Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD
Abstract Chronic obstructive pulmonary disease (COPD) treatment guidelines do not currently include recommendations for escalation directly from monotherapy to triple therapy. This 12-week, double-blind, double-dummy study randomized 800 symptomatic moderate-to-very-severe COPD patients receiving ti...
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2021-05-01
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| Series: | npj Primary Care Respiratory Medicine |
| Online Access: | https://doi.org/10.1038/s41533-021-00241-z |
| _version_ | 1818344190375886848 |
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| author | Sandeep Bansal Martin Anderson Antonio Anzueto Nicola Brown Chris Compton Thomas C. Corbridge David Erb Catherine Harvey Morrys C. Kaisermann Mitchell Kaye David A. Lipson Neil Martin Chang-Qing Zhu Alberto Papi |
| author_facet | Sandeep Bansal Martin Anderson Antonio Anzueto Nicola Brown Chris Compton Thomas C. Corbridge David Erb Catherine Harvey Morrys C. Kaisermann Mitchell Kaye David A. Lipson Neil Martin Chang-Qing Zhu Alberto Papi |
| author_sort | Sandeep Bansal |
| collection | DOAJ |
| description | Abstract Chronic obstructive pulmonary disease (COPD) treatment guidelines do not currently include recommendations for escalation directly from monotherapy to triple therapy. This 12-week, double-blind, double-dummy study randomized 800 symptomatic moderate-to-very-severe COPD patients receiving tiotropium (TIO) for ≥3 months to once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 mcg via ELLIPTA (n = 400) or TIO 18 mcg via HandiHaler (n = 400) plus matched placebo. Study endpoints included change from baseline in trough forced expiratory volume in 1 s (FEV1) at Days 85 (primary), 28 and 84 (secondary), health status (St George’s Respiratory Questionnaire [SGRQ] and COPD Assessment Test [CAT]) and safety. FF/UMEC/VI significantly improved trough FEV1 at all timepoints (Day 85 treatment difference [95% CI] 95 mL [62–128]; P < 0.001), and significantly improved SGRQ and CAT versus TIO. Treatment safety profiles were similar. Once-daily single-inhaler FF/UMEC/VI significantly improved lung function and health status versus once-daily TIO in symptomatic moderate-to-very-severe COPD patients, with a similar safety profile. |
| first_indexed | 2024-12-13T16:42:32Z |
| format | Article |
| id | doaj.art-dac6017c105b4a2b8e947907b8317115 |
| institution | Directory Open Access Journal |
| issn | 2055-1010 |
| language | English |
| last_indexed | 2024-12-13T16:42:32Z |
| publishDate | 2021-05-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | npj Primary Care Respiratory Medicine |
| spelling | doaj.art-dac6017c105b4a2b8e947907b83171152022-12-21T23:38:15ZengNature Portfolionpj Primary Care Respiratory Medicine2055-10102021-05-013111910.1038/s41533-021-00241-zSingle-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPDSandeep Bansal0Martin Anderson1Antonio Anzueto2Nicola Brown3Chris Compton4Thomas C. Corbridge5David Erb6Catherine Harvey7Morrys C. Kaisermann8Mitchell Kaye9David A. Lipson10Neil Martin11Chang-Qing Zhu12Alberto Papi13The Lung Center, Penn Highlands HealthcareKarolinska InstitutetDivision of Pulmonary Diseases and Critical Care Medicine, School of Medicine, The University of Texas Health Science CenterGSK, Stockley Park West, Iron Bridge Road NorthGSKGSKVitaLink Research GaffneyGSK, Stockley Park West, Iron Bridge Road NorthGSKMinnesota Lung CenterGSKGSKGSK, Stockley Park West, Iron Bridge Road NorthRespiratory Unit, Department of Morphology, Surgery and Experimental Medicine, University of FerraraAbstract Chronic obstructive pulmonary disease (COPD) treatment guidelines do not currently include recommendations for escalation directly from monotherapy to triple therapy. This 12-week, double-blind, double-dummy study randomized 800 symptomatic moderate-to-very-severe COPD patients receiving tiotropium (TIO) for ≥3 months to once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 mcg via ELLIPTA (n = 400) or TIO 18 mcg via HandiHaler (n = 400) plus matched placebo. Study endpoints included change from baseline in trough forced expiratory volume in 1 s (FEV1) at Days 85 (primary), 28 and 84 (secondary), health status (St George’s Respiratory Questionnaire [SGRQ] and COPD Assessment Test [CAT]) and safety. FF/UMEC/VI significantly improved trough FEV1 at all timepoints (Day 85 treatment difference [95% CI] 95 mL [62–128]; P < 0.001), and significantly improved SGRQ and CAT versus TIO. Treatment safety profiles were similar. Once-daily single-inhaler FF/UMEC/VI significantly improved lung function and health status versus once-daily TIO in symptomatic moderate-to-very-severe COPD patients, with a similar safety profile.https://doi.org/10.1038/s41533-021-00241-z |
| spellingShingle | Sandeep Bansal Martin Anderson Antonio Anzueto Nicola Brown Chris Compton Thomas C. Corbridge David Erb Catherine Harvey Morrys C. Kaisermann Mitchell Kaye David A. Lipson Neil Martin Chang-Qing Zhu Alberto Papi Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD npj Primary Care Respiratory Medicine |
| title | Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD |
| title_full | Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD |
| title_fullStr | Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD |
| title_full_unstemmed | Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD |
| title_short | Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus tiotropium monotherapy in patients with COPD |
| title_sort | single inhaler fluticasone furoate umeclidinium vilanterol ff umec vi triple therapy versus tiotropium monotherapy in patients with copd |
| url | https://doi.org/10.1038/s41533-021-00241-z |
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