Trial Outcomes & Findings for A Comparison of Critical Errors, Overall Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA Versus BREEZHALER Dry Powder Inhalers (DPIs) in Adult Participants With Asthma (NCT NCT04813354)
NCT ID: NCT04813354
Last Updated: 2023-05-15
Results Overview
Participants were asked to demonstrate use of their prescribed DPI on Day 1 and any error made by the participant was recorded by the health care practitioner (HCP) in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical" when an error was most likely to result in no or significantly reduced medication being inhaled. Percentage values are rounded off.
COMPLETED
PHASE4
114 participants
Day 1
2023-05-15
Participant Flow
This was a multicenter study conducted across 3 centers in the Netherlands.
A total of 114 participants were enrolled in the study.
Participant milestones
| Measure |
ELLIPTA/ BREEZHALER/Questionnaire Version 1
Participants received placebo ELLIPTA Dry Powder Inhaler (DPI) followed by placebo BREEZHALER DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and visual analogue scale (VAS) on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 1 on Day 1.
|
ELLIPTA/ BREEZHALER/Questionnaire Version 2
Participants received placebo ELLIPTA DPI followed by placebo BREEZHALER DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 2 on Day 1.
|
BREEZHALER/ ELLIPTA/Questionnaire Version 1
Participants received placebo BREEZHALER DPI followed by placebo ELLIPTA DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 1 on Day 1.
|
BREEZHALER/ ELLIPTA/Questionnaire Version 2
Participants received placebo BREEZHALER DPI followed by placebo ELLIPTA DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 2 on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
28
|
28
|
|
Overall Study
COMPLETED
|
29
|
29
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Critical Errors, Overall Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA Versus BREEZHALER Dry Powder Inhalers (DPIs) in Adult Participants With Asthma
Baseline characteristics by cohort
| Measure |
ELLIPTA/ BREEZHALER/Questionnaire Version 1
n=29 Participants
Participants received placebo ELLIPTA Dry Powder Inhaler (DPI) followed by placebo BREEZHALER DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and visual analogue scale (VAS) on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 1 on Day 1.
|
ELLIPTA/ BREEZHALER/Questionnaire Version 2
n=29 Participants
Participants received placebo ELLIPTA DPI followed by placebo BREEZHALER DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 2 on Day 1.
|
BREEZHALER/ ELLIPTA/Questionnaire Version 1
n=28 Participants
Participants received placebo BREEZHALER DPI followed by placebo ELLIPTA DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 1 on Day 1.
|
BREEZHALER/ ELLIPTA/Questionnaire Version 2
n=28 Participants
Participants received placebo BREEZHALER DPI followed by placebo ELLIPTA DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 2 on Day 1.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Customized
19-64 years
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
ASIAN - SOUTH EAST ASIAN HERITAGE
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
WHITE - ARABIC/NORTH AFRICAN HERITAGE
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
MIXED RACE
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Modified intention-to-treat (mITT) Population comprised of all participants who were randomized to study intervention in the study, completed reading of the PIL and attempted demonstration of both inhalers.
Participants were asked to demonstrate use of their prescribed DPI on Day 1 and any error made by the participant was recorded by the health care practitioner (HCP) in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical" when an error was most likely to result in no or significantly reduced medication being inhaled. Percentage values are rounded off.
Outcome measures
| Measure |
ELLIPTA DPI
n=114 Participants
Participants received placebo via the ELLIPTA DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using ELLIPTA DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
BREEZHALER DPI
n=114 Participants
Participants received placebo via the BREEZHALER DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using BREEZHALER DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
|---|---|---|
|
Percentage of Participants Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL)
|
6 Percentage of participants
|
26 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1Population: Modified intention-to-treat (mITT) Population
Participants were asked to demonstrate inhaler use after reading PIL. The errors made during demonstration by participants were defined as "critical" when an error was most likely to result in no or significantly reduced medication being inhaled. If the participant made any error according to the error checklists, the HCP provided instructions on the correct use of the inhaler to the participant and the participant was then asked to demonstrate the inhaler use again. Any error made by the participant were recorded by the HCP in the checklist. The same procedure was repeated if the participant continued to make errors in the use of the inhaler. In total, the HCP provided up to 3 instructions on the use of the inhaler. Same procedure was followed for second inhaler. Percentage of participants making at least one critical error after receiving 1st instruction, 2nd instruction and 3rd instruction from HCP were reported. Percentage values are rounded off.
