asthma but robust improvement on inhaled corticosteroids. J Allergy Clin Immunol 141:1459-1467.e2 |
| Anderson 3rd, William C; Gleason, Melanie C; Miyazawa, Naomi et al. (2017) Approaching Current and New Drug Therapies for Pediatric Asthma. Pediatr Clin North Am 64:1197-1207 |
| Burbank, Allison J; Szefler, Stanley J (2017) Current and future management of the young child with early onset wheezing. Curr Opin Allergy Clin Immunol 17:146-152 |
| Durack, Juliana; Lynch, Susan V; Nariya, Snehal et al. (2017) Features of the bronchial bacterial microbiome associated with atopy, asthma, and responsiveness to inhaled corticosteroid treatment. J Allergy Clin Immunol 140:63-75 |
| Nyenhuis, Sharmilee M; Krishnan, Jerry A; Berry, Alalia et al. (2017) Race is associated with differences in airway inflammation in patients with asthma. J Allergy Clin Immunol 140:257-265.e11 |
| 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 |
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