CAMP Continuation Study Phase 2 (CAMPCS / 2)

Washington University, Saint Louis MO

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Abstract

DESCRIPTION (provided by applicant): Childhood asthma can result in significant lung disease in adulthood and possibly the development of COPD. None of the long-term follow-up studies of childhood asthma have had the close follow-up needed to define determinants of outcomes in young adulthood. No study has examined the effects of intensive treatment with potent anti-inflammatory agents on outcomes. CAMP was a multicenter randomized clinical trial designed to determine the effects of three treatments (albuterol alone, albuterol with inhaled corticosteroid [ICS], albuterol with inhaled non-steroid) in 1,041 children (randomized at ages 5-12 years) with mild to moderate asthma on pulmonary function during a 3.5-5.5 year treatment phase. The cohort is being followed currently in a 4-year observational phase (CAMP Continuation Study, CAMPCS) to determine longer-term effects of the treatments on lung and somatic growth. 88% of the original cohort enrolled, with a missed visit rate of less than 1%. At the scheduled end of CAMPCS, only 70% of females and 38% of males will have achieved an age of likely maximal height and level of pulmonary function. Additional follow-up of the CAMP cohort, CAMPCS/2, is designed to follow the cohort for 4 additional years into early adulthood, when the patients will be 17-26 years (55% >greater than or equal too 21 years). We propose 5 specific aims. We will determine the effects of 3.5-5.5 years of ICS therapy started at ages 5 to 12 years on outcomes of pulmonary function, height, bone density, and the clinical course of asthma in young adulthood. Natural history aims will focus on 1) effects of lower respiratory symptoms, allergy, peripheral blood eosinophilia, and personal smoking on attained level lung function FEV1, FVC, FEV1/FVC) and airway reactivity in young adulthood, 2) effects of lung function, airway reactivity, allergy, peripheral blood eosinophilia, and personal smoking on lower respiratory symptoms in young adulthood, and 3) factors associated with a low FEV1/FVC ratio by comparison of FEV1/FVC and FEV1 and FVC in CAMP patients to three sets of pulmonary function values from normal. Genetic analyses will be done by Dr. Weiss and the Center for Genetics and Genomics at Harvard (without cost to this application) with comparison of the genetic data to the phenotypic data collected during CAMP, CAMPCS, and CAMPCS/2 will allow definitive determination of effect of ICS on these measures. CAMP is the largest and most completely characterized group of children with asthma. Follow-up of this cohort for another 4 years in CAMPCS/2 will provide valuable information about the natural history of this important childhood lung disease, and information on how the childhood illness affects adult lung health.