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 o 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; Jose M. Echave-Sustaeta Maria-Tome; 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 o 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, Jose M. Echave-Sustaeta Maria-Tome, Neil Martin, Fernando J. Martinez, Holly Quasny, Lynda Sail, Thomas M. Siler, Dave Singh, Byron ThomashowHenrik Watz, Robert Wise, Nicola A. Hanania^*

^*Corresponding author af dette arbejde

Afdeling for Epidemiologi

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

2 Citationer (Scopus)

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 100/62.5/25 mu g, FF/VI 100/25 mu g, or UMEC/VI 62.5/25 mu g. 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

Conclusions: 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.

Originalsprog	Engelsk
Tidsskrift	Chronic Obstructive Pulmonary Diseases
Vol/bind	8
Udgave nummer	1
Sider (fra-til)	76-90
Antal sider	15
ISSN	2372-952X
DOI	https://doi.org/10.15326/jcopdf.2020.0158
Status	Udgivet - 2021

Adgang til dokumentet

10.15326/jcopdf.2020.0158

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8047616/pdf/JCOPDF-8-076.pdfLicens: Andet

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., Maria-Tome, J. M. E-S., 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 o the Western Europe and North America Regions. Chronic Obstructive Pulmonary Diseases, 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 o the Western Europe and North America Regions. / Bourdin, Arnaud; Criner, Gerard; Devouassoux, Gilles; Dransfield, Mark; Halpin, David M. G.; Han, MeiLan K.; Jones, C. Elaine; Kalhan, Ravi; Lange, Peter; Lettis, Sally; Lipson, David A.; Lomas, David A.; Maria-Tome, Jose M. Echave-Sustaeta; Martin, Neil; Martinez, Fernando J.; Quasny, Holly; Sail, Lynda; Siler, Thomas M.; Singh, Dave; Thomashow, Byron; Watz, Henrik; Wise, Robert; Hanania, Nicola A.

I: Chronic Obstructive Pulmonary Diseases, Bind 8, Nr. 1, 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, Maria-Tome, JME-S, 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 o the Western Europe and North America Regions', Chronic Obstructive Pulmonary Diseases, 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 o the Western Europe and North America Regions. Chronic Obstructive Pulmonary Diseases. 2021;8(1):76-90. https://doi.org/10.15326/jcopdf.2020.0158

Bourdin, Arnaud ; Criner, Gerard ; Devouassoux, Gilles ; Dransfield, Mark ; Halpin, David M. G. ; Han, MeiLan K. ; Jones, C. Elaine ; Kalhan, Ravi ; Lange, Peter ; Lettis, Sally ; Lipson, David A. ; Lomas, David A. ; Maria-Tome, Jose M. Echave-Sustaeta ; Martin, Neil ; Martinez, Fernando J. ; Quasny, Holly ; Sail, Lynda ; Siler, Thomas M. ; Singh, Dave ; Thomashow, Byron ; Watz, Henrik ; Wise, Robert ; Hanania, Nicola A. / 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 o the Western Europe and North America Regions. I: Chronic Obstructive Pulmonary Diseases. 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 o 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 100/62.5/25 mu g, FF/VI 100/25 mu g, or UMEC/VI 62.5/25 mu g. 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], PConclusions: 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.",

keywords = "COPD, single-inhaler triple therapy, exacerbations, Western Europe, North America, OBSTRUCTIVE PULMONARY-DISEASE, BURDEN, PREVALENCE, CARE",

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 Maria-Tome, {Jose M. Echave-Sustaeta} 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.}",

year = "2021",

doi = "10.15326/jcopdf.2020.0158",

language = "English",

volume = "8",

pages = "76--90",

journal = "Chronic Obstructive Pulmonary Diseases",

issn = "2372-952X",

publisher = "COPD Foundation",

number = "1",

}

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 o 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 - Maria-Tome, Jose M. Echave-Sustaeta

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

Y1 - 2021

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 100/62.5/25 mu g, FF/VI 100/25 mu g, or UMEC/VI 62.5/25 mu g. 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], PConclusions: 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.

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 100/62.5/25 mu g, FF/VI 100/25 mu g, or UMEC/VI 62.5/25 mu g. 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], PConclusions: 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.

KW - COPD

KW - single-inhaler triple therapy

KW - exacerbations

KW - Western Europe

KW - North America

KW - OBSTRUCTIVE PULMONARY-DISEASE

KW - BURDEN

KW - PREVALENCE

KW - CARE

U2 - 10.15326/jcopdf.2020.0158

DO - 10.15326/jcopdf.2020.0158

M3 - Journal article

C2 - 33156982

VL - 8

SP - 76

EP - 90

JO - Chronic Obstructive Pulmonary Diseases

JF - Chronic Obstructive Pulmonary Diseases

SN - 2372-952X

IS - 1

ER -