The Effect of Budesonide/Formoterol Pressurized Metered-Dose Inhaler on Predefined Criteria for Worsening Asthma in Four Different Patient Populations with Asthma

Abstract

Background: Previous studies have shown disparities between Black and Hispanic patients compared with other populations in response to asthma medications. Objective: The aim of this analysis was to assess the effect of budesonide/ formoterol pressurized metered-dose inhaler (BUD/FM pMDI) and BUD on predefined criteria for asthma worsening, an asthma control metric generally aligned with definitions of moderate asthma exacerbations, across four different populations. Methods: Data were from four 12-week, randomized, double-blind, US studies of BUD/FM pMDI treatment in patients aged 12 years or older with varying asthma severities and of varying races. Predefined asthma events and withdrawals due to predefined events were assessed as secondary study endpoints. Study I (NCT00651651) includes data from predominantly White patients with mild to moderate asthma who were randomized to BUD/FM pMDI 160/9 mg twice daily (bid; n = 123) or BUD pMDI 160 mg bid (n = 121). Study II (NCT00652002) includes data from predominantly White patients with moderate to severe asthma who were randomized to BUD/FM pMDI 320/9 mg bid (n = 124) or BUD pMDI 320 mg bid (n = 109). Study III (NCT00702325) included self-reported Black patients with moderate to severe asthma who were randomized to BUD/FM pMDI 320/9 mg bid (n = 153) or BUD dry powder inhaler 360 mg bid (n = 148). Study IV (NCT00419757) included self-reported Hispanic patients with moderate to severe asthma who were randomized to BUD/FM pMDI 320/9 mg bid (n = 127) or BUD pMDI 320 mg bid (n = 123). Patients were to be withdrawn from the studies if they developed an asthma event, as determined by predefined criteria, except for night-time awakenings, where withdrawal was left to the study physician's judgment.