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Single-inhaler triple therapy in symptomatic COPD patients: FULFIL subgroup analyses

David M.G. Halpin, Ruby Birk, Noushin Brealey, Gerard J. Criner, Mark T. Dransfield, Emma Hilton, David A. Lomas, Chang-Qing Zhu, David A. Lipson
ERJ Open Research 2018 4: 00119-2017; DOI: 10.1183/23120541.00119-2017
David M.G. Halpin
1Dept of Respiratory Medicine, Royal Devon and Exeter Hospital, Exeter, UK
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Ruby Birk
2GSK, Uxbridge, UK
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Noushin Brealey
2GSK, Uxbridge, UK
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Gerard J. Criner
3Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA
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Mark T. Dransfield
4Division of Pulmonary, Allergy and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA
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Emma Hilton
2GSK, Uxbridge, UK
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David A. Lomas
5UCL Respiratory, University College London, London, UK
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Chang-Qing Zhu
2GSK, Uxbridge, UK
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David A. Lipson
6GSK, King of Prussia, PA, USA
7Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
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  • FIGURE 1
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    FIGURE 1

    Least squares (LS) mean change from baseline (95% CI) in trough forced expiratory volume in 1 s (FEV1) according to previous chronic obstructive pulmonary disease medication (intent-to-treat population). ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; BUD: budesonide; FOR: formoterol; LAMA: long-acting muscarinic antagonist; TIO: tiotropium; FF/UMEC/VI: fluticasone furoate/umeclidinium/vilanterol (100/62.5/25 µg); BUD/FOR: budesonide/formoterol (400/12 µg). a) ICS+LABA, b) BUD+FOR, c) ICS+LABA+LAMA, d) LAMA alone, e) TIO alone and f) LAMA+LABA.

  • FIGURE 2
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    FIGURE 2

    Least squares (LS) mean change from baseline (95% CI) in St George's Respiratory Questionnaire (SGRQ) Total score according to previous chronic obstructive pulmonary disease medication subgroups (intent-to-treat population). ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; BUD: budesonide; FOR: formoterol; LAMA: long-acting muscarinic antagonist; TIO: tiotropium; FF/UMEC/VI: fluticasone furoate/umeclidinium/vilanterol (100/62.5/25 µg); BUD/FOR: budesonide/formoterol (400/12 µg). a) ICS+LABA, b) BUD+FOR, c) ICS+LABA+LAMA, d) LAMA alone, e) TIO alone and f) LAMA+LABA. The grey line indicates the 4-unit change in SGRQ score considered the minimal clinically important difference.

  • FIGURE 3
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    FIGURE 3

    Least squares (LS) mean change from baseline (95% CI) in trough forced expiratory volume in 1 s (FEV1) according to chronic obstructive pulmonary disease severity (intent-to-treat population). FF/UMEC/VI: fluticasone furoate/umeclidinium/vilanterol (100/62.5/25 µg); BUD/FOR: budesonide/formoterol (400/12 µg). a) FEV1 % pred <50%, no moderate/severe exacerbations (n=626), b) FEV1 % pred <50%, ≥1 moderate/severe exacerbations (n=589) and c) FEV1 % pred 50– <80%, ≥2 moderate or ≥1 severe exacerbations (n=585).

  • FIGURE 4
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    FIGURE 4

    Least squares (LS) mean change from baseline (95% CI) in St George's Respiratory Questionnaire (SGRQ) Total score according to chronic obstructive pulmonary disease severity (intent-to-treat population). FF/UMEC/VI: fluticasone furoate/umeclidinium/vilanterol (100/62.5/25 µg); BUD/FOR: budesonide/formoterol (400/12 µg). a) Forced expiratory volume in 1 s (FEV1) % pred <50%, no moderate/severe exacerbations (n=626), b) FEV1 % pred <50%, ≥1 moderate/severe exacerbations (n=589) and c) FEV1 % pred 50– <80%, ≥2 moderate or ≥1 severe exacerbations (n=585). The grey line indicates the 4-unit change in SGRQ score considered the minimal clinically important difference.

  • FIGURE 5
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    FIGURE 5

    Least squares (LS) mean change from baseline (95% CI) in trough forced expiratory volume in 1 s (FEV1) according to exacerbation history (intent-to-treat population). FF/UMEC/VI: fluticasone furoate/umeclidinium/vilanterol (100/62.5/25 µg); BUD/FOR: budesonide/formoterol (400/12 µg). a) 0/1 moderate exacerbations, b) ≥2 moderate exacerbations and c) ≥1 severe exacerbations.

  • FIGURE 6
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    FIGURE 6

    Least squares (LS) mean change from baseline (95% CI) in St George's Respiratory Questionnaire (SGRQ) Total score according to exacerbation history (intent-to-treat population). FF/UMEC/VI: fluticasone furoate/umeclidinium/vilanterol (100/62.5/25 µg); BUD/FOR: budesonide/formoterol (400/12 µg). a) 0/1 moderate exacerbations, b) ≥2 moderate exacerbations and c) ≥1 severe exacerbations. The grey line indicates the 4-unit change in SGRQ score considered the minimal clinically important difference.

