A Phase 4 interventional study of ELLIPTA and BREEZHALER in Asthma, sponsored by GlaxoSmithKline. Completed at 3 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-15.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Other
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.
4,012 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's enrollment of 114 is above the median of 83 across 2,814 interventional studies indexed under Asthma.
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Exclusion Criteria:
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.
Device: ELLIPTA · Device: BREEZHALER
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.
Device: ELLIPTA · Device: BREEZHALER
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.
Device: ELLIPTA · Device: BREEZHALER
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.
Device: ELLIPTA · Device: BREEZHALER
* 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
* 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
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
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
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
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
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
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
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
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
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
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
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
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
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
This was a multicenter study conducted across 3 centers in the Netherlands.
| Milestone | ELLIPTA/ BREEZHALER/Questionnaire Version 1 | ELLIPTA/ BREEZHALER/Questionnaire Version 2 | BREEZHALER/ ELLIPTA/Questionnaire Version 1 | BREEZHALER/ ELLIPTA/Questionnaire Version 2 |
|---|---|---|---|---|
| Started | 29 | 29 | 28 | 28 |
| Completed | 29 | 29 | 28 | 28 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| Percentage of participants | ELLIPTA DPI | BREEZHALER DPI |
|---|---|---|
| Percentage of Participants Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL) | 6 | 26 |
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.
| Percentage of participants | ELLIPTA DPI | BREEZHALER DPI |
|---|---|---|
| After 1st Instruction by HCP | 1 | 4 |
| After 2nd Instruction by HCP | 0 | 0 |
| After 3rd Instruction by HCP | 0 | 0 |
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 | ELLIPTA DPI | BREEZHALER DPI |
|---|---|---|
| Percentage of Participants Making at Least One Overall Error After Reading PIL | 27 | 41 |
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.
| Percentage of participants | ELLIPTA DPI | BREEZHALER DPI |
|---|---|---|
| After 1st Instruction by HCP | 3 | 9 |
| After 2nd Instruction by HCP | 0 | 1 |
| After 3rd Instruction by HCP | 0 | 0 |
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.
| Errors | ELLIPTA DPI | BREEZHALER DPI |
|---|---|---|
| Critical Errors; After reading PIL | 7 | 47 |
| Critical Errors; After 1st instruction | 1 | 8 |
| Critical Errors; After 2nd instruction | 0 | 0 |
| Critical Errors; After 3rd instruction | 0 | 0 |
| Overall Errors; After reading PIL | 44 | 121 |
| Overall Errors; After 1st instruction | 3 | 18 |
| Overall Errors; After 2nd instruction | 0 | 3 |
| Overall Errors; After 3rd instruction | 0 | 0 |
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.
| Percentage of participants | ELLIPTA DPI | BREEZHALER DPI |
|---|---|---|
| Zero instructions | 73 | 59 |
| 1st instruction | 25 | 32 |
| 2nd instruction | 3 | 8 |
| 3rd instruction | 0 | 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.
| Minutes | ELLIPTA DPI | BREEZHALER DPI |
|---|---|---|
| Time Taken to Demonstrate Inhaler Use After Reading PIL Without HCP Intervention (T1) | 1.00 (0.00 to 2.00) | 2.00 (2.00 to 4.00) |
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.
| Minutes | ELLIPTA DPI | BREEZHALER DPI |
|---|---|---|
| Time Taken to Give Instructions by HCP on the Use of Inhaler and to Demonstrate the Correct Inhaler Use (T2) | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 2.00) |
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.
| Minutes | ELLIPTA DPI | BREEZHALER DPI |
|---|---|---|
| Total Time Taken for Demonstration of Correct Use After Reading PIL (T1+T2) | 1.00 (0.00 to 1.00) | 2.00 (2.00 to 4.00) |
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.
| Participants | ELLIPTA DPI | BREEZHALER DPI |
|---|---|---|
| Ease of use of inhaler, Very Easy | 64 | 18 |
| Ease of use of inhaler, Easy | 43 | 41 |
| Ease of use of inhaler, Neutral | 5 | 28 |
| Ease of use of inhaler, Difficult | 2 | 26 |
| Ease of use of inhaler, Very difficult | 0 | 1 |
| Ease of telling number of doses left, Very easy | 85 | 35 |
| Ease of telling number of doses left, Easy | 27 | 47 |
| Ease of telling number of doses left, Neutral | 2 | 19 |
| Ease of telling number of doses left, Difficult | 0 | 11 |
| Ease of telling number of dose left,Very difficult | 0 | 2 |
| Ease of learning how to use inhaler, Very easy | 63 | 28 |
| Ease of learning how to use inhaler, Easy | 47 | 41 |
| Ease of learning how to use inhaler, Neutral | 2 | 27 |
| Ease of learning how to use inhaler, Difficult | 2 | 17 |
| Ease of learning how to use inhaler,Very difficult | 0 | 1 |
| Ease of handling the inhaler, Very easy | 67 | 24 |
| Ease of handling the inhaler, Easy | 42 | 44 |
| Ease of handling the inhaler, Neutral | 3 | 28 |
| Ease of handling the inhaler, Difficult | 2 | 17 |
| Ease of handling the inhaler, Very difficult | 0 | 1 |
| Ease of preparing the inhaler for use,Very easy | 70 | 19 |
| Ease of preparing the inhaler for use, Easy | 42 | 45 |
| Ease of preparing the inhaler for use, Neutral | 2 | 26 |
| Ease of preparing the inhaler for use, Difficult | 0 | 21 |
| Ease of preparing the inhaler for use, Very difficult | 0 | 3 |
| Ease of holding inhaler while using, Very easy | 56 | 31 |
| Ease of holding inhaler while using, Easy | 47 | 53 |
| Ease of holding inhaler while using, Neutral | 7 | 21 |
| Ease of holding inhaler while using, Difficult | 3 | 9 |
| Ease of holding inhaler while using,Very difficult | 1 | 0 |
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
| Participants | ELLIPTA DPI | BREEZHALER DPI |
|---|---|---|
| Ease of use of inhaler, Easy | 107 | 59 |
| Ease of use of inhaler, Difficult | 7 | 55 |
| Ease of telling number of doses left,Easy | 112 | 82 |
| Ease of telling number of doses left, Difficult | 2 | 32 |
| Ease of learning how to use inhaler, Easy | 110 | 69 |
| Ease of learning how to use inhaler, Difficult | 4 | 45 |
| Ease of handling the inhaler, Easy | 109 | 68 |
| Ease of handling the inhaler, Difficult | 5 | 46 |
| Ease of preparing the inhaler for use, Easy | 112 | 64 |
| Ease of preparing the inhaler for use, Difficult | 2 | 50 |
| Ease of holding inhaler while using it, Easy | 103 | 84 |
| Ease of holding inhaler while using it, Difficult | 11 | 30 |
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.
