Trial Outcomes & Findings for A Clinical Study Assessing Critical Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA® Dry Powder Inhaler, in Comparison to Combinations of Dry Powder Inhalers Used to Provide Triple Therapy, in Patients With Chronic Obstructive Pulmonary Disease (NCT NCT02982187)
NCT ID: NCT02982187
Last Updated: 2019-10-21
Results Overview
Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. After reading the PIL for each DPI to be tested, participants demonstrated the DPI and critical errors made by the participants while using each DPI were recorded by the Healthcare Professional (HCP) on the checklists provided. Percentage of participants making at least one critical error after reading PIL were reported.
COMPLETED
PHASE4
160 participants
Day 1
2019-10-21
Participant Flow
This is a randomized, multi-center, open-label, cross-over study comparing Placebo ELLIPTA Dry Power Inhaler (DPI) with either Placebo DISKUS DPI + Placebo Handihaler or Placebo Turbuhaler plus Placebo Handihaler to assess correct inhaler use. A total of 5 centers, 3 in the Netherlands and 2 in the United Kingdom participated in the study.
A total of 160 participants were screened. Eighty were assigned to sub-study 1 and 80 to sub-study 2 according to naivety to inhalers in each sub-study. One participant in sub-study 2 withdrew consent prior to device assessment. Therefore 80 par in sub-study 1 and 79 par in sub-study 2 are included in the intent to treat population.
Participant milestones
| Measure |
ELLIPTA/DISKUS+HandiHaler/Q1
Participants received placebo via ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by preference questionnaire (PQ) 1. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
ELLIPTA/DISKUS+HandiHaler/Q2
Participants received placebo via ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
DISKUS+HandiHaler/ELLIPTA/Q1
Participants received placebo via DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1 respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
DISKUS+HandiHaler/ELLIPTA/Q2
Participants received placebo via DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ2. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
ELLIPTA/Turbuhaler+HandiHaler/Q3
Participants received placebo via ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ3. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
ELLIPTA/Turbuhaler+HandiHaler/Q4
Participants received placebo via ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ4. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
Turbuhaler+HandiHaler/ELLIPTA/Q3
Participants received placebo via Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ3. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
Turbuhaler+HandiHaler/ELLIPTA/Q4
Participants received placebo via Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ4. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
20
|
20
|
20
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
ELLIPTA/DISKUS+HandiHaler/Q1
Participants received placebo via ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by preference questionnaire (PQ) 1. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
ELLIPTA/DISKUS+HandiHaler/Q2
Participants received placebo via ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
DISKUS+HandiHaler/ELLIPTA/Q1
Participants received placebo via DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1 respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
DISKUS+HandiHaler/ELLIPTA/Q2
Participants received placebo via DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ2. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
ELLIPTA/Turbuhaler+HandiHaler/Q3
Participants received placebo via ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ3. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
ELLIPTA/Turbuhaler+HandiHaler/Q4
Participants received placebo via ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ4. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
Turbuhaler+HandiHaler/ELLIPTA/Q3
Participants received placebo via Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ3. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
Turbuhaler+HandiHaler/ELLIPTA/Q4
Participants received placebo via Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ4. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Clinical Study Assessing Critical Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA® Dry Powder Inhaler, in Comparison to Combinations of Dry Powder Inhalers Used to Provide Triple Therapy, in Patients With Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Sub Study 1: ELLIPTA vs DISKUS + HandiHaler
n=80 Participants
Participants received placebo via one of the following devices: ELLIPTA® DPI or DISKUS® DPI in combination with HANDIHALER® DPI based on the following four sequences. The sequences also include the preference questionnaire version: A (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2,followed by PQ1), B (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2,followed by PQ2), C (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2), D (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1) respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
Sub Study 2: ELLIPTA vs Turbuhaler + HandiHaler
n=79 Participants
Participants received placebo via one of the following devices: ELLIPTA DPI or TURBUHALER® DPI in combination with HANDIHALER DPI based on the following four sequences. The sequences also include the preference questionnaire version: : E (ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ3), F (Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ4), G (ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ4), H (Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ3) respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.3 Years
STANDARD_DEVIATION 8.69 • n=93 Participants
|
65.7 Years
STANDARD_DEVIATION 8.49 • n=4 Participants
|
65.0 Years
STANDARD_DEVIATION 8.60 • n=27 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
53 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Intent-to-Treat Population
Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. After reading the PIL for each DPI to be tested, participants demonstrated the DPI and critical errors made by the participants while using each DPI were recorded by the Healthcare Professional (HCP) on the checklists provided. Percentage of participants making at least one critical error after reading PIL were reported.
