NULL HYPOTHESIS

The regularly scheduled administration of inhaled long-acting beta-agonist will have similar effects on asthma control, as defined by AM PEF, in subjects with asthma receiving inhaled corticosteroids who bear the B16-Arg/Arg genotype, as in subjects with asthma receiving inhaled corticosteroids who bear the B16-Gly/Gly genotype of the b₂-adrenergic receptor.

DESIGN

This randomized, double-blind, crossover, placebo-controlled trial will examine the effects of regularly scheduled long-acting beta-agonist in a group of asthmatic patients harboring the B16-Arg/Arg genotype and in a separate group of FEV₁- and race- (Caucasian versus non-Caucasian) matched patients harboring the B16-Gly/Gly genotype at the b₂-adrenergic receptor. Both groups will receive concurrent inhaled corticosteroids. To minimize confounding by use of b₂-agonists during the treatment periods, subjects will use an anticholinergic as a rescue reliever.

RESULTS

Enrollment for the LARGE trial began in November 2004 and the last patient visits are anticipated to occur in March 2007. The target sample size is 80 randomized patients.