Journal Article

Indacaterol acetate/mometasone furoate provides sustained improvements in lung function compared with salmeterol xinafoate/fluticasone propionate in patients with moderate-to-very-severe COPD: results from a Phase II randomized, double-blind 12-week study

Kornmann, Oliver, Cao, Weihua, Tanase, Ana-Maria, Richard, Alexia, Beeh, Kai Michael, Hederer, Bettina, van Zyl-Smit, Richard N, Beier, Jutta, Kirsten, Anne-Marie

2018

Overview

Fixed-dose combinations of a long-acting beta agonist and an inhaled corticosteroid are more effective than the individual components in COPD. The primary study objective was to demonstrate that the combination indacaterol acetate/mometasone furoate (IND/MF [QMF149]) was non-inferior to the twice-daily combination salmeterol xinafoate/fluticasone propionate (Sal/Flu) in terms of trough FEV at week 12 (day 85). Secondary objectives were to compare the efficacy of IND/MF (QMF149) vs Sal/Flu with respect to other lung function parameters, COPD exacerbations, symptoms and dyspnea, health status/health-related quality of life, and rescue medication use. This was a 12-week multicenter, randomized, double-blind, double-dummy, parallel-group, Phase II study in patients with moderate-to-very-severe COPD, who were randomized (1:1) to IND/MF (QMF149) (150/160 µg once daily; n=316) or Sal/Flu (50/500 µg twice daily; n=313). Over 90% of patients completed the study: 94.6% in the IND/MF (QMF149) group and 92.0% in the Sal/Flu group. The primary objective of non-inferiority of IND/MF (QMF149) to Sal/Flu for trough FEV at week 12 (day 85) was met: the lower limit of the CI (95% CI: 27.7, 83.3 mL) was greater than -60 mL. The analysis for superiority of IND/MF (QMF149) to Sal/Flu demonstrated superiority of IND/MF (QMF149), with a difference of 56 mL ( <0.001). In addition, IND/MF (QMF149) treatment significantly improved COPD exacerbation-related parameters during the 12-week period. Other significant improvements with IND/MF (QMF 149) vs Sal/Flu were noted for dyspnea at week 12 and other COPD symptoms and COPD rescue medication use over the 12 weeks. The safety and tolerability profiles of both the treatments were similar. IND/MF (QMF149) (150/160 µg once daily) offered superior lung function and symptom efficacy and a favorable safety profile compared with Sal/Flu (50/500 µg twice daily) in patients with moderate-to-very severe COPD.

• Publisher: Dove Medical Press Limited,Dove Medical Press Ltd,Dove Press,Dove Medical Press
• Subject: Adrenal Cortex Hormones - adverse effects / Adrenal Cortex Hormones - therapeutic use / Adrenergic beta-2 Receptor Agonists - adverse effects / Adrenergic beta-2 Receptor Agonists - therapeutic use / Adult / Aged / Asthma / Bronchodilator Agents - adverse effects / Bronchodilator Agents - therapeutic use / Chronic obstructive pulmonary disease / Combination drug therapy / Comparative analysis / COPD / Double-Blind Method / Double-blind studies / Drug Combinations / Dyspnea / Female / fixed-combination inhalers / Fluticasone-Salmeterol Drug Combination - adverse effects / Fluticasone-Salmeterol Drug Combination - therapeutic use / Forced Expiratory Volume / Glucocorticoids / Health Status / Humans / Indacaterol / Indans - adverse effects / Indans - therapeutic use / Inhalers / LABA/ICS combinations / Lung - drug effects / Lung - physiopathology / Lung diseases / Male / Middle Aged / mometasone / Mometasone Furoate - adverse effects / Mometasone Furoate - therapeutic use / once-daily inhalers / Original Research / Pulmonary Disease, Chronic Obstructive - diagnosis / Pulmonary Disease, Chronic Obstructive - drug therapy / Pulmonary Disease, Chronic Obstructive - physiopathology / Quality of Life / Quinolones - adverse effects / Quinolones - therapeutic use / Recovery of Function / Respiratory system agents / Severity of Illness Index / Smoking / Steroids / Steroids (Organic compounds) / Time Factors / Treatment Outcome / Vilanterol