1. Efficacy and safety of coadministration of once-daily indacaterol and glycopyrronium versus indacaterol alone in COPD patients: the GLOW6 study
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Hungta Chen, Danny McBryan, Pankaj Goyal, Joseph Aumann, Walter Vincken, and Michelle Henley
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Male ,Time Factors ,Copd patients ,Vital Capacity ,bronchodilation ,Quinolones ,Severity of Illness Index ,Pulmonary Disease, Chronic Obstructive ,indacaterol ,Forced Expiratory Volume ,Bronchodilator ,Lung ,Breezhaler® ,Original Research ,COPD ,General Medicine ,Middle Aged ,Bronchodilator Agents ,Europe ,Treatment Outcome ,Area Under Curve ,Anesthesia ,Indans ,Drug Therapy, Combination ,Female ,Inspiratory Capacity ,medicine.drug ,medicine.drug_class ,Muscarinic Antagonists ,International Journal of Chronic Obstructive Pulmonary Disease ,Drug Administration Schedule ,glycopyrronium ,inhalation therapy ,Double-Blind Method ,Administration, Inhalation ,Severity of illness ,medicine ,Humans ,Adrenergic beta-2 Receptor Agonists ,Glycopyrrolate ,Aged ,business.industry ,Nebulizers and Vaporizers ,Muscarinic antagonist ,biochemical phenomena, metabolism, and nutrition ,medicine.disease ,Indacaterol ,business - Abstract
Walter Vincken,1 Joseph Aumann,2 Hungta Chen,3 Michelle Henley,3 Danny McBryan,4 Pankaj Goyal4 1Respiratory Division, University Hospital, UZ Brussel, Free University of Brussels, Brussels, Belgium; 2Longartsenpraktijk, Prins Bisschopssingel, Hasselt, Belgium; 3Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 4Novartis Pharma AG, Basel, Switzerland 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
- Published
- 2014
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