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DOI: 10.1055/s-0037-1598308
Tiotropium + olodaterol in patients with moderate to severe COPD with chronic bronchitis and/or emphysema
Publication History
Publication Date:
23 February 2017 (online)
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 (AUC0 – 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