Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
BREEZHALER, DISKUS/ACCUHALER, MDI, Inhaler preference, Overall inhaler error, HANDIHALER, Ease of use, TURBUHALER, ELLIPTA, Critical inhaler error
Brief summary
This is a randomised, open-label, placebo, crossover, multicentre study with a single visit. The study will comprise five sub-studies. Subjects will receive inactive treatment (placebo) via the ELLIPTA® inhaler and one of the other inhaler devices depending on the sub-study they are randomised to. Only subjects who are naïve to the ELLIPTA inhaler and to one of the other inhaler devices that will be used in this study will be included. Furthermore, subjects who are naïve to the BREEZEHALER® and HANDIHALER® inhalers must be naïve to all other inhaler devices that requires a capsule. The study will be conducted in the UK and the Netherlands, and comprises one visit only. A sufficient number of subjects (at least 600) with COPD will be screened and 570 will be randomised to one of five sub-studies. Eligible subjects will be allocated to one of the sub-studies depending on their experience of using the other inhaler (i.e., depending on which other inhaler they are naïve to). This study is designed to assess the proportion of COPD subjects making critical and overall (i.e., critical and non-critical errors) errors in using ELLIPTA inhaler and other commercially available inhaler devices such as the TURBUHALER®, HANDIHALER, BREEZHALER, MDI and DISKUS®/ACCUHALER® inhalers. This study will also assess the 'ease of use' and preference between the ELLIPTA inhaler and the other commercially available inhaler devices. ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies. TURBUHALER is a registered trademark of AstraZeneca. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG. BREEZHALER is a registered trademark of Novartis AG.
Interventions
DEVICEELLIPTA
Dry powder inhaler (placebo) with two blister strips. One placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate.
DEVICEDISKUS/ACCUHALER
Placebo inhaler with one blister strip containing lactose monohydrate.
DEVICEMDI
Placebo inhaler containing propellant (1,1,1, 2-Tetrafluoroethane).
DEVICETURBUHALER
Placebo inhaler containing lactose monohydrate.
DEVICEHANDIHALER
Placebo inhaler containing lactose monohydrate in a capsule.
DEVICEBREEZEHALER
Placebo inhaler containing lactose monohydrate in a capsule.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent: Subject must give their signed and dated written informed consent to participate in the study; Subject understands and is willing, able, and likely to comply with study procedures and restrictions; Subject must be able to read, comprehend, and record information in Dutch and/or English. * Age: \>=40 years of age * Gender: Male or female subjects. * Primary diagnosis of COPD: subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society. Comorbidities (rheumatoid arthritis or other locomotor problems, visual impairment, and depression or anxiety) will be documented as relevant to inhaler use. * COPD treatment: All patients should be currently receiving treatment for COPD. * Must be naïve to using ELLIPTA inhaler and at least one other inhaler device. Subjects who are naïve to the BREEZEHALER and HANDIHALER inhalers must be naïve to all other inhaler devices that requires a capsule.
Exclusion criteria
* Asthma: Subjects with a current diagnosis of asthma only. Note: Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD. * Contraindications: A history of allergy or hypersensitivity to lactose/milk protein or magnesium stearate or to any other excipient. * Subjects who are currently participating in another randomised pharmacological interventional trial. * Inability to Read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire and understand verbal instructions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP | Day 1 | 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. |
| Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP | Day 1 | 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. |
| Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet | Day 1 | 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. |
| Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire | Day 1 | 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. |
| Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire | Day 1 | 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 |
| Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Day 1 | 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. |
Countries
Netherlands, United Kingdom
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Sub-study 1:ELLIPTA 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 COPD maintenance and other medication(s) during the study. | 171 |
| Sub-study 2: ELLIPTA Vs 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. | 80 |
| 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. | 100 |
| 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. | 118 |
| 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. | 98 |
| Total | 567 |
Baseline characteristics
| Characteristic | Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | Sub-study 2: ELLIPTA Vs MDI | Sub-study 3: ELLIPTA Vs TURBUHALER | Sub-study 4: ELLIPTA Vs HANDIHALER | Sub-study 5: ELLIPTA Vs BREEZHALER | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 67.8 Years STANDARD_DEVIATION 7.41 | 65.6 Years STANDARD_DEVIATION 8.76 | 68.1 Years STANDARD_DEVIATION 8.66 | 67.3 Years STANDARD_DEVIATION 8.98 | 67.2 Years STANDARD_DEVIATION 8.17 | 67.3 Years STANDARD_DEVIATION 8.31 |
| Race/Ethnicity, Customized African American/African Heritage | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 171 Participants | 78 Participants | 99 Participants | 118 Participants | 96 Participants | 562 Participants |
