Table 4.

Summary of data from FF–VI safety trials

Drugs studied	Doses (ICS µg/LABA µg)	Duration of trial	Common adverse effects reported (%)
			ADR	FF–VI 100/25 µg	FF–VI 200/25 µg	FP 500 µg
FF–VI40	100/25 or 200/25 once daily	52 weeks	Headache	39	35	23
			URTI	34	30	18
FP	500 μg twice daily		Nasopharyngitis	25	19	10
			Cough	9	11	13
			Oral candidiasis	15	13	3
			Sinusitis	9	4	5
			ADR	FF–VI 100/25 µg	FF 100 µg
FF–VI41	100/25 once daily	14-day initial therapy +7-day wash-out +14-day cross-over to other treatment	Headache	1	0
			URTI	0	1
FF	100 μg twice daily		Conjunctivitis	1	0
			Bronchitis	1	0
			Streptococcal pharyngitis	1	0
			ADR	FF–VI 100/25 µg	FF–VI 200/25 µg
FF–VI42	100/25 or 200/25 once daily	42 days	Headache	27	16
			Nasopharyngitis	4	2
			Sinus headache	2	4
			Cough	0	0
			Sinusitis	4	0
			Oropharyngeal candidiasis	0	2

Note: Data from Busse WW et al,⁴⁰ Oliver A et al,⁴¹ and Allen A et al.⁴²

Abbreviations: ADR, adverse drug reaction; FF–VI, fluticasone furoate–vilanterol; FP, fluticasone propionate; FF, fluticasone furoate; ICS, inhaled corticosteroid; LABA, long-acting beta₂ receptor agonist; URTI, upper respiratory tract infection.