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Relationship Between On-treatment Rescue Medication Use, Exacerbation Rates, and Health-related Quality of Life in Chronic Obstructive Pulmonary Disease: Post-hoc Analysis of the ETHOS Study (ID 369)

Singh D, Martinez FJ, Hurst JR, Darken P, Dorinsky P, Patel M

Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester, UK

Funding: This study was supported by AstraZeneca.

Abstract

Aim: To evaluate relationships between on-treatment short-acting β2-agonist (SABA) use, exacerbation rates, and health-related quality of life (HRQoL) while exploring the potential benefits of budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) in patients with chronic obstructive pulmonary disease (COPD) in the ETHOS study.

Method: In ETHOS (NCT02465567), patients with moderate-to-very severe COPD who experienced ≥1 moderate/severe exacerbation in the previous year were randomized to twice-daily BGF 320/14.4/10 µg, BGF 160/14.4/10 μg, glycopyrronium/formoterol fumarate dihydrate 14.4/10 µg, or budesonide/formoterol fumarate dihydrate 320/10 µg via a single metered dose AerosphereTM inhaler. As-needed SABA treatment was provided as rescue medication throughout the study. Exacerbation rates and change from baseline in HRQoL, assessed using St George’s Respiratory Questionnaire (SGRQ) total score, were analyzed post-hoc in patients with on-treatment SABA use of ≤1 versus >1 canister every 2 months using the SABA rescue population (patients in the intent-to-treat population with average baseline SABA use ≥1.0 puff/day). Since this analysis used post-randomization information, and the amount of rescue medication differed by treatment group, there is potential confounding with treatment.

Results: Across treatments, exacerbation rates were higher and improvements in SGRQ total score were smaller in patients with higher on-treatment SABA use (Table). Although the magnitude of treatment differences should be interpreted with caution due to the use of post-randomization information, benefits of BGF 320 versus dual therapies on exacerbation rates and SGRQ total score were observed in both SABA use subgroups.

Conclusion: BGF 320 reduced exacerbations and improved HRQoL versus dual therapies in patients with moderate-to-very severe COPD who used SABA rescue medication at either a low or high frequency during the treatment period. High SABA rescue medication use (>1 canister every 2 months) identifies patients at greater risk of exacerbations, who may derive greater benefit from triple therapy relative to dual therapies.


Previously submitted to and presented at the American Thoracic Society 2022, 13–18 May.

Published abstract citation: Martinez FJ, Hurst JR, Darken P, Dorinsky P, Patel M. Relationship Between On-Treatment Rescue Medication Use, Exacerbation Rates, and Health-Related Quality of Life in Chronic Obstructive Pulmonary Disease: Post-Hoc Analysis of the ETHOS Study. American Thoracic Society - 118th International Conference. 2022;205:A1455. URL: https://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2022.205.1_MeetingAbstracts.A1455

Conflicts of interest: Dave Singh reports personal fees from AstraZeneca during the conduct of the study; and personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Genentech, GlaxoSmithKline, Glenmark, Gossamer Bio, Menarini, Mundipharma, Novartis, Peptinnovate, Pfizer, Pulmatrix, Theravance, and Verona, outside the submitted work.
Fernando J Martinez reports grants, personal fees, and non-financial support from AstraZeneca during the conduct of the study; grants, personal fees, and non-financial support from AstraZeneca, Boehringer Ingelheim, Chiesi, CSL Behring, Gala, GlaxoSmithKline, Metronic, Novartis, Polarean, Pulmatrix, Pulmonx, Sanofi/Regeneron, Sunovion, Tevan, Theravance/Viatris, and Verona; grants and personal fees from AstraZeneca, Chiesi, GlaxoSmithKline, and Sanofi/Regeneron.
John R Hurst reports consulting fees from AstraZeneca; speaker fees from AstraZeneca, Chiesi, Pfizer, and Takeda; and travel support from GlaxoSmithKline and AstraZeneca.
Patrick Darken and Mehul Patel are employees of AstraZeneca and hold stock and/or stock options in the company.
Paul Dorinsky is a former employee of AstraZeneca and previously held stock and/or stock options in the company.

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