| Sex/Gender, Customized Female | 67 Participants | 26 Participants | 33 Participants | 46 Participants | 51 Participants | 223 Participants |
| Sex/Gender, Customized Male | 103 Participants | 53 Participants | 67 Participants | 72 Participants | 47 Participants | 342 Participants |
| Sex/Gender, Customized Unknown | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 171 | 0 / 80 | 0 / 100 | 0 / 118 | 0 / 98 |
| serious Total, serious adverse events | 0 / 171 | 0 / 80 | 0 / 100 | 0 / 118 | 0 / 98 |
Outcome results
Primary
Percentage of Participants Who Made at Least One Critical Error After Reading the 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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | 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 |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet | Error with both inhalers | 4 Percentage of participants |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | 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 |
| Sub-study 2: ELLIPTA Vs MDI | Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet | Error with only non-ELLIPTA inhaler | 51 Percentage of participants |
| Sub-study 2: ELLIPTA Vs MDI | Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet | Error with only ELLIPTA inhaler | 4 Percentage of participants |
| Sub-study 2: ELLIPTA Vs MDI | Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet | Error with both inhalers | 9 Percentage of participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet | Error with only non-ELLIPTA inhaler | 37 Percentage of participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet | Error with only ELLIPTA inhaler | 1 Percentage of participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet | Error with both inhalers | 7 Percentage of participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet | Error with only ELLIPTA inhaler | 4 Percentage of participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet | Error with both inhalers | 10 Percentage of participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet | Error with only non-ELLIPTA inhaler | 38 Percentage of participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet | Error with only non-ELLIPTA inhaler | 41 Percentage of participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet | Error with only ELLIPTA inhaler | 8 Percentage of participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet | Error with both inhalers | 5 Percentage of participants |
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique
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.
Time frame: Day 1
Population: Modified Intent-to-Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Zero HCP Instructions , ELLIPTA inhaler | 119 Participants |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Zero HCP Instructions , Non-ELLIPTA inhaler | 59 Participants |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | One HCP Instructions , ELLIPTA inhaler | 45 Participants |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | One HCP Instructions , Non-ELLIPTA inhaler | 85 Participants |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Two HCP Instructions , ELLIPTA inhaler | 5 Participants |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Two HCP Instructions , Non-ELLIPTA inhaler | 19 Participants |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Three HCP Instructions , ELLIPTA inhaler | 1 Participants |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Three HCP Instructions , Non-ELLIPTA inhaler | 4 Participants |
| Sub-study 2: ELLIPTA Vs MDI | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | One HCP Instructions , ELLIPTA inhaler | 22 Participants |
| Sub-study 2: ELLIPTA Vs MDI | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Two HCP Instructions , Non-ELLIPTA inhaler | 12 Participants |
| Sub-study 2: ELLIPTA Vs MDI | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Zero HCP Instructions , ELLIPTA inhaler | 55 Participants |
| Sub-study 2: ELLIPTA Vs MDI | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | One HCP Instructions , Non-ELLIPTA inhaler | 48 Participants |
| Sub-study 2: ELLIPTA Vs MDI | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Zero HCP Instructions , Non-ELLIPTA inhaler | 12 Participants |
| Sub-study 2: ELLIPTA Vs MDI | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Three HCP Instructions , Non-ELLIPTA inhaler | 2 Participants |
| Sub-study 2: ELLIPTA Vs MDI | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Two HCP Instructions , ELLIPTA inhaler | 2 Participants |
| Sub-study 2: ELLIPTA Vs MDI | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Three HCP Instructions , ELLIPTA inhaler | 0 Participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Three HCP Instructions , ELLIPTA inhaler | 1 Participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Three HCP Instructions , Non-ELLIPTA inhaler | 1 Participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | One HCP Instructions , Non-ELLIPTA inhaler | 52 Participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Two HCP Instructions , Non-ELLIPTA inhaler | 11 Participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | One HCP Instructions , ELLIPTA inhaler | 25 Participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Zero HCP Instructions , Non-ELLIPTA inhaler | 29 Participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Zero HCP Instructions , ELLIPTA inhaler | 69 Participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Two HCP Instructions , ELLIPTA inhaler | 4 Participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Zero HCP Instructions , Non-ELLIPTA inhaler | 45 Participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | One HCP Instructions , ELLIPTA inhaler | 38 Participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | One HCP Instructions , Non-ELLIPTA inhaler | 44 Participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Two HCP