Trial Outcomes & Findings for Study of Inhaler Device Attributes Investigating Critical and Overall Errors, Ease of Use, and Preference Between a Number of Inhaler Devices (NCT NCT02184624)

Results Overview

A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. The percentage of participants who made at least one critical error was reported for each inhaler regardless sequence.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

569 participants

Primary outcome timeframe

Day 1

Results posted on

2017-05-23

Participant Flow

The study was conducted between 28 August 2014 and 31 July 2015 at 8 centers, 6 in the Netherlands and 2 in the United Kingdom. Only participants who were naïve to the ELLIPTA inhaler and to one of the other inhaler devices that was used in this study were included.

A total of 575 participants were enrolled in the study out of them 8 failed in screening and remaining 567 were randomized and included in intent to treat population. Participants were allocated to a particular sub-study depending on their experience of using the other inhaler (i.e., depending on which other inhaler they were naïve to using).

Participant milestones

Participant milestones
Measure	Sub-study 1:ELLIPTA Versus (Vs) DISKUS/ACCUHALER Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily Chronic Obstructive Pulmonary Disease (COPD) maintenance and other medication(s) during the study.	Sub-study 2: ELLIPTA Vs Metered-dose Inhaler (MDI) Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 3: ELLIPTA Vs TURBUHALER Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 4: ELLIPTA Vs HANDIHALER Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 5: ELLIPTA Vs BREEZHALER Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
Overall Study STARTED	171	80	100	118	98
Overall Study COMPLETED	171	80	100	118	98
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Inhaler Device Attributes Investigating Critical and Overall Errors, Ease of Use, and Preference Between a Number of Inhaler Devices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER n=171 Participants Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 2: ELLIPTA Vs MDI n=80 Participants Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 3: ELLIPTA Vs TURBUHALER n=100 Participants Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 4: ELLIPTA Vs HANDIHALER n=118 Participants Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 5: ELLIPTA Vs BREEZHALER n=98 Participants Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Total n=567 Participants Total of all reporting groups
Age, Continuous	67.8 Years STANDARD_DEVIATION 7.41 • n=5 Participants	65.6 Years STANDARD_DEVIATION 8.76 • n=7 Participants	68.1 Years STANDARD_DEVIATION 8.66 • n=5 Participants	67.3 Years STANDARD_DEVIATION 8.98 • n=4 Participants	67.2 Years STANDARD_DEVIATION 8.17 • n=21 Participants	67.3 Years STANDARD_DEVIATION 8.31 • n=8 Participants
Sex/Gender, Customized Female	67 Participants n=5 Participants	26 Participants n=7 Participants	33 Participants n=5 Participants	46 Participants n=4 Participants	51 Participants n=21 Participants	223 Participants n=8 Participants
Sex/Gender, Customized Male	103 Participants n=5 Participants	53 Participants n=7 Participants	67 Participants n=5 Participants	72 Participants n=4 Participants	47 Participants n=21 Participants	342 Participants n=8 Participants
Sex/Gender, Customized Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized African American/African Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	171 Participants n=5 Participants	78 Participants n=7 Participants	99 Participants n=5 Participants	118 Participants n=4 Participants	96 Participants n=21 Participants	562 Participants n=8 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Modified Intent-to-Treat Population comprised of all participants in the Intent-to-Treat Population who completed demonstration of using both study inhaler devices after reading patient information leaflet.

A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. The percentage of participants who made at least one critical error was reported for each inhaler regardless sequence.

Outcome measures

Outcome measures
Measure	Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER n=171 Participants Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 2: ELLIPTA Vs MDI n=80 Participants Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 3: ELLIPTA Vs TURBUHALER n=100 Participants Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 4: ELLIPTA Vs HANDIHALER n=118 Participants Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 5: ELLIPTA Vs BREEZHALER n=98 Participants Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet Error with only ELLIPTA inhaler	2 Percentage of participants	4 Percentage of participants	1 Percentage of participants	4 Percentage of participants	8 Percentage of participants
Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet Error with only non-ELLIPTA inhaler	40 Percentage of participants	51 Percentage of participants	37 Percentage of participants	38 Percentage of participants	41 Percentage of participants
Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet Error with both inhalers	4 Percentage of participants	9 Percentage of participants	7 Percentage of participants	10 Percentage of participants	5 Percentage of participants

SECONDARY outcome

Timeframe: Day 1

Population: Modified Intent-to-Treat Population.

An overall error includes a critical and non-critical error. Any error made by the participants while demonstrating the use of the inhaler after reading the patient instruction leaflet was recorded by health care professional (HCP). The percentage of participants who made at least one overall error was reported. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1.

Outcome measures

Outcome measures
Measure	Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER n=171 Participants Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 2: ELLIPTA Vs MDI n=80 Participants Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 3: ELLIPTA Vs TURBUHALER n=100 Participants Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 4: ELLIPTA Vs HANDIHALER n=118 Participants Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 5: ELLIPTA Vs BREEZHALER n=98 Participants Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet Error with both inhalers	20 Percentage of participants	30 Percentage of participants	26 Percentage of participants	33 Percentage of participants	22 Percentage of participants
Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet Error with only ELLIPTA inhaler	10 Percentage of participants	1 Percentage of participants	5 Percentage of participants	10 Percentage of participants	8 Percentage of participants
Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet Error with only non-ELLIPTA inhaler	45 Percentage of participants	55 Percentage of participants	45 Percentage of participants	29 Percentage of participants	34 Percentage of participants

SECONDARY outcome

Timeframe: Day 1

Population: Modified Intent-to-Treat Population

A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further critical error were made by the participant, the error were recorded by HCP.

