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Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD
Open accessAbstract
BACKGROUND: -agonist (LABA), as compared with dual therapy (either inhaled glucocorticoid-LABA or LAMA-LABA), are uncertain. METHODS: In this randomized trial involving 10,355 patients with COPD, we compared 52 weeks of a once-daily combination of fluticasone furoate (an inhaled glucocorticoid) at a dose of 100 μg, umeclidinium (a LAMA) at a dose of 62.5 μg, and vilanterol (a LABA) at a dose of 25 μg (triple therapy) with fluticasone furoate-vilanterol (at doses of 100 μg and 25 μg, respectively) and umeclidinium-vilanterol (at doses of 62.5 μg and 25 μg, respectively). Each regimen was administered in a single Ellipta inhaler. The primary outcome was the annual rate of moderate or severe COPD exacerbations during treatment. RESULTS: The rate of moderate or severe exacerbations in the triple-therapy group was 0.91 per year, as compared with 1.07 per year in the fluticasone furoate-vilanterol group (rate ratio with triple therapy, 0.85; 95% confidence interval [CI], 0.80 to 0.90; 15% difference; P<0.001) and 1.21 per year in the umeclidinium-vilanterol group (rate ratio with triple therapy, 0.75; 95% CI, 0.70 to 0.81; 25% difference; P<0.001). The annual rate of severe exacerbations resulting in hospitalization in the triple-therapy group was 0.13, as compared with 0.19 in the umeclidinium-vilanterol group (rate ratio, 0.66; 95% CI, 0.56 to 0.78; 34% difference; P<0.001). There was a higher incidence of pneumonia in the inhaled-glucocorticoid groups than in the umeclidinium-vilanterol group, and the risk of clinician-diagnosed pneumonia was significantly higher with triple therapy than with umeclidinium-vilanterol, as assessed in a time-to-first-event analysis (hazard ratio, 1.53; 95% CI, 1.22 to 1.92; P<0.001). CONCLUSIONS: Triple therapy with fluticasone furoate, umeclidinium, and vilanterol resulted in a lower rate of moderate or severe COPD exacerbations than fluticasone furoate-vilanterol or umeclidinium-vilanterol in this population. Triple therapy also resulted in a lower rate of hospitalization due to COPD than umeclidinium-vilanterol. (Funded by GlaxoSmithKline; IMPACT ClinicalTrials.gov number, NCT02164513 .).
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Vogelmeier, C. F., Criner, G. J., Martinez, F. J., Anzueto, A., Barnes, P. J., Bourbeau, J., Celli, B. R., Chen, R., Decramer, M., Fabbri, L. M., et al. (2017) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/rccm.201701-0218pp · Cited by 3,187
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Wedzicha, J. A., Banerji, D., Chapman, K. R., Vestbo, J., Roche, N., Ayers, R. T., Thach, C., Fogel, R., Patalano, F., & Vogelmeier, C. F. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1516385 · Cited by 844
Aaron, S. D., Vandemheen, K. L., Fergusson, D., Maltais, F., Bourbeau, J., Goldstein, R., Balter, M., O'Donnell, D., McIvor, A., Sharma, S., et al. (2007) · Annals of Internal Medicine · doi:10.7326/0003-4819-146-8-200704170-00152 · Cited by 649
Vestbo, J., Anderson, J. A., Brook, R. D., Calverley, P. M. A., Celli, B. R., Crim, C., Martinez, F., Yates, J., & Newby, D. E. (2016) · The Lancet · doi:10.1016/s0140-6736(16)30069-1 · Cited by 483
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Self-citationVestbo, J., Papi, A., Corradi, M., Blazhko, V., Montagna, I., Francisco, C., Cohuet, G., Vezzoli, S., Scuri, M., & Singh, D. (2017) · The Lancet · doi:10.1016/s0140-6736(17)30188-5 · Cited by 425
Self-citationWelte, T., Miravitlles, M., Hernandez, P., Eriksson, G., Peterson, S., Polanowski, T., & Kessler, R. (2009) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/rccm.200904-0492oc · Cited by 408
FULFIL Trial: Once-Daily Triple Therapy for Patients with Chronic Obstructive Pulmonary Disease
Lipson, D. A., Barnacle, H., Birk, R., Brealey, N., Locantore, N., Lomas, D. A., Ludwig-Sengpiel, A., Mohindra, R., Tabberer, M., Zhu, C.-Q., et al. (2017) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/rccm.201703-0449oc · Cited by 327
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Cazzola, M., Andò, F., Santus, P., Ruggeri, P., Marco, F. D., Sanduzzi, A., & D’Amato, M. (2006) · Pulmonary Pharmacology & Therapeutics · doi:10.1016/j.pupt.2006.06.001 · Cited by 102
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Self-citationMacLeod, M., Papi, A., Contoli, M., Beghé, B., Celli, B. R., Wedzicha, J. A., & Fabbri, L. M. (2021) · Respirology · doi:10.1111/resp.14041 · Cited by 359
Martinez, F. J., Rabe, K. F., Ferguson, G. T., Wedzicha, J. A., Singh, D., Wang, C., Rossman, K., St. Rose, E., Trivedi, R., Ballal, S., et al. (2021) · American Journal of Respiratory and Critical Care Medicine · doi:10.1164/rccm.202006-2618oc · Cited by 269
Self-citationChemokines in COPD: From Implication to Therapeutic Use
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Prevalence and Clinical Outcomes of Eosinophilic COPD in a Saudi Population: A Retrospective Study
Alshehri, F., Alghamdi, M., Aloqabi, F. A., Ibrahim, A., Tayeb, N., Hassosah, M., Abu-Zaid, A., Fan, H., & Vali, Y. (2025) · Saudi Journal of Medicine & Medical Sciences · doi:10.4103/sjmms.sjmms_248_24 · Cited by 3
Metadata
- Authors
- Lipson, D. A., Barnhart, F., Brealey, N., Brooks, J., Criner, G. J., Day, N. C., Dransfield, M. T., Halpin, D. M. G., Han, M. K., Jones, C. E., Kilbride, S., Lange, P., Lomas, D. A., Martinez, F. J., Singh, D., Tabberer, M., Wise, R. A., & Pascoe, S. J.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2018-05-03
- Volume
- 378
- Issue
- 18
- Pages
- 1671-1680
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2802221596
- Cited by
- 1,253
- References
- 14
- FWCI
- 101.79
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Lipson, D. A., Barnhart, F., Brealey, N., Brooks, J., Criner, G. J., Day, N. C., Dransfield, M. T., Halpin, D. M. G., Han, M. K., Jones, C. E., Kilbride, S., Lange, P., Lomas, D. A., Martinez, F. J., Singh, D., Tabberer, M., Wise, R. A., & Pascoe, S. J. (2018). Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1713901
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