Gary T Ferguson1, Donald P Tashkin2, Tor Skärby3, Carin Jorup4, Kristina Sandin5, Michael Greenwood6, Kristine Pemberton7, Frank Trudo8. 1. Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA. Electronic address: garytferguson@msn.com. 2. University of California, Los Angeles, CA, USA. Electronic address: DTashkin@mednet.ucla.edu. 3. AstraZeneca R&D, Gothenburg, Sweden. Electronic address: Tor.Skarby@astrazeneca.com. 4. AstraZeneca R&D, Gothenburg, Sweden. Electronic address: Carin.Jorup@astrazeneca.com. 5. AstraZeneca R&D, Gothenburg, Sweden. Electronic address: Kristina.Sandin@astrazeneca.com. 6. AstraZeneca R&D, Alderley Park, Cheshire, UK. Electronic address: mike.greenwood@phastar.com. 7. AstraZeneca R&D, Alderley Park, Cheshire, UK. Electronic address: kristine.pemberton@hotmail.co.uk. 8. AstraZeneca LP, Wilmington, DE, USA. Electronic address: Frank.Trudo@astrazeneca.com.
Abstract
BACKGROUND: Prevention of exacerbations is a primary goal for chronic obstructive pulmonary disease (COPD) therapy. This randomized, double-blind, double-dummy, parallel-group, multicenter study evaluated the effect of budesonide/formoterol pressurized metered-dose inhaler (pMDI) versus formoterol dry powder inhaler (DPI) on reducing COPD exacerbations. METHODS:1219 patients aged ≥40 years with moderate-to-very-severe COPD (per lung function) and a history of ≥1 COPD exacerbation receivedbudesonide/formoterol pMDI 320/9 μg twice daily (BID) during a 4-week run-in. Patients were then 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 using predefined criteria for symptom worsening and treatment with systemic corticosteroids and/or antibiotics and/or hospitalization. The primary endpoint was annual rate of exacerbations. RESULTS:Budesonide/formoterol pMDI resulted in a 24% reduction 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. The most commonly reported adverse events (AEs; ≥3%) in budesonide/formoterol and formoterol groups were COPD (4.5% vs 8.6%) and nasopharyngitis (5.0% vs 5.2%). Pneumonia AEs were reported in 0.5% and 1.0% of budesonide/formoterol-treated and formoterol-treated patients, respectively. CONCLUSIONS:Budesonide/formoterol pMDI is an effective treatment option for reducing exacerbation rates in COPD patients with moderate-to-very-severe airflow limitation and history of exacerbations. No increase in pneumonia was observed with budesonide/formoterol; safety data were consistent with its established profile.
RCT Entities:
BACKGROUND: Prevention of exacerbations is a primary goal for chronic obstructive pulmonary disease (COPD) therapy. This randomized, double-blind, double-dummy, parallel-group, multicenter study evaluated the effect of budesonide/formoterol pressurized metered-dose inhaler (pMDI) versus formoterol dry powder inhaler (DPI) on reducing COPD exacerbations. METHODS: 1219 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. Patients were then 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 using predefined criteria for symptom worsening and treatment with systemic corticosteroids and/or antibiotics and/or hospitalization. The primary endpoint was annual rate of exacerbations. RESULTS:Budesonide/formoterol pMDI resulted in a 24% reduction 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. The most commonly reported adverse events (AEs; ≥3%) in budesonide/formoterol and formoterol groups were COPD (4.5% vs 8.6%) and nasopharyngitis (5.0% vs 5.2%). PneumoniaAEs were reported in 0.5% and 1.0% of budesonide/formoterol-treated and formoterol-treated patients, respectively. CONCLUSIONS:Budesonide/formoterol pMDI is an effective treatment option for reducing exacerbation rates in COPD patients with moderate-to-very-severe airflow limitation and history of exacerbations. No increase in pneumonia was observed with budesonide/formoterol; safety data were consistent with its established profile.
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Authors: Gary T Ferguson; Alberto Papi; Antonio Anzueto; Edward M Kerwin; Christy Cappelletti; Elizabeth A Duncan; Jack Nyberg; Paul Dorinsky Journal: Eur Respir J Date: 2018-09-16 Impact factor: 16.671