LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD

• Published in: International journal of chronic obstructive pulmonary disease Vol. 10; no. Issue 1; pp. 1015 - 1026
• Main Authors: Zhong, Nanshan, Wang, Changzheng, Zhou, Xiangdong, Zhang, Nuofu, Humphries, Michael, Wang, Linda, Thach, Chau, Patalano, Francesco, Banerji, Donald
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01.01.2015; Dove Medical Press Ltd; Dove Medical Press
• Subjects: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists - administration & dosage; Adrenergic beta-2 Receptor Agonists - adverse effects; Adrenergic beta-2 Receptor Agonists - therapeutic use; Adult; Aged; Bronchodilator agents; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - adverse effects; Bronchodilator Agents - therapeutic use; Care and treatment; Chronic obstructive pulmonary disease; Comparative analysis; Double-Blind Method; Drug dosages; Drug therapy; Drug therapy, Combination; Dyspnea; Female; Fluticasone-Salmeterol Drug Combination - administration & dosage; Fluticasone-Salmeterol Drug Combination - adverse effects; Fluticasone-Salmeterol Drug Combination - therapeutic use; Forced Expiratory Volume; Glucocorticoids - administration & dosage; Glucocorticoids - adverse effects; Glucocorticoids - therapeutic use; Glycopyrrolate - administration & dosage; Glycopyrrolate - adverse effects; Glycopyrrolate - analogs & derivatives; Glycopyrrolate - therapeutic use; Humans; Indans - administration & dosage; Indans - adverse effects; Indans - therapeutic use; Lung - drug effects; Lung - physiopathology; Lung diseases, Obstructive; Male; Methods; Middle Aged; Mortality; Muscarinic Antagonists - administration & dosage; Muscarinic Antagonists - adverse effects; Muscarinic Antagonists - therapeutic use; Nebulizers and Vaporizers; Original Research; Patients; Pulmonary Disease, Chronic Obstructive - diagnosis; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonary Disease, Chronic Obstructive - physiopathology; Quality of life; Quinolones - administration & dosage; Quinolones - adverse effects; Quinolones - therapeutic use; Recovery of Function; Severity of Illness Index; Spirometry; Steroids; Surveys and Questionnaires; Time Factors; Treatment Outcome; clinical trial; long-acting muscarinic antagonist; COPD; long-acting β2-agonists
• ISSN: 1178-2005; 1176-9106; 1178-2005
• DOI: 10.2147/COPD.S84436

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. 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. 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%). 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.