Asthma
Conditions
Keywords
ELLIPTA, BREEZHALER, Dry powder inhaler, Asthma
Brief summary
This study aims to provide data in adult participants with mild to moderate asthma to assist healthcare professionals (HCPs) in assessing various attributes of ELLIPTA and BREEZHALER DPIs, by comparing the incidence of critical and overall errors, participant preference, willingness to continue with the inhaler and time to correct use. ELLIPTA® is a registered trademark of GlaxoSmithKline (GSK) and BREEZHALER® is a registered trademark of Novartis.
Interventions
DEVICEELLIPTA
* ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 1 * ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 2 * BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 1 * BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 2
DEVICEBREEZHALER
* ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 1 * ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 2 * BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 1 * BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 2
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
The study will be a randomized, multi-center, open label, placebo- controlled device handling study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must be aged 18 years or older at the time of signing the informed consent. * Participants who have a confirmed mild or moderate asthma diagnosis as per Global Initiative for Asthma (GINA), 2020. * Participants must be on asthma maintenance therapy (Inhaled corticosteroids \[ICS\] or ICS/ Long acting beta 2-agonist \[LABA\]) for at least 12 weeks prior to study participation. * Participants must be naïve to both the ELLIPTA and BREEZHALER inhalers. * Females who are not pregnant or not planning a pregnancy during the study or not Lactating. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria
* Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other respiratory disorders. * History of hypersensitivity to any components of the study inhaler (e.g., lactose). In addition, participants with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation will also be excluded. * Historical or current evidence of clinically significant or rapidly progressing or unstable disease that, in the opinion of the investigator, would put the safety of the participant at risk through participation, or which would affect the analysis if the disease/condition exacerbated during the study. * Drug/alcohol abuse: Participants with a known or suspected alcohol or drug abuse, which in the opinion of the investigator could interfere with the participant's proper completion of the protocol requirement. * A participant will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator, as well as employees of GSK or Novartis. * Inability to Read: In the opinion of the investigator, any participant who is unable to read and/or would not be able to complete a questionnaire and understand verbal instructions. * Medical and physical conditions that in the opinion of the investigator could impact the ability of the participant to manipulate the inhaler.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL) | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Making at Least One Overall Error After Reading PIL | Day 1 | 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. |
| Percentage of Participants Making at Least One Overall Error After Receiving Further Instructions (up to 3) From the HCP | Day 1 | 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. |
| Number of Critical and Overall Errors Made by Participants After Reading PIL and After Receiving Further Instructions (up to 3) From HCP | Day 1 | 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. |
| Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use | Day 1 | 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. |
| Time Taken to Demonstrate Inhaler Use After Reading PIL Without HCP Intervention (T1) | Day 1 | 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. |
| Percentage of Participants Making at Least One Critical Error After Receiving Further Instructions (up to 3) From HCP | Day 1 | 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. |
| Total Time Taken for Demonstration of Correct Use After Reading PIL (T1+T2) | Day 1 | 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. |
| 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') | Day 1 | 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. |
| Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Easy' and 'Difficult') | Day 1 | 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 |
| Visual Analogue Scale (VAS) for the Assessment of Participants Willingness to Continue With the Inhaler | Day 1 | 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. |
| Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Day 1 | 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). |
| Time Taken to Give Instructions by HCP on the Use of Inhaler and to Demonstrate the Correct Inhaler Use (T2) | Day 1 | 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. |
Countries
Netherlands
Participant flow
Recruitment details
This was a multicenter study conducted across 3 centers in the Netherlands.
Pre-assignment details
A total of 114 participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| 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. | 29 |
| 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. | 28 |
| 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. | 28 |
| Total | 114 |
Baseline characteristics
| Characteristic | ELLIPTA/ BREEZHALER/Questionnaire Version 1 | ELLIPTA/ BREEZHALER/Questionnaire Version 2 | BREEZHALER/ ELLIPTA/Questionnaire Version 1 | BREEZHALER/ ELLIPTA/Questionnaire Version 2 | Total |
|---|---|---|---|---|---|
| Age, Customized <=18 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Customized 19-64 years | 18 Participants | 17 Participants | 18 Participants | 21 Participants | 74 Participants |
| Age, Customized >=65 years | 10 Participants | 12 Participants | 10 Participants | 7 Participants | 39 Participants |
| Race/Ethnicity, Customized ASIAN - SOUTH EAST ASIAN HERITAGE | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized MIXED RACE | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized WHITE - ARABIC/NORTH AFRICAN HERITAGE | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE | 28 Participants | 28 Participants | 28 Participants | 25 Participants | 109 Participants |
| Sex: Female, Male Female | 21 Participants | 12 Participants | 15 Participants | 17 Participants | 65 Participants |
| Sex: Female, Male Male | 8 Participants | 17 Participants | 13 Participants | 11 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 114 | 0 / 114 |
| other Total, other adverse events | 0 / 114 | 0 / 114 |
| serious Total, serious adverse events | 0 / 114 | 0 / 114 |
Outcome results
Primary
Percentage of Participants Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL)
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.
