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. Preschool aged children with recurrent episodes of wheezing have different long-term outcomes. Most will stop wheezing by 6 years of age, with only 14% of children who wheeze during the first 3 years of life continuing to wheeze at 6 years of age. Thus, most children with wheezing early in life do not go on to have persistent wheezing (i.e. asthma). Nevertheless, the recurrent wheezing episodes impact upon the lives of children and their families. While most of these patients would not appear to be candidates for long-term asthma controller therapy, as they are generally entirely well without symptoms of airway hyper-reactivity between episodes of wheezing, an intervention to alter the progression of RTI to severe wheezing episodes is necessary. The literature contains numerous trials exploring a variety of interventions for this clinical situation, including oral corticosteroids at symptom onset, oral corticosteroids after symptoms present for a least 48 hours, and inhaled corticosteroids at onset of RTI symptoms. The majority of these studies suggest that such interventions are generally beneficial in reducing lower respiratory tract symptoms. However, small sample sizes and significant heterogeneity of the patient populations complicate the interpretation of these findings. Given the clinical importance of this issue, a well-designed prospective trial with adequate sample size is critical to address this problem. In addition, emerging evidence of the role of leukotrienes in viral infection associated wheezing as well as asthma, along with the availability of potent leukotriene receptor antagonists, makes this a potential acute intervention which has not yet, to our knowledge, been explored. The selected design of this study is a randomized, double-blind, double-dummy placebo-controlled parallel comparison of three strategies directed at minimizing symptoms of wheezing during acute RTIs in children 12-59 months of age with histories of moderate-severe episodes of wheezing. There will be a 2-week observation period to qualify and characterize children. Children will be randomized to one of three treatments for 7 days at the first-sign of RTI-associated symptoms: 1. Active inhaled corticosteroid (ICS) (budesonide (Pulmicort Respules 1.0 mg BID)and placebo leukotriene receptor antagonist (LTRA), or 2. Active LTRA (montelukast (Singulair 4 mg once daily (Granules for children 12-23 months of age and chewable tablets for children 24-59 months of age) and placebo ICS, or 3. Placebo ICS and placebo LTRA.
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