Asthma
Conditions
Brief summary
This study is conducted to assess the ease of device mastery of a placebo SYMBICORT TURBOHALER vs a placebo Budesonide/Formoterol SPIROMAX device among healthcare professionals in-training (HCP).
Detailed description
The purpose of this study is to identify how intuitive devices are to use and what level of training is required to ensure that HCPs are able to demonstrate the correct technique. The two devices examined will be the SYMBICORT TURBOHALER and placebo Budesonide/Formoterol SPIROMAX device among healthcare professionals (HCP).
Interventions
DEVICETraining on BF Spiromax followed by SYMBICORT Turbohaler
Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
DEVICETraining on SYMBICORT Turbohaler followed by BF Spiromax
Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
University of Sydney
Woolcock Institute of Medical Research
University of Technology, Sydney
The University of New South Wales
Research in Real-Life Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent is obtained and dated by the participant before conducting any study related procedures. * The participant is a student that is currently enrolled in the University where the study is conducted * The participant must be willing and able to comply with study restrictions and to remain at the study site for the required duration during the study period, and willing to return to the site for the follow up evaluation as specified in this protocol. * The participant has not previously used or received training in the use of either the SPIROMAX or the TURBOHALER in the last 6 months
Exclusion criteria
* Participants will be excluded from participating in this study if they have asthma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Maintaining Correct Inhaler Technique for Spiromax Compared With Turbohaler 4 Weeks After Training as Assessed by Expert Assessor | 4 weeks | Examine if recall of device mastery is superior for the SPIROMAX inhaler as compared to the TURBOHALER after training to device mastery on both devices. The proportion of subjects achieving mastery of inhaler technique between the two inhaler devices was compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process as Assessed by Expert Assessor | 0 weeks (Visit 1) | Examined for both at the end of level 2 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate. |
| Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor | 4 weeks | Examined at the end of level 1 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate. |
| Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor | 4 weeks | Examined at the end of level 2 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate. |
| Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor | 8 weeks | Examined for both at the end of level 1 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate. |
| Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor | 8 weeks | Examined for both at the end of level 2 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate. |
| Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor | 0 weeks (Visit 1) | Number of participants achieving mastery at each level in the 6 level training process at baseline visit as assessed by expert assessor |
| Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor | 0 weeks (Visit 1) | Number of participants achieving mastery at each level in the 6 level training process after 4 weeks from baseline visit as assessed by expert assessor |
| Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor | 8 weeks | Number of participants achieving mastery at each level in the 6 level training process after 8 weeks from baseline visit as assessed by expert assessor |
| The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor | 4 weeks | Number of levels required to achieve device mastery out of a 6 level training processrequired by each patient at each visit as assessed by expert assessor |
| Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process as Assessed by Expert Assessor | 0 weeks (Visit 1) | Examined for both at the end of level 1 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate. |
| Number of Assessor-observed Errors Recalled at 4 Weeks After Baseline Visit by All Participants | 4 weeks | Quantity of errors made at each level recalled by expert assessors at 4 weeks after baseline visit by all participants |
| Number of Assessor-observed Errors Recalled 8 Weeks After Baseline Visit by All Participants | 8 weeks | Quantity of errors made at each level recalled by expert assessors at 8 weeks after baseline visit by all participants |
| Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | 0 weeks (Visit 1) | — |
| Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | 4 weeks | — |
| Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | 8 weeks | — |
| Preference of Participant Device Questionnaire Assessed by PASAPQ Part II Q15 Score | 0 weeks (Visit 1) | Device preference for either Spiromax or Turbohaler device at baseline assessed by PASAPQ Part II Q15 score |
| Preference of Device Questionnaire 4 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score | 4 weeks | Device preference for either Spiromax or Turbohaler device 4 weeks after baseline visit assessed by PASAPQ Part II Q15 score |
| Preference of Device Questionnaire 8 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score | 8 weeks | Device preference for either Spiromax or Turbohaler device 8 weeks after baseline visit assessed by PASAPQ Part II Q15 score |
| Number of Assessor-observed Errors Recalled During Baseline Visit by All Participants | 0 weeks (Visit 1) | Quantity of errors made at each level recalled during baseline visit by all participants using an expert assessor |
Participant flow
Pre-assignment details
Participants were re-randomised to either the BF Spiromax first or Symbicort Turbohaler first at each visit.
