Tags

Type your tag names separated by a space and hit enter

Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study.
Respir Med. 2013 Oct; 107(10):1558-67.RM

Abstract

BACKGROUND

QVA149 is an inhaled, once-daily fixed-dose dual bronchodilator combination of the long-acting β2-agonist indacaterol and long-acting muscarinic antagonist glycopyrronium (NVA237) for the treatment of chronic obstructive pulmonary disease (COPD). We investigated the safety and efficacy of QVA149 over 52 weeks.

METHODS

This 52-week, multicenter, double-blind, parallel-group, placebo-controlled study randomized (2:1) patients with moderate-to-severe COPD to once-daily QVA149 (110 μg indacaterol/50 μg glycopyrronium) or placebo delivered via the Breezhaler device. Primary endpoint was safety and tolerability for treatment-emergent adverse events (AEs). Secondary endpoints included safety based on vital signs, electrocardiograms (ECGs), laboratory evaluations, and pre-dose forced expiratory volume in 1 s (FEV1).

RESULTS

Of 339 patients randomized, QVA149 [n = 226], placebo [n = 113]; 76.9% male, mean age: 62.6 years, post-bronchodilator FEV1: 57.4% predicted, 83.5% completed study. A smaller percentage of patients discontinued in the QVA149 group (14.2%) compared with placebo (21.2%). Overall incidence of AEs was similar in the QVA149 (57.8%) and placebo (56.6%) groups, with most AEs being mild to moderate in severity. The numerical differences in some AEs observed could be at least in part explained by differences in baseline patient characteristics. No clinically relevant differences were observed between treatment groups for vital signs or ECG parameters. The five deaths reported were unrelated to study medication (QVA149, n = 4 [1.8%]; placebo, n = 1 [0.9%]). QVA149 demonstrated rapid and clinically meaningful bronchodilation sustained over 52 weeks versus placebo.

CONCLUSION

QVA149 demonstrated a good safety and tolerability profile, providing rapid and sustained bronchodilation over 52 weeks in patients with moderate-to-severe COPD. ClinicalTrials.gov identifier: NCT01120717.

Authors+Show Affiliations

Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. Electronic address: ronadahl@rm.dk.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23867808

Citation

Dahl, Ronald, et al. "Safety and Efficacy of Dual Bronchodilation With QVA149 in COPD Patients: the ENLIGHTEN Study." Respiratory Medicine, vol. 107, no. 10, 2013, pp. 1558-67.
Dahl R, Chapman KR, Rudolf M, et al. Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. Respir Med. 2013;107(10):1558-67.
Dahl, R., Chapman, K. R., Rudolf, M., Mehta, R., Kho, P., Alagappan, V. K., Chen, H., & Banerji, D. (2013). Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. Respiratory Medicine, 107(10), 1558-67. https://doi.org/10.1016/j.rmed.2013.05.016
Dahl R, et al. Safety and Efficacy of Dual Bronchodilation With QVA149 in COPD Patients: the ENLIGHTEN Study. Respir Med. 2013;107(10):1558-67. PubMed PMID: 23867808.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. AU - Dahl,Ronald, AU - Chapman,Kenneth R, AU - Rudolf,Michael, AU - Mehta,Rajendra, AU - Kho,Pearl, AU - Alagappan,Vijay K T, AU - Chen,Hungta, AU - Banerji,Donald, Y1 - 2013/07/16/ PY - 2013/02/18/received PY - 2013/05/28/revised PY - 2013/05/29/accepted PY - 2013/7/23/entrez PY - 2013/7/23/pubmed PY - 2014/5/14/medline KW - Bronchodilators KW - Chronic obstructive pulmonary disease KW - Lung function KW - QVA149 KW - Safety SP - 1558 EP - 67 JF - Respiratory medicine JO - Respir Med VL - 107 IS - 10 N2 - BACKGROUND: QVA149 is an inhaled, once-daily fixed-dose dual bronchodilator combination of the long-acting β2-agonist indacaterol and long-acting muscarinic antagonist glycopyrronium (NVA237) for the treatment of chronic obstructive pulmonary disease (COPD). We investigated the safety and efficacy of QVA149 over 52 weeks. METHODS: This 52-week, multicenter, double-blind, parallel-group, placebo-controlled study randomized (2:1) patients with moderate-to-severe COPD to once-daily QVA149 (110 μg indacaterol/50 μg glycopyrronium) or placebo delivered via the Breezhaler device. Primary endpoint was safety and tolerability for treatment-emergent adverse events (AEs). Secondary endpoints included safety based on vital signs, electrocardiograms (ECGs), laboratory evaluations, and pre-dose forced expiratory volume in 1 s (FEV1). RESULTS: Of 339 patients randomized, QVA149 [n = 226], placebo [n = 113]; 76.9% male, mean age: 62.6 years, post-bronchodilator FEV1: 57.4% predicted, 83.5% completed study. A smaller percentage of patients discontinued in the QVA149 group (14.2%) compared with placebo (21.2%). Overall incidence of AEs was similar in the QVA149 (57.8%) and placebo (56.6%) groups, with most AEs being mild to moderate in severity. The numerical differences in some AEs observed could be at least in part explained by differences in baseline patient characteristics. No clinically relevant differences were observed between treatment groups for vital signs or ECG parameters. The five deaths reported were unrelated to study medication (QVA149, n = 4 [1.8%]; placebo, n = 1 [0.9%]). QVA149 demonstrated rapid and clinically meaningful bronchodilation sustained over 52 weeks versus placebo. CONCLUSION: QVA149 demonstrated a good safety and tolerability profile, providing rapid and sustained bronchodilation over 52 weeks in patients with moderate-to-severe COPD. ClinicalTrials.gov identifier: NCT01120717. SN - 1532-3064 UR - https://www.unboundmedicine.com/medline/citation/23867808/Safety_and_efficacy_of_dual_bronchodilation_with_QVA149_in_COPD_patients:_the_ENLIGHTEN_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0954-6111(13)00210-2 DB - PRIME DP - Unbound Medicine ER -