Outcome measures
| Measure |
Sub-study 1 : ELLIPTA
n=80 Participants
Participants were randomized to use placebo via ELLIPTA in either period 1 or 2.
|
Sub-study 1 : DISKUS + HandiHaler
n=80 Participants
Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2.
|
Sub-study 2 : ELLIPTA
n=79 Participants
Participants were randomized to use placebo via ELLIPTA in period 1 or 2.
|
Sub-study 2 : Turbuhaler + HandiHaler
n=79 Participants
Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2.
|
|---|---|---|---|---|
|
Percentage of Participants Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL)
|
9 Percentage of participants
|
75 Percentage of participants
|
9 Percentage of participants
|
73 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat Population
Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. After reading PIL for each DPI to be tested, participants demonstrated the DPI and errors made by the participants while using each DPI were recorded by the HCP on the checklists provided. If a participant made errors while demonstrating DPI, HCP provided instruction on the correct use of the DPI. The participant then repeated the demonstration of DPI use, and the HCP recorded the critical errors made on the checklists. Percentage of participants making at least one critical error after the first instruction from the HCP were reported.
Outcome measures
| Measure |
Sub-study 1 : ELLIPTA
n=80 Participants
Participants were randomized to use placebo via ELLIPTA in either period 1 or 2.
|
Sub-study 1 : DISKUS + HandiHaler
n=80 Participants
Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2.
|
Sub-study 2 : ELLIPTA
n=79 Participants
Participants were randomized to use placebo via ELLIPTA in period 1 or 2.
|
Sub-study 2 : Turbuhaler + HandiHaler
n=79 Participants
Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2.
|
|---|---|---|---|---|
|
Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP
|
1 Percentage of participants
|
9 Percentage of participants
|
3 Percentage of participants
|
14 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat Population
Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. After reading the PIL for each DPI to be tested, participants demonstrated the DPI and errors made by the participants while using each DPI were recorded by the HCP on the checklists provided. If a participant made an error while demonstrating DPI use after first instruction from the HCP, then the HCP provided instructions again on the correct use of the inhaler. The participant then demonstrated the DPI for one last time, and the HCP recorded the critical errors made on the checklists. Participants making at least one critical error after the second instruction from the HCP were reported.
Outcome measures
| Measure |
Sub-study 1 : ELLIPTA
n=80 Participants
Participants were randomized to use placebo via ELLIPTA in either period 1 or 2.
|
Sub-study 1 : DISKUS + HandiHaler
n=80 Participants
Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2.
|
Sub-study 2 : ELLIPTA
n=79 Participants
Participants were randomized to use placebo via ELLIPTA in period 1 or 2.
|
Sub-study 2 : Turbuhaler + HandiHaler
n=79 Participants
Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2.
|
|---|---|---|---|---|
|
Percentage of Participants Making at Least One Critical Error After the Second Instruction From the HCP
|
0 Percentage of participants
|
6 Percentage of participants
|
0 Percentage of participants
|
5 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat Population
Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. Overall error was defined as an error including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL. For each DPI to be tested, overall errors including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL were recorded by the HCP on the checklists provided. Percentage of participants making at least one overall error after reading the PIL were reported.
Outcome measures
| Measure |
Sub-study 1 : ELLIPTA
n=80 Participants
Participants were randomized to use placebo via ELLIPTA in either period 1 or 2.
|
Sub-study 1 : DISKUS + HandiHaler
n=80 Participants
Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2.
|
Sub-study 2 : ELLIPTA
n=79 Participants
Participants were randomized to use placebo via ELLIPTA in period 1 or 2.
|
Sub-study 2 : Turbuhaler + HandiHaler
n=79 Participants
Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2.
|
|---|---|---|---|---|
|
Percentage of Participants Making at Least One Overall Error After Reading the PIL
|
24 Percentage of participants
|
80 Percentage of participants
|
22 Percentage of participants
|
80 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat Population
For each DPI to be tested, overall errors including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL following first instruction from the HCP were recorded by the HCP on the checklists provided. Percentage of participants making at least one overall error after the first instruction from the HCP were reported.
