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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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nhlbi asthma networks
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
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/

slide4

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

slide5

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

slide6

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

slide7

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