Abstract
Inhaled corticosteroid/long-acting β2-agonist combination therapy is a recommended treatment option for patients with chronic obstructive pulmonary disease (COPD) and increased exacerbation risk, particularly those with elevated blood eosinophil levels. SOPHOS (NCT02727660) evaluated the efficacy and safety of two doses of budesonide/formoterol fumarate dihydrate metered dose inhaler (BFF MDI) versus formoterol fumarate dihydrate (FF) MDI, each delivered using co-suspension delivery technology, in patients with moderate-to-very severe COPD and a history of exacerbations.In this phase 3, randomised, double-blind, parallel-group, 12–52-week, variable length study, patients received twice-daily BFF MDI 320/10 µg or 160/10 µg, or FF MDI 10 µg. The primary endpoint was change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV1) at week 12. Secondary and other endpoints included assessments of moderate/severe COPD exacerbations and safety.The primary analysis (modified intent-to-treat) population included 1843 patients (BFF MDI 320/10 µg, n=619; BFF MDI 160/10 µg, n=617; and FF MDI, n=607). BFF MDI 320/10 µg and 160/10 µg improved morning pre-dose trough FEV1 at week 12 versus FF MDI (least squares mean differences 34 mL [p=0.0081] and 32 mL [p=0.0134], respectively), increased time to first exacerbation (hazard ratios 0.827 [p=0.0441] and 0.803 [p=0.0198], respectively) and reduced exacerbation rate (rate ratios 0.67 [p=0.0001] and 0.71 [p=0.0010], respectively). Lung function and exacerbation benefits were driven by patients with blood eosinophil counts ≥150 cells·mm−3. The incidence of adverse events was similar, and pneumonia rates were low (≤2.4%) across treatments.SOPHOS demonstrated the efficacy and tolerability of BFF MDI 320/10 µg and 160/10 µg in patients with moderate-to-very severe COPD at increased risk of exacerbations.
Highlights
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends the use of an inhaled corticosteroid (ICS) as an add-on treatment with a long-acting β2-agonist (LABA) for patients with chronic obstructive pulmonary disease (COPD) who experience exacerbations despite long-acting bronchodilator monotherapy; when they have elevated blood eosinophil levels [1]
Clinical studies have demonstrated that ICS/LABA combination therapy can improve lung function and reduce COPD exacerbation rates more effectively than LABA monotherapy [2,3,4,5,6,7,8,9,10,11]
The recently completed phase 3 TELOS study (NCT02766608), conducted in patients with moderate-to-very severe COPD who were not required to have an exacerbation history, demonstrated that budesonide/formoterol fumarate dihydrate metered dose inhaler (BFF MDI) 320/10 μg and 160/10 μg improved lung function over 24 weeks compared with ICS monotherapy and reduced COPD exacerbations compared with LABA monotherapy
Summary
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends the use of an inhaled corticosteroid (ICS) as an add-on treatment with a long-acting β2-agonist (LABA) for patients with chronic obstructive pulmonary disease (COPD) who experience exacerbations despite long-acting bronchodilator monotherapy; when they have elevated blood eosinophil levels [1]. The recently completed phase 3 TELOS study (NCT02766608), conducted in patients with moderate-to-very severe COPD who were not required to have an exacerbation history, demonstrated that BFF MDI 320/10 μg and 160/10 μg improved lung function over 24 weeks compared with ICS monotherapy (which is not a recommended therapy for COPD) and reduced COPD exacerbations compared with LABA monotherapy. The current SOPHOS study (NCT02727660) evaluated lung function ( primary objective), COPD exacerbations (secondary objectives) and safety, following treatment with BFF MDI 320/10 μg, BFF MDI 160/10 μg or formoterol fumarate dihydrate (FF) MDI monotherapy for at least 12, and up to 52, weeks in patients with moderate-to-very severe COPD who had a documented history of at least one moderate/ severe COPD exacerbation in the previous 12 months
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