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
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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 › fagfællebedømt
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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 -
ID: 258373540