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Efficacy of indacaterol/glycopyrronium versus salmeterol/fluticasone in current and ex-smokers: a pooled analysis of IGNITE trials

David M.G. Halpin, Claus F. Vogelmeier, Karen Mezzi, Pritam Gupta, Konstantinos Kostikas, Jadwiga A. Wedzicha
ERJ Open Research 2021 7: 00816-2020; DOI: 10.1183/23120541.00816-2020
David M.G. Halpin
1University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK
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  • For correspondence: d.halpin@nhs.net
Claus F. Vogelmeier
2University Medical Centre Giessen and Marburg, member of the German Centre for Lung Research (DZL), Marburg, Germany
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Karen Mezzi
3Novartis Pharma AG, Basel, Switzerland
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Pritam Gupta
4Novartis Healthcare Pvt. Ltd., Hyderabad, India
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Konstantinos Kostikas
5Respiratory Medicine Dept, University of Ioannina, Ioannina, Greece
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  • ORCID record for Konstantinos Kostikas
Jadwiga A. Wedzicha
6National Heart and Lung Institute, Imperial College London, London, UK
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  • FIGURE 1
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    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
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    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
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    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
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    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.

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    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
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    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

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  • Supplementary Materials
  • TABLE 1

    Baseline demographics and clinical characteristics (full analysis set)

    CharacteristicCurrent smoker#Ex-smoker¶
    IND/GLY
    110/50 µg
    once daily
    SFC
    50/500 µg
    twice daily
    IND/GLY
    110/50 µg
    once daily
    SFC
    50/500 µg
    twice daily
    Subjects n87989014271421
    Age years62.1±7.5162.0±7.0766.0±7.8066.0±7.76
    Male643 (73.2)638 (71.7)1175 (82.3)1136 (79.9)
    BMI kg·m−225.0±5.0025.1±5.2426.0±5.0726.1±4.95
    Estimated number of pack-years43.0±18.5144.4±21.8839.6±22.5839.3±22.00
    Duration of COPD years6.0±4.756.3±5.137.2±5.547.4±5.60
    Blood eosinophil count at baseline cells·µL−1205.4±141.32205.9±160.36209.5±156.47207.1±166.62
    Severity of airflow limitation, GOLD 2019 [25]
     Mild, GOLD 12 (0.2)1 (0.1)
     Moderate, GOLD 2386 (43.8)397 (44.6)573 (40.2)573 (40.3)
     Severe, GOLD 3437 (49.6)442 (49.6)761 (53.3)758 (53.3)
     Very severe, GOLD 447 (5.3)44 (4.9)85 (6.0)80 (5.6)
     Missing9 (1.0)7 (0.8)8 (0.6)11 (0.8)
    Treatments at baseline+
     LABA430 (48.8)453 (50.8)698 (48.9)674 (47.5)
     LAMA393 (44.6)415 (46.6)613 (43.0)612 (43.0)
     ICS442 (50.2)448 (50.3)826 (57.9)802 (56.4)
     LABA/ICS283 (32.1)295 (33.1)501 (35.1)483 (34.0)
    COPD exacerbation history
     0209 (23.7)200 (22.4)361 (25.3)340 (23.9)
     1549 (62.3)570 (64.0)863 (60.5)878 (61.7)
     ≥2123 (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 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.

      Supplementary material 00816-2020.SUPPLEMENT

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    Efficacy of indacaterol/glycopyrronium versus salmeterol/fluticasone in current and ex-smokers: a pooled analysis of IGNITE trials
    David M.G. Halpin, Claus F. Vogelmeier, Karen Mezzi, Pritam Gupta, Konstantinos Kostikas, Jadwiga A. Wedzicha
    ERJ Open Research Jan 2021, 7 (1) 00816-2020; DOI: 10.1183/23120541.00816-2020

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    Efficacy of indacaterol/glycopyrronium versus salmeterol/fluticasone in current and ex-smokers: a pooled analysis of IGNITE trials
    David M.G. Halpin, Claus F. Vogelmeier, Karen Mezzi, Pritam Gupta, Konstantinos Kostikas, Jadwiga A. Wedzicha
    ERJ Open Research Jan 2021, 7 (1) 00816-2020; DOI: 10.1183/23120541.00816-2020
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