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Pediatric asthma studies Hengameh H. Raissy, Pharm.D . Research Associate Professor. Asthma Clinical Research Network (ACRN) 6 centers: 1993, 1998; 8 centers, 2003 Columbia U./Harlem Hosp. National Jewish Medical & Research Ctr. Penn State U. (Data Coordinating Center) Thomas Jefferson U.
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Pediatric asthma studiesHengameh H. Raissy, Pharm.D.Research Associate Professor
Asthma Clinical Research Network (ACRN) 6 centers: 1993, 1998; 8 centers, 2003 Columbia U./Harlem Hosp. National Jewish Medical & Research Ctr. Penn State U. (Data Coordinating Center) Thomas Jefferson U. U. Calif./San Diego U. Calif./San Francisco U. Texas/Galveston U. Wisconsin Wake Forest U. Washington U. Childhood Asthma Research and Education (CARE) Network 5 centers: 1999, 2004 National Jewish Medical & Research Ctr. Penn State U. (Data Coordinating Center) U. Arizona U. Calif./S.D./Kaiser Perm. U. Wisconsin/Madison Washington U. NHLBI Asthma Networks
Childhood Asthma Research and Education Network (CARE) Network CARE Network Participants • NIH Funding Agency National Heart, Lung and Blood InstituteBethesda, MD • Data Coordinating Center Pennsylvania State UniversityHershey, PA • Clinical Centers University of New MexicoAlbuquerque, NM - (505) 272-8626 National Jewish Medical & Research CenterDenver, CO - (303) 270-2267 University of WisconsinMadison, WI - (608) 262-7190 Center for Urban Population HealthMilwaukee, WI - (414)219-4084 University of California Kaiser Permanente California San Diego, CA - (858) 573-5404Washington UniversitySt. Louis, MI - (314) 286-1178 University of ArizonaTucson, AZ - (520) 626-8834 http://www.asthma-carenet.org/
Step 3 (Moderate) Step 2 (Mild) Step 1 CARE Clinical Trials S T E D P O W N Step 4 (Severe) CLIC/PACT AIMS/MIST PEAK BADGER MARS TREXA INTERMITTENT PERSISTENT
TReating Children to Prevent EXacerbations of Asthma (TREXA) Cohort: ages 6-17 years old with mild asthma Run-in to demonstrate control on low dose ICS
MaintenancevsIntermittent InhaledSteroidsInWheezing Toddlers (MIST) 2 weeks 52 weeks Cohort: ages 12-59 mo, recurrent wheezing, + API and severe episode prior yr Arm A Run-in Randomization Arm B Randomized, DBPC parallel multicenter trial comparing maintenance low-dose ICS vs intermittent high-dose ICS x 7days with every RTI on rate of exacerbations requiring systemic corticosteroids. * Maintenance therapy continued during every respiratory tract illness ‡ Conventional episodic therapy: albuterol qid x 2 days, then prn and, if indicated, oral steroid rescue
Episodic use of an inhaled corticosteroid or leukotriene receptor antagonist in preschool children with moderate-to-severe intermittent wheezing, Bacharier LB et al. JACI 2008 • Azithromycin or montelukast as inhaled corticosteroid–sparing agents in moderate-to-severe childhood asthma study. Strunk RC et al, JACI 2008 • Factors associated with asthma exacerbations during a long-term clinical trial of controller medications in children. Covar RA et al, JACI 2008;122:741-7. • Severe intermittent wheezing in preschool children: A distinct phenotype. Bacharier LB et al. JACI 2007;119:604-10. • Long-term comparison of 3 controller regimens for mild-moderate persistent childhood asthma: The Pediatric Asthma Controller Trial. Sorkness C et al. JACI 2007;119:64-72 • Long-Term Inhaled Corticosteroids in Preschool Children at High Risk for Asthma. Guilbert T et al. N Engl J Med 2006;354:1985-97. • Relationship of exhaled nitric oxide to clinical and inflammatory markers of persistent asthma in children. Strunk R et al. JACI 2003;112:883-92 • Response profiles to fluticasone and montelukast in mild-to-moderate persistent childhood asthma. Zeiger R et al. JACI 2006;117:45-52 • A General Class of Correlation Coefficients for the 2 x 2 Crossover Design. Chinchilli VM et al. Biometrical Journal 47 (2005) 5, 644–653 • Characterization of within-subject responses to fluticasone and montelukast in childhood asthma. Szefler SJ et al. J Allergy Clin Immunol 2005;115:233-42. • Classifying Asthma Severity in Children –Mismatch Between Symptoms, Medication Use and Lung Function. Bacharier L. AJRCCM, 2004 15;170(4):426-32 • Atopic characteristics of children with recurrent wheezing at high risk for the development of childhood asthma. Guilbert TW et al. JACI 2004;114:1282-7 • The Prevention of Early Asthma in Kids study: design, rationale and methods for the Childhood Asthma • Research and Education network. Guilbert T et al. Controlled Clinical Trials 25 (2004) 286–310