InforMing the PAthway of COPD Treatment (IMPACT Trial) Single-Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients With COPD: Analysis of the Western Europe and North America Regions

Arnaud Bourdin; Gerard Criner; Gilles Devouassoux; Mark Dransfield; David M G Halpin; MeiLan K Han; C Elaine Jones; Ravi Kalhan; Peter Lange; Sally Lettis; David A Lipson; David A Lomas; José M Echave-Sustaeta María-Tomé; Neil Martin; Fernando J Martinez; Holly Quasny; Lynda Sail; Thomas M Siler; Dave Singh; Byron Thomashow; Henrik Watz; Robert Wise; Nicola A Hanania

doi:10.15326/JCOPDF.2020.0158

InforMing the PAthway of COPD Treatment (IMPACT Trial) Single-Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients With COPD: Analysis of the Western Europe and North America Regions

Arnaud Bourdin, Gerard Criner, Gilles Devouassoux, Mark Dransfield, David M G Halpin, MeiLan K Han, C Elaine Jones, Ravi Kalhan, Peter Lange, Sally Lettis, David A Lipson, David A Lomas, José M Echave-Sustaeta María-Tomé, Neil Martin, Fernando J Martinez, Holly Quasny, Lynda Sail, Thomas M Siler, Dave Singh, Byron ThomashowHenrik Watz, Robert Wise, Nicola A Hanania

Abstract

Background: The InforMing the Pathway of COPD Treatment (IMPACT) trial demonstrated lower moderate/severe exacerbation rates with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI or UMEC/VI in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. Since IMPACT was a global study, post-hoc analyses were conducted by geographic region to investigate potential differences in overall findings.

Methods: IMPACT was a 52-week, randomized, double-blind trial. Patients with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25µg, FF/VI 100/25µg, or UMEC/VI 62.5/25µg. Endpoints assessed in the overall, Western Europe and North America populations included on-treatment moderate/severe exacerbation (rates and time-to-first), trough forced expiratory volume in 1 second and St George's Respiratory Questionnaire (SGRQ) total score. Safety was assessed.

Results: Overall, 10,355 patients were enrolled, 3164 from Western Europe, 2639 from North America. FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in Western Europe (rate ratios 0.82 [95%CI 0.74-0.91], P<.001 and 0.76 [0.67-0.87], P<.001) and in North America (0.87 [0.77-0.97], P=.014 and 0.69 [0.60-0.80], P<.001). FF/UMEC/VI reduced time-to-first moderate/severe exacerbation and improved lung function versus FF/VI and UMEC/VI in both regions, and improved SGRQ total score in Western Europe, but not North America. Safety profiles were generally similar between treatment groups/regions; the inhaled corticosteroid class effect of increased pneumonia incidence was seen in North America but not Western Europe.

Conclusion: Consistent with intent-to-treat results, FF/UMEC/VI reduced moderate/severe exacerbation rate and risk and improved lung function in Western Europe and North America; however, between-regions differences were seen for SGRQ total score and pneumonia incidence.

Clinical Trial Registration: NCT02164513.

Originalsprog	Engelsk
Tidsskrift	Chronic obstructive pulmonary diseases (Miami, Fla.)
Vol/bind	8
Udgave nummer	1
Sider (fra-til)	76-90
Antal sider	14
ISSN	2372-952X
DOI	https://doi.org/10.15326/JCOPDF.2020.0158
Status	Udgivet - jan. 2021

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10.15326/JCOPDF.2020.0158

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Citationsformater

Bourdin, A., Criner, G., Devouassoux, G., Dransfield, M., Halpin, D. M. G., Han, M. K., Jones, C. E., Kalhan, R., Lange, P., Lettis, S., Lipson, D. A., Lomas, D. A., Echave-Sustaeta María-Tomé, J. M., Martin, N., Martinez, F. J., Quasny, H., Sail, L., Siler, T. M., Singh, D., ... Hanania, N. A. (2021). InforMing the PAthway of COPD Treatment (IMPACT Trial) Single-Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients With COPD: Analysis of the Western Europe and North America Regions. Chronic obstructive pulmonary diseases (Miami, Fla.), 8(1), 76-90. https://doi.org/10.15326/JCOPDF.2020.0158

