The Prevention of Early Asthma in Kids study: design, rationale and methods for the Childhood Asthma Research and Education network.
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 microg 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.
Guilbert
Theresa W
TW
Division of Pediatric Pulmonary Medicine, Arizona Respiratory Center, University of Arizona, 1501 N Campbell Avenue, PO Box 245073, Tucson, AZ 85724, USA. guilbert@resp-sci.arizona.edu
Morgan
Wayne J
WJ
Krawiec
Marzena
M
Lemanske
Robert F
RF
Sorkness
Chris
C
Szefler
Stanley J
SJ
Larsen
Gary
G
Spahn
Joseph D
JD
Zeiger
Robert S
RS
Heldt
Gregory
G
Strunk
Robert C
RC
Bacharier
Leonard B
LB
Bloomberg
Gordon R
GR
Chinchilli
Vernon M
VM
Boehmer
Susan J
SJ
Mauger
Elizabeth A
EA
Mauger
David T
DT
Taussig
Lynn M
LM
Martinez
Fernando D
FD
D000280:Administration, Inhalation; D000367:Age Factors; D000730:Androstadienes / Q000008:administration & dosage / Q000627:therapeutic use*; D001249:Asthma / Q000175:diagnosis / Q000517:prevention & control*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002675:Child, Preschool; D015331:Cohort Studies; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D005712:Galvanic Skin Response; D006801:Humans; D008297:Male; D010353:Patient Education as Topic; D018579:Patient Selection; D011237:Predictive Value of Tests; D011314:Preventive Health Services; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012129:Respiratory Function Tests; D013147:Spirometry / Q000379:methods
D000730:Androstadienes; D001993:Bronchodilator Agents; D000068298:Fluticasone