title: The Prevention of Early Asthma in Kids study: design, rationale and methods for the Childhood Asthma Research and Education network.
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 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.
authors.affiliation: 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
authors.forename: Theresa W
authors.initials: TW
authors.lastname: Guilbert
authors.forename: Wayne J
authors.initials: WJ
authors.lastname: Morgan
authors.forename: Marzena
authors.initials: M
authors.lastname: Krawiec
authors.forename: Robert F
authors.initials: RF
authors.lastname: Lemanske
authors.forename: Chris
authors.initials: C
authors.lastname: Sorkness
authors.forename: Stanley J
authors.initials: SJ
authors.lastname: Szefler
authors.forename: Gary
authors.initials: G
authors.lastname: Larsen
authors.forename: Joseph D
authors.initials: JD
authors.lastname: Spahn
authors.forename: Robert S
authors.initials: RS
authors.lastname: Zeiger
authors.forename: Gregory
authors.initials: G
authors.lastname: Heldt
authors.forename: Robert C
authors.initials: RC
authors.lastname: Strunk
authors.forename: Leonard B
authors.initials: LB
authors.lastname: Bacharier
authors.forename: Gordon R
authors.initials: GR
authors.lastname: Bloomberg
authors.forename: Vernon M
authors.initials: VM
authors.lastname: Chinchilli
authors.forename: Susan J
authors.initials: SJ
authors.lastname: Boehmer
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Mauger
authors.forename: David T
authors.initials: DT
authors.lastname: Mauger
authors.forename: Lynn M
authors.initials: LM
authors.lastname: Taussig
authors.forename: Fernando D
authors.initials: FD
authors.lastname: Martinez
mesh_terms: 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
chemical_list: D000730:Androstadienes; D001993:Bronchodilator Agents; D000068298:Fluticasone