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LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD
BACKGROUND: The current Global initiative for chronic Obstructive Lung Disease (GOLD) treatment strategy recommends the use of one or more bronchodilators according to the patient’s airflow limitation, their history of exacerbations, and symptoms. The LANTERN study evaluated the effect of the long-a...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Dove Medical Press
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4461092/ https://www.ncbi.nlm.nih.gov/pubmed/26082625 http://dx.doi.org/10.2147/COPD.S84436 |
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author | Zhong, Nanshan Wang, Changzheng Zhou, Xiangdong Zhang, Nuofu Humphries, Michael Wang, Linda Thach, Chau Patalano, Francesco Banerji, Donald |
author_facet | Zhong, Nanshan Wang, Changzheng Zhou, Xiangdong Zhang, Nuofu Humphries, Michael Wang, Linda Thach, Chau Patalano, Francesco Banerji, Donald |
author_sort | Zhong, Nanshan |
collection | PubMed |
description | BACKGROUND: The current Global initiative for chronic Obstructive Lung Disease (GOLD) treatment strategy recommends the use of one or more bronchodilators according to the patient’s airflow limitation, their history of exacerbations, and symptoms. The LANTERN study evaluated the effect of the long-acting β(2)-agonist (LABA)/long-acting muscarinic antagonist (LAMA) dual bronchodilator, QVA149 (indacaterol/glycopyrronium), as compared with the LABA/inhaled corticosteroid, salmeterol/fluticasone (SFC), in patients with moderate-to-severe COPD with a history of ≤1 exacerbation in the previous year. METHODS: In this double-blind, double-dummy, parallel-group study, 744 patients with moderate-to-severe COPD with a history of ≤1 exacerbations in the previous year were randomized (1:1) to QVA149 110/50 μg once daily or SFC 50/500 μg twice daily for 26 weeks. The primary endpoint was noninferiority of QVA149 versus SFC for trough forced expiratory volume in 1 second (FEV(1)) at week 26. RESULTS: Overall, 676 patients completed the study. The primary objective of noninferiority between QVA149 and SFC in trough FEV(1) at week 26 was met. QVA149 demonstrated statistically significant superiority to SFC for trough FEV(1) (treatment difference [Δ]=75 mL; P<0.001). QVA149 demonstrated a statistically significant improvement in standardized area under the curve (AUC) from 0 hours to 4 hours for FEV(1) (FEV(1) AUC(0–4h)) at week 26 versus SFC (Δ=122 mL; P<0.001). QVA149 and SFC had similar improvements in transition dyspnea index focal score, St George Respiratory Questionnaire total score, and rescue medication use. However, QVA149 significantly reduced the rate of moderate or severe exacerbations by 31% (P=0.048) over SFC. Overall, the incidence of adverse events was comparable between QVA149 (40.1%) and SFC (47.4%). The incidence of pneumonia was threefold lower with QVA149 (0.8%) versus SFC (2.7%). CONCLUSION: These findings support the use of the LABA/LAMA, QVA149 as an alternative treatment, over LABA/inhaled corticosteroid, in the management of moderate-to-severe COPD patients (GOLD B and GOLD D) with a history of ≤1 exacerbation in the previous year. |
format | Online Article Text |
id | pubmed-4461092 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-44610922015-06-16 LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD Zhong, Nanshan Wang, Changzheng Zhou, Xiangdong Zhang, Nuofu Humphries, Michael Wang, Linda Thach, Chau Patalano, Francesco Banerji, Donald Int J Chron Obstruct Pulmon Dis Original Research BACKGROUND: The current Global initiative for chronic Obstructive Lung Disease (GOLD) treatment strategy recommends the use of one or more bronchodilators according to the patient’s airflow limitation, their history of exacerbations, and symptoms. The LANTERN study evaluated the effect of the long-acting β(2)-agonist (LABA)/long-acting muscarinic antagonist (LAMA) dual bronchodilator, QVA149 (indacaterol/glycopyrronium), as compared with the LABA/inhaled corticosteroid, salmeterol/fluticasone (SFC), in patients with moderate-to-severe COPD with a history of ≤1 exacerbation in the previous year. METHODS: In this double-blind, double-dummy, parallel-group study, 744 patients with moderate-to-severe COPD with a history of ≤1 exacerbations in the previous year were randomized (1:1) to QVA149 110/50 μg once daily or SFC 50/500 μg twice daily for 26 weeks. The primary endpoint was noninferiority of QVA149 versus SFC for trough forced expiratory volume in 1 second (FEV(1)) at week 26. RESULTS: Overall, 676 patients completed the study. The primary objective of noninferiority between QVA149 and SFC in trough FEV(1) at week 26 was met. QVA149 demonstrated statistically significant superiority to SFC for trough FEV(1) (treatment difference [Δ]=75 mL; P<0.001). QVA149 demonstrated a statistically significant improvement in standardized area under the curve (AUC) from 0 hours to 4 hours for FEV(1) (FEV(1) AUC(0–4h)) at week 26 versus SFC (Δ=122 mL; P<0.001). QVA149 and SFC had similar improvements in transition dyspnea index focal score, St George Respiratory Questionnaire total score, and rescue medication use. However, QVA149 significantly reduced the rate of moderate or severe exacerbations by 31% (P=0.048) over SFC. Overall, the incidence of adverse events was comparable between QVA149 (40.1%) and SFC (47.4%). The incidence of pneumonia was threefold lower with QVA149 (0.8%) versus SFC (2.7%). CONCLUSION: These findings support the use of the LABA/LAMA, QVA149 as an alternative treatment, over LABA/inhaled corticosteroid, in the management of moderate-to-severe COPD patients (GOLD B and GOLD D) with a history of ≤1 exacerbation in the previous year. Dove Medical Press 2015-06-05 /pmc/articles/PMC4461092/ /pubmed/26082625 http://dx.doi.org/10.2147/COPD.S84436 Text en © 2015 Zhong et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. |
spellingShingle | Original Research Zhong, Nanshan Wang, Changzheng Zhou, Xiangdong Zhang, Nuofu Humphries, Michael Wang, Linda Thach, Chau Patalano, Francesco Banerji, Donald LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD |
title | LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD |
title_full | LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD |
title_fullStr | LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD |
title_full_unstemmed | LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD |
title_short | LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD |
title_sort | lantern: a randomized study of qva149 versus salmeterol/fluticasone combination in patients with copd |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4461092/ https://www.ncbi.nlm.nih.gov/pubmed/26082625 http://dx.doi.org/10.2147/COPD.S84436 |
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