COPD Maintenance Therapy with Tiotropium/Olodaterol Compared with Tiotropium: An Analysis in the Absence of Additional ICS Therapy

Figures & data

Table 1. This is currently in the middle of the introduction - please could it be moved to the next page, closer to where it's first cited.

Characteristic	Tio (n = 825)	T/O (n = 771)
Age, years	63.5 (8.4)	63.6 (8.7)
Male, n (%)	585 (70.9)	525 (68.1)
Smoking status, n (%)
Never smoked	0 (0.0)	0 (0.0)
Ex-smoker	463 (56.1)	399 (51.8)
Current smoker	362 (43.9)	372 (48.2)
Weight, kg	76.9 (19.2)^a	75.1 (18.5)^b
Pre-bronchodilator FEV1, L	1.318 (0.53)	1.296 (0.51)
Pre-bronchodilator FVC, L	2.795 (0.85)	2.770 (0.86)
Pre-bronchodilator FEV1/FVC, %	47.189 (11.88)	46.798 (11.26)
Baseline SGRQ score	42.4 (17.7)^c	42.0 (17.2)^d
Baseline BDI score	6.6 (2.2)^e	6.7 (2.1)^f
Baseline medication, n (%)
Treatment-naïve	560 (67.9)	518 (67.2)
LABA only	52 (6.3)	40 (5.2)
LAMA only	151 (18.3)	148 (19.2)
LAMA + LABA	62 (7.5)	65 (8.4)
GOLD stage, n (%)
1	2 (0.2)	0 (0.0)
2	490 (59.4)	460 (59.7)
3	269 (32.6)	255 (33.1)
4	64 (7.8)	56 (7.3)

Data are mean (SD) unless otherwise stated.

^a–fSome patient data were not available for each of the recorded outcomes: ^a n = 822, ^b n = 760, ^c n = 820, ^d n = 765, ^e n = 808, ^f n = 765.

BDI, Baseline Dyspnea Index; FEV₁, forced expiratory volume in 1 s; FVC, forced vital capacity; GOLD, Global Initiative for Chronic Obstructive Lung Disease; LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist; SD, standard deviation; SGRQ, St. George’s Respiratory Questionnaire; T/O, tiotropium/olodaterol; Tio, tiotropium.

Figure 1. (a) Change in trough FEV₁ at Week 12 from baseline; all patients and by GOLD status. (b) Change in trough FEV₁ at Week 12 from baseline; by baseline SGRQ and BDI status.

BDI, Baseline Dyspnea Index; CI, confidence interval; FEV₁, forced expiratory volume in 1 second; GOLD, Global Initiative for Chronic Obstructive Lung Disease; SE, standard error; SGRQ, St. George’s Respiratory Questionnaire; T/O, tiotropium/olodaterol; Tio, tiotropium.

N numbers below bars, adjusted mean response within bars.

Figure 2. (a) Change in SGRQ at Week 12 from baseline; all patients and by GOLD status. (b) Change in SGRQ at Week 12 from baseline; by baseline SGRQ and BDI status.

BDI, Baseline Dyspnea Index; CI, confidence interval; GOLD, Global Initiative for Chronic Obstructive Lung Disease; SE, standard error; SGRQ, St. George’s Respiratory Questionnaire; T/O, tiotropium/olodaterol; Tio, tiotropium.

N numbers below bars, adjusted mean response within bars.

Figure 3. (a) Change in TDI at Week 12 from baseline; all patients and by GOLD status. (b) Change in TDI at Week 12 from baseline; by baseline SGRQ and BDI status.

BDI, Baseline Dyspnea Index; CI, confidence interval; GOLD, Global Initiative for Chronic Obstructive Lung Disease; SE, standard error; SGRQ, St. George’s Respiratory Questionnaire; T/O, tiotropium/olodaterol; TDI, Transition Dyspnea Index; Tio, tiotropium.

N numbers below bars, adjusted mean response within bars.

Table 2. Adverse event profile.

Characteristic	Tio (n = 825)	T/O (n = 771)
Patients with any AE, n (%)	510 (61.8)	470 (61.0)
Patients with severe AEs, n (%)	80 (9.7)	73 (9.5)
Patients with investigator-defined drug-related AEs, n (%)	46 (5.6)	49 (6.4)
Patients with other significant AEs (according to ICH E3), n (%)	28 (3.4)	14 (1.8)
Patients with AEs leading to discontinuation of trial drug, n (%)	54 (6.5)	31 (4.0)
Patients with serious AEs, n (%)	99 (12.0)	77 (10.0)
Fatal	9 (1.1)	11 (1.4)
Life-threatening	1 (0.1)	1 (0.1)
Disability/incapacity	2 (0.2)	1 (0.1)
Requires hospitalization	87 (10.5)	64 (8.3)
Prolonged hospitalization	1 (0.1)	1 (0.01)
Other	12 (1.5)	6 (0.8)

A patient may be counted in more than one seriousness criterion. Percentages are calculated using total number of patients per treatment as the denominator. MedDRA version used for reporting: 20.0.

AE, adverse event; ICH, International Council for Harmonization; MedDRA, Medical Dictionary for Regulatory Activities.

Data availability

The data that support the findings of this study are available from the corresponding author, PMAC, upon reasonable request.