Long-Term Safety Of Budesonide/formoterol Pressurized Metered-Dose Inhaler (PMDI) And Budesonide PMDI In African-American Patients With Asthma: Asthma Exacerbations And Adverse Events

Rationale: Little information exists about the safety of combination inhaled corticosteroid and long-acting beta2-adrenergic agonist therapies in specific racial or ethnic populations at higher risk for asthma morbidity and disparate outcomes. We present unique safety data regarding combination therapy from a 52-week, randomized, double-blind phase 3 study (NCT00419952) comparing budesonide/formoterol (BUD/FM) delivered via pressurized metered-dose inhaler (pMDI) with BUD pMDI in self-reported African- American patients with moderate to severe asthma. Methods: After a 2-wk run-in period on BUD pMDI 160 μg × 2 inhalations (320 μg) twice daily (bid), 742 self-reported African-American patients aged ≥12 years were randomized 1:1 to BUD/FM pMDI 160/4.5 μg × 2 inhalations (320/9 μg) bid or BUD pMDI 160 μg × 2 inhalations (320 μg) bid. Safety variables included asthma exacerbations (oral/systemic corticosteroid use or an asthma-related hospitalization or emergency room/urgent care visit) and adverse events (AEs). Results: Fewer (P=.006) patients receiving BUD/FM (7.7%) vs BUD (14.0%) had ≥1 asthma exacerbation. The number of exacerbations per patient-treatment year was lower with BUD/FM vs BUD (0.131 vs 0.213, respectively; P=.002). The time to first asthma exacerbation was prolonged (P=.018) in patients treated with BUD/FM vs BUD. One patient in the BUD/FM group and 4 patients in the BUD group experienced a hospitalization due to an exacerbation. Similar percentages of patients in the BUD/FM and BUD groups had ≥1 AE (51.2% vs 47.8%, respectively). Most common AEs were headache, nasopharyngitis, sinusitis, and viral upper respiratory tract infection; no new safety concerns were identified with BUD/FM. Discontinuations due to AEs occurred in 2.7% and 2.2% of patients in the BUD/FM and BUD groups, respectively. Serious AEs (not considered drug-related) occurred in 12 and 15 patients in the BUD/FM and BUD groups, respectively. Conclusion: This study showed that in African-American patients with moderate to severe asthma, BUD/FM pMDI treatment was well tolerated and more effective for preventing exacerbations compared with BUD pMDI.