InforMing the PAthway of COPD Treatment (IMPACT Trial) Single-Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients With COPD: Analysis of the Western Europe and North America Regions. / Bourdin, Arnaud; Criner, Gerard; Devouassoux, Gilles et al.
I: Chronic obstructive pulmonary diseases (Miami, Fla.), Bind 8, Nr. 1, 01.2021, s. 76-90.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Bourdin, A, Criner, G, Devouassoux, G, Dransfield, M, Halpin, DMG, Han, MK, Jones, CE, Kalhan, R, Lange, P, Lettis, S, Lipson, DA, Lomas, DA, Echave-Sustaeta María-Tomé, JM, Martin, N, Martinez, FJ, Quasny, H, Sail, L, Siler, TM, Singh, D, Thomashow, B, Watz, H, Wise, R & Hanania, NA 2021, 'InforMing the PAthway of COPD Treatment (IMPACT Trial) Single-Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients With COPD: Analysis of the Western Europe and North America Regions', Chronic obstructive pulmonary diseases (Miami, Fla.), bind 8, nr. 1, s. 76-90. https://doi.org/10.15326/JCOPDF.2020.0158

Bourdin A, Criner G, Devouassoux G, Dransfield M, Halpin DMG, Han MK et al. InforMing the PAthway of COPD Treatment (IMPACT Trial) Single-Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients With COPD: Analysis of the Western Europe and North America Regions. Chronic obstructive pulmonary diseases (Miami, Fla.). 2021 jan.;8(1):76-90. doi: 10.15326/JCOPDF.2020.0158

Bourdin, Arnaud ; Criner, Gerard ; Devouassoux, Gilles et al. / InforMing the PAthway of COPD Treatment (IMPACT Trial) Single-Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients With COPD : Analysis of the Western Europe and North America Regions. I: Chronic obstructive pulmonary diseases (Miami, Fla.). 2021 ; Bind 8, Nr. 1. s. 76-90.

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title = "InforMing the PAthway of COPD Treatment (IMPACT Trial) Single-Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients With COPD: Analysis of the Western Europe and North America Regions",

abstract = "Background: The InforMing the Pathway of COPD Treatment (IMPACT) trial demonstrated lower moderate/severe exacerbation rates with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI or UMEC/VI in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. Since IMPACT was a global study, post-hoc analyses were conducted by geographic region to investigate potential differences in overall findings.Methods: IMPACT was a 52-week, randomized, double-blind trial. Patients with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25µg, FF/VI 100/25µg, or UMEC/VI 62.5/25µg. Endpoints assessed in the overall, Western Europe and North America populations included on-treatment moderate/severe exacerbation (rates and time-to-first), trough forced expiratory volume in 1 second and St George's Respiratory Questionnaire (SGRQ) total score. Safety was assessed.Results: Overall, 10,355 patients were enrolled, 3164 from Western Europe, 2639 from North America. FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in Western Europe (rate ratios 0.82 [95%CI 0.74-0.91], P<.001 and 0.76 [0.67-0.87], P<.001) and in North America (0.87 [0.77-0.97], P=.014 and 0.69 [0.60-0.80], P<.001). FF/UMEC/VI reduced time-to-first moderate/severe exacerbation and improved lung function versus FF/VI and UMEC/VI in both regions, and improved SGRQ total score in Western Europe, but not North America. Safety profiles were generally similar between treatment groups/regions; the inhaled corticosteroid class effect of increased pneumonia incidence was seen in North America but not Western Europe.Conclusion: Consistent with intent-to-treat results, FF/UMEC/VI reduced moderate/severe exacerbation rate and risk and improved lung function in Western Europe and North America; however, between-regions differences were seen for SGRQ total score and pneumonia incidence.Clinical Trial Registration: NCT02164513.",

author = "Arnaud Bourdin and Gerard Criner and Gilles Devouassoux and Mark Dransfield and Halpin, {David M G} and Han, {MeiLan K} and Jones, {C Elaine} and Ravi Kalhan and Peter Lange and Sally Lettis and Lipson, {David A} and Lomas, {David A} and {Echave-Sustaeta Mar{\'i}a-Tom{\'e}}, {Jos{\'e} M} and Neil Martin and Martinez, {Fernando J} and Holly Quasny and Lynda Sail and Siler, {Thomas M} and Dave Singh and Byron Thomashow and Henrik Watz and Robert Wise and Hanania, {Nicola A}",

note = "JCOPDF {\textcopyright} 2021.",

year = "2021",

month = jan,

doi = "10.15326/JCOPDF.2020.0158",

language = "English",

volume = "8",

pages = "76--90",

journal = "Chronic obstructive pulmonary diseases (Miami, Fla.)",

issn = "2372-952X",

publisher = "Informa Healthcare",

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}

TY - JOUR

T1 - InforMing the PAthway of COPD Treatment (IMPACT Trial) Single-Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients With COPD