Outcome measures

Outcome measures
Measure	Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER n=171 Participants Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 2: ELLIPTA Vs MDI n=80 Participants Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 3: ELLIPTA Vs TURBUHALER n=100 Participants Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 4: ELLIPTA Vs HANDIHALER n=118 Participants Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 5: ELLIPTA Vs BREEZHALER n=98 Participants Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP Error with both inhalers	0.6 Percentage of participants	0 Percentage of participants	1 Percentage of participants	2 Percentage of participants	0 Percentage of participants
Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP Error with only non-ELLIPTA inhaler	2 Percentage of participants	15 Percentage of participants	10 Percentage of participants	17 Percentage of participants	11 Percentage of participants
Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP Error with only ELLIPTA inhaler	0.6 Percentage of participants	4 Percentage of participants	0 Percentage of participants	0 Percentage of participants	1 Percentage of participants

SECONDARY outcome

Timeframe: Day 1

Population: Modified Intent-to-Treat Population.

An overall error includes a critical and non-critical error. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further error was made by the participant was recorded by HCP.

Outcome measures

Outcome measures
Measure	Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER n=171 Participants Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 2: ELLIPTA Vs MDI n=80 Participants Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 3: ELLIPTA Vs TURBUHALER n=100 Participants Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 4: ELLIPTA Vs HANDIHALER n=118 Participants Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 5: ELLIPTA Vs BREEZHALER n=98 Participants Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP Error with both inhalers	4 Percentage of participants	1 Percentage of participants	4 Percentage of participants	8 Percentage of participants	0 Percentage of participants
Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP Error with only ELLIPTA inhaler	0.6 Percentage of participants	3 Percentage of participants	2 Percentage of participants	3 Percentage of participants	2 Percentage of participants
Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP Error with only non-ELLIPTA inhaler	12 Percentage of participants	24 Percentage of participants	15 Percentage of participants	17 Percentage of participants	15 Percentage of participants

SECONDARY outcome

Timeframe: Day 1

Population: Modified Intent-to-Treat Population

If the participant made any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participant was then asked to demonstrate inhaler use again. Any errors made by the participant were recorded by the HCP. The same procedure was repeated if the participant continues to make errors in the use of the inhaler. In total, the HCP demonstrated the use of the inhaler up to three times. Same procedure was followed for second inhaler. The number of participants who demonstrated the adequate inhalation technique after third time instructions from HCP was reported.

Outcome measures

Outcome measures
Measure	Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER n=171 Participants Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 2: ELLIPTA Vs MDI n=80 Participants Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 3: ELLIPTA Vs TURBUHALER n=100 Participants Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 4: ELLIPTA Vs HANDIHALER n=118 Participants Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 5: ELLIPTA Vs BREEZHALER n=98 Participants Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique One HCP Instructions , ELLIPTA inhaler	45 Participants	22 Participants	25 Participants	38 Participants	28 Participants
Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique One HCP Instructions , Non-ELLIPTA inhaler	85 Participants	48 Participants	52 Participants	44 Participants	40 Participants
Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique Two HCP Instructions , Non-ELLIPTA inhaler	19 Participants	12 Participants	11 Participants	13 Participants	8 Participants
Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique Three HCP Instructions , Non-ELLIPTA inhaler	4 Participants	2 Participants	1 Participants	6 Participants	4 Participants
Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique Zero HCP Instructions , ELLIPTA inhaler	119 Participants	55 Participants	69 Participants	67 Participants	68 Participants
Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique Zero HCP Instructions , Non-ELLIPTA inhaler	59 Participants	12 Participants	29 Participants	45 Participants	43 Participants
Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique Two HCP Instructions , ELLIPTA inhaler	5 Participants	2 Participants	4 Participants	8 Participants	0 Participants
Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique Three HCP Instructions , ELLIPTA inhaler	1 Participants	0 Participants	1 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 1

Population: Modified Intent-to-Treat population. Only participants who completed the questionnaire were included in the analysis.

After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from preference questionnaire. Preference questionnaire consisted of eight questions related to both inhalers used during the study. Each question had one response to choose from 3 preference options (Other inhaler device, ELLIPTA inhaler device and No preference). The number of participants who overall preferred the ELLIPTA device compared to non-ELLIPTA inhalers (First question in the preference questionnaire) were reported.

Outcome measures

Outcome measures
Measure	Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER n=170 Participants Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 2: ELLIPTA Vs MDI n=80 Participants Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 3: ELLIPTA Vs TURBUHALER n=100 Participants Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 4: ELLIPTA Vs HANDIHALER n=118 Participants Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.	Sub-study 5: ELLIPTA Vs BREEZHALER n=98 Participants Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire No preference	15 Percentage of participants	6 Percentage of participants	8 Percentage of participants	2 Percentage of participants	8 Percentage of participants
Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire Non-ELLIPTA Device Preferred	11 Percentage of participants	19 Percentage of participants	6 Percentage of participants	11 Percentage of participants	19 Percentage of participants
Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire ELLIPTA preferred	74 Percentage of participants	75 Percentage of participants	86 Percentage of participants	87 Percentage of participants	72 Percentage of participants

SECONDARY outcome

Timeframe: Day 1

Population: Modified Intent-to-Treat Population.

After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from ease of use questionnaire. Ease of use questionnaire consisted of six questions each for ELLIPTA inhaler and the other inhaler under study. Each question had one response to choose from 5 options of ease of use (Very easy, easy, neutral, difficult and very difficult). Based upon the response given by the participants the number of participants who rated ease of use higher for ELLIPTA, higher for non- ELLIPTA, or rated the same were reported