Outcome measures
| Measure |
Sub-study 1 : ELLIPTA
n=80 Participants
Participants were randomized to use placebo via ELLIPTA in either period 1 or 2.
|
Sub-study 1 : DISKUS + HandiHaler
n=80 Participants
Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2.
|
Sub-study 2 : ELLIPTA
n=79 Participants
Participants were randomized to use placebo via ELLIPTA in period 1 or 2.
|
Sub-study 2 : Turbuhaler + HandiHaler
n=79 Participants
Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2.
|
|---|---|---|---|---|
|
Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP
|
5 Percentage of participants
|
15 Percentage of participants
|
5 Percentage of participants
|
20 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat Population
For each DPI to be tested, overall errors including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL following first, and second instruction from the HCP were recorded by the HCP on the checklists provided. Percentage of participants making at least one overall error after the second instruction from the HCP were reported. These statistics are only presented when the model has successfully converged.
Outcome measures
| Measure |
Sub-study 1 : ELLIPTA
n=80 Participants
Participants were randomized to use placebo via ELLIPTA in either period 1 or 2.
|
Sub-study 1 : DISKUS + HandiHaler
n=80 Participants
Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2.
|
Sub-study 2 : ELLIPTA
n=79 Participants
Participants were randomized to use placebo via ELLIPTA in period 1 or 2.
|
Sub-study 2 : Turbuhaler + HandiHaler
n=79 Participants
Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2.
|
|---|---|---|---|---|
|
Percentage of Participants Making at Least One Overall Error After the Second Instruction From the HCP
|
4 Percentage of participants
|
8 Percentage of participants
|
1 Percentage of participants
|
6 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat Population
In each sub-study, if the participant made error while demonstrating the use of the DPI after reading the PIL, the HCP demonstrated the correct usage instructions to the participant. The participant was then asked to demonstrate the DPI again. Any errors made were recorded by the HCP, and the same process was repeated one more time. In total, the HCP instructed the participants on the use of the DPI up to two times after which there were no assessment scheduled. Number of participants with instructions (0, 1 or 2) needed to demonstrate correct DPI use by the participants were reported.
Outcome measures
| Measure |
Sub-study 1 : ELLIPTA
n=80 Participants
Participants were randomized to use placebo via ELLIPTA in either period 1 or 2.
|
Sub-study 1 : DISKUS + HandiHaler
n=80 Participants
Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2.
|
Sub-study 2 : ELLIPTA
n=79 Participants
Participants were randomized to use placebo via ELLIPTA in period 1 or 2.
|
Sub-study 2 : Turbuhaler + HandiHaler
n=79 Participants
Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2.
|
|---|---|---|---|---|
|
Number of Participants With Instructions (0, 1 or 2 Times) From the HCP Which Are Needed to Demonstrate Correct Inhaler Use
Number of Instructions, 0
|
61 Participants
|
16 Participants
|
62 Participants
|
16 Participants
|
|
Number of Participants With Instructions (0, 1 or 2 Times) From the HCP Which Are Needed to Demonstrate Correct Inhaler Use
Number of Instructions, 1
|
15 Participants
|
52 Participants
|
13 Participants
|
47 Participants
|
|
Number of Participants With Instructions (0, 1 or 2 Times) From the HCP Which Are Needed to Demonstrate Correct Inhaler Use
Number of Instructions, 2
|
1 Participants
|
6 Participants
|
3 Participants
|
11 Participants
|
|
Number of Participants With Instructions (0, 1 or 2 Times) From the HCP Which Are Needed to Demonstrate Correct Inhaler Use
Failed to demonstrate correct use
|
3 Participants
|
6 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat Population.
For each DPI being tested, the total time taken from when participant started reading the PIL until when correct use was demonstrated (that is the time required to read PIL, and two attempts for correct use of DPI following instructions provided by the HCP ) was recorded. A participant who did not demonstrate correct use at the end of the time period was censored. The median time to demonstrate correct DPI use (minutes) is taken from the Kaplan-Meier analysis. If more than 50% of the data is censored therefore the median is not applicable.
