Real-life effectiveness of indacaterol–glycopyrronium after switching from tiotropium or salmeterol/fluticasone therapy in patients with symptomatic COPD: the POWER study

Abstract

Purpose

In contrast to randomized controlled trials (RCTs), changes in maintenance pharmacotherapy in clinical practice occur without a washout period. The Prospective cohort study for the real-life effectiveness evaluation of glycOpyrronium With indacatERol combination in the management of COPD in Canada (POWER) study evaluated the real-life effectiveness of indacaterol/glycopyrronium (IND/GLY) following a direct switch from a long-acting muscarinic antagonist (LAMA, tiotropium) or long-acting β₂-agonist (LABA)/inhaled corticosteroid (ICS) maintenance treatment (salmeterol/fluticasone [SFC]).

Methods

POWER was a single-cohort, prospective, multicenter, interventional study in which patients with moderate-to-severe COPD, who remained symptomatic on their current treatment of once-daily (od) tiotropium 18 µg or twice-daily (bid) SFC (any dose), were switched to treatment with open-label IND/GLY 110/50 µg od for 16 weeks. Effectiveness end points were change from baseline in trough FEV₁, transition dyspnea index (TDI) total scores, and COPD assessment test (CAT) scores at 16 weeks.

Results

Trough FEV₁ improved by 175 mL at Week 16 in patients who switched to IND/GLY. The change was 176 mL (95% CI: 135–217) when switched from tiotropium and 172 mL (95% CI: 85–258) when switched from SFC fixed-dose combination (FDC). At Week 16, significant improvements were observed in the mean TDI total scores (Δ=2.5) and CAT scores (Δ=−6.5) after the switch to IND/GLY treatment (both P<0.0001). Additionally, IND/GLY was well tolerated in patients with moderate-to-severe COPD, and no safety signal was observed.

Conclusion

In clinical practice settings, a direct switch from previous treatment with either tiotropium or SFC to IND/GLY was safe and provided superior clinically significant improvements in lung function and patient-related outcomes in patients with moderate-to-severe COPD.

Clinical trial registration

NCT2202616.

Keywords:

• COPD assessment test
• dyspnea
• FEV₁
• indacaterol/glycopyrronium
• lung function
• TDI

Acknowledgments

The authors thank all principal investigators and patients involved in the study. Writing and editorial assistance for this manuscript were provided by Chiranjit Ghosh and M Fahad Haroon (Novartis Healthcare Pvt. Ltd., India) and was funded by Novartis Pharmaceuticals Canada Inc., Mon-treal, Québec, Canada, in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3). The authors also acknowledge the contribution of Dr John Sampalis et al at JSS Medical Research (Saint-Laurent, Québec, Canada) for their assistance with study monitoring and interim analysis. The study was supported and funded by Novartis Pharmaceuticals Canada Inc. The abstract of this study was presented at the ATS conference 2018 as a poster presentation with interim findings. The poster’s abstract was published in “Poster Abstracts” in American Journal of Respiratory and Critical Care Medicine 2018: https://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2018.197.1_MeetingAbstracts.A3031.

Author contributions

All authors contributed to data analysis, drafting and revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.

Disclosure

AK reports nonfinancial support from Novartis, during the conduct of the study; personal fees from Novartis, Boehringer Ingelheim, AstraZeneca, Teva, Pfizer, Sanofi, Purdue, and Paladdin; and grants and personal fees from Benton Dickinson, outside the submitted work. KRC reports grants and personal fees from AstraZeneca, grants and personal fees from Boehringer Ingelheim, grants from Baxter, grants and personal fees from CSL Behring, grants and personal fees from Grifols, grants from GlaxoSmithKline, grants and personal fees from Sanofi, grants and personal fees from Genentech, grants and personal fees from Kamada, grants from Amgen, grants and personal fees from Roche, grants and personal fees from Novartis, personal fees from Merck, and personal fees from CIHR-GSK Research Chair in Respiratory Health Care Deliveryat the University Health Network, during the conduct of the study. IM reports honoraria for continuing medical education related to COPD and asthma. DR is an employee of and reports personal fees from Novartis Pharmaceuticals Canada Inc. MD was a former employee of Novartis Pharmaceuticals Canada Inc. during this study. SMA reports clinical trial fees and speaking fees from Novartis. DP is an employee of and reports personal fees from Novartis Pharmaceuticals Canada Inc. DP also reports personal fees from Novartis Pharma AG, during the conduct of the study. AM reports honoraria for attending advisory boards and providing CME for AstraZeneca, Boehringer Ingelheim, Novartis, and Takeda. The authors report no other conflicts of interest in this work.