Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials

Table 1 Patient demographics and lung function at screening and baseline (Efficacy population)

	Japan N = 148	Not-Japan N = 3,066	Overall N = 3,214
Demographic characteristics
Age, years*	47.5 (14.66)	41.9 (16.63)	42.2 (16.59)
Range: min, max	20, 82	12, 84	12, 84
Male/female, %	38/62	36/64	36/64
Weight, kg*	62.5 (13.63)	76.2 (19.29)	75.5 (19.28)
Height, cm*	160.7 (8.05)	165.7 (9.98)	165.5 (9.96)
Screening and baseline lung function characteristics
Screening
Pre-bronchodilator FEV₁, L*	1.87 (0.505)	2.13^† (0.619)	2.12^‡(0.617)
% predicted pre-bronchodilator FEV₁, %*	72.63 (10.715)	67.39^† (11.179)	67.63^‡ (11.210)
Post-bronchodilator FEV₁, L *	2.34 (0.638)	2.67^§ (0.768)	2.65^¶ (0.766)
Absolute reversibility in FEV₁, mL*	463.6 (258.51)	537.5^‖ (306.75)	534.1** (305.05)
Range: min,max	197.0, 2055.0	6.0, 2628.0	6.0, 2628.0
FEV₁ reversibility, %*	25.3 (14.00)	26.1^‖ (14.95)	26.1** (14.90)
Range: min, max	12.0–129.9	0.3–125.2	0.3–129.9
Baseline
Baseline FEV₁, L*	1.93^†† (0.548)	2.23^‡‡ (0.647)	2.22^§§ (0.646)
% predicted^¶¶ FEV₁ at baseline, %*	74.66^†† (11.127)	70.57^‡‡ (11.182)	70.75^§§ (11.210)

FEV ₁ forced expiratory volume in one second, min minimum, max maximum
Efficacy population consists of data from studies HZA106827, HZA106829, and HZA106837. *Mean (SD); ^† N = 3,055; ^‡ N = 3,203; ^§ N = 3,063; ^¶ N = 3,211; ^‖ N = 3,052; **N = 3,200; ^†† N = 147; ^‡‡ N = 3,059; ^§§ N = 3,206; ^¶¶Study HZA106837 used the prediction equation of Hankinson et al. 1999 [34]; studies HZA106827 and HZA106829 used Hankinson et al. 2010 [35]

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