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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 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, United Kingdom
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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 Department, University of Ioannina, Ioannina, Greece
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Jadwiga A. Wedzicha
6National Heart and Lung Institute, Imperial College London, London, United Kingdom
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Abstract

Inhaled corticosteroids have proven to be less effective in smoking asthmatic patients; 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. Further, 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.

Footnotes

This manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.

Conflict of interest: Dr. Halpin reports personal fees from AstraZeneca, personal fees and non-financial support from Boehringer Ingelheim, personal fees from Chiesi, personal fees from GlaxoSmithKline, personal fees and non-financial support from Novartis, personal fees from Pfizer, personal fees from CSL Behring, personal fees from Sanofi, outside the submitted work;.

Conflict of interest: Dr. Vogelmeier reports grants and personal fees from AstraZeneca, grants and personal fees from Boehringer Ingelheim, grants and personal fees from Chiesi, grants and personal fees from GlaxoSmithKline, grants and personal fees from Grifols, grants and personal fees from Mundipharma, grants and personal fees from Novartis, personal fees from Cipla, personal fees from Berlin Chemie/Menarini, personal fees from CSL Behring, personal fees from Teva, grants from German Federal Ministry of Education and Research (BMBF) Competence Network Asthma and COPD (ASCONET), grants from Bayer Schering Pharma AG, grants from MSD, grants from Pfizer, outside the submitted work;.

Conflict of interest: Dr. Mezzi has nothing to disclose.

Conflict of interest: Dr. Gupta reports personal fees from Novartis Healthcare Pvt Ltd, outside the submitted work;.

Conflict of interest: Dr. Kostikas reports grants and personal fees from AstraZeneca, grants and personal fees from Boehringer Ingelheim, grants and personal fees from Chiesi, grants and personal fees from ELPEN, grants and personal fees from Innovis, grants and personal fees from Novartis, grants and personal fees from Menarini, grants and personal fees from GSK, outside the submitted work; and was an employee of Novartis Pharma AG, Basel during the conduct of this study.

Conflict of interest: Dr. Wedzicha reports grants from GSK, grants from Johnson and Johnson, other from Novartis, other from Boehringer Ingelheim, other from Astra Zeneca, other from GSK, grants from GSK, grants from Astra Zeneca, grants from Boehringer Ingelheim, grants from Novartis, outside the submitted work;.

This is a PDF-only article. Please click on the PDF link above to read it.

  • Received November 2, 2020.
  • Accepted November 5, 2020.
  • Copyright ©ERS 2020
http://creativecommons.org/licenses/by-nc/4.0/

This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0.

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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 2020, 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 2020, 00816-2020; DOI: 10.1183/23120541.00816-2020
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