Participants by arm
| Arm | Count |
|---|---|
| SYMBICORT Turbohaler® First, Then Spiromax® Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline | 242 |
| Budesonide/Formoterol (BF) Spiromax® First, Then Turbohaler® Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device | 274 |
| Total | 516 |
Baseline characteristics
| Characteristic | Budesonide/Formoterol (BF) Spiromax® First, Then Turbohaler® | SYMBICORT Turbohaler® First, Then Spiromax® | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 274 Participants | 242 Participants | 516 Participants |
| Age, Continuous | 22.3 years STANDARD_DEVIATION 4.7 | 22.9 years STANDARD_DEVIATION 4.5 | 22.6 years STANDARD_DEVIATION 4.6 |
| Region of Enrollment Australia | 274 participants | 242 participants | 516 participants |
| Sex: Female, Male Female | 169 Participants | 146 Participants | 315 Participants |
| Sex: Female, Male Male | 105 Participants | 96 Participants | 201 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percentage of Participants Maintaining Correct Inhaler Technique for Spiromax Compared With Turbohaler 4 Weeks After Training as Assessed by Expert Assessor
Examine if recall of device mastery is superior for the SPIROMAX inhaler as compared to the TURBOHALER after training to device mastery on both devices. The proportion of subjects achieving mastery of inhaler technique between the two inhaler devices was compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYMBICORT Turbohaler® | Percentage of Participants Maintaining Correct Inhaler Technique for Spiromax Compared With Turbohaler 4 Weeks After Training as Assessed by Expert Assessor | 40 percent of participants |
| Budesonide/Formoterol (BF) Spiromax® | Percentage of Participants Maintaining Correct Inhaler Technique for Spiromax Compared With Turbohaler 4 Weeks After Training as Assessed by Expert Assessor | 64 percent of participants |
Secondary
Number of Assessor-observed Errors Recalled 8 Weeks After Baseline Visit by All Participants
Quantity of errors made at each level recalled by expert assessors at 8 weeks after baseline visit by all participants
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYMBICORT Turbohaler® | Number of Assessor-observed Errors Recalled 8 Weeks After Baseline Visit by All Participants | 296 errors |
| Budesonide/Formoterol (BF) Spiromax® | Number of Assessor-observed Errors Recalled 8 Weeks After Baseline Visit by All Participants | 175 errors |
Secondary
Number of Assessor-observed Errors Recalled at 4 Weeks After Baseline Visit by All Participants
Quantity of errors made at each level recalled by expert assessors at 4 weeks after baseline visit by all participants
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYMBICORT Turbohaler® | Number of Assessor-observed Errors Recalled at 4 Weeks After Baseline Visit by All Participants | 780 errors |
| Budesonide/Formoterol (BF) Spiromax® | Number of Assessor-observed Errors Recalled at 4 Weeks After Baseline Visit by All Participants | 367 errors |
Secondary
Number of Assessor-observed Errors Recalled During Baseline Visit by All Participants
Quantity of errors made at each level recalled during baseline visit by all participants using an expert assessor
Time frame: 0 weeks (Visit 1)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYMBICORT Turbohaler® | Number of Assessor-observed Errors Recalled During Baseline Visit by All Participants | 2540 errors |
| Budesonide/Formoterol (BF) Spiromax® | Number of Assessor-observed Errors Recalled During Baseline Visit by All Participants | 1447 errors |
Secondary
Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor
Number of participants achieving mastery at each level in the 6 level training process at baseline visit as assessed by expert assessor
Time frame: 0 weeks (Visit 1)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SYMBICORT Turbohaler® | Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor | Level 1: Intuitive Use | 20 participants |
| SYMBICORT Turbohaler® | Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor | Level 2: Patient Information Leaflet | 142 participants |
| SYMBICORT Turbohaler® | Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor | Level 3: Instructional Video | 176 participants |
| SYMBICORT Turbohaler® | Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor | Level 4: Expert Tuition | 158 participants |
| SYMBICORT Turbohaler® | Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor | Level 5: Repeat of Expert Tuition | 19 participants |
| SYMBICORT Turbohaler® | Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor | Level 6: Second Repeat of Expert Tuition | 1 participants |
| Budesonide/Formoterol (BF) Spiromax® | Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor | Level 5: Repeat of Expert Tuition | 13 participants |
| Budesonide/Formoterol (BF) Spiromax® | Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor | Level 1: Intuitive Use | 113 participants |
| Budesonide/Formoterol (BF) Spiromax® | Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor | Level 4: Expert Tuition | 116 participants |
| Budesonide/Formoterol (BF) Spiromax® | Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor | Level 2: Patient Information Leaflet | 186 participants |
| Budesonide/Formoterol (BF) Spiromax® | Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor | Level 6: Second Repeat of Expert Tuition | 1 participants |
| Budesonide/Formoterol (BF) Spiromax® | Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor | Level 3: Instructional Video | 87 participants |
