Figures
- FIGURE 1
Treatment difference with indacaterol/glycopyrronium 110/50 μg once daily (IND/GLY) versus salmeterol/fluticasone 50/500 μg twice daily (SFC) in current and ex-smokers for pre-dose trough forced expiratory volume in 1 s (FEV1) after 26 weeks of treatment (full analysis set). Data are presented as least squares mean (LSM)±se. Δ: LSM treatment difference.
- FIGURE 2
Treatment difference with indacaterol/glycopyrronium 110/50 μg once daily (IND/GLY) versus salmeterol/fluticasone 50/500 μg twice daily (SFC) in current and ex-smokers for transition dyspnoea index (TDI) focal score after 26 weeks of treatment (full analysis set). Data are presented as least squares mean (LSM)±se. Δ: LSM treatment difference.
- FIGURE 3
Treatment difference with indacaterol/glycopyrronium 110/50 μg once daily (IND/GLY) versus salmeterol/fluticasone 50/500 μg twice daily (SFC) in current and ex-smokers for St George's Respiratory Questionnaire (SGRQ) total score after 26 weeks of treatment (full analysis set). Data are presented as least squares mean (LSM)±se. Δ: LSM treatment difference.
- FIGURE 4
Treatment difference with indacaterol/glycopyrronium 110/50 μg once daily (IND/GLY) versus salmeterol/fluticasone 50/500 μg twice daily (SFC) in current and ex-smokers in rescue medication use after 26 weeks of treatment (full analysis set). Data are presented as least squares mean (LSM)±se. Δ: LSM treatment difference.
- FIGURE 5
Proportion of patients achieving the minimal clinically important difference (MCID) for trough forced expiratory volume in 1 s (FEV1), St George's Respiratory Questionnaire (SGRQ) total score and transition dyspnoea index (TDI) focal score with indacaterol/glycopyrronium 110/50 μg once daily (IND/GLY) and salmeterol/fluticasone 50/500 μg twice daily (SFC) after 26 weeks (full analysis set).
- FIGURE 6
Annualised rate of all (mild/moderate/severe), moderate/severe and severe exacerbations after 26 weeks by baseline smoking status (full analysis set). IND/GLY: indacaterol/glycopyrronium 110/50 μg once daily; SFC: salmeterol/fluticasone 50/500 μg twice daily. #: including mild/moderate/severe exacerbations.
Tables
- TABLE 1
Baseline demographics and clinical characteristics (full analysis set)
Characteristic Current smoker# Ex-smoker¶ IND/GLY
110/50 µg
once dailySFC
50/500 µg
twice dailyIND/GLY
110/50 µg
once dailySFC
50/500 µg
twice dailySubjects n 879 890 1427 1421 Age years 62.1±7.51 62.0±7.07 66.0±7.80 66.0±7.76 Male 643 (73.2) 638 (71.7) 1175 (82.3) 1136 (79.9) BMI kg·m−2 25.0±5.00 25.1±5.24 26.0±5.07 26.1±4.95 Estimated number of pack-years 43.0±18.51 44.4±21.88 39.6±22.58 39.3±22.00 Duration of COPD years 6.0±4.75 6.3±5.13 7.2±5.54 7.4±5.60 Blood eosinophil count at baseline cells·µL−1 205.4±141.32 205.9±160.36 209.5±156.47 207.1±166.62 Severity of airflow limitation, GOLD 2019 [25] Mild, GOLD 1 2 (0.2) 1 (0.1) Moderate, GOLD 2 386 (43.8) 397 (44.6) 573 (40.2) 573 (40.3) Severe, GOLD 3 437 (49.6) 442 (49.6) 761 (53.3) 758 (53.3) Very severe, GOLD 4 47 (5.3) 44 (4.9) 85 (6.0) 80 (5.6) Missing 9 (1.0) 7 (0.8) 8 (0.6) 11 (0.8) Treatments at baseline+ LABA 430 (48.8) 453 (50.8) 698 (48.9) 674 (47.5) LAMA 393 (44.6) 415 (46.6) 613 (43.0) 612 (43.0) ICS 442 (50.2) 448 (50.3) 826 (57.9) 802 (56.4) LABA/ICS 283 (32.1) 295 (33.1) 501 (35.1) 483 (34.0) COPD exacerbation history 0 209 (23.7) 200 (22.4) 361 (25.3) 340 (23.9) 1 549 (62.3) 570 (64.0) 863 (60.5) 878 (61.7) ≥2 123 (14.0) 120 (13.5) 203 (14.2) 204 (14.3) Data are presented as mean±sd or n (%), unless otherwise stated. IND/GLY: indacaterol/glycopyrronium; SFC: salmeterol/fluticasone; BMI: body mass index; GOLD: Global Initiative for Chronic Obstructive Lung Disease; LABA: long-acting β2-agonist; LAMA: long-acting muscarinic antagonist; ICS: inhaled corticosteroid. #: N=1769; ¶: N=2848; +: patients might be on more than one COPD therapy at baseline.
Supplementary Material
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Supplementary material 00816-2020.SUPPLEMENT
