Table 4.

Safety Overview (Safety Population)

	Study 1		Study 2		Study 3
Treatmenta	100/50 μg		250/50 μg		500/50 μg
Device	T (n = 65)	R (n = 65)	T (n = 65)	R (n = 64)	T (n = 65)	R (n = 66)
Subjects reporting ≥1 treatment-emergent AE, n (%)	4 (6.2)	9 (13.8)	11 (16.9)	5 (7.8)	4 (6.2)	0
Subjects reporting ≥1 serious AE, n (%)	0	1 (1.5)b	0	0	0	0
Subjects reporting ≥1 AE leading to study discontinuation, n (%)	1 (1.5)c	0	1 (1.5)	1 (1.6)	0	0
Most commonly reported AEsd, n (%)
Headache	1 (1.5)	2 (3.1)	0	2 (3.1)	0	0
Dizziness	0	1 (1.5)	1 (1.5)	0 (0.0)	0	0
Vessel puncture site pain	0	0	3 (4.6)	2 (3.1)	0	0
Presyncope	1 (1.5)	1 (1.5)	2 (3.1)	0 (0.0)	0	0

^aThree inhalations were administered in each study, resulting in total FP/S doses of 300/150 μg (study 1), 750/150 μg (study 2), and 1500/150 μg (study 3).

^bOne case of moderate dyspnea was reported 2 days 7 hours after FP/S administration and after completion of all study procedures; this AE was considered by the investigator as not related to study treatment.

^cOne nonserious case of mild upper respiratory tract infection led to discontinuation of this subject before period 2; this AE was considered by the investigator as not related to study treatment.

^dAEs (preferred terms) reported by two or more subjects with any treatment.

AE, adverse event; FP/S, fluticasone propionate/salmeterol; R, reference product (Advair^® Diskus^®); T, test product (Wixela^® Inhub^®).