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Efficacy and safety of coadministration of once-daily indacaterol and glycopyrronium versus indacaterol alone in COPD patients: the GLOW6 study.

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.

Authors+Show Affiliations

Respiratory Division, University Hospital, UZ Brussel, Free University of Brussels, Brussels, Belgium.Longartsenpraktijk, Prins Bisschopssingel, Hasselt, Belgium.Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.Novartis Pharma AG, Basel, Switzerland.Novartis Pharma AG, Basel, Switzerland.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24596459

Citation

Vincken, Walter, et al. "Efficacy and Safety of Coadministration of Once-daily Indacaterol and Glycopyrronium Versus Indacaterol Alone in COPD Patients: the GLOW6 Study." International Journal of Chronic Obstructive Pulmonary Disease, vol. 9, 2014, pp. 215-28.
Vincken W, Aumann J, Chen H, et al. Efficacy and safety of coadministration of once-daily indacaterol and glycopyrronium versus indacaterol alone in COPD patients: the GLOW6 study. Int J Chron Obstruct Pulmon Dis. 2014;9:215-28.
Vincken, W., Aumann, J., Chen, H., Henley, M., McBryan, D., & Goyal, P. (2014). Efficacy and safety of coadministration of once-daily indacaterol and glycopyrronium versus indacaterol alone in COPD patients: the GLOW6 study. International Journal of Chronic Obstructive Pulmonary Disease, 9, 215-28. https://doi.org/10.2147/COPD.S51592
Vincken W, et al. Efficacy and Safety of Coadministration of Once-daily Indacaterol and Glycopyrronium Versus Indacaterol Alone in COPD Patients: the GLOW6 Study. Int J Chron Obstruct Pulmon Dis. 2014;9:215-28. PubMed PMID: 24596459.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of coadministration of once-daily indacaterol and glycopyrronium versus indacaterol alone in COPD patients: the GLOW6 study. AU - Vincken,Walter, AU - Aumann,Joseph, AU - Chen,Hungta, AU - Henley,Michelle, AU - McBryan,Danny, AU - Goyal,Pankaj, Y1 - 2014/02/24/ PY - 2014/3/6/entrez PY - 2014/3/7/pubmed PY - 2014/8/26/medline KW - Breezhaler® KW - COPD KW - bronchodilation KW - glycopyrronium KW - indacaterol KW - inhalation therapy SP - 215 EP - 28 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 9 N2 - 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. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/24596459/Efficacy_and_safety_of_coadministration_of_once_daily_indacaterol_and_glycopyrronium_versus_indacaterol_alone_in_COPD_patients:_the_GLOW6_study_ L2 - https://dx.doi.org/10.2147/COPD.S51592 DB - PRIME DP - Unbound Medicine ER -