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SPARK trial: efficacy and safety of Ultibro Breezhaler versus Glycopyrronium and Tiotropium in a subgroup of patients with severe COPD


Dual bronchodilation with a long-acting beta2-agonist ( LABA ) and long-acting muscarinic antagonist ( LAMA ) is recommended for patients with a high symptomatic burden and/or risk of exacerbations ( GOLD 2013 patient groups B–D ) and may provide additional clinical benefits over single bronchodilator therapy.

QVA149 ( Ultibro Breezhaler ) is a once-daily dual bronchodilator with a fixed-dose combination of LABA Indacaterol and the LAMA Glycopyrronium for the maintenance treatment of patients with COPD.

Researchers have evaluated the effect of QVA149 versus Glycopyrronium and Tiotropium on lung function, health status and safety in the subgroup of patients with severe COPD from the SPARK study.

SPARK was a 64-week, multicenter, randomized, double-blind, parallel-group, active-controlled study. Patients aged greater than or equal to 40 years with severe-to-very severe stable COPD and greater than or equal to 1 COPD exacerbation in the past year were randomized ( 1:1:1 ) to once-daily double-blind QVA149 110/50 mcg, Glycopyrronium 50 mcg ( both via the Breezhaler device ), or open-label Tiotropium 18 mcg ( via the Handihaler device ).

Efficacy parameters assessed include pre-dose FEV1 ( defined as the average of the -45 minutes and -15 minutes values taken prior to each dose during treatment period ) and health status ( assessed via St George’s Respiratory questionnaire [ SGRQ ] ).
Safety data ( adverse events [ AEs ] and serious AEs ) were also recorded.

Of the 2224 randomized patients, 1742 patients had severe COPD ( QVA149=578; Glycopyrronium=583; Tiotropium=581 ).

In patients with severe COPD, pre-dose FEV1 was significantly higher with QVA149 at all assessments compared with Glycopyrronium ( treatment differences 80–90 mL; p less than 0.0001 ) and Tiotropium ( treatment differences 70–90 mL; p less than 0.0001 ).

At week 64, SGRQ total score was significantly lower in the QVA149 group than in the Glycopyrronium ( treatment difference: -2.56; p=0.002 ) or Tiotropium ( treatment difference: -3.38; p less than 0.001 ) groups.

The incidence of adverse effects were similar across all groups ( QVA149=92.9%; Glycopyrronium=93.0%; Tiotropium=94.1% ) with most being mild to moderate in severity.
The number of severe adverse effects per 100 patient years in QVA149, Glycopyrronium and Tiotropium groups was 38.1%, 40.2%, and 28.4%, respectively.
Cardiac severe adverse effects ( QVA149=2.9%; Glycopyrronium=2.9%; Tiotropium=2.1% ) occurred with similar frequency across the treatment groups.
Similar numbers of deaths occurred in each treatment group ( QVA149=12; Glycopyrronium=14; Tiotropium=15 ).

Conclusion: in patients with severe COPD, QVA149 treatment resulted in significant improvements in lung function and health status ( SGRQ ) compared with Glycopyrronium and Tiotropium with a safety profile similar to that of both Glycopyrronium and Tiotropium. ( Xagena )

Source: American Thoracic Society ( ATS ) Meeting, 2014

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