Ferguson GT, et al. – This research scrutinized the impact of budesonide/formoterol pressurized metered-dose inhaler (pMDI) versus formoterol dry powder inhaler (DPI) on reducing chronic obstructive pulmonary disease (COPD) exacerbations. It was concluded that budesonide/formoterol pMDI was an effective treatment option for decreasing exacerbation rates in COPD patients with moderate-to-very-severe airflow limitation and history of exacerbations. However, no increase in pneumonia was seen with budesonide/formoterol. Safety data were consistent with its established profile.

Methods

• It was a randomized, double-blind, double-dummy, parallel-group, multicenter study.
• For this purpose, one thousand, two hundred nineteen patients aged ≥ 40 years with moderate-to-very-severe COPD (per lung function) and a history of ≥1 COPD exacerbation received budesonide/formoterol pMDI 320/9 μg twice daily (BID) during a 4-week run-in.
• After that, patients were randomized 1:1 to receive budesonide/formoterol pMDI 320/9 μg BID (n = 606) or formoterol DPI 9 μg BID (n = 613) for 26 weeks.
• Exacerbations were identified utilizing predefined criteria for symptom worsening and treatment with systemic corticosteroids and/or antibiotics and/or hospitalization.
• Annual rate of exacerbations was the primary endpoint.

Results

• According to the findings obtained, budesonide/formoterol pMDI resulted in a 24% lessening in annual rate of exacerbations (0.85 vs 1.12; rate ratio: 0.76 [95% CI: 0.62, 0.92]; P = 0.006), and a significant risk reduction for time to first exacerbation (hazard ratio: 0.78 [95% CI: 0.64, 0.96]; P = 0.016) versus formoterol DPI.
• COPD (4.5% vs 8.6%) and nasopharyngitis (5.0% vs 5.2%) were the most commonly reported adverse events (AEs; ≥3%) in budesonide/formoterol and formoterol groups .
• Results revealed that pneumonia AEs were reported in 0.5% and 1.0% of budesonide/formoterol-treated and formoterol-treated patients, respectively.