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LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD.
Int J Chron Obstruct Pulmon Dis. 2015; 10:1015-26.IJ

Abstract

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 β2-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 (FEV1) at week 26.

RESULTS

Overall, 676 patients completed the study. The primary objective of noninferiority between QVA149 and SFC in trough FEV1 at week 26 was met. QVA149 demonstrated statistically significant superiority to SFC for trough FEV1 (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 FEV1 (FEV1 AUC0-4h) 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.

Authors+Show Affiliations

State Key Laboratory of Respiratory Diseases, First Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, People's Republic of China.Institute of Respiratory Disease, Xin Qiao Hospital, Third Military Medical University, Chongqing City, Chongqing, People's Republic of China.Department of Respiratory Medicine, Southwest Hospital, Third Military Medical University, Chongqing City, Chongqing, People's Republic of China.State Key Laboratory of Respiratory Diseases, First Affiliated Hospital, Guangzhou Medical University, Guangzhou, Guangdong, People's Republic of China.Beijing Novartis Pharma Co. Ltd., Shanghai, People's Republic of China.Beijing Novartis Pharma Co. Ltd., Shanghai, People's Republic of China.Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.Novartis Pharma AG, Basel, Switzerland.Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.No affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

26082625

Citation

Zhong, Nanshan, et al. "LANTERN: a Randomized Study of QVA149 Versus Salmeterol/fluticasone Combination in Patients With COPD." International Journal of Chronic Obstructive Pulmonary Disease, vol. 10, 2015, pp. 1015-26.
Zhong N, Wang C, Zhou X, et al. LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2015;10:1015-26.
Zhong, N., Wang, C., Zhou, X., Zhang, N., Humphries, M., Wang, L., Thach, C., Patalano, F., & Banerji, D. (2015). LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD. International Journal of Chronic Obstructive Pulmonary Disease, 10, 1015-26. https://doi.org/10.2147/COPD.S84436
Zhong N, et al. LANTERN: a Randomized Study of QVA149 Versus Salmeterol/fluticasone Combination in Patients With COPD. Int J Chron Obstruct Pulmon Dis. 2015;10:1015-26. PubMed PMID: 26082625.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD. AU - Zhong,Nanshan, AU - Wang,Changzheng, AU - Zhou,Xiangdong, AU - Zhang,Nuofu, AU - Humphries,Michael, AU - Wang,Linda, AU - Thach,Chau, AU - Patalano,Francesco, AU - Banerji,Donald, AU - ,, Y1 - 2015/06/05/ PY - 2015/6/18/entrez PY - 2015/6/18/pubmed PY - 2016/3/22/medline KW - COPD KW - clinical trial KW - long-acting muscarinic antagonist KW - long-acting β2-agonists SP - 1015 EP - 26 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 10 N2 - 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 β2-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 (FEV1) at week 26. RESULTS: Overall, 676 patients completed the study. The primary objective of noninferiority between QVA149 and SFC in trough FEV1 at week 26 was met. QVA149 demonstrated statistically significant superiority to SFC for trough FEV1 (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 FEV1 (FEV1 AUC0-4h) 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. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/26082625/LANTERN:_a_randomized_study_of_QVA149_versus_salmeterol/fluticasone_combination_in_patients_with_COPD_ L2 - https://dx.doi.org/10.2147/COPD.S84436 DB - PRIME DP - Unbound Medicine ER -