Table 1.
study | Treatment (μg) | Number of subjects | Duration (weeks) |
Key inclusion criteria | Male (%) | Mean age (years) | Baseline FEV1 (%predicted) |
---|---|---|---|---|---|---|---|
Donohue 2002 |
Tiotoropium 18 Salmeterol 100 |
623 | 24 |
%FEV1 < 60% > 40 yrs., > 10PY |
74.6 | 64.0 | 40.2 |
Brusasco 2003 |
Tiotoropium 18 Salmeterol 100 |
807 | 24 |
%FEV1 ≤ 65%, > 40 yrs., > 10PY |
76.2 | 64.0 | 42.9 |
Briggs 2005 |
Tiotoropium 18 Salmeterol 100 |
653 | 12 |
%FEV1 < 60%, > 40 yrs., > 10PY |
66.4 | 64.4 | 37.7 |
Buhl 2011 INTENSITY study |
Tiotoropium 18 Indacaterol 150 |
1598 | 12 |
%FEV1 30–80%, > 40 yrs., > 10PY |
69.0 | 63.5 | 54.4 |
Vogelmeier 2011 POET study |
Tiotoropium 18 Salmeterol 100 |
7376 | 52 |
%FEV1 ≤ 70%, ≥ 40 yrs., ≥ 10PY, Ex (+) |
74.6 | 62.9 | 49.3 |
Bateman 2013 SHINE study |
Glycopyrronium 50a Indacaterol 150a |
1435 | 26 |
%FEV1 ≥ 30%, < 80% ≥ 40 yrs., ≥ 10PY |
75.4 | 63.9 | 53.7 |
Decramer 2013 INVIGORATE |
Tiotoropium 18 Indacaterol 150 |
3439 | 52 |
%FEV1 > 30%, ≤ 50% ≥ 40 yrs., ≥ 10PY, Ex (+) |
77.0 | 64.0 | 40.5 |
Donohue 2013 |
Umeclidinium 62.5a Vilanterol 25a |
839 | 24 |
%FEV1 ≤ 70% mMRC ≥2, ≥ 40 yrs., ≥ 10PY |
69.0 | 63.3 | 47.5 |
Celli 2014 |
Umeclidinium 125a Vilanterol 25a |
811 | 24 |
%FEV1 ≤ 70% mMRC ≥2, ≥ 40 yrs., ≥ 10PY |
66.0 | 63.0 | 48.7 |
Decramer 2014 |
Tiotoropium 18a Vilanterol 25a |
417 | 24 |
%FEV1 ≤ 70% mMRC ≥2, ≥ 40 yrs., ≥ 10PY |
68.0 | 62.9 | 47.7 |
D’Urzo 2014 AUGMENT study |
Aclidinium 800a Formoterol 24a |
669 | 24 |
%FEV1 ≥ 30%, < 80% mMRC ≥2, ≥ 40 yrs., > 10PY |
56.0 | 64.2 | 53.3 |
Singh 2014 ACLIFORM-COPD |
Aclidinium 800a Formoterol 24a |
769 | 24 |
%FEV1 < 70% mMRC ≥2, ≥ 40 yrs., > 10PY |
66.5 | 63.2 | 54.0 |
Buhl 2015 TOnado 1 and 2 |
Tiotoropium 2.5/5a Olodaterol 5a |
2071 | 52 |
%FEV1 > 30%, < 80% mMRC ≥2, ≥ 40 yrs., > 10PY |
73.4 | 64.1 | 50.0 |
Mahler 2015 FLIGHT1 and 2 |
Glycopyrrolate 31.2a Indacaterol 55a | 1022 | 12 |
%FEV1 > 30%, < 80% mMRC ≥2, ≥ 40 yrs., > 10PY |
64.8 | 63.6 | 54.5 |
Mahler 2016 GEM3 study |
glycopyrrolate 31.2 Indacaterol 75 |
511 | 52 |
%FEV1 ≥ 30%, < 80% mMRC> 2, ≥ 40 yrs., ≥ 10PY |
57.2 | 63.2 | 53.1 |
D’Urzo 2017 AUGMENT study |
Aclidinium 800a Formoterol 24a |
669 | 52 |
%FEV1 ≥ 30%, < 80% ≥ 40 yrs., ≥ 10PY |
56.0 | 64.2 | 53.3 |
Hanania 2017 PINNACLE-3 |
Glycopyrronium 36a Formoterol 19.2a |
1772 | 52 |
%FEV1 ≥ 30%, < 80% or %FEV1 < 30% & FEV1 ≥ 750 ml, 40–80 yrs |
55.8 | 62.8 | 51.3 |
Martinez 2017 PINNACLE-1, −2 |
Glycopyrronium 36a Formoterol 19.2a |
1776 | 24 |
%FEV1 ≥ 30%, < 80% or %FEV1 < 30% & FEV1 ≥ 750 ml, 40–80 yrs |
55.8 | 62.8 | 51.3 |
Lipworth 2018 PINNACLE-4 |
Glycopyrronium 36a Formoterol 19.2a |
954 | 24 |
%FEV1 < 80% 40–80 yrs., ≥ 10PY |
74.1 | 64.1 | 54.4 |
Definition of abbreviations: FEV1 forced expiratory volume in 1 s, yrs years, PY pack-years
Ex(+): at least one exacerbation in the previous year; mMRC: modified Medical Research Council dyspnoea scale
aindividual components of subgroup analysis in comparison of LAMA/LABA combination therapy