. 2019 May 22;79(9):997–1008. doi: 10.1007/s40265-019-01133-w

Table 2.

Efficacy of tiotropium/olodaterol in patients with moderate to very severe [9] or moderate to severe [10] COPD

Study (timepoint)	Treatment (μg/day)	No. of pts^a	FEV₁ AUC_0–3 response (L)^b,c		Trough FEV₁ response (L)^b,c		SGRQ total score^b,d
				Diff from TIO/OLO		Diff from TIO/OLO	Mean values	Diff from TIO/OLO
TOnado 1 [9] (24 weeks)	TIO/OLO 5/5	522	0.256		0.136
	TIO 5	526	0.139	0.117***	0.065	0.071***
	OLO 5	525	0.133	0.123***	0.054	0.082***
TOnado 2 [9] (24 weeks)	TIO/OLO 5/5	502	0.268		0.145
	TIO 5	500	0.165	0.103***	0.096	0.050***
	OLO 5	507	0.136	0.132***	0.057	0.088***
TOnado combined analysis [9] (24 weeks)	TIO/OLO 5/5	1023					36.67
	TIO 5	1026		0.110***		0.060***	37.91	− 1.23*
	OLO 5	1032		0.128***		0.085***	38.37	− 1.69**
OTEMTO 1 [10] (12 weeks)	TIO/OLO 5/5	202					37.14
	TIO 5	203		0.111***^,e		0.028*^,e	39.64	− 2.49*^,e
	PL	204		0.331***		0.162***	42.04	− 4.89***
OTEMTO 2 [10] (12 weeks)	TIO/OLO 5/5	200					38.01
	TIO 5	201		0.105***^,e		0.039*^,e	39.73	− 1.72^e
	PL	199		0.299***		0.166***	42.58	− 4.56***

SGRQ total score at BL was 43.51 in the TOnado combined analysis, 42.43 in OTEMTO 1 and 42.70 in OTEMTO 2

AUC_0–3 area under the curve from 0–3 h, BL baseline, COPD chronic obstructive pulmonary disease, diff difference, FEV₁ forced expiratory volume in 1 s, OLO olodaterol, PL placebo, pts patients, SGRQ St George’s Respiratory Questionnaire, TIO tiotropium

*p < 0.05, **p < 0.005, ***p ≤ 0.0001 vs. TIO/OLO 5/5

^aNo. of pts evaluable for FEV₁ AUC_0–3 response

^bCo-primary endpoints

^cResponse defined as adjusted mean change from BL

^dA reduction in score indicates improvement

^eIn OTEMTO 1 and 2, TIO 5 pts also had significantly greater improvements in FEV₁ AUC_0–3 response (between-group diff 0.219 and 0.194 L; p < 0.0001), trough FEV₁ response (0.134 and 0.127 L; p < 0.0001) and SGRQ total scores (− 2.40 and − 2.85; p < 0.05) than PL pts