? ? In January 1999, the NHLBI created a federally sponsored clinical research program to study childhood asthma and competitively selected 5 academic Clinical Centers and a Data Coordinating Center to participate in the Childhood Asthma Research and Education (CARE) Network that began work in September 1999. The CARE Network successfully initiated four clinical trials: (1) a long-term early secondary asthma prevention intervention protocol entitled Prevention of Early Asthma in Kids (PEAK); (2) a protocol to characterize the response to a leukotriene antagonist and an inhaled corticosteroid (CLIC); (3) a protocol to compare head-to-head the efficacy of the controller treatment regimens for persistent asthma [Pediatric Asthma Controller Trial (PACT)]; and (4) a protocol to evaluate two different acute intervention management strategies (AIMS) for young children with recurrent episodes of wheezing associated with significant morbidity. This application presents how the CARE network has established a successful infrastructure to conduct clinical research, reviews progress made with the currently conducted and/or completed trials and presents three sample protocols that the network considers to be of sufficient scientific merit to warrant renewed funding for an additional five years. Beta Adrenergic Genotype Response Evaluation (BADGRE) is a 54-week parallel group, randomized, crossover study, stratified by genotype at the ?2-adrenergic receptor, to evaluate the efficacy of doubling the dose of ICS versus adding a long-acting beta-agonist (LABA) to a low dose of ICS and whether there is a genotype-attributable effect in subjects 6-18 years of age who have mild to moderate persistent asthma and are inadequately controlled on monotherapy of low dose ICS. Preventing Asthma by Treating Obesity (PATO) is a 24 week, randomized, controlled, multicenter trial that will be used to determine if a family-based, traffic-light diet associate with behavioral change, will result in a significant decrease in the need to use controller medications in children with moderate persistent asthma aged 7-18 years, with weight 20 to 100% greater than the weight at the 50th percentile. MAXimizing Intervention in Severe Asthma (MAXISA) is a 49-week reandomized, double-masked, prospective placebo-controlled trial to determine whether there is a potential role for anti-IgE in the treatment of severe persistent asthma as classified by current guidelines for children and adolescents on existing Step 3 or Step 4 therapy. All of these protocols incorporate state of the art technology for objective measures of response, validated measures of asthma control, and biomarker and genetic analyses to identify individual patient characteristics associated with response to the intervention. (End of abstract.) ? ?

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
Application #
Study Section
Special Emphasis Panel (ZHL1-CSR-L (M1))
Program Officer
Taggart, Virginia
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Washington University
Schools of Medicine
Saint Louis
United States
Zip Code
Beigelman, Avraham; Bacharier, Leonard B (2016) Management of Preschool Children with Recurrent Wheezing: Lessons from the NHLBI's Asthma Research Networks. J Allergy Clin Immunol Pract 4:1-8; quiz 9-10
Israel, Elliot; Lasky-Su, Jessica; Markezich, Amy et al. (2015) Genome-wide association study of short-acting ?2-agonists. A novel genome-wide significant locus on chromosome 2 near ASB3. Am J Respir Crit Care Med 191:530-7
Gerald, Joe K; Gerald, Lynn B; Vasquez, Monica M et al. (2015) Markers of Differential Response to Inhaled Corticosteroid Treatment Among Children with Mild Persistent Asthma. J Allergy Clin Immunol Pract 3:540-6.e3
Beigelman, Avraham; Zeiger, Robert S; Mauger, David et al. (2014) The association between vitamin D status and the rate of exacerbations requiring oral corticosteroids in preschool children with recurrent wheezing. J Allergy Clin Immunol 133:1489-92, 1492.e1-3
Rabinovitch, Nathan; Mauger, David T; Reisdorph, Nichole et al. (2014) Predictors of asthma control and lung function responsiveness to step 3 therapy in children with uncontrolled asthma. J Allergy Clin Immunol 133:350-6
Beigelman, Avraham; Zeiger, Robert S; Kelly, H William et al. (2014) The challenge of treating preschool wheezing episodes: the need for evidence-based approaches. J Allergy Clin Immunol 133:1016-7
Malka, Jonathan; Mauger, David T; Covar, Ronina et al. (2014) Eczema and race as combined determinants for differential response to step-up asthma therapy. J Allergy Clin Immunol 134:483-5
Chang, Timothy S; Lemanske Jr, Robert F; Mauger, David T et al. (2014) Childhood asthma clusters and response to therapy in clinical trials. J Allergy Clin Immunol 133:363-9
Himes, Blanca E; Sheppard, Keith; Berndt, Annerose et al. (2013) Integration of mouse and human genome-wide association data identifies KCNIP4 as an asthma gene. PLoS One 8:e56179
Himes, Blanca E; Qiu, Weiliang; Klanderman, Barbara et al. (2013) ITGB5 and AGFG1 variants are associated with severity of airway responsiveness. BMC Med Genet 14:86

Showing the most recent 10 out of 41 publications