This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Asthma is one of the most important challenges to public health in the pediatric age group. Not only is the prevalence of the disease increasing, especially during the early school years, but the financial burden of childhood asthma on the health care system is also on the rise. Although effective therapy is available for the treatment of asthma, the evidence that such treatment can change the natural course of the disease is limited. The main purpose of this study is to determine if early intervention with inhaled anti-inflammatory agents in young children at high risk for the development of asthma may prevent the subsequent development of significant asthma symptoms. The study will compare the effects of inhaled fluticasone, an inhaled corticosteriod, to placebo in children 2 to 4 years of age at high risk of developing asthma, on altering the course of asthma. There will be a four-week run-in period to qualify and characterize children. Children will be randomized to one of two treatment groups; one receiving active treatment, the other placebo. The children will receive continuous treatment for a period of twenty-four months, followed by an observation period of one year that will assess the pattern of asthma symptoms. There are three specific objectives of this study: 1) To assess if continuous treatment with inhaled corticosteroids initiated in children 4 years or less at high risk of developing asthma can prevent the development of significant asthma at four to six years of age, 2) To determine if this asthma therapy can prevent both losses lung function and the development of airway sensitivity associated with early onset asthma, and 3) To assess potential side effects that may be associated with long term use of inhaled steroids in early life. If this treatment is effective, it will change the way we manage asthma in early childhood.
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