Outcome measures
| Measure |
ELLIPTA DPI
n=114 Participants
Participants received placebo via the ELLIPTA DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using ELLIPTA DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
BREEZHALER DPI
n=114 Participants
Participants received placebo via the BREEZHALER DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using BREEZHALER DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
|---|---|---|
|
Percentage of Participants Making at Least One Critical Error After Receiving Further Instructions (up to 3) From HCP
After 1st Instruction by HCP
|
1 Percentage of participants
|
4 Percentage of participants
|
|
Percentage of Participants Making at Least One Critical Error After Receiving Further Instructions (up to 3) From HCP
After 2nd Instruction by HCP
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Making at Least One Critical Error After Receiving Further Instructions (up to 3) From HCP
After 3rd Instruction by HCP
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1Population: Modified intention-to-treat (mITT) Population
Participants were asked to demonstrate use of their prescribed DPI on Day 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. An overall error was any error in inhaler technique which includes a critical and non-critical error. Percentage values are rounded off.
Outcome measures
| Measure |
ELLIPTA DPI
n=114 Participants
Participants received placebo via the ELLIPTA DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using ELLIPTA DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
BREEZHALER DPI
n=114 Participants
Participants received placebo via the BREEZHALER DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using BREEZHALER DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
|---|---|---|
|
Percentage of Participants Making at Least One Overall Error After Reading PIL
|
27 Percentage of participants
|
41 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1Population: Modified intention-to-treat (mITT) Population
Participants were asked to demonstrate inhaler use after reading PIL. If the participant made any error according to the error checklists, the HCP provided instructions on the correct use of the inhaler to the participant and the participant was then asked to demonstrate the inhaler use again. Any error made by the participant were recorded by the HCP in the checklist. The same procedure was repeated if the participant continued to make errors in the use of the inhaler. In total, the HCP provided up to 3 instructions on the use of the inhaler. Same procedure was followed for second inhaler. An overall error was any error in inhaler technique which includes a critical and non-critical error. Percentage of participants making at least one overall error after receiving 1st instruction, 2nd instruction and 3rd instruction from HCP were reported. Percentage values are rounded off.
Outcome measures
| Measure |
ELLIPTA DPI
n=114 Participants
Participants received placebo via the ELLIPTA DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using ELLIPTA DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
BREEZHALER DPI
n=114 Participants
Participants received placebo via the BREEZHALER DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using BREEZHALER DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
|---|---|---|
|
Percentage of Participants Making at Least One Overall Error After Receiving Further Instructions (up to 3) From the HCP
After 1st Instruction by HCP
|
3 Percentage of participants
|
9 Percentage of participants
|
|
Percentage of Participants Making at Least One Overall Error After Receiving Further Instructions (up to 3) From the HCP
After 2nd Instruction by HCP
|
0 Percentage of participants
|
1 Percentage of participants
|
|
Percentage of Participants Making at Least One Overall Error After Receiving Further Instructions (up to 3) From the HCP
After 3rd Instruction by HCP
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1Population: Modified intention-to-treat (mITT) Population
Participants were asked to demonstrate inhaler use after reading PIL. If participant made any error according to error checklists, the HCP provided instructions on correct use of inhaler to participant and participant was then asked to demonstrate inhaler use again. Critical error was any error which most likely to result in no or significantly reduced medication being inhaled. An overall error was any error in inhaler technique, which includes a critical and non-critical. Any error made by the participant was recorded by the HCP in checklist. The same procedure was repeated if the participant continued to make errors in the use of inhaler. In total, HCP provided up to 3 time instructions on correct use of inhaler. Same procedure was followed for second inhaler. The number of critical and overall errors made by participants after reading PIL and after receiving 1st instruction, 2nd instruction and 3rd instruction from HCP were reported.
