TREATING CHILDREN TO PREVENT EXACERBATIONS OF ASTHMA (TREXA)

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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. With inhaled corticosteroid (ICS) established as the best medication for mild persistent asthma, a crucial unresolved issue in children whose asthma is under good control with daily ICS is for how long this treatment has to be maintained and when is it safe to wean and/or discontinued daily therapy. To our knowledge, no studies have systematically addressed this issue, or defined the criteria on which to base this decision. The NAEPP guidelines suggest that, in this group of patients, reducing ICS therapy can be considered after a 1-3 month period of acceptable control of symptoms; however, given the paucity of evidence, the Guidelines offer no parameters that would guide the clinician in this process. Another important consideration is treatment of exacerbations that occur intermittently in children with otherwise mild disease when a child has stopped regular medications. TReating children to prevent EXacerbations of Asthma will test the hypothesis that children with mild persistent asthma, under good control on low dose ICS and thus eligible for weaning from ICS, do not differ in their effects on time to first asthma exacerbation during 44 weeks of therapy with: 1. the same dose of ICS twice daily and use of ICS + albuterol as reliever; 2. the same dose of ICS twice daily and use of placebo ICS + albuterol as reliever; 3. placebo ICS twice daily and use of ICS + albuterol as reliever; 4. placebo ICS twice daily and use of placebo ICS + albuterol as reliever