| Scores on a scale | ELLIPTA DPI | BREEZHALER DPI |
|---|---|---|
| Visual Analogue Scale (VAS) for the Assessment of Participants Willingness to Continue With the Inhaler | 79.9 ± 24.30 | 52.3 ± 30.86 |
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).
| Participants | All Treated Participants |
|---|---|
| Preferred inhaler- overall; ELLIPTA | 85 |
| Preferred inhaler- overall;BREEZHALER | 19 |
| Preferred inhaler- overall;No preference | 10 |
| Preference by Number of Steps Needed;ELLIPTA | 99 |
| Preference by Number of Steps Needed;BREEZHALER | 5 |
| Preference by Number of Steps Needed;No preference | 10 |
| Preference based on time needed,ELLIPTA | 90 |
| Preference based on time needed,BREEZHALER | 6 |
| Preference based on time needed;No preference | 18 |
| Preference based on How Easy to Use;ELLIPTA | 94 |
| Preference based on How Easy to Use;BREEZHALER | 11 |
| Preference based on How Easy to Use;No preference | 9 |
| Preference based on Size;ELLIPTA | 58 |
| Preference based on Size;BREEZHALER | 39 |
| Preference based on Size;No preference | 17 |
| Preference based on Comfort;ELLIPTA | 52 |
| Preference based on Comfort;BREEZHALER | 41 |
| Preference based on Comfort;No preference | 21 |
| Preference based on Ease of Opening;ELLIPTA | 80 |
| Preference based on Ease of Opening;BREEZHALER | 13 |
| Preference based on Ease of Opening;No preference | 21 |
Collected over All-cause mortality, serious adverse events (SAEs) and non-serious AEs (non-SAEs) were collected on Day 1 of the study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ELLIPTA DPI | 0/114 (0%) | 0/114 (0%) | 0/114 (0%) |
| Breezhaler DPI | 0/114 (0%) | 0/114 (0%) | 0/114 (0%) |
| Age, Customized(Participants) | ELLIPTA/ BREEZHALER/Questionnaire Version 1 | ELLIPTA/ BREEZHALER/Questionnaire Version 2 | BREEZHALER/ ELLIPTA/Questionnaire Version 1 | BREEZHALER/ ELLIPTA/Questionnaire Version 2 | Total |
|---|---|---|---|---|---|
| <=18 years | 1 | 0 | 0 | 0 | 1 |
| 19-64 years | 18 | 17 | 18 | 21 | 74 |
| >=65 years | 10 | 12 | 10 | 7 | 39 |
| Sex: Female, Male(Participants) | ELLIPTA/ BREEZHALER/Questionnaire Version 1 | ELLIPTA/ BREEZHALER/Questionnaire Version 2 | BREEZHALER/ ELLIPTA/Questionnaire Version 1 | BREEZHALER/ ELLIPTA/Questionnaire Version 2 | Total |
|---|---|---|---|---|---|
| Female | 21 | 12 | 15 | 17 | 65 |
| Male | 8 | 17 | 13 | 11 | 49 |
| Race/Ethnicity, Customized(Participants) | ELLIPTA/ BREEZHALER/Questionnaire Version 1 | ELLIPTA/ BREEZHALER/Questionnaire Version 2 | BREEZHALER/ ELLIPTA/Questionnaire Version 1 | BREEZHALER/ ELLIPTA/Questionnaire Version 2 | Total |
|---|---|---|---|---|---|
| ASIAN - SOUTH EAST ASIAN HERITAGE | 0 | 1 | 0 | 1 | 2 |
| WHITE - ARABIC/NORTH AFRICAN HERITAGE | 1 | 0 | 0 | 1 | 2 |
| WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE | 28 | 28 | 28 | 25 | 109 |
| MIXED RACE | 0 | 0 | 0 | 1 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Ran from Apr 2021 to primary completion in Jul 2021, 2 months.
Results were first posted in May 2023, 1 year 10 months after primary completion.
Of 59 industry-sponsored phase 4 interventional studies under Asthma, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's 2 months is below that.
Counting every sponsor, half of 135 studies reached it within 22 months; a quarter within 11 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.