PURPOSE: There is a paucity of information regarding response to inhaled corticosteroid (ICS)/long-acting β2-adrenergic agonist versus ICS in African Americans. Long-term effects on patient-reported outcomes and healthcare utilization with BUD/FM pMDI versus BUD pMDI were assessed as secondary end points in self-reported African-American patients with moderate to severe asthma.
METHODS: This randomized, double-blind, parallel-group, 1-year multicenter study (NCT00419952) included self-reported African-American patients aged ≥12 years with a diagnosis of asthma for ≥6 months. After a 2-week run-in on BUD pMDI 320 μg twice daily (bid), 742 patients were randomized 1:1 to receive BUD/FM pMDI 320/9 μg bid or BUD pMDI 320 μg bid.
RESULTS: The reduction in rescue medication use from baseline to the mean over the 1-year treatment period was greater with BUD/FM versus BUD (-0.52 vs -0.29 inhalations/day; unadjusted P=.003). Improvements were greater with BUD/FM versus BUD for percentage of rescue medication-free days (15.9% vs 10.6%; unadjusted P=.003) and asthma control days (16.7% vs 11.6%; unadjusted P=.006). Improvements in symptom-free days were similar with BUD/FM and BUD (9.5% vs 7.6%; unadjusted P=.178). Asthma-related resource utilization (number per patient-treatment year) was lower with BUD/FM versus BUD for unscheduled physician visits (0.08 vs 0.13; unadjusted P=.014), emergency department visits (0.03 vs 0.07; unadjusted P<.001), urgent care clinic visits (0.01 vs 0.04; unadjusted P<.001), and days of adjunctive asthma medication use (0.39 vs 1.78; unadjusted P<.001). Number of unscheduled phone calls to physicians per patient-treatment year was similar between treatments (0.42 for BUD/FM and 0.48 for BUD; unadjusted P=.461). No patients in the BUD/FM group and 4 patients in the BUD group experienced ≥1 hospitalization due to asthma (unadjusted P=.041).
CONCLUSIONS: BUD/FM pMDI 320/9 μg bid improved patient-reported outcomes and decreased healthcare utilization versus BUD pMDI 320 μg bid over 1 year in African-American patients with moderate to severe persistent asthma.
CLINICAL IMPLICATIONS: These findings support the use of BUD/FM pMDI in African-American patients with moderate to severe asthma.
DISCLOSURE: Randall Brown: Consultant fee, speaker bureau, advisory committee, etc.: Merck & Company, Inc; Teva Pharmaceuticals, LTD, Grant monies (from industry related sources): AstraZeneca LP
Christopher O'Brien: Shareholder: AstraZeneca LP, Employee: AstraZeneca LP
Ubaldo Martin: Employee: AstraZeneca LP, Shareholder: AstraZeneca LP
Tom Uryniak: Employee: AstraZeneca LP, Shareholder: AstraZeneca LP
Kathy Lampl: Employee: AstraZeneca LP, Shareholder: AstraZeneca LP
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