PURPOSE: Chronic obstructive pulmonary disease (COPD) symptom relief is one of the primary goals of effective COPD management. Long-term effects on COPD symptoms and health status of budesonide/formoterol (BUD/FM) pressurized metered-dose inhaler (pMDI) versus formoterol (FM) dry powder inhaler (DPI) were assessed as secondary end points in a study in COPD patients.
METHODS: This randomized, double-blind, double-dummy, parallel-group, 12-month multicenter study (NCT00419744) included patients aged ≥40 years with COPD who had a history of COPD symptoms for >2 years and ≥1 exacerbation within 12 months before screening. After 2 weeks during which patients discontinued current medications except inhaled corticosteroids, 1219 patients were randomized to BUD/FM pMDI 320/9 μg, BUD/FM pMDI 160/9 μg, or FM DPI 9 μg twice daily (bid).
RESULTS: Reductions from baseline in the Breathlessness, Cough, and Sputum Scale (BCSS) total score (scale: 0-12 [higher score=worse symptoms]), were similar in the BUD/FM (-1.06 to -1.08) and FM (-0.96) groups. Reductions from baseline in dyspnea score (scale: 0-4 [higher score=worse dyspnea]) were greater with BUD/FM 320/9 μg (-0.39) and BUD/FM 160/9 μg (-0.36) versus FM (-0.29) (P=.026 for BUD/FM 320/9 vs FM; P=.098 for BUD/FM 160/9 vs FM). Improvements from baseline were greater with both BUD/FM doses versus FM for nighttime awakenings (scale: 0-4 [higher score=more severe sleep disturbance]) (-0.32 [both BUD/FM doses] vs -0.24) and total rescue medication use (-1.22 to -1.52 vs -0.53 inhalations/day) (P≤.044). Improvements from baseline in St. George’s Respiratory Questionnaire total score exceeded ≥4 units (ie, clinically meaningful change from baseline [Eur Respir J. 2002;19:398]) in the BUD/FM (-7.18 to -5.49) and FM (-5.92) groups.
CONCLUSIONS: BUD/FM pMDI (320/9 μg and 160/9 μg bid) generally improved COPD symptoms versus FM 9 μg bid, with improvements from baseline in health status observed with all treatments, over 12 months in patients with COPD and a history of previous exacerbations.
CLINICAL IMPLICATIONS: Findings suggest that BUD/FM pMDI is effective for relieving COPD symptoms and improving nighttime awakenings in this patient population.
DISCLOSURE: Amir Sharafkhaneh: Grant monies (from sources other than industry): NIH, Grant monies (from industry related sources): GSK, Boehringer Ingelheim, AstraZeneca, Pfizer, DEY, Consultant fee, speaker bureau, advisory committee, etc.: GSK, Boehringer Ingelheim, AstraZeneca, Pfizer, DEY
Tom Uryniak: Shareholder: AstraZeneca LP, Employee: AstraZeneca LP
Ubaldo Martin: Shareholder: AstraZeneca LP, Employee: AstraZeneca LP
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