Instructions , ELLIPTA inhaler | 8 Participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Two HCP Instructions , Non-ELLIPTA inhaler | 13 Participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Three HCP Instructions , Non-ELLIPTA inhaler | 6 Participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Zero HCP Instructions , ELLIPTA inhaler | 67 Participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Three HCP Instructions , ELLIPTA inhaler | 3 Participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | One HCP Instructions , Non-ELLIPTA inhaler | 40 Participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Three HCP Instructions , Non-ELLIPTA inhaler | 4 Participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | One HCP Instructions , ELLIPTA inhaler | 28 Participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Three HCP Instructions , ELLIPTA inhaler | 2 Participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Zero HCP Instructions , ELLIPTA inhaler | 68 Participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Two HCP Instructions , Non-ELLIPTA inhaler | 8 Participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Zero HCP Instructions , Non-ELLIPTA inhaler | 43 Participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique | Two HCP Instructions , ELLIPTA inhaler | 0 Participants |
p-value: <0.001Wilcoxon signed rank test
p-value: <0.001Wilcoxon signed rank test
p-value: <0.001Wilcoxon signed rank test
p-value: <0.001Wilcoxon signed rank test
p-value: <0.001Wilcoxon signed rank test
Secondary
Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP
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.
Time frame: Day 1
Population: Modified Intent-to-Treat Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | 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 |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | 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 |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | 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 |
| Sub-study 2: ELLIPTA Vs MDI | Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP | Error with only non-ELLIPTA inhaler | 15 Percentage of participants |
| Sub-study 2: ELLIPTA Vs MDI | Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP | Error with only ELLIPTA inhaler | 4 Percentage of participants |
| Sub-study 2: ELLIPTA Vs MDI | Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP | Error with both inhalers | 0 Percentage of participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP | Error with only non-ELLIPTA inhaler | 10 Percentage of participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP | Error with only ELLIPTA inhaler | 0 Percentage of participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP | Error with both inhalers | 1 Percentage of participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP | Error with only ELLIPTA inhaler | 0 Percentage of participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP | Error with both inhalers | 2 Percentage of participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP | Error with only non-ELLIPTA inhaler | 17 Percentage of participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP | Error with only non-ELLIPTA inhaler | 11 Percentage of participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP | Error with only ELLIPTA inhaler | 1 Percentage of participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP | Error with both inhalers | 0 Percentage of participants |
p-value: 0.48Cochran-Mantel-Haenszel
p-value: 0.044Cochran-Mantel-Haenszel
p-value: 0.025Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: 0.014Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP
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.
Time frame: Day 1
Population: Modified Intent-to-Treat Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | 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 |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP | Error with both inhalers | 4 Percentage of participants |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | 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 |
| Sub-study 2: ELLIPTA Vs MDI | Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP | Error with only non-ELLIPTA inhaler | 24 Percentage of participants |
| Sub-study 2: ELLIPTA Vs MDI | Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP | Error with only ELLIPTA inhaler | 3 Percentage of participants |
| Sub-study 2: ELLIPTA Vs MDI | Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP | Error with both inhalers | 1 Percentage of participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP | Error with only non-ELLIPTA inhaler | 15 Percentage of participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP | Error with only ELLIPTA inhaler | 2 Percentage of participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP | Error with both inhalers | 4 Percentage of participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP | Error with only ELLIPTA inhaler | 3 Percentage of participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP | Error with both inhalers | 8 Percentage of participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP | Error with only non-ELLIPTA inhaler | 17 Percentage of participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP | Error with only non-ELLIPTA inhaler | 15 Percentage of participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP | Error with only ELLIPTA inhaler | 2 Percentage of participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP | Error with both inhalers | 0 Percentage of participants |
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: 0.002Cochran-Mantel-Haenszel
p-value: 0.001Cochran-Mantel-Haenszel
p-value: 0.003Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet
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.
