Pneumologie 2018; 72(S 01): S90-S91
DOI: 10.1055/s-0037-1619358
Sektion 7 – Klinische Pneumologie
Posterbegehung – Titel: COPD II
Georg Thieme Verlag KG Stuttgart · New York

Classifying patients as GOLD A-D using the 2017 strategy criteria: impact on efficacy by GOLD stage in the OTEMTO tiotropium+olodaterol clinical trials

F Fuchs
1   Medizinische Klinik, Universitätsklinikum Erlangen
,
D Singh
2   University of Manchester
,
L Bjermer
3   Dept. of Respiratory Medicine & Allergology, Skane University Hospital, Lund, Sweden
,
R Abrahams
4   Morgantown Pulmonary Clinical Research, Morgantown, USA
,
L Grönke
5   Boehringer Ingelheim Corporation, Ingelheim am Rhein
,
F Voss
5   Boehringer Ingelheim Corporation, Ingelheim am Rhein
,
G Ferguson
6   Pulmonary Research Institute of Southeast Michigan, USA
› Author Affiliations
Further Information

Publication History

Publication Date:
21 February 2018 (online)

Also available at
 

Introduction:

The 2017 GOLD strategy uses symptoms and exacerbations to class patients as A-D, but no longer includes lung function as the previous strategy did. This has implications for treatment decisions.

Aims and objectives:

To investigate the efficacy of tiotropium+olodaterol (T+O) compared with tiotropium and placebo in patients classed as GOLD A or B using the GOLD 2017 strategy, and compare with the subgroup defined using the 2014 strategy.

Methods:

OTEMTO 1 & 2 (NCT01964352, NCT02006732) were replicate, placebo-controlled Phase III trials: patients with COPD received T+O 5/5 µg, 2.5/5 µg, tiotropium 5 µg orplacebo via the Respimat® device for 12 weeks. SGRQ and transition dyspnoea index (TDI) data from patients with either GOLD 2017 A or B status (using modified Medical Research Council Dyspnoea Scale [mMRC] and exacerbation history) or GOLD 2014 A or B status (using lung function, exacerbation history and mMRC) were analysed.

Results:

More patients are in groups A and B with the 2017 strategy than with the 2014 strategy. T+O and tiotropium were more effective than placebo at improving SGRQ score and TDI score across groups, and the results are similar using the 2017 and 2014 classifications (Tab).

Tab. 1:

SGRQ and TDI after 12 weeks by baseline GOLD status according to the 2017 strategy and the 2014 strategy (OTEMTO pooled data, full analysis set)

SGRQ total score change from baseline

Mahler TDI focal score

2017

2014

2017

2014

n

Adj mean

Resp,† n

n

Adj mean

Resp,† n

n

Adj mean

Resp* n

n

Adj mean

Resp * n

(SE)

(%)

(SE)

(%)

(SE)

(%)

(SE)

(%)

GOLD A

T+O 5/5 µg

164

-4.26 (0.71)

79 (48)

116

-2.79 (0.84)

53 (46)

164

1.73 (0.21)

84 (51)

116

1.60 (0.25)

55 (47)

Tio 5 µg

168

-3.59 (0.70)

74 (44)

123

-3.29 (0.82)

52 (42)

167

1.13 (0.21)

67 (40)

122

1.09 (0.31)

51 (42)

Placebo

156

0.19 (0.73)

49 (31)

115

-0.15 (0.86)

40 (35)

156

0.20 (0.22)

42 (27)

115

0.46 (0.31)

36 (31)

GOLD B

T+O 5/5 µg

195

-5.99 (0.74)

116 (60)

108

-6.92 (1.00)

70 (65)

195

1.73 (0.19)

110 (56)

108

1.73 (0.23)

62 (57)

Tio 5 µg

184

-2.45 (0.76)

74 (40)

112

-1.04 (0.98)

42 (38)

185

1.03 (0.19)

75 (41)

113

1.03 (0.23)

41 (36)

Placebo

185

-0.70 (0.76)

59 (32)

115

-1.56 (1.48)

38 (33)

185

0.03 (0.19)

46 (25)

116

0.34 (0.23)

28 (24)

†Change from baseline ≥4 units; *change from baseline ≥1.0.

Adj, adjusted; Resp, responder; SE, standard error; SGRQ, St. George's Respiratory Questionnaire; T+O, tiotropium+olodaterol; TDI, transition dyspnoea index; Tio, tiotropium.

Conclusions:

More patients are classed as GOLD A or B with the 2017 strategy than with the 2014 strategy but the efficacy conclusions remain the same.

Sponsored by Boehringer Ingelheim.

Previously presented at ERS 2017.