Time frame: Day 1
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELLIPTA DPI | Percentage of Participants Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL) | 6 Percentage of participants |
| BREEZHALER DPI | Percentage of Participants Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL) | 26 Percentage of participants |
p-value: <0.00195% CI: [0.01, 0.4]Exact conditional logistic regression
Secondary
Number of Critical and Overall Errors Made by Participants After Reading PIL and After Receiving Further Instructions (up to 3) From HCP
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.
Time frame: Day 1
Population: Modified intention-to-treat (mITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| BREEZHALER DPI | 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 |
| BREEZHALER DPI | 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 | 47 Errors |
| BREEZHALER DPI | 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 | 121 Errors |
| BREEZHALER DPI | 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 | 8 Errors |
| BREEZHALER DPI | 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 | 3 Errors |
| BREEZHALER DPI | 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 |
| BREEZHALER DPI | 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 | 18 Errors |
| BREEZHALER DPI | 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 |
Secondary
Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Easy' and 'Difficult')
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
Time frame: Day 1
Population: Modified intention-to-treat (mITT) Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| BREEZHALER DPI | 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 | 84 Participants |
| BREEZHALER DPI | 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 | 59 Participants |
| BREEZHALER DPI | 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 | 68 Participants |
| BREEZHALER DPI | 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 | 55 Participants |
| BREEZHALER DPI | 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 | 50 Participants |
| BREEZHALER DPI | 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 | 82 Participants |
| BREEZHALER DPI | 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 | 46 Participants |
| BREEZHALER DPI | 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 | 32 Participants |
| BREEZHALER DPI | 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 | 30 Participants |
| BREEZHALER DPI | 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 | 69 Participants |
| BREEZHALER DPI | 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 | 64 Participants |
| BREEZHALER DPI | 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 | 45 Participants |
Secondary
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')
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.
Time frame: Day 1
Population: Modified intention-to-treat (mITT) Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| BREEZHALER DPI | 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 | 0 Participants |
| BREEZHALER DPI | 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 | 18 Participants |
| BREEZHALER DPI | 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 | 41 Participants |
| BREEZHALER DPI | 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 | 28 Participants |
| BREEZHALER DPI | 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 | 26 Participants |
| BREEZHALER DPI | 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 | 1 Participants |
| BREEZHALER DPI | 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 | 35 Participants |
| BREEZHALER DPI | 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 | 47 Participants |
| BREEZHALER DPI | 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 | 19 Participants |
| BREEZHALER DPI | 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 | 11 Participants |
| BREEZHALER DPI | 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 | 2 Participants |
| BREEZHALER DPI | 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 | 28 Participants |
| BREEZHALER DPI | 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 | 41 Participants |
| BREEZHALER DPI | 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 | 27 Participants |
| BREEZHALER DPI | 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 | 17 Participants |
| BREEZHALER DPI | 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 | 1 Participants |
| BREEZHALER DPI | 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 | 24 Participants |
| BREEZHALER DPI | 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 | 44 Participants |
| BREEZHALER DPI | 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 | 28 Participants |
| BREEZHALER DPI | 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 | 17 Participants |
| BREEZHALER DPI | 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 | 1 Participants |
| BREEZHALER DPI | 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 | 19 Participants |
| BREEZHALER DPI | 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 | 45 Participants |
| BREEZHALER DPI | 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 | 26 Participants |
| BREEZHALER DPI | 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 | 21 Participants |
| BREEZHALER DPI | 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 | 3 Participants |
| BREEZHALER DPI | 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 | 31 Participants |
| BREEZHALER DPI | 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 | 53 Participants |
| BREEZHALER DPI | 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 | 21 Participants |
| BREEZHALER DPI | 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 | 9 Participants |
Secondary
Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire
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).
Time frame: Day 1
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preferred inhaler- overall; ELLIPTA | 85 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preferred inhaler- overall;BREEZHALER | 19 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preferred inhaler- overall;No preference | 10 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preference by Number of Steps Needed;ELLIPTA | 99 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preference by Number of Steps Needed;BREEZHALER | 5 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preference by Number of Steps Needed;No preference | 10 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preference based on time needed,ELLIPTA | 90 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preference based on time needed,BREEZHALER | 6 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preference based on time needed;No preference | 18 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preference based on How Easy to Use;ELLIPTA | 94 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preference based on How Easy to Use;BREEZHALER | 11 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preference based on How Easy to Use;No preference | 9 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preference based on Size;ELLIPTA | 58 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preference based on Size;BREEZHALER | 39 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preference based on Size;No preference | 17 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preference based on Comfort;ELLIPTA | 52 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preference based on Comfort;BREEZHALER | 41 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preference based on Comfort;No preference | 21 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preference based on Ease of Opening;ELLIPTA | 80 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preference based on Ease of Opening;BREEZHALER | 13 Participants |
| ELLIPTA DPI | Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire | Preference based on Ease of Opening;No preference | 21 Participants |
Secondary
Percentage of Participants Making at Least One Critical Error After Receiving Further Instructions (up to 3) From HCP
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.
