Patient perspectives on fluticasone–vilanterol versus other corticosteroid combination products for the treatment of asthma

Figures & data

Table 1 Stepwise approach to treating patients with asthma with preferred agents

Medication class	Step 1	Step 2	Step 3	Step 4	Step 5	Step 6a
Controller(s)	None	Low-dose ICS^Citation1,Citation4	Low-dose ICS + LABA^Citation1,Citation4 or medium-dose ICS^Citation4	Medium-dose ICS + LABA^Citation1,Citation4 High-dose ICS + LABA^Citation1 Add tiotropium^Citation1,b	High-dose ICS + LABA^Citation4 Consider omalizumab^Citation1,Citation4 Add tiotropium^Citation1,b Add low-dose oral steroid^Citation1 Consider mepolizumab^Citation1	High-dose ICS + LABA + oral steroid^Citation4 Consider omalizumab^Citation4
Quick relief	As needed SABA^Citation1,Citation4	As needed SABA^Citation1,Citation4	As needed SABA^Citation1,Citation4 As needed SABA or low-dose ICS/formoterolc	As needed SABA^Citation1,Citation4 As needed SABA or low-dose ICS/formoterolc	As needed SABA^Citation1,Citation4 As needed SABA or low-dose ICS/formoterolc	As needed SABA^Citation1,Citation4

Notes: Data from Global Strategy for Asthma Management and Prevention, Global Iniative for Asthma (GINA),¹ Expert Panel Report 3 (EPR3): guidelines for the diagnosis and management of asthma.⁴

a Step 6 is included in the US guidelines only.⁴

b Addition of tiotropium is for patients with a history of exacerbations.¹

c Included in Global guidelines¹ only; not approved in the US for this indication.

Abbreviations: ICS, inhaled corticosteroid; LABA, long-acting beta₂ receptor agonist; SABA, short-acting beta₂ receptor agonist.

Table 2 Available ICS plus LABA combination products

Medications	Device	Minimum age approved in the US (years)	Dose approved in asthma (µg ICS/µg LABA)	Dose	Device comparison
Fluticasone propionate and salmeterol	DPI: Diskus^®	4	100/50 250/50 500/50	One puff twice daily	Breath activated 10-Second breath hold Separate step to load dose Hold level after dose loaded More rapid inspiratory rate Contains lactose; caution lactose intolerance Small dose counter Secondary expiration date after opening
Fluticasone propionate and salmeterol	MDI HFA	12	45/21 115/21 230/21	Two puffs twice daily	Manual coordination (may need holding chamber) Prime before first use Slower inspiratory rate
Budesonide and formoterola	MDI HFA	12	80/4.5 160/4.5	Two puffs twice daily	10-Second breath hold Routine cleaning necessary
Mometasone and formoterol	MDI HFA	12	100/5 200/5	Two puffs twice daily
Fluticasone propionate and formoterol	MDI HFA	12b 12b 18b	50/5 125/5 250/5	Two puffs twice daily
Fluticasone furoate and vilanterol	DPI: Ellipta^®	18	100/25 200/25	One puff once daily	Breath activated Single step to open cover and load dose Caution: not to obstruct air vents More rapid inspiratory rate 3-Second breath hold Contains lactose; caution lactose intolerance Large dose counter Secondary expiration date after opening

Notes:

a In some countries, it may be used as both controller and rescue inhaler.

b Not approved in the US.

Abbreviations: DPI, dry powdered inhaler; HFA, hydrofluoroalkane; ICS, inhaled corticosteroid; LABA, long-acting beta₂ receptor agonist; MDI, metered-dose inhaler.

Table 3 Comparison of FF–VI to another ICS–LABA combination product

Study	Products (regimen) studied	End points	Most common ADRs reported (%)
			ADR	FF–VI	FP–S
Woodcock et al^Citation39	FF–VI (100/25 μg once daily) versus	Primary	Nasopharyngitis	53	49
	FP–S (250/50 μg twice daily)	Change in 0- to 24-hour FEV1	Headache	34	41
		FF–VI (341 mL) versus FP–S	URTI	26	16
		(377 mL) (NS)	Cough	15	13
			Sinusitis	12	7
		Secondary (all NS)
		Exacerbation rates
		ACT scores
		QOL questionnaire scores
		Unscheduled health care use

Abbreviations: ACT, Asthma Control Test^®; ADR, adverse drug reaction; FEV₁, forced expiratory volume at 1 second; FF–VI, fluticasone furoate–vilanterol; FP–S, fluticasone propionate–salmeterol; ICS, inhaled corticosteroid; LABA, long-acting beta₂ receptor agonist; NS, not significant; QOL, quality-of-life; URTI, upper respiratory tract infection.

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–VI^Citation40	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–VI^Citation41	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–VI^Citation42	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.

Global Strategy for Asthma Management and PreventionGlobal Iniative for Asthma (GINA)2016 Available from: http://ginasthma.org/2016-gina-report-global-strategy-for-asthma-management-and-prevention/Accessed April 25, 2016

 Google Scholar

Expert Panel Report 3 (EPR3): guidelines for the diagnosis and management of asthma Available from: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdfAccessed January 28, 2016

 Google Scholar

WoodcockABleeckerERLotvallJEfficacy and safety of fluticasone furoate/vilanterol compared with fluticasone propionate/salmeterol combination in adult and adolescent patients with persistent asthmaChest20131441222122923846316

 PubMed Web of Science ®Google Scholar

BusseWWO’ByrnePMBleeckerERSafety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the β2 agonist vilanterol administered once daily for 52 weeks in patients $12 years old with asthma: a randomized trialThorax20136851352023440247

 PubMed Web of Science ®Google Scholar

OliverAVanBurenSAllenATolerability of fluticasone furoate/vilanterol combination therapy in children aged 5 to 11 years with persistent asthmaClin Ther20143692893924793536

 PubMed Web of Science ®Google Scholar

AllenASchenkenbergerITrivediRInhaled fluticasone furoate/vilanterol dose not affect hypothalamic-pituitary-adrenal axis function in adolescent and adult asthma: randomized, double-blind, placebo-controlled studyClin Respir J2013739740623578031

 PubMed Web of Science ®Google Scholar