NHLBI TOPMed: Best ADd-on Therapy Giving Effective Response (BADGER)

BADGER is a 56-week randomized, double-blind, three-treatment, three-period cross-over trial that will evaluate the differential improvement in control that is achieved following three separate treatment interventions in children whose asthma is not acceptably controlled on a low dose of ICS (per NAEPP guidelines). All participants will enter an 8-week run-in period during which time they will receive a dose of 1x ICS (fluticasone 200 μg/day). During this 8-week time period, running 2-week averages to establish the lack of acceptable asthma control will be calculated. Thus, a child could qualify for randomization at any time during this 8-week run-in period. This approach should maximize both patient safety and successful enrollment. Children will continue to receive 1x ICS during the entire treatment phase. During each period of the treatment phase, they also will receive one add-on therapy in the form of LABA, LTRA or additional 1x ICS. The order of the add-on therapy assignment will be determined by randomization into one of six treatment sequences (order determined randomly). Each treatment period will be 16 weeks in length; the initial 4 weeks of each period will be considered to be the washout period for the previous treatment. The primary outcome measures will be frequency of asthma exacerbations, asthma control days, and FEV1.]]>
TOPMed Whole Genome Sequencing Methods: Freeze 9TOPMed Whole Genome Sequencing Methods: Freeze 10Children who had uncontrolled asthma while receiving 100 micrograms of fluticasone twice daily. Inclusion criteria were mild-to-moderate asthma diagnosed by a physician on the basis of criteria recommended by the National Asthma Education and Prevention Program, an ability to perform reproducible spirometry, an FEV1 of at least 60% before bronchodilation, and an increase in the FEV1 of at least 12% (bronchodilator reversibility) or a methacholine provocation concentration causing a 20% fall (PC20) in the FEV1 of 12.5 mg per milliliter or less.]]>