Outcome measures
| Measure |
ELLIPTA DPI
n=114 Participants
Participants received placebo via the ELLIPTA DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using ELLIPTA DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
BREEZHALER DPI
n=114 Participants
Participants received placebo via the BREEZHALER DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using BREEZHALER DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
|---|---|---|
|
Number of Critical and Overall Errors Made by Participants After Reading PIL and After Receiving Further Instructions (up to 3) From HCP
Critical Errors; After reading PIL
|
7 Errors
|
47 Errors
|
|
Number of Critical and Overall Errors Made by Participants After Reading PIL and After Receiving Further Instructions (up to 3) From HCP
Critical Errors; After 1st instruction
|
1 Errors
|
8 Errors
|
|
Number of Critical and Overall Errors Made by Participants After Reading PIL and After Receiving Further Instructions (up to 3) From HCP
Critical Errors; After 2nd instruction
|
0 Errors
|
0 Errors
|
|
Number of Critical and Overall Errors Made by Participants After Reading PIL and After Receiving Further Instructions (up to 3) From HCP
Critical Errors; After 3rd instruction
|
0 Errors
|
0 Errors
|
|
Number of Critical and Overall Errors Made by Participants After Reading PIL and After Receiving Further Instructions (up to 3) From HCP
Overall Errors; After reading PIL
|
44 Errors
|
121 Errors
|
|
Number of Critical and Overall Errors Made by Participants After Reading PIL and After Receiving Further Instructions (up to 3) From HCP
Overall Errors; After 1st instruction
|
3 Errors
|
18 Errors
|
|
Number of Critical and Overall Errors Made by Participants After Reading PIL and After Receiving Further Instructions (up to 3) From HCP
Overall Errors; After 2nd instruction
|
0 Errors
|
3 Errors
|
|
Number of Critical and Overall Errors Made by Participants After Reading PIL and After Receiving Further Instructions (up to 3) From HCP
Overall Errors; After 3rd instruction
|
0 Errors
|
0 Errors
|
SECONDARY outcome
Timeframe: Day 1Population: Modified intention-to-treat (mITT) Population
Participants were asked to demonstrate inhaler use after reading PIL. If the participant made any error according to the error checklists, the HCP provided instructions on the correct use of the inhaler to the participant and the participant was then asked to demonstrate the inhaler use again. Any error made by the participant were recorded by the HCP in the checklist. The same procedure was repeated if the participant continued to make errors in the use of the inhaler. In total, the HCP provided up to 3 times instructions on the correct use of inhaler. Same procedure was followed for second inhaler. Percentage of participants who required zero, 1st, 2nd and 3rd instruction from HCP to demonstrate correct inhaler use were reported. Percentage values are rounded off.
Outcome measures
| Measure |
ELLIPTA DPI
n=114 Participants
Participants received placebo via the ELLIPTA DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using ELLIPTA DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
BREEZHALER DPI
n=114 Participants
Participants received placebo via the BREEZHALER DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using BREEZHALER DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
|---|---|---|
|
Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use
Zero instructions
|
73 Percentage of participants
|
59 Percentage of participants
|
|
Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use
1st instruction
|
25 Percentage of participants
|
32 Percentage of participants
|
|
Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use
2nd instruction
|
3 Percentage of participants
|
8 Percentage of participants
|
|
Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use
3rd instruction
|
0 Percentage of participants
|
1 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1Population: Modified intention-to-treat (mITT) Population. Only those participants with data available at specified time points were analyzed.
Participants were asked to demonstrate inhaler use after reading PIL and any error made by the participant was recorded by the HCP in the checklist. Time taken to demonstrate inhaler use after reading PIL without HCP intervention was the amount of time taken to correctly demonstrate inhaler use without HCP intervention. T1 was calculated from the start of inhaler demonstration by the participant after reading the PIL until completion of the first attempt.