Time frame: Day 1
Population: Modified Intent-to-Treat Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | 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 |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet | Error with both inhalers | 20 Percentage of participants |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | 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 |
| Sub-study 2: ELLIPTA Vs MDI | Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet | Error with only non-ELLIPTA inhaler | 55 Percentage of participants |
| Sub-study 2: ELLIPTA Vs MDI | Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet | Error with only ELLIPTA inhaler | 1 Percentage of participants |
| Sub-study 2: ELLIPTA Vs MDI | Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet | Error with both inhalers | 30 Percentage of participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | 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 |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet | Error with only ELLIPTA inhaler | 5 Percentage of participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet | Error with both inhalers | 26 Percentage of participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | 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 |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet | Error with both inhalers | 33 Percentage of participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet | Error with only non-ELLIPTA inhaler | 29 Percentage of participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet | Error with only non-ELLIPTA inhaler | 34 Percentage of participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet | Error with only ELLIPTA inhaler | 8 Percentage of participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet | Error with both inhalers | 22 Percentage of participants |
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire
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
Time frame: Day 1
Population: Modified Intent-to-Treat Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire | RATED HIGHER FOR ELLIPTA | 66 Percentage of participants |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire | RATED SAME FOR BOTH TYPES | 29 Percentage of participants |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire | RATED HIGHER FOR NON-ELLIPTA DEVICES | 5 Percentage of participants |
| Sub-study 2: ELLIPTA Vs MDI | Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire | RATED HIGHER FOR NON-ELLIPTA DEVICES | 10 Percentage of participants |
| Sub-study 2: ELLIPTA Vs MDI | Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire | RATED HIGHER FOR ELLIPTA | 66 Percentage of participants |
| Sub-study 2: ELLIPTA Vs MDI | Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire | RATED SAME FOR BOTH TYPES | 24 Percentage of participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire | RATED HIGHER FOR NON-ELLIPTA DEVICES | 4 Percentage of participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire | RATED HIGHER FOR ELLIPTA | 72 Percentage of participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire | RATED SAME FOR BOTH TYPES | 24 Percentage of participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire | RATED HIGHER FOR ELLIPTA | 78 Percentage of participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire | RATED SAME FOR BOTH TYPES | 20 Percentage of participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire | RATED HIGHER FOR NON-ELLIPTA DEVICES | 2 Percentage of participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire | RATED HIGHER FOR NON-ELLIPTA DEVICES | 12 Percentage of participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire | RATED HIGHER FOR ELLIPTA | 65 Percentage of participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire | RATED SAME FOR BOTH TYPES | 22 Percentage of participants |
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire
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.
Time frame: Day 1
Population: Modified Intent-to-Treat population. Only participants who completed the questionnaire were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | 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 |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | 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 |
| Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER | 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 |
| Sub-study 2: ELLIPTA Vs MDI | Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire | Non-ELLIPTA Device Preferred | 19 Percentage of participants |
| Sub-study 2: ELLIPTA Vs MDI | Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire | ELLIPTA preferred | 75 Percentage of participants |
| Sub-study 2: ELLIPTA Vs MDI | Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire | No preference | 6 Percentage of participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire | Non-ELLIPTA Device Preferred | 6 Percentage of participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire | ELLIPTA preferred | 86 Percentage of participants |
| Sub-study 3: ELLIPTA Vs TURBUHALER | Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire | No preference | 8 Percentage of participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire | ELLIPTA preferred | 87 Percentage of participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire | No preference | 2 Percentage of participants |
| Sub-study 4: ELLIPTA Vs HANDIHALER | 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 |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire | Non-ELLIPTA Device Preferred | 19 Percentage of participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire | ELLIPTA preferred | 72 Percentage of participants |
| Sub-study 5: ELLIPTA Vs BREEZHALER | Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire | No preference | 8 Percentage of participants |
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel