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. 2021 Feb 22;7(1):00816-2020.
doi: 10.1183/23120541.00816-2020. eCollection 2021 Jan.

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

David M G Halpin  1 , Claus F Vogelmeier  2 , Karen Mezzi  3 , Pritam Gupta  4 , Konstantinos Kostikas  5 , Jadwiga A Wedzicha  6
Affiliations

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

David M G Halpin et al. ERJ Open Res. .

Abstract

Inhaled corticosteroids have proven to be less effective in asthmatic patients who smoke; however, there is limited information on the efficacy of inhaled corticosteroid-containing regimens in COPD patients who continue smoking. We evaluate the differential efficacy of once-daily indacaterol/glycopyrronium 110/50 µg compared with twice-daily salmeterol/fluticasone 50/500 µg in current smokers and ex-smokers with COPD. A pooled analysis of data from ILLUMINATE, LANTERN and FLAME studies was conducted to assess the efficacy of indacaterol/glycopyrronium compared with salmeterol/fluticasone in current smokers and ex-smokers with COPD. Efficacy was assessed in terms of improvements in trough forced expiratory volume in 1 s (FEV1), transition dyspnoea index (TDI) focal score, St George's Respiratory Questionnaire (SGRQ) total score, reduced rescue medication use and exacerbation prevention at 26 weeks after the start of the therapy. In total, 1769 (38%) current smokers and 2848 (62%) ex-smokers were included. Patients treated with indacaterol/glycopyrronium experienced greater improvements in trough FEV1 versus salmeterol/fluticasone in both current and ex-smokers (least squares mean treatment difference, 105 mL and 78 mL, respectively). Improvements in TDI focal score, SGRQ total score and reduction in rescue medication use were also greater with indacaterol/glycopyrronium versus salmeterol/fluticasone in current and ex-smokers. Furthermore, indacaterol/glycopyrronium reduced all exacerbations (moderate/severe) compared with salmeterol/fluticasone, irrespective of smoking status. The difference in efficacy in favour of indacaterol/glycopyrronium was more prominent in current smokers in most cases. Indacaterol/glycopyrronium demonstrated greater efficacy versus salmeterol/fluticasone, and the differences were generally more prominent in current smokers suggesting smoking may reduce the effects of salmeterol/fluticasone.

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Conflict of interest statement

Conflict of interest: D.M.G. Halpin reports personal fees from AstraZeneca, personal fees and nonfinancial support from Boehringer Ingelheim, personal fees from Chiesi and GlaxoSmithKline, personal fees and nonfinancial support from Novartis, and personal fees from Pfizer, CSL Behring and Sanofi, outside the submitted work. Conflict of interest: C.F. Vogelmeier reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Grifols, Mundipharma and Novartis, personal fees from Cipla, Berlin Chemie/Menarini, CSL Behring and Teva, and grants from the German Federal Ministry of Education and Research (BMBF) Competence Network Asthma and COPD (ASCONET), Bayer Schering Pharma AG, MSD and Pfizer, outside the submitted work. Conflict of interest: K. Mezzi has nothing to disclose. Conflict of interest: P. Gupta is an employee of Novartis Healthcare Pvt. Ltd. Conflict of interest: K. Kostikas reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, ELPEN, Innovis, Novartis, Menarini and GSK, outside the submitted work; and was an employee of Novartis Pharma AG, Basel during the conduct of this study. Conflict of interest: J.A. Wedzicha reports grants from GSK, and Johnson and Johnson; other support from Novartis, Boehringer Ingelheim, AstraZeneca and GSK; and grants from GSK, AstraZeneca, Boehringer Ingelheim and Novartis, all outside the submitted work.

Figures

FIGURE 1
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
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
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
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
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
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.
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