Outcome measures
| Measure |
Sub-study 1 : ELLIPTA
n=80 Participants
Participants were randomized to use placebo via ELLIPTA in either period 1 or 2.
|
Sub-study 1 : DISKUS + HandiHaler
n=80 Participants
Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2.
|
Sub-study 2 : ELLIPTA
n=79 Participants
Participants were randomized to use placebo via ELLIPTA in period 1 or 2.
|
Sub-study 2 : Turbuhaler + HandiHaler
n=79 Participants
Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2.
|
|---|---|---|---|---|
|
The Median Time to Demonstrate Correct Inhaler Use (T1+T2)
|
2.68 Minutes
Interval 0.8 to 12.9
|
10.57 Minutes
Interval 1.5 to 42.4
|
2.58 Minutes
Interval 0.7 to 25.2
|
11.30 Minutes
Interval 3.3 to 55.8
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat Population..
For each DPI being tested, the time taken from when participant started reading the PIL until when correct use was demonstrated with no need of instructions by HCP was reported. A participant who did not demonstrate correct use at the end of the time period was censored. The median time to demonstrate correct DPI use (minutes) is taken from the Kaplan-Meier analysis. If more than 50% of the data is censored therefore the median is not applicable.
Outcome measures
| Measure |
Sub-study 1 : ELLIPTA
n=80 Participants
Participants were randomized to use placebo via ELLIPTA in either period 1 or 2.
|
Sub-study 1 : DISKUS + HandiHaler
n=80 Participants
Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2.
|
Sub-study 2 : ELLIPTA
n=79 Participants
Participants were randomized to use placebo via ELLIPTA in period 1 or 2.
|
Sub-study 2 : Turbuhaler + HandiHaler
n=79 Participants
Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2.
|
|---|---|---|---|---|
|
Time Taken to Read the PIL and Demonstrate Correct Inhaler Use (T1)
|
2.88 Minutes
Interval 0.8 to 7.2
|
NA Minutes
Interval 1.5 to 19.2
\>50% of participants were censored; therefore the median is not applicable.
|
2.78 Minutes
Interval 0.7 to 8.6
|
NA Minutes
Interval 3.3 to 15.1
\>50% of participants were censored; therefore the median is not applicable.
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat Population.
The time in minutes from when the HCP started to instruct participant for the correct use of DPI until correct use was demonstrated including maximum of two attempts only, was recorded. A participant who did not demonstrate correct use at the end of the time period was censored. Participants who demonstrated correct use after reading the PIL (T1) were included with a time of 0 for T2. The median time to demonstrate correct DPI use (minutes) is taken from the Kaplan-Meier analysis. If more than 50% of the data is censored then the median is not applicable. Participants who demonstrated correct use after reading the PIL are included with T2=0.
Outcome measures
| Measure |
Sub-study 1 : ELLIPTA
n=80 Participants
Participants were randomized to use placebo via ELLIPTA in either period 1 or 2.
|
Sub-study 1 : DISKUS + HandiHaler
n=80 Participants
Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2.
|
Sub-study 2 : ELLIPTA
n=79 Participants
Participants were randomized to use placebo via ELLIPTA in period 1 or 2.
|
Sub-study 2 : Turbuhaler + HandiHaler
n=79 Participants
Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2.
|
|---|---|---|---|---|
|
Time Taken to be Given Instruction by the HCP (up to 2 Times) on Use of the Inhaler and to Demonstrate Correct Inhaler Use (T2)
|
0.00 Minutes
Interval 0.0 to 3.3
|
2.89 Minutes
Interval 0.0 to 16.5
|
0.00 Minutes
Interval 0.0 to 6.3
|
3.12 Minutes
Interval 0.0 to 14.3
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat Population
Participants demonstrated the use of ELLIPTA, and depending on the substudy DISKUS plus HandiHaler or Turbuhaler plus Handihaler. At the end of Visit 1, participants completed specific versions of the inhaler PQ (PQ1, PQ2, PQ3 or PQ4) according to the questionnaire they were randomized to. Participants assessed the inhaler preference based on the number of steps needed to take the COPD medication. Participants checked the response from the choice of ELLIPTA, DISKUS + HandiHaler (sub-study 1), Turbuhaler + Handihaler (sub-study 2) and No Preference. Number of participants with treatment preference based on responses to the preference questionnaire were reported.