Outcome measures
| Measure |
ELLIPTA DPI
n=83 Participants
Participants received placebo via the ELLIPTA DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using ELLIPTA DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
BREEZHALER DPI
n=67 Participants
Participants received placebo via the BREEZHALER DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using BREEZHALER DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
|---|---|---|
|
Time Taken to Demonstrate Inhaler Use After Reading PIL Without HCP Intervention (T1)
|
1.00 Minutes
Interval 0.0 to 2.0
|
2.00 Minutes
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 1Population: Modified intention-to-treat (mITT) Population
Time taken by HCP to demonstrate the correct use of inhaler was the time from when the HCP started to instruct the participant until correct use was demonstrated. It includes the time used by the HCP for re-instructing the participants throughout. T2 was calculated from the first instruction provided by the HCP until demonstration of correct use. Up to 3 further attempts were made after completion of the first attempt.
Outcome measures
| Measure |
ELLIPTA DPI
n=114 Participants
Participants received placebo via the ELLIPTA DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using ELLIPTA DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
BREEZHALER DPI
n=114 Participants
Participants received placebo via the BREEZHALER DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using BREEZHALER DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
|---|---|---|
|
Time Taken to Give Instructions by HCP on the Use of Inhaler and to Demonstrate the Correct Inhaler Use (T2)
|
0.00 Minutes
Interval 0.0 to 0.0
|
0.00 Minutes
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Day 1Population: Modified intention-to-treat (mITT) Population
Participants were asked to demonstrate inhaler use after reading PIL and any error made by the participant was recorded by the HCP in the checklist. Total time taken for demonstration of correct use after reading PIL was the time from when the participant started the demonstration until correct use is demonstrated (4 attempts= once after the reading the PIL and following instruction from investigator up to 3 times). T1+T2 was calculated from the start of inhaler demonstration after reading the PIL until correct demonstration was observed.
Outcome measures
| Measure |
ELLIPTA DPI
n=114 Participants
Participants received placebo via the ELLIPTA DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using ELLIPTA DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
BREEZHALER DPI
n=114 Participants
Participants received placebo via the BREEZHALER DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using BREEZHALER DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
|---|---|---|
|
Total Time Taken for Demonstration of Correct Use After Reading PIL (T1+T2)
|
1.00 Minutes
Interval 0.0 to 1.0
|
2.00 Minutes
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 1Population: Modified intention-to-treat (mITT) Population
Participant were asked to complete the ease of use questionnaire for the DPI once error assessment of each inhaler was completed. This was a series of 6 questions (Ease of use rating, Telling how many doses were left in inhaler, Learning how to use inhaler, Handling the inhaler, Preparing inhaler and Holding inhaler while using it). Each question had one response to choose from 5 options of ease of use (Very easy, easy, neutral, difficult and very difficult). Participants were asked to rate based on their ease of use experience with device using a scale ranging from 1 (very easy) to 5 (very difficult). A higher rating indicated that the inhaler was difficult to use and a lower rating indicated that inhaler was easier to use. This questionnaire was completed for the first device before moving to the critical errors assessment of the second device. Data has been categorized and reported as 'Very easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult' with respect to each question.
