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TReating Children to Prevent EXacerbations of Asthma (TREXA)
In children with mild persistent asthma who are under good control with low dose inhaled corticosteroid (ICS) (100 μg 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:
- the same dose of ICS twice daily and use of ICS + albuterol as reliever;
- the same dose of ICS twice daily and use of placebo ICS + albuterol as reliever;
- placebo ICS twice daily and use of ICS + albuterol as reliever;
- 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 4 weeks of the run-in period on a 1x dose of ICS (100 μg 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.
Enrollment for TREXA began in November 2006 with a target sample size of 280 randomized children into the four treatment groups. The final patient visits occurred in February 2010 with a total sample size of 288 randomized children: combined (n=71); daily beclomethasone (n=72); rescue beclomethasone (n=71); placebo (n=74). Compared with the placebo group (49%, 95% CI 37–61), the frequency of exacerbations was lower in the daily (28%, 18–40, p=0.03), combined (31%, 21–43, p=0.07), and rescue (35%, 24–47, p=0.07) groups. Frequency of treatment failure was 23% (95% CI 14–43) in the placebo group, compared with 5.6% (1.6–14) in the combined (p=0.01), 2.8% (0–10) in the daily (p=0.009), and 8.5% (2–15) in the rescue (p=0.02) groups. Compared with the placebo group, linear growth was 1.1 cm (SD 0.3) less in the combined and daily arms (p<0.0001), but not the rescue group (p=0.26).The major publication appeared in The Lancet:
- Martinez FD, Chinchilli VM, Morgan WJ, Boehmer SJ, Lemanske Jr RF, Mauger DT, Strunk RC, Szefler SJ, Zeiger RS, Bacharier LB, Bade E, Covar RA, Friedman NJ, Guilbert TW, Heidarian-Raissy H, Kelly HW, Malka-Rais J, Mellon MH, Sorkness CA, Taussig L. Preventing exacerbations in mild persistent childhood asthma: Use of beclomethasone diproprionate as rescue therapy in a randomized, placebo controlled trial. The Lancet 2011; 377:650-657. PMID: 21324520