COPD patients with depressive symptoms have a significantly higher risk for exacerbations. Early screening for depression in patients with COPD may help identify those patients at higher risk for subsequent exacerbations.
Examine the influence of baseline airflow limitation on outcomes in a 12-week, randomized, double-blind, multicenter trial that compared fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) with tiotropium (TIO) in patients with symptomatic chronic obstructive pulmonary disease (COPD) at risk of exacerbations. METHODS: Eligible patients had symptomatic COPD (COPD Assessment Test [CAT] score $10), post-bronchodilator forced expiratory volume in 1 second (FEV1) <50% predicted (or FEV1 <80% predicted and $2 moderate or 1 severe exacerbation in the prior year) and had received TIO maintenance therapy for $3 months prior to screening. Patients were randomized 1:1 to once-daily single-inhaler FF/UMEC/VI 100/62.5/25 mg via Ellipta or once-daily TIO 18 mg via HandiHaler. Primary endpoint was change from baseline (CFB) in trough FEV1 at Day 85. Post hoc analyses evaluated the effect of baseline % predicted FEV1 (<50% and $50% subgroups) on least squares mean CFB in trough FEV1 at Week 4, Week 12 (Day 84) and Day 85, and St George's Respiratory Questionnaire (SGRQ) total score and CAT score at Week 4 and Week 12. Safety was also assessed. RESULTS: The <50% and $50% baseline % predicted FEV1 subgroups comprised 415 and 380 patients, respectively. FF/UMEC/ VI significantly improved trough FEV1 CFB versus TIO in <50% and $50% baseline % predicted FEV1 subgroups at Week 4 (treatment difference: 117 mL and 124 mL, respectively; both p<0.001), Week 12 (92 mL and 81 mL, both p<0.001) and Day 85 (70 mL [p¼0.003] and 119 mL [p<0.001]). In the <50% baseline percent predicted FEV1 subgroup, FF/UMEC/VI also significantly improved CFB in SGRQ total score and CAT score versus TIO at Week 4 (treatment difference: SGRQ total score, À3.8 [p¼0.002]; CAT score, À1.5 [p<0.001]) and Week 12 (SGRQ total score, À3.0 [p¼0.020]; CAT score, À1.7 [p<0.001]). In the $50% baseline % predicted FEV1 subgroup, FF/UMEC/VI significantly improved CFB in SGRQ total score versus TIO at Week 12 (treatment difference:-3.4 [p¼0.010]) but not at Week 4 (-1.9 [p¼0.122]) and no improvement in CAT score was observed at either timepoint (Week 4,-0.2 [p¼0.639]; Week 12,-0.6 [p¼0.228]). Treatments had comparable safety profiles; pneumonia occurred in 3 (<1%) patients in each treatment arm. CONCLUSIONS: Treatment with once-daily single-inhaler FF/UMEC/VI triple therapy significantly improved lung function compared with TIO monotherapy, regardless of airflow limitation at baseline, and had a similar safety profile. Improvements in health status with FF/UMEC/VI compared with TIO were more pronounced in patients with more severe baseline airflow limitation. CLINICAL IMPLICATIONS: FF/UMEC/VI provides a viable option for patients with symptomatic COPD and at risk of exacerbations currently receiving long-acting muscarinic antagonist monotherapy.
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