TReating Children to Prevent EXacerbations of Asthma (TREXA)
NULL HYPOTHESIS
In children with mild persistent asthma who are under good control with low dose inhaled corticosteroid (ICS) (100 mg fluticasone b.i.d. or its equivalent) for at least 8 weeks, and are thus eligible for weaning from ICS therapy according to NAEPP guidelines, treatments for 44 weeks 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
do not differ in their effects on the time to first asthma exacerbation.
TREXA is a 44-week randomized, double-blind, double-masked, four-treatment, parallel trial that will evaluate the weaning strategy that provides the best protection against the development of exacerbations in children whose asthma is acceptably controlled on a low dose of ICS (per NAEPP guidelines). Following the 8 weeks of the run-in period on a 1X dose of ICS (100 mg fluticasone b.i.d. or its equivalent), children who do not meet the definition of acceptable asthma control will be randomized to the parallel BADGER protocol; those who meet the definition of acceptable asthma control will be enrolled into the 44-week treatment phase of the study. The primary outcome measure will be time to first exacerbation requiring a prednisone course.
RESULTS
Enrollment for TREXA began in November 2006 with a target sample size of 280 randomized children into the four treatment groups and the final patient visits will occur in November 2008.