Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus dual therapy in current and former smokers with COPD: IMPACT trial post hoc analysis
dc.contributor.author | Bardsley, S | |
dc.contributor.author | Criner, GJ | |
dc.contributor.author | Halpin, DMG | |
dc.contributor.author | Han, MK | |
dc.contributor.author | Hanania, NA | |
dc.contributor.author | Hill, D | |
dc.contributor.author | Lange, P | |
dc.contributor.author | Lipson, DA | |
dc.contributor.author | Martinez, FJ | |
dc.contributor.author | Midwinter, D | |
dc.contributor.author | Siler, TM | |
dc.contributor.author | Singh, D | |
dc.contributor.author | Wise, RA | |
dc.contributor.author | van Zyl-Smit, RN | |
dc.contributor.author | Berkman, N | |
dc.date.accessioned | 2023-06-20T14:12:01Z | |
dc.date.issued | 2022-11-11 | |
dc.date.updated | 2023-06-20T08:46:48Z | |
dc.description.abstract | BACKGROUND: Smoking is the major risk factor for chronic obstructive pulmonary disease (COPD). In IMPACT, single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy significantly reduced moderate/severe exacerbation rates and improved lung function and health status versus FF/VI or UMEC/VI in COPD patients. This post hoc analysis investigated trial outcomes by smoking status. METHODS: IMPACT was a double-blind, 52-week trial. Patients aged ≥40 years with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to FF/UMEC/VI 100/62.5/25 μg, FF/VI 100/25 μg, or UMEC/VI 62.5/25 μg. Endpoints assessed by smoking status at screening included rate and risk of moderate/severe exacerbations, change from baseline in trough forced expiratory volume in 1 s, and St George's Respiratory Questionnaire total score at Week 52. Safety was also assessed. RESULTS: Of the 10,355 patients in the intent-to-treat population, 3,587 (35%) were current smokers. FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in current (rate ratio 0.85 [95% confidence interval: 0.77-0.95]; P = 0.003 and 0.86 [0.76-0.98]; P = 0.021) and former smokers (0.85 [0.78-0.91]; P < 0.001 and 0.70 [0.64-0.77]; P < 0.001). FF/UMEC/VI significantly reduced time-to-first on-treatment moderate/severe exacerbation versus FF/VI and UMEC/VI in former smokers, and versus FF/VI in current smokers. Similar trends were seen for lung function and health status. Former smokers receiving inhaled corticosteroid-containing therapy had higher pneumonia incidence than current smokers. CONCLUSIONS: FF/UMEC/VI improved clinical outcomes versus dual therapy regardless of smoking status. Benefits of FF/UMEC/VI versus UMEC/VI were greatest in former smokers, potentially due to relative corticosteroid resistance in current smokers. CLINICAL TRIAL REGISTRATION: GSK (CTT116855/NCT02164513). | en_GB |
dc.description.sponsorship | GlaxoSmithKlein | en_GB |
dc.format.extent | 107040- | |
dc.identifier.citation | Vol. 205, article 107040 | en_GB |
dc.identifier.doi | https://doi.org/10.1016/j.rmed.2022.107040 | |
dc.identifier.grantnumber | CTT116855 | en_GB |
dc.identifier.grantnumber | NCT02164513 | en_GB |
dc.identifier.uri | http://hdl.handle.net/10871/133437 | |
dc.identifier | ORCID: 0000-0003-2009-4406 (Halpin, David MG) | |
dc.language.iso | en | en_GB |
dc.publisher | Elsevier | en_GB |
dc.relation.url | https://www.ncbi.nlm.nih.gov/pubmed/36470149 | en_GB |
dc.relation.url | http://www.clinicalstudydatarequest.com | en_GB |
dc.rights | © 2022 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). | en_GB |
dc.title | Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus dual therapy in current and former smokers with COPD: IMPACT trial post hoc analysis | en_GB |
dc.type | Article | en_GB |
dc.date.available | 2023-06-20T14:12:01Z | |
dc.identifier.issn | 0954-6111 | |
exeter.article-number | 107040 | |
exeter.place-of-publication | England | |
dc.description | This is the final version. Available from Elsevier via the DOI in this record. | en_GB |
dc.description | Data sharing: Anonymized individual participant data and study documents can be requested for further research from www.clinicalstudydatarequest.com. | en_GB |
dc.identifier.eissn | 1532-3064 | |
dc.identifier.journal | Respiratory Medicine | en_GB |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0/ | en_GB |
dcterms.dateAccepted | 2022-11-07 | |
dc.rights.license | CC BY | |
rioxxterms.version | VoR | en_GB |
rioxxterms.licenseref.startdate | 2022-11-11 | |
rioxxterms.type | Journal Article/Review | en_GB |
refterms.dateFCD | 2023-06-20T14:07:43Z | |
refterms.versionFCD | VoR | |
refterms.dateFOA | 2023-06-20T14:12:06Z | |
refterms.panel | A | en_GB |
refterms.dateFirstOnline | 2023-11-11 |
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Except where otherwise noted, this item's licence is described as © 2022 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).