Pneumologie 2017; 71(S 01): S1-S125
DOI: 10.1055/s-0037-1598309
Posterbegehung – Sektion Klinische Pneumologie
COPD I – Andreas Rembert Koczulla/Marburg, Henrik Watz/Großhansdorf
Georg Thieme Verlag KG Stuttgart · New York

Tiotropium + olodaterol provides significant lung-function benefits compared to flucticasone + salmeterol regardless of prior bronchodilator use

E Derom
1  Department of Pulmonology, Ghent University Hospital
,
KM Beeh
2  Respiratory Research Institute GmbH
,
J Echave-Sustaeta
3  Hospital Universitario Quirón Madrid
,
L Grönke
4  Boehringer Ingelheim Pharma GmbH & Co. KG
,
D Zhai
5  Inventiv Health Clinical
,
L Bjermer
6  Skane University Hospital
› Author Affiliations
Further Information

Publication History

Publication Date:
23 February 2017 (online)

 

Introduction:

The ENERGITO® study demonstrated superior lung function with long-acting muscarinic antagonist (LAMA) tiotropium + long-acting β2-agonist (LABA) olodaterol (T+O) compared to inhaled corticosteroid (ICS) fluticasone + LABA salmeterol (F+S) in patients with COPD.

Aim:

To investigate if lung-function benefits of T+O compared to F+S were affected by prior ICS, LAMA or LABA treatment in ENERGITO®.

Methods:

In ENERGITO® (1237.11, NCT01969721; Phase IIIb, randomised, double-blind), patients with moderate to severe COPD received once-daily T+O 2.5/5 or 5/5 µg and twice-daily F+S 250/50 or 500/50 µg for 6 weeks. A post hoc analysis evaluated FEV1 AUC0 – 12 and AUC0 – 24 responses in patients with or without LAMA, LABA or ICS therapy at screening.

Results:

229 patients were enrolled and treated: 123 received prior LAMA, 141 LABA, 109 ICS. T+O significantly improved FEV1 AUC0 – 12 and AUC0 – 24 responses in patients with or without prior LAMA, LABA or ICS therapy compared to F+S (Table).

Conclusions:

In ENERGITO®, patients with moderate or severe COPD showed improved lung function with T+O compared to F+S regardless of prior treatment. T+O is a better choice than LABA/ICS to optimise lung function when initiating maintenance treatment.

Funding:

Boehringer Ingelheim

Tab. 1

Treatment difference

Adjusted mean FEV1 AUC0 – 12 response, L (SE)

Prior LAMA

No LAMA

Prior LABA

No LABA

Prior ICS

No ICS

T+O 5/5 µg vs. F+S 250/50 µg

T+O 5/5 µg vs. F+S 500/50 µg

0.121a (0.016)

0.130a (0.016)

0.129a (0.016)

0.127a (0.016)

0.123a (0.012)

0.137a (0.012)

0.128a (0.021)

0.118a (0.021)

0.129a (0.013)

0.139a (0.013)

0.123a (0.017)

0.120a (0.017)

Adjusted mean FEV1 AUC0 – 24 response, L (SE)

Prior LAMA

No LAMA

Prior LABA

No LABA

Prior ICS

No ICS

T+O 5/5 µg vs. F+S 250/50 µg

T+O 5/5 µg vs. F+S 500/50 µg

0.083a (0.015)

0.092a (0.015)

0.081a (0.016)

0.079a (0.015)

0.083a (0.012)

0.096a (0.012)

0.082a (0.020)

0.072a (0.020)

0.084a (0.013)

0.099a (0.012)

0.081a (0.017)

0.076a (0.017)

ap < 0.001

SE, standard error

Content already presented at ERS congress 2016