Outcome measures
| Measure |
ELLIPTA DPI
n=114 Participants
Participants received placebo via the ELLIPTA DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using ELLIPTA DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
BREEZHALER DPI
n=114 Participants
Participants received placebo via the BREEZHALER DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using BREEZHALER DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
|---|---|---|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of use of inhaler, Very Easy
|
64 Participants
|
18 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of use of inhaler, Easy
|
43 Participants
|
41 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of use of inhaler, Neutral
|
5 Participants
|
28 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of use of inhaler, Difficult
|
2 Participants
|
26 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of use of inhaler, Very difficult
|
0 Participants
|
1 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of telling number of doses left, Very easy
|
85 Participants
|
35 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of telling number of doses left, Easy
|
27 Participants
|
47 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of telling number of doses left, Neutral
|
2 Participants
|
19 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of telling number of doses left, Difficult
|
0 Participants
|
11 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of telling number of dose left,Very difficult
|
0 Participants
|
2 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of learning how to use inhaler, Very easy
|
63 Participants
|
28 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of learning how to use inhaler, Easy
|
47 Participants
|
41 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of learning how to use inhaler, Neutral
|
2 Participants
|
27 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of learning how to use inhaler, Difficult
|
2 Participants
|
17 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of learning how to use inhaler,Very difficult
|
0 Participants
|
1 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of handling the inhaler, Very easy
|
67 Participants
|
24 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of handling the inhaler, Easy
|
42 Participants
|
44 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of handling the inhaler, Neutral
|
3 Participants
|
28 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of handling the inhaler, Difficult
|
2 Participants
|
17 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of handling the inhaler, Very difficult
|
0 Participants
|
1 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of preparing the inhaler for use,Very easy
|
70 Participants
|
19 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of preparing the inhaler for use, Easy
|
42 Participants
|
45 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of preparing the inhaler for use, Neutral
|
2 Participants
|
26 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of preparing the inhaler for use, Difficult
|
0 Participants
|
21 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of preparing the inhaler for use, Very difficult
|
0 Participants
|
3 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of holding inhaler while using, Very easy
|
56 Participants
|
31 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of holding inhaler while using, Easy
|
47 Participants
|
53 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of holding inhaler while using, Neutral
|
7 Participants
|
21 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of holding inhaler while using, Difficult
|
3 Participants
|
9 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')
Ease of holding inhaler while using,Very difficult
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Modified intention-to-treat (mITT) Population
The ease-of-use questionnaire consists of a series of 6 questions (Ease of use rating, Telling how many doses were left in inhaler, Learning how to use inhaler, Handling inhaler, Preparing inhaler and Holding inhaler while using it). Each question had one response to choose from 5 options of ease of use(Very easy, easy, neutral, difficult and very difficult). Participants were asked to rate based on their ease of use experience with device using a scale ranging from 1(very easy) to 5(very difficult). A higher rating indicated that inhaler was difficult to use and a lower rating indicated that inhaler was easy to use. This questionnaire was completed for first device before moving to critical errors assessment of second device. Participant who responded Very Easy or Easy was considered Easy and participant who responded Neutral, Difficult or Very Difficult was considered Difficult. Data has been categorized and reported as Easy and Difficult with respect to each question
Outcome measures
| Measure |
ELLIPTA DPI
n=114 Participants
Participants received placebo via the ELLIPTA DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using ELLIPTA DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
BREEZHALER DPI
n=114 Participants
Participants received placebo via the BREEZHALER DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using BREEZHALER DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
|---|---|---|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Easy' and 'Difficult')
Ease of use of inhaler, Easy
|
107 Participants
|
59 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Easy' and 'Difficult')
Ease of use of inhaler, Difficult
|
7 Participants
|
55 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Easy' and 'Difficult')
Ease of telling number of doses left,Easy
|
112 Participants
|
82 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Easy' and 'Difficult')
Ease of telling number of doses left, Difficult
|
2 Participants
|
32 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Easy' and 'Difficult')
Ease of learning how to use inhaler, Easy
|
110 Participants
|
69 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Easy' and 'Difficult')
Ease of learning how to use inhaler, Difficult
|
4 Participants
|
45 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Easy' and 'Difficult')
Ease of handling the inhaler, Easy
|
109 Participants
|
68 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Easy' and 'Difficult')
Ease of handling the inhaler, Difficult
|
5 Participants
|
46 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Easy' and 'Difficult')
Ease of preparing the inhaler for use, Easy
|
112 Participants
|
64 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Easy' and 'Difficult')
Ease of preparing the inhaler for use, Difficult
|
2 Participants
|
50 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Easy' and 'Difficult')
Ease of holding inhaler while using it, Easy
|
103 Participants
|
84 Participants
|
|
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Easy' and 'Difficult')
Ease of holding inhaler while using it, Difficult
|
11 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Modified intention-to-treat (mITT) Population
Participants were asked the question regarding their willingness to continue with the inhaler using a visual analogue scale ranging from 0 (not willing) to 100 (definitely willing) after completion of the critical errors assessment for each inhaler and the ease of use questionnaire for that inhaler. Participants marked on the VAS scale, how willing they were to continue using the inhaler. That mark was measured with a ruler to determine the numerical score. It ranges from 0 to 100 where, higher score on the scale indicates better outcome, means participant was definitely willing to continue using the inhaler.
