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Efficacy and safety of QVA149 compared to the concurrent administration of its monocomponents indacaterol and glycopyrronium: the BEACON study.

Abstract

INTRODUCTION

The BEACON study evaluated the efficacy and safety of QVA149, a once-daily dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist (LABA) indacaterol and long-acting muscarinic antagonist (LAMA) glycopyrronium (NVA237), in development for the treatment of patients with chronic obstructive pulmonary disease (COPD), compared with the free-dose concurrent administration of indacaterol plus glycopyrronium (IND+GLY).

METHODS

In this multicenter, double-blind, parallel group study, patients with stage II or stage III COPD (Global initiative for chronic Obstructive Lung Disease [GOLD] 2010) were randomized (1:1) to once-daily QVA149 (110 μg indacaterol/50 μg glycopyrronium) or concurrent administration of indacaterol (150 μg) and glycopyrronium (50 μg) via the Breezhaler® device (Novartis AG, Basel, Switzerland) for 4 weeks. The primary endpoint was to evaluate the noninferiority of QVA149 as compared with concurrent administration of IND+GLY, for trough forced expiratory volume in 1 second (FEV1) after 4 weeks of treatment. The other assessments included FEV1 area under the curve from 0 to 4 hours (AUC0-4 hours) at day 1 and week 4, symptom scores, rescue medication use, safety, and tolerability over the 4-week study period.

RESULTS

Of 193 patients randomized, 187 (96.9%) completed the study.Trough FEV1 at week 4 for QVA149 and IND+GLY was 1.5 L ± 0.02 [DOSAGE ERROR CORRECTED] and 1.46 L ± 0.18, respectively. The FEV1 AUC0-4 hours at day 1 and week 4 were similar between the two treatment groups. Both treatment groups had a similar reduction in symptom scores and rescue medication use for the 4-week treatment period. Overall, 25.6% of patients in QVA149 group and 25.2% in the IND+GLY group experienced an adverse event, with the majority being mild-to-moderate in severity. No deaths were reported during the study or during the 30 days follow-up period.

CONCLUSION

The BEACON study demonstrated that once-daily QVA149 provides an efficacy and safety profile similar to the concurrent administration of its monocomponents indacaterol and glycopyrronium.

Authors+Show Affiliations

Department of Dermatology, Allergy Centre, Odense University Hospital, Odense, Denmark.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

24159259

Citation

Dahl, Ronald, et al. "Efficacy and Safety of QVA149 Compared to the Concurrent Administration of Its Monocomponents Indacaterol and Glycopyrronium: the BEACON Study." International Journal of Chronic Obstructive Pulmonary Disease, vol. 8, 2013, pp. 501-8.
Dahl R, Jadayel D, Alagappan VK, et al. Efficacy and safety of QVA149 compared to the concurrent administration of its monocomponents indacaterol and glycopyrronium: the BEACON study. Int J Chron Obstruct Pulmon Dis. 2013;8:501-8.
Dahl, R., Jadayel, D., Alagappan, V. K., Chen, H., & Banerji, D. (2013). Efficacy and safety of QVA149 compared to the concurrent administration of its monocomponents indacaterol and glycopyrronium: the BEACON study. International Journal of Chronic Obstructive Pulmonary Disease, 8, 501-8. https://doi.org/10.2147/COPD.S49615
Dahl R, et al. Efficacy and Safety of QVA149 Compared to the Concurrent Administration of Its Monocomponents Indacaterol and Glycopyrronium: the BEACON Study. Int J Chron Obstruct Pulmon Dis. 2013;8:501-8. PubMed PMID: 24159259.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of QVA149 compared to the concurrent administration of its monocomponents indacaterol and glycopyrronium: the BEACON study. AU - Dahl,Ronald, AU - Jadayel,Dalal, AU - Alagappan,Vijay K T, AU - Chen,Hungta, AU - Banerji,Donald, Y1 - 2013/10/17/ PY - 2013/10/26/entrez PY - 2013/10/26/pubmed PY - 2014/4/4/medline KW - COPD KW - FEV1 AUC0–4 hours KW - LABA KW - LAMA KW - rescue medication SP - 501 EP - 8 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 8 N2 - INTRODUCTION: The BEACON study evaluated the efficacy and safety of QVA149, a once-daily dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist (LABA) indacaterol and long-acting muscarinic antagonist (LAMA) glycopyrronium (NVA237), in development for the treatment of patients with chronic obstructive pulmonary disease (COPD), compared with the free-dose concurrent administration of indacaterol plus glycopyrronium (IND+GLY). METHODS: In this multicenter, double-blind, parallel group study, patients with stage II or stage III COPD (Global initiative for chronic Obstructive Lung Disease [GOLD] 2010) were randomized (1:1) to once-daily QVA149 (110 μg indacaterol/50 μg glycopyrronium) or concurrent administration of indacaterol (150 μg) and glycopyrronium (50 μg) via the Breezhaler® device (Novartis AG, Basel, Switzerland) for 4 weeks. The primary endpoint was to evaluate the noninferiority of QVA149 as compared with concurrent administration of IND+GLY, for trough forced expiratory volume in 1 second (FEV1) after 4 weeks of treatment. The other assessments included FEV1 area under the curve from 0 to 4 hours (AUC0-4 hours) at day 1 and week 4, symptom scores, rescue medication use, safety, and tolerability over the 4-week study period. RESULTS: Of 193 patients randomized, 187 (96.9%) completed the study.Trough FEV1 at week 4 for QVA149 and IND+GLY was 1.5 L ± 0.02 [DOSAGE ERROR CORRECTED] and 1.46 L ± 0.18, respectively. The FEV1 AUC0-4 hours at day 1 and week 4 were similar between the two treatment groups. Both treatment groups had a similar reduction in symptom scores and rescue medication use for the 4-week treatment period. Overall, 25.6% of patients in QVA149 group and 25.2% in the IND+GLY group experienced an adverse event, with the majority being mild-to-moderate in severity. No deaths were reported during the study or during the 30 days follow-up period. CONCLUSION: The BEACON study demonstrated that once-daily QVA149 provides an efficacy and safety profile similar to the concurrent administration of its monocomponents indacaterol and glycopyrronium. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/24159259/Efficacy_and_safety_of_QVA149_compared_to_the_concurrent_administration_of_its_monocomponents_indacaterol_and_glycopyrronium:_the_BEACON_study_ L2 - https://dx.doi.org/10.2147/COPD.S49615 DB - PRIME DP - Unbound Medicine ER -