1. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol–fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE): a randomised, double-blind, parallel group study Claus F Vogelmeier, Eric D Bateman, John Pallante, Vijay K T Alagappan, Peter D’Andrea, Hungta Chen, Donald Banerji Lancet Respir Med Vol 1 March R2 홍인택 / Prof. 박명재

2. Introduction
In 2011, the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
Drug treatment should be predicated according to the level of patient’s risk, defined in terms of airflow limitation , symptoms, and history of exacerbations
The use of ICS should be reserved for those patients at high risk (group C and D)

3. Introduction
In 2011, the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
Drug treatment should be predicated according to the level of patient’s risk, defined in terms of airflow limitation , symptoms, and history of exacerbations
The use of ICS should be reserved for those patients at high risk (group C and D)

4. Introduction
Whether such patients (patients with more moderate disease(equivalent to group B)) would benefit from an approach of intensive bronchodilation rather than with a combination of an ICS and a longacting β2-agonist (LABA) has not previously been explored.

5. Introduction
Compare the efficacy, safety, and tolerability of QVA149 versus salmeterol–fluticasone (SFC) over 26 weeks in patients with moderate-to-severe COPD.
QVA149
indacaterol (a longacting β2-agonist) with glycopyrronium (a longacting muscarinic antagonist) as a dual bronchodilator

6. Method

7. Study design
A multicentre ,randomised, double-blind, double dummy,parallel-group, 26-week study
patients
moderate-to-severe COPD (GOLD II or III as defined in the 2009 GOLD guidelines)
Patients with a history of a COPD exacerbation needing treatment with antibiotics, systemic corticosteroids, or hospitalization in the year leading up to and including randomization were excluded

8. wash-out period
During the run-in period, patients
were provided with ipratropium bromide (shortacting
muscarinic antagonist; two puff s four times a day)
and salbutamol (shortacting β2-agonist; as needed)
inhalers.

9. Interventions
QVA /50 μg once daily (delivered via the Breezhalerdevice[Novartis Pharma AG, Stein, Switzerland])
SFC 50/500 μg twice daily (delivered via the Accuhaler-device [Glaxo Operations UK, Ware, UK])
wash-out period (체내에서 약이 다 사리지는 기간)
During the run-in period, patients
were provided with ipratropium bromide (shortacting
muscarinic antagonist; two puff s four times a day)
and salbutamol (shortacting β2-agonist; as needed)
inhalers.

10. Assessments
Patients were assessed in the clinic at randomisation (day 1) and at weeks 6, 12, 18, and 26.
Adverse events, including COPD exacerbations, and vital signs were recorded at each visit
Electrocardiogram(ECG) and laboratory analyses (haematology,clinical chemistry, and urinalysis) were done on day 1 and week 26

11. Result

13. Baseline characteristics

14. Efficacy outcomes

15. Efficacy outcomes

21. Adverse events

22. Serious adverse events

23. Serious adverse events

24. Serious adverse events

25. Adverse events leading to permanent discontinuation

26. Conclusion
Once-daily QVA149 provides significant, sustained, and clinically meaningful improvements in lung function versus twice-daily SFC, with significant symptomatic benefit.
These results indicate the potential of dual bronchodilation as a treatment option for non-exacerbating symptomatic COPD patients
Support the GOLD 2011 strategy recommendation of using one or more longacting bronchodilators without an inhaled corticosteroid in the management of symptomatic COPD patients at low risk for exacerbations