Childhood Asthma Research and Education (CARE) Network

Best ADd-on Therapy Giving Effective Response (BADGER)

NULL HYPOTHESIS

In children 6-18 years of age, whose asthma symptoms are not acceptably controlled by low dose inhaled corticosteroid (ICS) therapy, the following three step-up therapies will not differ with respect to asthma control: (1) doubling the dose of the current ICS regimen; (2) adding a long-acting beta-agonist and not increasing the ICS dose; (3) adding a leukotriene receptor antagonist and not increasing the ICS dose.

DESIGN

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 mg/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 measure will be the annualized number of asthma control days during the last 12 weeks of each treatment period.

RESULTS

Enrollment for BADGER will begin in the early part of 2007 with a target sample size of 180 randomized children into the six treatment sequences and the final patient visits will occur in November 2008.