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 three controller treatment regimens for persistent asthma [Pediatric Asthma Controller Trial (PACT)]; and (4) a protocolto evaluate two different acute intervention management strategies (AIMS) for young children with recurrent episodes of wheezing associated with significant morbidity. The application submitted by the CARE Network Clinical Centers (CCs) 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 (BADGRE, PATO, and MAXISA) that the CARE Network considers to be of sufficient scientific merit to warrant renewed funding for an additional five years. This application submitted by the CARE Network Data Coordinating Center (DCC) describes the function and activities of the DCC. The six specific aims of the DCC are as follows: (1) provide biostatistical leadership and scientific coordination for the CARE Network, such as optimizing trial designs for increased accuracy and precision, projecting sample sizes, selecting and implementing randomization schemes, analyzing data, developing presentations/publications, preparing and leading training sessions, establishing certification criteria, writing the Manuals of Operations (MOPs), collaborating on recruitment/retention strategies, and resolving questions from the CCs; (2) establish and maintain the CARE Network computer network and website; (3) design and maintain the CARE Network data management system based on a wide-area network and world-wide web implementation; (4) develop and maintain the CARE Network data quality assurance and monitoring program, such as developing high-quality data collection forms, MOPs, and subject handouts, training and certifying CC staff in all CARE Network procedures and clinical trials, supporting CC staff during the conduct of CARE Network trials, and performing site visits and data audits; (5) provide project management and administrative support for the CARE Network; (6) provide oversight and management of data acquisition from biological samples.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HL064313-08
Application #
7088882
Study Section
Special Emphasis Panel (ZHL1-CSR-L (M1))
Program Officer
Taggart, Virginia
Project Start
1999-09-30
Project End
2009-05-31
Budget Start
2006-06-01
Budget End
2007-05-31
Support Year
8
Fiscal Year
2006
Total Cost
$3,404,574
Indirect Cost
Name
Pennsylvania State University
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
129348186
City
Hershey
State
PA
Country
United States
Zip Code
17033
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
Bunyavanich, Supinda; Schadt, Eric E; Himes, Blanca E et al. (2014) Integrated genome-wide association, coexpression network, and expression single nucleotide polymorphism analysis identifies novel pathway in allergic rhinitis. BMC Med Genomics 7:48
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

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