Outcome measures
| Measure |
ELLIPTA DPI
n=114 Participants
Participants received placebo via the ELLIPTA DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using ELLIPTA DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
BREEZHALER DPI
n=114 Participants
Participants received placebo via the BREEZHALER DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using BREEZHALER DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
|---|---|---|
|
Visual Analogue Scale (VAS) for the Assessment of Participants Willingness to Continue With the Inhaler
|
79.9 Scores on a scale
Standard Deviation 24.30
|
52.3 Scores on a scale
Standard Deviation 30.86
|
SECONDARY outcome
Timeframe: Day 1Population: Modified intention-to-treat (mITT) Population. Data has been presented for All treated participants in a single arm as the intent of this endpoint was to assess the participant's preference to the inhaler (among both the inhalers) that was used.
Participants were asked to complete the assigned preference questionnaires after completing the errors in use assessment for both devices. Participants were asked to provide their responses in terms of their preference to the ELLIPTA inhaler or BREEZHALER inhaler or No preference. Participants preference was assessed using series of 7 questions (Preferred inhaler-overall, Preference based on the number of steps to take the medication, Preference based on the time needed to take the medication, Preference based on how easy the inhaler was to use, Preference based on the size of the inhaler, Preference based on the comfort of the mouthpiece and Preference based on the ease of opening the inhaler). Participants had to choose one response from 3 preference options (ELLIPTA inhaler or BREEZHALER inhaler or No preference).
Outcome measures
| Measure |
ELLIPTA DPI
n=114 Participants
Participants received placebo via the ELLIPTA DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using ELLIPTA DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
BREEZHALER DPI
Participants received placebo via the BREEZHALER DPI on Day 1 of the study. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using BREEZHALER DPI. Participants also completed preference questionnaire version 1 or 2 after completing the ease-of-use questionnaire and VAS on Day 1.
|
|---|---|---|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preferred inhaler- overall; ELLIPTA
|
85 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preferred inhaler- overall;BREEZHALER
|
19 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preferred inhaler- overall;No preference
|
10 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preference by Number of Steps Needed;ELLIPTA
|
99 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preference by Number of Steps Needed;BREEZHALER
|
5 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preference by Number of Steps Needed;No preference
|
10 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preference based on time needed,ELLIPTA
|
90 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preference based on time needed,BREEZHALER
|
6 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preference based on time needed;No preference
|
18 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preference based on How Easy to Use;ELLIPTA
|
94 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preference based on How Easy to Use;BREEZHALER
|
11 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preference based on How Easy to Use;No preference
|
9 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preference based on Size;ELLIPTA
|
58 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preference based on Size;BREEZHALER
|
39 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preference based on Size;No preference
|
17 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preference based on Comfort;ELLIPTA
|
52 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preference based on Comfort;BREEZHALER
|
41 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preference based on Comfort;No preference
|
21 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preference based on Ease of Opening;ELLIPTA
|
80 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preference based on Ease of Opening;BREEZHALER
|
13 Participants
|
—
|
|
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
Preference based on Ease of Opening;No preference
|
21 Participants
|
—
|
Adverse Events
ELLIPTA DPI
Breezhaler DPI
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER