Tiotropium + olodaterol in patients with moderate to severe COPD with chronic bronchitis and/or emphysema

Introduction:

Chronic bronchitis and emphysema are two COPD phenotypes that can affect pharmacologic treatment decisions.

Aims:

Tiotropium (T) + olodaterol (O) was established for COPD treatment in two large Phase III trials. This post hoc analysis assessed the effect of T+O on lung function, symptoms and health-related quality of life (QoL) in patients (pts) with investigator-defined bronchitis and/or emphysema.

Methods:

TONADO® 1+2 were replicate, randomised, double-blind, parallel-group trials. Pts with GOLD 2 – 4 COPD were randomised to once-daily T+O 2.5/5 or 5/5 µg, T 2.5 or 5 µg, or O 5 µg via Respimat® inhaler.¹ End points included forced expiratory volume in 1 second (FEV₁) area under the curve from 0 – 3 hours (AUC_{0 – 3}) and trough FEV₁ responses, St George's Respiratory Questionnaire (SGRQ) and Mahler Transition Dyspnoea Index (TDI). We show results for T+O 5/5 µg, T 5 µg and O 5 µg at Week 24.

Results:

Baseline characteristics were similar between pts with bronchitis (n = 2210), emphysema (n = 2351) or both (n = 1179). Significant improvements in lung function and improvements in SGRQ and TDI were observed with T+O in all groups (Table).

	Comparison at Week 24
	FEV1 AUC 0 – 3 response	Trough FEV 1 response	SGRQ	TDI
Bronchitis Yes
T+O vs. O 5 µg	0.145 (0.119, 0.172)***	0.094 (0.068, 0.121)***	-1.32 (-3.14, 0.51)	0.36 (-0.05, 0.77)
T+O vs. T 5 µg	0.105 (0.080, 0.131)***	0.054 (0.028, 0.080)***	0.04 (-1.70, 1.77)	0.25 (-0.15, 0.64)
No
T+O vs. O 5 µg	0.115 (0.093, 0.136)***	0.077 (0.055, 0.100)***	-2.04 (-3.42, -0.65)*	0.47 (0.12, 0.81)*
T+O vs. T 5 µg	0.116 (0.093, 0.138)***	0.065 (0.042, 0.088)***	-2.32 (-3.74, -0.90)*	0.48 (0.12, 0.83)*
Emphysema Yes
T+O vs. O 5 µg	0.144 (0.121, 0.166)***	0.099 (0.076, 0.122)***	-1.59 (-3.16, -0.02)*	0.45 (0.07, 0.84)*
T+O vs. T 5 µg	0.114 (0.091, 0.136)***	0.065 (0.041, 0.088)***	-1.70 (-3.28, -0.12)*	0.46 (0.08, 0.84)*
No
T+O vs. O 5 µg	0.115 (0.091, 0.140)***	0.073 (0.048, 0.098)***	-1.82 (-3.32, -0.32)*	0.40 (0.03, 0.76)*
T+O vs. T 5 µg	0.108 (0.084, 0.132)***	0.056 (0.032, 0.081)***	-0.89 (-2.38, 0.60)	0.27 (-0.09, 0.64)
Both Yes
T+O vs. O 5 µg	0.154 (0.121, 0.188)***	0.107 (0.073, 0.141)***	-1.37 (-3.86, 1.11)	0.31 (-0.24, 0.85)
T+O vs. T 5 µg	0.108 (0.075, 0.140)***	0.056 (0.023, 0.088)**	0.31 (-2.08, 2.69)	0.15 (-0.38, 0.68)
No
T+O vs. O 5 µg	0.120 (0.101, 0.139)***	0.078 (0.058, 0.098)***	-1.80 (-3.03, -0.58)*	0.45 (0.15, 0.75)*
T+O vs. T 5 µg	0.110 (0.091, 0.130)***	0.061 (0.041, 0.081)***	-1.71 (-2.93, -0.48)*	0.42 (0.11, 0.72)*
*p < 0.05; **p < 0.001; ***p < 0.0001

Conclusions:

In moderate to severe COPD, T+O improves lung function, symptoms and QoL in all pts. Improvements in emphysema pts were slightly superior than in chronic bronchitis pts.

Reference:

[1] Buhl R et al. Eur Respir J 2015;45:969 – 79.

Funding:

Boehringer Ingelheim

Content already presented at ERS congress 2016