1. Efficacy and safety of coadministration of once-daily indacaterol and glycopyrronium versus indacaterol alone in COPD patients: the GLOW6 study.
- Author
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Vincken W, Aumann J, Chen H, Henley M, McBryan D, and Goyal P
- Subjects
- Administration, Inhalation, Adrenergic beta-2 Receptor Agonists adverse effects, Aged, Area Under Curve, Bronchodilator Agents adverse effects, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Europe, Female, Forced Expiratory Volume, Glycopyrrolate adverse effects, Humans, Indans adverse effects, Inspiratory Capacity, Lung physiopathology, Male, Middle Aged, Muscarinic Antagonists adverse effects, Nebulizers and Vaporizers, Pulmonary Disease, Chronic Obstructive diagnosis, Pulmonary Disease, Chronic Obstructive physiopathology, Quinolones adverse effects, Severity of Illness Index, Time Factors, Treatment Outcome, Vital Capacity, Adrenergic beta-2 Receptor Agonists administration & dosage, Bronchodilator Agents administration & dosage, Glycopyrrolate administration & dosage, Indans administration & dosage, Lung drug effects, Muscarinic Antagonists administration & dosage, Pulmonary Disease, Chronic Obstructive drug therapy, Quinolones administration & dosage
- Abstract
Background: Addition of a second bronchodilator from a different pharmacological class may benefit patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) whose symptoms are insufficiently controlled by bronchodilator monotherapy. GLOW6 evaluated the efficacy and safety of once-daily coadministration of the long-acting β2-agonist indacaterol (IND) and the long-acting muscarinic antagonist glycopyrronium (GLY) versus IND alone in patients with moderate-to-severe COPD., Materials and Methods: In this randomized, double-blind, parallel group, placebo-controlled, 12-week study, patients were randomized 1:1 to IND 150 μg and GLY 50 μg daily (IND + GLY) or IND 150 μg daily and placebo (IND + PBO) (all delivered via separate Breezhaler® devices). The primary objective was to demonstrate the superiority of IND + GLY versus IND + PBO for trough forced expiratory volume in 1 second (FEV1) at week 12. Other end points included trough FEV1 at day 1, FEV1 area under the curve from 30 minutes to 4 hours (AUC30min-4h), peak FEV1, inspiratory capacity and trough forced vital capacity (FVC) at day 1 and week 12, and transition dyspnea index (TDI) focal score, COPD symptoms, and rescue medication use over 12 weeks., Results: A total of 449 patients were randomized (IND + GLY, 226; IND + PBO, 223); 94% completed the study. On day 1 and at week 12, IND + GLY significantly improved trough FEV1 versus IND + PBO, with treatment differences of 74 mL (95% CI 46-101 mL) and 64 mL (95% CI 28-99 mL), respectively (both P<0.001). IND + GLY significantly improved postdose peak FEV1, FEV1 AUC30min-4h, and trough FVC at day 1 and week 12 versus IND + PBO (all P<0.01). TDI focal score and COPD symptoms (percentage of days able to perform usual daily activities and change from baseline in mean daytime respiratory score) were significantly improved with IND + GLY versus IND + PBO (P<0.05). The incidence of adverse events was similar for the two treatment groups., Conclusion: In patients with moderate-to-severe COPD, once-daily coadministration of IND and GLY provides significant and sustained improvement in bronchodilation versus IND alone from day 1, with significant improvements in patient-centered outcomes.
- Published
- 2014
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