Tags

Type your tag names separated by a space and hit enter

The IMPACT Study - Single Inhaler Triple Therapy (FF/UMEC/VI) Versus FF/VI And UMEC/VI In Patients With COPD: Efficacy And Safety In A Japanese Population.
Int J Chron Obstruct Pulmon Dis. 2019; 14:2849-2861.IJ

Abstract

Purpose

The Informing the Pathway of COPD Treatment (IMPACT) study demonstrated that single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) reduces moderate/severe exacerbation rates and improves lung function and health status versus FF/VI or UMEC/VI dual therapy in patients with symptomatic COPD and a history of exacerbations. This analysis evaluated the efficacy and safety of FF/UMEC/VI in patients enrolled in Japan.

Patients and methods

IMPACT was a 52-week, randomized, double-blind, multicenter study comparing FF/UMEC/VI 100/62.5/25 µg with FF/VI 100/25 µg or UMEC/VI 62.5/25 µg in patients ≥40 years with symptomatic COPD and ≥1 moderate/severe exacerbation in the previous year. Endpoints included annual rate of on-treatment moderate/severe exacerbations (primary endpoint), time-to-first on-treatment moderate/severe exacerbation and change from baseline at Week 52 in trough FEV1, post-bronchodilator FEV1, St. George's Respiratory Questionnaire, and COPD Assessment Test score. Safety was also assessed.

Results

The Japan subgroup accounted for only 4% (378/10,355) of the overall IMPACT intent-to-treat (ITT) population. In the Japan subgroup, FF/UMEC/VI reduced the annual rate of on-treatment moderate/severe exacerbations by 15% (95% CI: -20, 40) versus FF/VI (compared with 15% [10, 20] in the ITT) and 36% (95% CI: 6, 57) versus UMEC/VI (compared with 25% [19, 30] in the ITT). FF/UMEC/VI reduced moderate/severe exacerbation risk (time-to-first), improved lung function and health status at Week 52 versus both dual therapies. These results were in the same direction and of a generally similar magnitude to those seen in the overall ITT population. No new safety signals were identified in the Japan subgroup compared with the ITT population. Pneumonia incidence was higher with FF/UMEC/VI and FF/VI versus UMEC/VI.

Conclusion

These results highlight the favorable benefit-risk profile of FF/UMEC/VI single-inhaler triple therapy compared with FF/VI or UMEC/VI dual therapy in patients in Japan with symptomatic COPD and ≥1 exacerbation in the prior year.

Authors+Show Affiliations

Chest Disease Clinical and Research Institute, Kishiwada City Hospital, Kishiwada, Japan.Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.Evidence Generation Department, GlaxoSmithKline K.K., Tokyo, Japan.Evidence Generation Department, GlaxoSmithKline K.K., Tokyo, Japan.MA Respiratory Department, GlaxoSmithKline K.K., Tokyo, Japan.Development, R&D, GlaxoSmithKline, Research Triangle Park, NC, USA.Biostatistics, GlaxoSmithKline, Uxbridge, Middlesex, UK.Clinical Pharmacology Modelling & Simulation, GlaxoSmithKline R&D, Sydney, Australia.Clinical Pharmacology Modelling & Simulation, GlaxoSmithKline R&D, Sydney, Australia.Clinical Sciences, GlaxoSmithKline, Collegeville, PA, USA. Pulmonary, Allergy and Critical Care Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

