The impact of grouping patients by the 2017 GOLD COPD strategy on response to therapy: post hoc results from the TONADO tiotropium+olodaterol trials

Introduction:

In the 2017 GOLD COPD strategy the classification of patients by assessment of symptoms and history of exacerbation is used to guide treatment choices. The previous strategy also included lung function.

Aims and objectives:

To investigate the effect of the 2017 classification on an analysis of the efficacy of tiotropium+olodaterol (T+O) in GOLD stage A/B patients with COPD.

Methods:

Patients from the Phase III, replicate 52-week TONADO studies (NCT01431274, NCT01431287), who received T+O or the mono-components, were classified as GOLD A/B or C/D by the 2017 strategy (using exacerbation history) or 2014 strategy (using lung function and exacerbation history). Since mMRC dyspnoea scale and COPD Assessment Test had not been used, distinction between A and B was not possible. SGRQ and transition dyspnoea index (TDI) data were analysed.

Results:

More patients are classified as GOLD A/B with 2017 criteria than with 2014 recommendations. T+O was superior to monotherapy for SGRQ and TDI in the analysed 2017 A/B population (Tab).

Conclusions:

Using exacerbation history alone (2017), rather than combined with lung function (2014), results in more patients classified as GOLD A/B, leading to more statistical power to investigate differences between T+O and monotherapies. Using the 2017 strategy, T+O had a greater impact on SGRQ and TDI than monotherapies in GOLD A/B patients.

Tab. 1:

SGRQ and TDI after 24 weeks by baseline GOLD status according to the 2017 strategy and the 2014 strategy (TONADO pooled data, full analysis set)

		2017 GOLD A/B			2014 GOLD A/B
	n	Adjusted	Responders,	n	Adjusted	Responders,
		mean (SE)	n(%)		mean (SE)	n (%)
SGRQ total score change from baseline
T+O 5/5 µg	739	-6.9 (0.4)	428 (58)†	390	-6.4 (0.6)	219 (56)†
Tio 5 µg	719	-5.0 (0.4)	343 (48)†	393	-5.2 (0.6)	195 (50)†
Olo 5 µg	744	-5.1 (0.4)	332 (45)†	412	-6.2 (0.6)	198 (48)†
Mahler TDI focal score
T+O 5/5 µg	751	1.95 (0.11)	400 (53)‡	396	2.12 (0.15)	219 (55)‡
Tio 5 µg	737	1.50 (0.11)	351 (48)‡	395	1.93 (0.15)	204 (52)‡
Olo 5 µg	768	1.51 (0.11)	358 (47)‡	425	1.88 (0.14)	213 (50)‡
†SGRQ total score is ≥4.0 units better than baseline SGRQ total score; ‡Mahler TDI focal score is ≥1.0 unit better than baseline TDI focal score. Olo, olodaterol; SE, standard error; SGRQ, St. George's Respiratory Questionnaire; T+O, tiotropium+olodaterol; TDI, transition dyspnoea index; Tio, tiotropium.

Sponsored by Boehringer Ingelheim.

Previously presented at ERS 2017.