The Prevention of Early Asthma in Kids study: Design, rationale and methods for the Childhood Asthma Research and Education network

Theresa W. Guilbert, Wayne J. Morgan, Marzena Krawiec, Robert F. Lemanske, Chris Sorkness, Stanley J. Szefler, Gary Larsen, Joseph D. Spahn, Robert S. Zeiger, Gregory Heldt, Robert C. Strunk, Leonard B. Bacharier, Gordon R. Bloomberg, Vernon M. Chinchilli, Susan J. Boehmer, Elizabeth A. Mauger, David T. Mauger, Lynn M. Taussig, Fernando D. Martinez

Research output: Contribution to journalArticle

134 Scopus citations

Abstract

Pediatric asthma remains an important public health concern as its prevalence and cost to the health care system is rising. In order to promote innovative research in asthma therapies, the National Heart, Lung and Blood Institute created the Childhood Asthma Research and Education Network in 1999. As its first study, the steering committee of the Childhood Asthma Research and Education Network designed a randomized clinical trial to determine if persistent asthma could be prevented in children at a high risk to develop the disease. This communication presents the design of its first clinical trial, the Prevention of Asthma in Kids (PEAK) trial and the organization of the Childhood Asthma Research and Education Network that developed and implemented this trial. Studies of the natural history of asthma have shown that, in persistent asthma, the initial asthma-like symptoms and loss of lung function occur predominately during the first years of life. Therefore, in the Prevention of Asthma in Kids study, children 2 and 3 years old with a positive asthma predictive index were randomized to twice daily treatment with fluticasone 88 μg or placebo via metered-dose inhaler and Aerochamber® for 2 years. The double blind treatment period was followed by a 1-year observational period. Lung function was measured by spirometry and oscillometry technique at 4-month intervals throughout the study. Bronchodilator reversibility and exhaled nitric oxide (ENO) studies were performed at the end of the treatment and observation periods. The primary outcome measure was the number of asthma-free days. Other secondary outcomes included number of exacerbations, use of asthma medications and lung function. These measures were chosen to reflect the progression of the disease from intermittent wheezing to persistent asthma and measurement of the extent of airflow limitation and airway reactivity.

Original languageEnglish (US)
Pages (from-to)286-310
Number of pages25
JournalControlled Clinical Trials
Volume25
Issue number3
DOIs
StatePublished - Jun 1 2004

Keywords

  • Allergens
  • Asthma predictive index
  • Atopy
  • Bronchial hyperresponsiveness
  • Clinical trials
  • Early childhood asthma
  • Exhaled nitric oxide
  • Fluticasone
  • Glucocorticoids
  • Intermittent wheezing
  • Oscillometry
  • Prevention of asthma
  • Research network
  • Spirometry

ASJC Scopus subject areas

  • Pharmacology

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    Guilbert, T. W., Morgan, W. J., Krawiec, M., Lemanske, R. F., Sorkness, C., Szefler, S. J., Larsen, G., Spahn, J. D., Zeiger, R. S., Heldt, G., Strunk, R. C., Bacharier, L. B., Bloomberg, G. R., Chinchilli, V. M., Boehmer, S. J., Mauger, E. A., Mauger, D. T., Taussig, L. M., & Martinez, F. D. (2004). The Prevention of Early Asthma in Kids study: Design, rationale and methods for the Childhood Asthma Research and Education network. Controlled Clinical Trials, 25(3), 286-310. https://doi.org/10.1016/j.cct.2004.03.002