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Randomized Controlled Trial
. 2013:8:501-8.
doi: 10.2147/COPD.S49615. Epub 2013 Oct 17.

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

Ronald Dahl  1 , Dalal Jadayel, Vijay K T Alagappan, Hungta Chen, Donald Banerji
Affiliations
Randomized Controlled Trial

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

Ronald Dahl et al. Int J Chron Obstruct Pulmon Dis. 2013.

Erratum in

  • Int J Chron Obstruct Pulmon Dis. 2014;9:85. Dosage error in published abstract; MEDLINE/PubMed abstract corrected; Dosage error in article text

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.

Keywords: COPD; FEV1 AUC0–4 hours; LABA; LAMA; rescue medication.

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Figures

Figure 1
Figure 1
BEACON study design. Abbreviation: od, once daily.
Figure 2
Figure 2
Patient disposition. Abbreviation: IND+GLY, indacaterol and glycopyrronium.
Figure 3
Figure 3
Trough FEV1 (L) at week 4. Abbreviations: IND+GLY, indacaterol and glycopyrronium; FEV1, forced expiratory volume in 1 second; CI, confidence interval.
Figure 4
Figure 4
FEV1 AUC0–4 hours at day 1 and week 4. Abbreviations: FEV1, forced expiratory volume in 1 second; AUC, area under curve; IND+GLY, indacaterol and glycopyrronium; CI, confidence interval.
Figure 5
Figure 5
FEV1 for the first 4 hours at week 4. Abbreviations: IND+GLY, indacaterol and glycopyrronium; FEV1, forced expiratory volume in 1 second.
See this image and copyright information in PMC

References

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