A Preference Study of Two Placebo Dry Powder Inhalers in Adults with COPD: ELLIPTA® Dry Powder Inhaler (DPI) versus DISKUS® DPI

Figures & data

Figure 1.  Inhalers used in the study: a) DISKUS DPI, b) ELLIPTA DPI.

Figure 2.  Study design schematic. BID, twice daily; DPI, dry powder inhaler; QD, once daily.

Figure 3.  CONSORT diagram.

Table 1.  Patient demographics, COPD history, and tobacco use

Demographic	ITT population (n = 287)
Sex, n (%)
Female	134 (47)
Male	153 (53)
Age, yr
Mean (SD)	64.7 (9.74)
Min, Max	39, 89
Ethnicity, n (%)
Not Hispanic/Latino	282 (98)
Hispanic/Latino	5 (2)
Body mass index (kg/m^2)
Mean (SD)	28.23 (6.336)
Min, Max	13.7, 57.4
Duration of COPD, n (%)
≥ 1 to < 5 years	94 (33)
≥ 5 years to < 10 years	97 (34)
≥ 10 years	96 (33)
Tobacco use
Smoking status, n (%)
Current smoker	126 (44)
Former smoker^a	161 (56)
Years smoked
Mean (SD)	41.3 (9.94)
Min, Max	10, 67
Smoking pack-years
Mean (SD)	56.5 (27.02)

^aPatients who had stopped smoking for at least 6 months prior to Visit 1. COPD, chronic obstructive pulmonary disease; ITT, intent to treat; SD, standard deviation.

Table 2.  Exposure and inhaler use compliance (ITT population)

	ELLIPTA DPI (n = 287)	DISKUS DPI (n = 285)
Exposure, n	286	285
Duration (days)
Mean (SD)	7.2 (0.99)	7.2 (1.17)
Median	7.0	7.0
Min, Max	5, 12	5, 18
Compliance, n	286	285
Rate (%)
Mean (SD)	105.6 (16.29)	96.1 (18.45)
Median	100.0	94.4
Min, Max	75, 200	43, 257
Compliance category, n (%)
< 80%	2 (<1)	24 (8)
≥ 80 to ≤ 120%	263 (92)	252 (88)
> 120%	21 (7)	9 (3)

ITT, intent to treat; SD, standard deviation.

Table 3.  Analysis of inhaler attribute and dose regimen preference (PP population)

	Number (%) of patients
Inhaler attribute	ELLIPTA DPI followed by DISKUS DPI (n = 142)	DISKUS DPI followed by ELLIPTA DPI (n = 143)	Total (n = 285)	p-value
Primary endpoint
Size of the numbers on the dose counter, n	142	143	285	< 0.001
Prefer ELLIPTA	86 (61)	107 (75)	193 (68)
Prefer DISKUS	34 (24)	23 (16)	57 (20)
No preference	22 (15)	13 (9)	35 (12)
Secondary endpoints
Number of steps to take the COPD medication, n	142	143	285	< 0.001
Prefer ELLIPTA	90 (63)	100 (70)	190 (67)
Prefer DISKUS	36 (25)	29 (20)	65 (23)
No preference	16 (11)	14 (10)	30 (11)
Size of the inhaler, n	141	143	284	< 0.001
Prefer ELLIPTA	70 (50)	75 (52)	145 (51)
Prefer DISKUS	36 (26)	40 (28)	76 (27)
No preference	35 (25)	28 (20)	63 (22)
Other endpoints
Comfort of the mouthpiece, n	142	143	285	< 0.001
Prefer ELLIPTA	61 (43)	72 (50)	133 (47)
Prefer DISKUS	45 (32)	32 (22)	77 (27)
No preference	36 (25)	39 (27)	75 (26)
Ease of opening the inhaler, n	142	143	285	< 0.001
Prefer ELLIPTA	81 (57)	91 (64)	172 (60)
Prefer DISKUS	40 (28)	31 (22)	71 (25)
No preference	21 (15)	21 (15)	42 (15)
Overall inhaler preference, n	142	143	285	< 0.001
Prefer ELLIPTA	84 (59)	96 (67)	180 (63)
Prefer DISKUS	48 (34)	39 (27)	87 (31)
No preference	10 (7)	8 (6)	18 (6)
Once-daily vs. twice-daily dosing, n	142	143	285	< 0.001
Prefer once daily	94 (66)	97 (68)	191 (67)
Prefer twice daily	35 (25)	30 (21)	65 (23)
No preference	13 (9)	16 (11)	29 (10)

PP, per protocol; COPD, chronic obstructive airways disease.

Table 4.  Adverse events occurring in more than one patient (ITT Population)

	ELLIPTA DPI (n = 287)	DISKUS DPI (n = 285)	Total (n = 287)
Any AE^a	23 (8)	14 (5)	36 (13)
Headache	2 (<1)	5 (2)	7 (2)
Back pain	3 (1)	0	3 (1)
Diarrhea	2 (<1)	0	2 (<1)
Dry mouth	1 (<1)	1 (<1)	2 (<1)
Neck pain	1 (<1)	1 (<1)	2 (<1)
Conjunctivitis	0	2 (<1)	2 (<1)

^aThe total number of any AE in the ELLIPTA DPI and DISKUS DPI columns does not sum to the Total column because one patient had an AE while using the ELLIPTA DPI and another AE while using the DISKUS DPI, but is only counted once in the Total column.

AE, adverse event; ITT, intent to treat.