Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2012 Nov;40(5):1106-14.
doi: 10.1183/09031936.00040712. Epub 2012 Jul 26.

Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study

Edward Kerwin  1 , Jacques Hébert, Nicola Gallagher, Carmen Martin, Tim Overend, Vijay K T Alagappan, Yimeng Lu, Donald Banerji
Affiliations
Free PMC article
Randomized Controlled Trial

Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study

Edward Kerwin et al. Eur Respir J. 2012 Nov.
Free PMC article

Abstract

NVA237 (glycopyrronium bromide) is a once-daily long-acting muscarinic antagonist (LAMA) in development for chronic obstructive pulmonary disease (COPD). The GLycopyrronium bromide in COPD airWays clinical Study 2 (GLOW2) evaluated the efficacy and safety of NVA237 in moderate-to-severe COPD over 52 weeks. Patients were randomised 2:1:1 to NVA237 50 μg, placebo or open-label tiotropium 18 μg for 52 weeks. Primary end-point was trough forced expiratory volume in 1 s (FEV(1)) at 12 weeks. 1,066 patients were randomised, 810 completed the study. At week 12, trough FEV(1) increased significantly by 97 mL with NVA237 (95% CI 64.6-130.2; p<0.001) and 83 mL with tiotropium (95% CI 45.6-121.4; p<0.001). Compared with placebo, NVA237 produced significant improvements in dyspnoea (Transition Dyspnoea Index at week 26; p=0.002) and health status (St George's Respiratory Questionnaire at week 52; p<0.001). NVA237 significantly reduced the risk of moderate-to-severe COPD exacerbations by 34% (p=0.001) and the use of rescue medication (p=0.039), versus placebo. NVA237-placebo and tiotropium-placebo differences were comparable for all outcomes. Safety profiles were similar across groups. NVA237 50 μg provided significant improvements in lung function, dyspnoea, health status, exacerbations and rescue medication use, versus placebo, and was comparable to tiotropium. NVA237 can potentially be an alternative choice of LAMA for COPD patients.

Trial registration: ClinicalTrials.gov NCT00929110.

PubMed Disclaimer

Conflict of interest statement

Statement of Interest

A statement of interest for all authors, and for the study itself, can be found at www.erj.ersjournals.com/site/misc/statements.xhtml

Figures

Figure 1–
Figure 1–
GLOW2 study design.
Figure 2–
Figure 2–
Patient disposition.
Figure 3–
Figure 3–
Trough forced expiratory volume in 1 s (FEV1) at day 1 and weeks 12, 26 and 52. Data presented as least squares mean±se. ***: p<0.001 versus placebo; #: p=0.007 versus tiotropium.
Figure 4–
Figure 4–
Serial spirometry on a) day 1, b) week 12 and c) week 52. a) NVA237 superior to placebo at all assessed time points (p<0.01), superior to tiotropium at 5, 15 and 30 min, 1 and 2 h (p<0.05). b) NVA237 versus placebo all time points statistically significant (p<0.05) except 16 h, 23 h 15 min and 23 h 45 min. c) NVA237 superior to placebo at all assessed time points (p<0.01), superior to tiotropium at 5 min,15 min and 30 min, and 1, 2 and 3 h (p<0.05). FEV1: forced expiratory volume in 1 s.
Figure 5–
Figure 5–
Kaplan–Meier plot of the time to first moderate or severe chronic obstructive pulmonary disease exacerbation.
See this image and copyright information in PMC

References

    1. Viegi G, Pistelli F, Sherrill DL, et al. Definition, epidemiology and natural history of COPD. Eur Respir J 2007; 30: 993–1013 - PubMed
    1. Global Initiative for Chronic Obstructive Lung Disease (GOLD2011) Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. Available from www.goldcopd.org. - PubMed
    1. Cooper N, Walker I, Knowles I. NVA237 has similar efficacy as tiotropium bromide against methacholine-induced bronchoconstriction and less systemic effect on cardiovascular variables in an anaesthetized rabbit model. Eur Respir J 2006; 28: Suppl. 50, 436s
    1. Trifilieff A, Cope N, Boivin JF, et al. The inhaled antimuscarinic receptor antagonist, NVA237 (glycopyrrolate), has a favorable side-effect profile in a Brown Norway rat lung function model when compared with tiotropium. Chest 2007; 132: 530a
    1. Fogarty C, Hattersley H, Di Scala L, et al. Bronchodilatory effects of NVA237, a once-daily long-acting muscarinic antagonist, in COPD patients. Respir Med 2011; 105;3: 337–342 - PubMed

Publication types

MeSH terms

Associated data