Time frame: Day 1
Population: Modified intention-to-treat (mITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| BREEZHALER DPI | Percentage of Participants Making at Least One Critical Error After Receiving Further Instructions (up to 3) From HCP | After 1st Instruction by HCP | 4 Percentage of participants |
| BREEZHALER DPI | 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 |
| BREEZHALER DPI | 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 |
Secondary
Percentage of Participants Making at Least One Overall Error After Reading PIL
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.
Time frame: Day 1
Population: Modified intention-to-treat (mITT) Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELLIPTA DPI | Percentage of Participants Making at Least One Overall Error After Reading PIL | 27 Percentage of participants |
| BREEZHALER DPI | Percentage of Participants Making at Least One Overall Error After Reading PIL | 41 Percentage of participants |
p-value: 0.00595% CI: [0.03, 0.74]Exact conditional logistic regression
Secondary
Percentage of Participants Making at Least One Overall Error After Receiving Further Instructions (up to 3) From the HCP
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.
Time frame: Day 1
Population: Modified intention-to-treat (mITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| ELLIPTA DPI | 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 |
| BREEZHALER DPI | Percentage of Participants Making at Least One Overall Error After Receiving Further Instructions (up to 3) From the HCP | After 1st Instruction by HCP | 9 Percentage of participants |
| BREEZHALER DPI | Percentage of Participants Making at Least One Overall Error After Receiving Further Instructions (up to 3) From the HCP | After 2nd Instruction by HCP | 1 Percentage of participants |
| BREEZHALER DPI | 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 |
Secondary
Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use
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.
Time frame: Day 1
Population: Modified intention-to-treat (mITT) Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ELLIPTA DPI | Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use | Zero instructions | 73 Percentage of participants |
| ELLIPTA DPI | Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use | 1st instruction | 25 Percentage of participants |
| ELLIPTA DPI | Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use | 2nd instruction | 3 Percentage of participants |
| ELLIPTA DPI | Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use | 3rd instruction | 0 Percentage of participants |
| BREEZHALER DPI | Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use | 3rd instruction | 1 Percentage of participants |
| BREEZHALER DPI | Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use | Zero instructions | 59 Percentage of participants |
| BREEZHALER DPI | Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use | 2nd instruction | 8 Percentage of participants |
| BREEZHALER DPI | Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use | 1st instruction | 32 Percentage of participants |
Secondary
Time Taken to Demonstrate Inhaler Use After Reading PIL Without HCP Intervention (T1)
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.
Time frame: Day 1
Population: Modified intention-to-treat (mITT) Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ELLIPTA DPI | Time Taken to Demonstrate Inhaler Use After Reading PIL Without HCP Intervention (T1) | 1.00 Minutes |
| BREEZHALER DPI | Time Taken to Demonstrate Inhaler Use After Reading PIL Without HCP Intervention (T1) | 2.00 Minutes |
Secondary
Time Taken to Give Instructions by HCP on the Use of Inhaler and to Demonstrate the Correct Inhaler Use (T2)
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.
Time frame: Day 1
Population: Modified intention-to-treat (mITT) Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ELLIPTA DPI | Time Taken to Give Instructions by HCP on the Use of Inhaler and to Demonstrate the Correct Inhaler Use (T2) | 0.00 Minutes |
| BREEZHALER DPI | Time Taken to Give Instructions by HCP on the Use of Inhaler and to Demonstrate the Correct Inhaler Use (T2) | 0.00 Minutes |
Secondary
Total Time Taken for Demonstration of Correct Use After Reading PIL (T1+T2)
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.
Time frame: Day 1
Population: Modified intention-to-treat (mITT) Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ELLIPTA DPI | Total Time Taken for Demonstration of Correct Use After Reading PIL (T1+T2) | 1.00 Minutes |
| BREEZHALER DPI | Total Time Taken for Demonstration of Correct Use After Reading PIL (T1+T2) | 2.00 Minutes |
Secondary
Visual Analogue Scale (VAS) for the Assessment of Participants Willingness to Continue With the Inhaler
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.
Time frame: Day 1
Population: Modified intention-to-treat (mITT) Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ELLIPTA DPI | Visual Analogue Scale (VAS) for the Assessment of Participants Willingness to Continue With the Inhaler | 79.9 Scores on a scale | Standard Deviation 24.3 |
| BREEZHALER DPI | Visual Analogue Scale (VAS) for the Assessment of Participants Willingness to Continue With the Inhaler | 52.3 Scores on a scale | Standard Deviation 30.86 |
p-value: <0.00195% CI: [21.31, 33.96]Paired samples t-test