NHLBI TOPMed: TReating Children to Prevent EXacerbations of Asthma (TREXA)

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.]]>
TOPMed Whole Genome Sequencing Methods: Freeze 9TOPMed Whole Genome Sequencing Methods: Freeze 10Children 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. Participants were eligible for inclusion if they were naive to controller treatment and had a history of one to two exacerbations in the previous year, if they were treated for the previous 8 weeks with a monotherapy other than inhaled corticosteroids, or if their illness was controlled for the previous 8 weeks on low-dose corticosteroids as monotherapy (≤160 µg daily with a beclomethasone equivalent). Participants were excluded from the study if they had a prebronchodilator forced expiratory volume in 1 s (FEV1) of less than 60% predicted at the first visit; were admitted to hospital for asthma in the previous year; had any asthma exacerbation in the previous 3 months or more than two in the previous year; had a history of life-threatening asthma exacerbations that required intubation or mechanical ventilation, or that resulted in a hypoxic seizure.]]>