Correct usage, ease of use, and preference of two dry powder inhalers in patients with COPD: analysis of five phase III, randomized trials

Figures & data

Figure 1 Illustration of the Ellipta™ dry powder inhaler.

Table 1 Summary of treatment compliance across the two 3-month placebo-controlled studies (114117/114418; ITT population)

Compliance	Placebo, n (%) N=321	UMEC 62.5 mcg, n (%) N=89	UMEC 125 mcg, n (%) N=91	VI 25 mcg, n (%) N=140	UMEC/VI 62.5/25 mcg, n (%) N=282	UMEC/VI 125/25 mcg, n (%) N=272
n	315	89	88	135	275	265
<80	2 (<1)	1 (1)	1 (1)	1 (<1)	1 (<1)	2 (<1)
≥80 to <95	32 (10)	9 (10)	4 (5)	11 (8)	25 (9)	27 (10)
≥95 to ≤105	268 (85)	75 (84)	79 (90)	115 (85)	243 (88)	229 (86)
>105 to ≤120	11 (3)	2 (2)	3 (3)	6 (4)	5 (2)	6 (2)
>120	2 (<1)	2 (2)	1 (1)	2 (1)	1 (<1)	1 (<1)

Notes: N is the number of patients in the ITT population; n is the number of patients with analyzable data. Compliance data were accessed separately in each treatment period.

Abbreviations: ITT, intent-to-treat; UMEC, umeclidinium bromide; VI, vilanterol.

Table 2 Summary of treatment compliance across the two 6-month active comparator studies (113360/113374; ITT population)

Compliance %	Overall, n (%) N=1,712
n	1,678
<80	18 (1)
≥80 to <95	219 (13)
≥95 to ≤105	1,418 (85)
>105 to ≤120	15 (<1)
>120	8 (<1)

Notes: N is the number of patients in the ITT population; n is the number of patients with analyzable data.

Abbreviation: ITT, intent-to-treat.

Table 3 Ellipta™ dry powder inhaler correct use, ease of use, and remaining dose determination (3-month placebo-controlled studies, 114417/114418; ITT population)

	Response	Total, n (%) N=655a
Day 1
Used correctly	n	632
	Yes	618 (98)
	No	14 (2)
	Missing	0
Day 2
Used correctly	n	629
	Yes	625 (>99)
	No	4 (<1)
	Missing	0
Week 6
Used correctly	n	587
	Yes	580 (99)
	No	6 (1)
	Missing	1 (<1)
Ease of use rating	n	587
	Very easy	433 (74)
	Easy	147 (25)
	Neutral	6 (1)
	Difficult	1 (<1)
Ease of telling how many doses left	n	587
	Very easy	471 (80)
	Easy	111 (19)
	Neutral	3 (<1)
	Difficult	2 (<1)

Notes:

a About 22 patients from Canada were excluded from these analyses, as they were not included in the inhaler preference part of the studies; one patient was randomized but did not receive study treatment or take part in the test. N is the number of patients in the total population; n is the number of patients with analyzable data at the current time point.

Abbreviation: ITT, intent-to-treat.

Table 4 Inhaler preference outcomes from using the COPD Device Preference Questionnaire in the two Phase IIIa active comparator studies (113360/113374; ITT population)

	Patients receiving active Ellipta™ N=1,274*	Patients receiving active HandiHaler^® N=418	All patients N=1,692
Number of steps, n (%)
n	1,228	404	1,632
Ellipta™	714 (58)	255 (63)	969 (59)
HandiHaler^®	211 (17)	65 (16)	276 (17)
No preference	303 (25)	84 (21)	387 (24)
Time needed to use, n (%)
n	1,228	404	1,632
Ellipta™	749 (61)	268 (66)	1,017 (62)
HandiHaler^®	181 (15)	44 (11)	225 (14)
No preference	298 (24)	92 (23)	390 (24)
Ease of use, n (%)
n	1,228	404	1,632
Ellipta™	760 (62)	260 (64)	1,020 (63)
HandiHaler^®	199 (16)	52 (13)	251 (15)
No preference	269 (22)	92 (23)	361 (22)

Notes: N is the number of patients in the total population; n is the number of patients with analyzable data at the current time point.

* This group includes patients receiving UMEC/VI, UMEC, or VI.

Abbreviations: COPD, chronic obstructive pulmonary disease; ITT, intent-to-treat; UMEC/VI, umeclidinium/vilanterol; UMEC, umeclidinium; VI, vilanterol.

Table

1. Which device do you prefer based on the number of steps needed to take your COPD medication?	□ No preference □ Handihaler device □ Novel dry powder inhaler device
2. Which device do you prefer based on the time needed to take your COPD medication?	□ No preference □ Handihaler device □ Novel dry powder inhaler device
3. Which device do you prefer based on how easy the device is to use?	□ No preference □ Handihaler device □ Novel dry powder inhaler device

Table S1 Summary of treatment compliance in the Phase IIIb active comparator study (117115; ITT population)

	Total N=905
Compliance
n	883
Compliance category, n (%)
<80	8 (<1%)
≥80 to <95	45 (5%)
≥95 to ≤105	827 (94%)
>105 to ≤120	2 (<1%)
>120	1 (<1%)

Notes: N is the number of patients in the ITT population; n is the number of patients with analyzable data.

Abbreviation: ITT, intent-to-treat.

Table S2 Inhaler preference outcomes from using the COPD Device Preference Questionnaire in the Phase IIIb active comparator study (intent-to-treat population)

	Patients receiving active Ellipta™ N=454	Patients receiving active HandiHaler^® N=451
Number of steps, n (%)
n	441	434
Ellipta™	262 (59)	242 (56)
HandiHaler^®	68 (15)	68 (16)
No preference	111 (25)	124 (29)
Time needed to use, n (%)
n	441	434
Ellipta™	270 (61)	256 (59)
HandiHaler^®	65 (15)	59 (14)
No preference	106 (24)	119 (27)
Ease of use, n (%)
n	441	434
Ellipta™	283 (64)	256 (59)
HandiHaler^®	61 (14)	62 (14)
No preference	97 (22)	116 (27)

Notes: N is the number of patients in the ITT population; n is the number of patients with analyzable data.

Abbreviations: COPD, chronic obstructive pulmonary disease; ITT, intent-to-treat.