Outcome measures
| Measure |
Sub-study 1 : ELLIPTA
n=80 Participants
Participants were randomized to use placebo via ELLIPTA in either period 1 or 2.
|
Sub-study 1 : DISKUS + HandiHaler
n=79 Participants
Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2.
|
Sub-study 2 : ELLIPTA
Participants were randomized to use placebo via ELLIPTA in period 1 or 2.
|
Sub-study 2 : Turbuhaler + HandiHaler
Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Preference Based on Responses to the Preference Questionnaire, Which Considered the Number of Steps Required to Take the COPD Medication
ELLIPTA
|
71 Participants
|
72 Participants
|
—
|
—
|
|
Number of Participants With Treatment Preference Based on Responses to the Preference Questionnaire, Which Considered the Number of Steps Required to Take the COPD Medication
DISKUS + HandiHaler
|
6 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Treatment Preference Based on Responses to the Preference Questionnaire, Which Considered the Number of Steps Required to Take the COPD Medication
No Preference
|
3 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-Treat Population
Participants demonstrated the use of ELLIPTA, and depending on the substudy DISKUS plus HandiHaler or Turbuhaler plus Handihaler. At the end of Visit 1, participants completed specific versions of the inhaler PQ (PQ1, PQ2, PQ3 or PQ4) according to the questionnaire they were randomized to. Participants assessed the inhaler preference based on overall treatment preference. Participants checked the response from the choice of ELLIPTA, DISKUS + HandiHaler (sub-study 1), Turbuhaler + Handihaler (sub-study 2) and No Preference. Number of participants with treatment preference based on responses to the preference questionnaire were reported.
Outcome measures
| Measure |
Sub-study 1 : ELLIPTA
n=80 Participants
Participants were randomized to use placebo via ELLIPTA in either period 1 or 2.
|
Sub-study 1 : DISKUS + HandiHaler
n=79 Participants
Participants were randomized to use placebo via DISKUS + HANDIHALER in period 1 or 2.
|
Sub-study 2 : ELLIPTA
Participants were randomized to use placebo via ELLIPTA in period 1 or 2.
|
Sub-study 2 : Turbuhaler + HandiHaler
Participants were randomized to use placebo via TURBUHALER + HANDIHALER in period 1 or 2.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Preference Based on Responses to the Preference Questionnaire, Which Considered Overall Treatment Preference
ELLIPTA
|
65 Participants
|
66 Participants
|
—
|
—
|
|
Number of Participants With Treatment Preference Based on Responses to the Preference Questionnaire, Which Considered Overall Treatment Preference
DISKUS + HandiHaler
|
7 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Treatment Preference Based on Responses to the Preference Questionnaire, Which Considered Overall Treatment Preference
No Preference
|
8 Participants
|
10 Participants
|
—
|
—
|
Adverse Events
Sub Study 1: ELLIPTA vs DISKUS + HandiHaler
Sub Study 2: ELLIPTA vs Turbuhaler + HandiHaler
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sub Study 1: ELLIPTA vs DISKUS + HandiHaler
n=80 participants at risk
Participants received placebo via one of the following devices: ELLIPTA® DPI or DISKUS® DPI in combination with HANDIHALER® DPI based on the following four sequences. The sequences also include the preference questionnaire version: A (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2,followed by PQ1), B (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2,followed by PQ2), C (ELLIPTA in period 1 and DISKUS + HandiHaler in period 2, followed by PQ2), D (DISKUS + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ1) respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
Sub Study 2: ELLIPTA vs Turbuhaler + HandiHaler
n=79 participants at risk
Participants received placebo via one of the following devices: ELLIPTA DPI or TURBUHALER® DPI in combination with HANDIHALER DPI based on the following four sequences. The sequences also include the preference questionnaire version: : E (ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ3), F (Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ4), G (ELLIPTA in period 1 and Turbuhaler + HandiHaler in period 2, followed by PQ4), H (Turbuhaler + HandiHaler in period 1 and ELLIPTA in period 2, followed by PQ3) respectively. There was no active treatment and participants continued to take their own prescribed COPD medication for the duration of the study.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Laceration
|
1.2%
1/80 • Day 1
Intent-to-Treat Population was used to collect Adverse Events. Since all participants received placebo as treatment, data has been clubbed for all the arms. No Serious Adverse Events or deaths were reported during this study.
|
0.00%
0/79 • Day 1
Intent-to-Treat Population was used to collect Adverse Events. Since all participants received placebo as treatment, data has been clubbed for all the arms. No Serious Adverse Events or deaths were reported during this study.
|
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