31839705

Citation

Kato, Motokazu, et al. "The IMPACT Study - Single Inhaler Triple Therapy (FF/UMEC/VI) Versus FF/VI and UMEC/VI in Patients With COPD: Efficacy and Safety in a Japanese Population." International Journal of Chronic Obstructive Pulmonary Disease, vol. 14, 2019, pp. 2849-2861.
Kato M, Tomii K, Hashimoto K, et al. The IMPACT Study - Single Inhaler Triple Therapy (FF/UMEC/VI) Versus FF/VI And UMEC/VI In Patients With COPD: Efficacy And Safety In A Japanese Population. Int J Chron Obstruct Pulmon Dis. 2019;14:2849-2861.
Kato, M., Tomii, K., Hashimoto, K., Nezu, Y., Ishii, T., Jones, C. E., Kilbride, S., Gross, A. S., Clifton, C. S., & Lipson, D. A. (2019). The IMPACT Study - Single Inhaler Triple Therapy (FF/UMEC/VI) Versus FF/VI And UMEC/VI In Patients With COPD: Efficacy And Safety In A Japanese Population. International Journal of Chronic Obstructive Pulmonary Disease, 14, 2849-2861. https://doi.org/10.2147/COPD.S226601
Kato M, et al. The IMPACT Study - Single Inhaler Triple Therapy (FF/UMEC/VI) Versus FF/VI and UMEC/VI in Patients With COPD: Efficacy and Safety in a Japanese Population. Int J Chron Obstruct Pulmon Dis. 2019;14:2849-2861. PubMed PMID: 31839705.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The IMPACT Study - Single Inhaler Triple Therapy (FF/UMEC/VI) Versus FF/VI And UMEC/VI In Patients With COPD: Efficacy And Safety In A Japanese Population. AU - Kato,Motokazu, AU - Tomii,Keisuke, AU - Hashimoto,Kenichi, AU - Nezu,Yasuko, AU - Ishii,Takeo, AU - Jones,C Elaine, AU - Kilbride,Sally, AU - Gross,Annette S, AU - Clifton,Christine S, AU - Lipson,David A, Y1 - 2019/12/06/ PY - 2019/08/09/received PY - 2019/10/31/accepted PY - 2019/12/17/entrez PY - 2019/12/17/pubmed PY - 2020/4/28/medline KW - COPD exacerbation KW - Japan KW - fluticasone furoate KW - triple therapy KW - umeclidinium KW - vilanterol SP - 2849 EP - 2861 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 14 N2 - Purpose: The Informing the Pathway of COPD Treatment (IMPACT) study demonstrated that single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) reduces moderate/severe exacerbation rates and improves lung function and health status versus FF/VI or UMEC/VI dual therapy in patients with symptomatic COPD and a history of exacerbations. This analysis evaluated the efficacy and safety of FF/UMEC/VI in patients enrolled in Japan. Patients and methods: IMPACT was a 52-week, randomized, double-blind, multicenter study comparing FF/UMEC/VI 100/62.5/25 µg with FF/VI 100/25 µg or UMEC/VI 62.5/25 µg in patients ≥40 years with symptomatic COPD and ≥1 moderate/severe exacerbation in the previous year. Endpoints included annual rate of on-treatment moderate/severe exacerbations (primary endpoint), time-to-first on-treatment moderate/severe exacerbation and change from baseline at Week 52 in trough FEV1, post-bronchodilator FEV1, St. George's Respiratory Questionnaire, and COPD Assessment Test score. Safety was also assessed. Results: The Japan subgroup accounted for only 4% (378/10,355) of the overall IMPACT intent-to-treat (ITT) population. In the Japan subgroup, FF/UMEC/VI reduced the annual rate of on-treatment moderate/severe exacerbations by 15% (95% CI: -20, 40) versus FF/VI (compared with 15% [10, 20] in the ITT) and 36% (95% CI: 6, 57) versus UMEC/VI (compared with 25% [19, 30] in the ITT). FF/UMEC/VI reduced moderate/severe exacerbation risk (time-to-first), improved lung function and health status at Week 52 versus both dual therapies. These results were in the same direction and of a generally similar magnitude to those seen in the overall ITT population. No new safety signals were identified in the Japan subgroup compared with the ITT population. Pneumonia incidence was higher with FF/UMEC/VI and FF/VI versus UMEC/VI. Conclusion: These results highlight the favorable benefit-risk profile of FF/UMEC/VI single-inhaler triple therapy compared with FF/VI or UMEC/VI dual therapy in patients in Japan with symptomatic COPD and ≥1 exacerbation in the prior year. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/31839705/The_IMPACT_Study___Single_Inhaler_Triple_Therapy__FF/UMEC/VI__Versus_FF/VI_And_UMEC/VI_In_Patients_With_COPD:_Efficacy_And_Safety_In_A_Japanese_Population_ L2 - https://dx.doi.org/10.2147/COPD.S226601 DB - PRIME DP - Unbound Medicine ER -