T2 - Analysis of the Western Europe and North America Regions

AU - Bourdin, Arnaud

AU - Criner, Gerard

AU - Devouassoux, Gilles

AU - Dransfield, Mark

AU - Halpin, David M G

AU - Han, MeiLan K

AU - Jones, C Elaine

AU - Kalhan, Ravi

AU - Lange, Peter

AU - Lettis, Sally

AU - Lipson, David A

AU - Lomas, David A

AU - Echave-Sustaeta María-Tomé, José M

AU - Martin, Neil

AU - Martinez, Fernando J

AU - Quasny, Holly

AU - Sail, Lynda

AU - Siler, Thomas M

AU - Singh, Dave

AU - Thomashow, Byron

AU - Watz, Henrik

AU - Wise, Robert

AU - Hanania, Nicola A

PY - 2021/1

Y1 - 2021/1

N2 - Background: The InforMing the Pathway of COPD Treatment (IMPACT) trial demonstrated lower moderate/severe exacerbation rates with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI or UMEC/VI in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. Since IMPACT was a global study, post-hoc analyses were conducted by geographic region to investigate potential differences in overall findings.Methods: IMPACT was a 52-week, randomized, double-blind trial. Patients with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25µg, FF/VI 100/25µg, or UMEC/VI 62.5/25µg. Endpoints assessed in the overall, Western Europe and North America populations included on-treatment moderate/severe exacerbation (rates and time-to-first), trough forced expiratory volume in 1 second and St George's Respiratory Questionnaire (SGRQ) total score. Safety was assessed.Results: Overall, 10,355 patients were enrolled, 3164 from Western Europe, 2639 from North America. FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in Western Europe (rate ratios 0.82 [95%CI 0.74-0.91], P<.001 and 0.76 [0.67-0.87], P<.001) and in North America (0.87 [0.77-0.97], P=.014 and 0.69 [0.60-0.80], P<.001). FF/UMEC/VI reduced time-to-first moderate/severe exacerbation and improved lung function versus FF/VI and UMEC/VI in both regions, and improved SGRQ total score in Western Europe, but not North America. Safety profiles were generally similar between treatment groups/regions; the inhaled corticosteroid class effect of increased pneumonia incidence was seen in North America but not Western Europe.Conclusion: Consistent with intent-to-treat results, FF/UMEC/VI reduced moderate/severe exacerbation rate and risk and improved lung function in Western Europe and North America; however, between-regions differences were seen for SGRQ total score and pneumonia incidence.Clinical Trial Registration: NCT02164513.

AB - Background: The InforMing the Pathway of COPD Treatment (IMPACT) trial demonstrated lower moderate/severe exacerbation rates with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI or UMEC/VI in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. Since IMPACT was a global study, post-hoc analyses were conducted by geographic region to investigate potential differences in overall findings.Methods: IMPACT was a 52-week, randomized, double-blind trial. Patients with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25µg, FF/VI 100/25µg, or UMEC/VI 62.5/25µg. Endpoints assessed in the overall, Western Europe and North America populations included on-treatment moderate/severe exacerbation (rates and time-to-first), trough forced expiratory volume in 1 second and St George's Respiratory Questionnaire (SGRQ) total score. Safety was assessed.Results: Overall, 10,355 patients were enrolled, 3164 from Western Europe, 2639 from North America. FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in Western Europe (rate ratios 0.82 [95%CI 0.74-0.91], P<.001 and 0.76 [0.67-0.87], P<.001) and in North America (0.87 [0.77-0.97], P=.014 and 0.69 [0.60-0.80], P<.001). FF/UMEC/VI reduced time-to-first moderate/severe exacerbation and improved lung function versus FF/VI and UMEC/VI in both regions, and improved SGRQ total score in Western Europe, but not North America. Safety profiles were generally similar between treatment groups/regions; the inhaled corticosteroid class effect of increased pneumonia incidence was seen in North America but not Western Europe.Conclusion: Consistent with intent-to-treat results, FF/UMEC/VI reduced moderate/severe exacerbation rate and risk and improved lung function in Western Europe and North America; however, between-regions differences were seen for SGRQ total score and pneumonia incidence.Clinical Trial Registration: NCT02164513.

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U2 - 10.15326/JCOPDF.2020.0158

DO - 10.15326/JCOPDF.2020.0158

M3 - Journal article

C2 - 33156982

SN - 2372-952X

VL - 8

SP - 76

EP - 90

JO - Chronic obstructive pulmonary diseases (Miami, Fla.)

JF - Chronic obstructive pulmonary diseases (Miami, Fla.)

IS - 1

ER -