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“Introduction Asthma disproportionately affects racial and ethnic populations. In the US in 2006, the age-adjusted, asthma-related mortality rates were approximately 3 times higher in non-Hispanic Blacks than in non-Hispanic Whites and Hispanics.[1] Although typical safety
and efficacy studies are underpowered or too short in duration to make definitive conclusions regarding severe asthma exacerbations (i.e. those requiring systemic corticosteroids), important insight into the efficacy of medications can be gained from analyzing related moderate exacerbation events characterized by a sustained loss of asthma control (beyond normal day-to-day SPTBN5 variation) that does not meet the definition of a severe exacerbation.[2] For the purpose of asthma research protocol development, moderate exacerbation events
have been captured using various terminology, such as asthma deterioration,[3] asthma worsenings,[4] and asthma events.[5] Few US studies have evaluated the safety and efficacy of an inhaled corticosteroid (ICS)/long-acting β2-adrenergic agonist (LABA) combination therapy in Black or Hispanic patients with asthma. The efficacy of budesonide/formoterol (BUD/FM) pressurized metered-dose inhaler (pMDI) has been evaluated in randomized, double-blind studies in predominantly White patients with mild to moderate asthma[6] and predominantly White,[5] Black,[7] and Hispanic[8] patients with moderate to severe asthma. Results for a predefined asthma event definition, which encompass moderate to severe asthma deteriorations, are presented as these findings have not been presented previously in detail or compared across patient populations. Methods Table I includes a brief summary of the studies that were included in this exploratory analysis. Additional details of the individual studies, including study design and methods, have been previously described.