Tables

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  • TABLE 1

    Distribution of patients within subgroups in the intent-to-treat (ITT) population (which included the extension (EXT) population up to week 24) and the EXT population (up to week 52)

    Week 24 (ITT population)Week 52 (EXT population)
    FF/UMEC/VIBUD/FORTotalFF/UMEC/VIBUD/FORTotal
    Total patients9118991810210220430
    COPD medication class at screening#
     Patients7056781383181171352
     ICS+LABA268 (29)259 (29)527 (29)72 (34)68 (31)140 (33)
     BUD+FOR87 (10)83 (9)170 (9)28 (13)25 (11)53 (12)
     ICS+LABA+LAMA257 (28)256 (28)513 (28)63 (30)58 (26)121 (28)
     LAMA alone79 (9)79 (9)158 (9)20 (10)20 (9)40 (9)
     TIO alone65 (7)67 (7)132 (7)15 (7)16 (7)31 (7)
     LAMA+LABA101 (11)84 (9)185 (10)26 (12)25 (11)51 (12)
    Disease severity
     Patients9068941800208218426
     FEV1 % pred <50%, no moderate/severe exacerbations311 (34)315 (35)626 (35)62 (30)71 (32)133 (31)
     FEV1 % pred <50%, ≥1 moderate/severe exacerbation299 (33)290 (32)589 (33)70 (33)73 (33)143 (33)
     FEV1 % pred 50– <80%, ≥2 moderate or ≥1 severe exacerbations296 (33)289 (32)585 (33)76 (36)74 (34)150 (35)
    Exacerbation history
     Patients9118991810210220430
     0/1 moderate exacerbations600 (66)613 (68)1213 (67)148 (70)159 (72)307 (71)
     ≥2 moderate exacerbations311 (34)286 (32)597 (33)62 (30)61 (28)123 (29)
     ≥1 severe exacerbations185 (20)200 (22)385 (21)58 (28)57 (26)115 (27)

    Data are presented as n or n (%). FF/UMEC/VI: fluticasone furoate/umeclidinium/vilanterol (100/62.5/25 µg); BUD/FOR: budesonide/formoterol (400/12 µg); COPD: chronic obstructive pulmonary disease; ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; LAMA: long-acting muscarinic antagonist; TIO: tiotropium; FEV1: forced expiratory volume in 1 s. #: subgroups are not exclusive (the n-values in the “Patients” row represent the number of patients in any of the categories for the subgroup; patients receiving BUD/FOR are included in the ICS+LABA group and patients receiving TIO alone are included in the LAMA alone group).

    • TABLE 2

      Mean annual moderate/severe exacerbation rates by subgroup (intent-to-treat (ITT) population; up to week 24)

      SubgroupFF/UMEC/VIBUD/FORRate reduction % (95% CI)
      nRatenRate
      Patients911899
      Prior medication
       ICS+LABA2660.102580.2763 (29–80)***
       BUD+FOR870.05830.1054 (−74–88)
       ICS+LABA+LAMA2560.282540.5347 (13–67)*
       LAMA alone790.12790.2349 (−42–81)
       TIO alone650.15670.2024 (−125–74)
       LAMA+LABA1000.38830.26−44 (−194–29)
      Disease severity
       FEV1 % pred <50%, no moderate/severe exacerbations3110.223150.3333 (−4–57)
       FEV1 % pred <50%, ≥1 moderate/severe exacerbation2990.222900.4145 (11–66)*
       FEV1 % pred 50– <80%, ≥2 moderate or ≥1 severe exacerbations2960.222890.3027 (−21–56)
      Exacerbation history
       0/1 moderate exacerbations5990.256090.4036 (11–54)**
       ≥2 moderate exacerbations3080.242830.3225 (−23–55)
       ≥1 severe exacerbations1850.131980.3259 (17–80)*

      FF/UMEC/VI: fluticasone furoate/umeclidinium/vilanterol (100/62.5/25 µg); BUD/FOR: budesonide/formoterol (400/12 µg); ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; LAMA: long-acting muscarinic antagonist; TIO: tiotropium; FEV1: forced expiratory volume in 1 s. *: p<0.05; **: p<0.01; ***: p<0.005, statistically significant difference for FF/UMEC/VI:BUD/FOR ratio.

      Supplementary Materials

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      • Supplementary Material

        Please note: supplementary material is not edited by the Editorial Office, and is uploaded as it has been supplied by the author.

        Tables S1–S4 00119-2017_supplementary

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      Single-inhaler triple therapy in symptomatic COPD patients: FULFIL subgroup analyses
      David M.G. Halpin, Ruby Birk, Noushin Brealey, Gerard J. Criner, Mark T. Dransfield, Emma Hilton, David A. Lomas, Chang-Qing Zhu, David A. Lipson
      ERJ Open Research Apr 2018, 4 (2) 00119-2017; DOI: 10.1183/23120541.00119-2017

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      Single-inhaler triple therapy in symptomatic COPD patients: FULFIL subgroup analyses
      David M.G. Halpin, Ruby Birk, Noushin Brealey, Gerard J. Criner, Mark T. Dransfield, Emma Hilton, David A. Lomas, Chang-Qing Zhu, David A. Lipson
      ERJ Open Research Apr 2018, 4 (2) 00119-2017; DOI: 10.1183/23120541.00119-2017
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