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

Table 3 Treatment differences and change from baseline in trough FEV1 (HZA106829; Efficacy population)

		FP 500 μg BD		FF/VI 200/25 μg OD		FF 200 μg OD
		Week 12	Week 24	Week 12	Week 24	Week 12	Week 24
Overall	N	195	195	197	197	194	194
	n^†	190	190	187	187	186	186
	LS mean change from baseline (SE)	0.178 (0.0291)	0.183 (0.0300)	0.364 (0.0293)	0.394 (0.0302)	0.209 (0.0294)	0.201 (0.0303)
	Difference vs FP 500 μg BD (95 % CI)	–	–	0.187 (0.106–0.268)	0.210* (0.127–0.294)	0.032 (−0.050–0.113)	0.018 (−0.066–0.102)
	Difference vs FF 200 μg OD (95 % CI)	–	–	0.155 (0.074–0.237)	0.193* (0.108–0.277)	–	–
Japan^‡	N	11	11	14	14	11	11
	n^†	10	10	13	13	11	11
	LS mean change from baseline (SE)	0.136(0.1271)	0.110(0.1310)	0.399 (0.1118)	0.355 (0.1152)	0.097 (0.1226)	0.086 (0.1263)
Not-Japan	N	184	184	183	183	183	183
	n^†	180	180	174	174	175	175
	LS mean change from baseline (SE)	0.183 (0.0300)	0.191 (0.0309)	0.361 (0.0304)	0.396 (0.0313)	0.214 (0.0304)	0.206 (0.0314)
	Difference vs FP 500 μg BD (95 % CI)	–	–	0.178 (0.094–0.262)	0.205 (0.119–0.291)	0.031 (−0.053–0.115)	0.015 (−0.072–0.101)
	Difference vs FF 200 μg OD (95 % CI)	–	–	0.147 (0.062–0.231)	0.190 (0.103–0.277)	–	–

BD twice daily, CI confidence interval, FEV ₁ forced expiratory volume in one second, FF fluticasone furoate, FP fluticasone propionate, LS least-squares, OD once daily, SE standard error, VI vilanterol
All values are in L. Analysis of covariance (ANCOVA) model using last observation carried forward. ^†Number of patients with analyzable data; ^‡Differences vs FP 500 μg BD and FF 200 μg BD are not presented for the Japan group due the low number of patients in this analysis; *P ≤ 0.001

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