Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study.
Eur Respir J
; 40(5): 1106-14, 2012 Nov.
Article
in En
| MEDLINE
| ID: mdl-23060624
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 211 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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Scopolamine Derivatives
/
Bronchodilator Agents
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Muscarinic Antagonists
/
Pulmonary Disease, Chronic Obstructive
/
Glycopyrrolate
Type of study:
Clinical_trials
Aspects:
Patient_preference
Limits:
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Eur Respir J
Year:
2012
Document type:
Article
Affiliation country:
Estados Unidos