Secondary
Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor
Number of participants achieving mastery at each level in the 6 level training process after 4 weeks from baseline visit as assessed by expert assessor
Time frame: 0 weeks (Visit 1)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SYMBICORT Turbohaler® | Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 1: Intuitive Use | 202 participants |
| SYMBICORT Turbohaler® | Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 2: Patient Information Leaflet | 182 participants |
| SYMBICORT Turbohaler® | Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 3: Instructional Video | 60 participants |
| SYMBICORT Turbohaler® | Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 4: Expert Tuition | 47 participants |
| SYMBICORT Turbohaler® | Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 5: Repeat of Expert Tuition | 7 participants |
| SYMBICORT Turbohaler® | Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 6: Second Repeat of Expert Tuition | 0 participants |
| Budesonide/Formoterol (BF) Spiromax® | Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 5: Repeat of Expert Tuition | 3 participants |
| Budesonide/Formoterol (BF) Spiromax® | Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 1: Intuitive Use | 317 participants |
| Budesonide/Formoterol (BF) Spiromax® | Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 4: Expert Tuition | 31 participants |
| Budesonide/Formoterol (BF) Spiromax® | Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 2: Patient Information Leaflet | 113 participants |
| Budesonide/Formoterol (BF) Spiromax® | Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 6: Second Repeat of Expert Tuition | 0 participants |
| Budesonide/Formoterol (BF) Spiromax® | Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 3: Instructional Video | 34 participants |
Secondary
Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor
Number of participants achieving mastery at each level in the 6 level training process after 8 weeks from baseline visit as assessed by expert assessor
Time frame: 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SYMBICORT Turbohaler® | Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 1: Intuitive Use | 299 participants |
| SYMBICORT Turbohaler® | Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 2: Patient Information Leaflet | 127 participants |
| SYMBICORT Turbohaler® | Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 3: Instructional Video | 16 participants |
| SYMBICORT Turbohaler® | Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 4: Expert Tuition | 14 participants |
| SYMBICORT Turbohaler® | Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 5: Repeat of Expert Tuition | 0 participants |
| SYMBICORT Turbohaler® | Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 6: Second Repeat of Expert Tuition | 0 participants |
| Budesonide/Formoterol (BF) Spiromax® | Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 5: Repeat of Expert Tuition | 0 participants |
| Budesonide/Formoterol (BF) Spiromax® | Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 1: Intuitive Use | 362 participants |
| Budesonide/Formoterol (BF) Spiromax® | Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 4: Expert Tuition | 19 participants |
| Budesonide/Formoterol (BF) Spiromax® | Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 2: Patient Information Leaflet | 63 participants |
| Budesonide/Formoterol (BF) Spiromax® | Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 6: Second Repeat of Expert Tuition | 0 participants |
| Budesonide/Formoterol (BF) Spiromax® | Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor | Level 3: Instructional Video | 20 participants |
Secondary
Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process as Assessed by Expert Assessor
Examined for both at the end of level 1 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.
Time frame: 0 weeks (Visit 1)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYMBICORT Turbohaler® | Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process as Assessed by Expert Assessor | 4 percent of participants |
| Budesonide/Formoterol (BF) Spiromax® | Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process as Assessed by Expert Assessor | 22 percent of participants |
Secondary
Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor
Examined at the end of level 1 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYMBICORT Turbohaler® | Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor | 40 percent of participants |
| Budesonide/Formoterol (BF) Spiromax® | Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor | 64 percent of participants |
Secondary
Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor
Examined for both at the end of level 1 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYMBICORT Turbohaler® | Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor | 65 percent of participants |
| Budesonide/Formoterol (BF) Spiromax® | Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor | 79 percent of participants |
Secondary
Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process as Assessed by Expert Assessor
Examined for both at the end of level 2 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.
Time frame: 0 weeks (Visit 1)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYMBICORT Turbohaler® | Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process as Assessed by Expert Assessor | 31 percent of participants |
| Budesonide/Formoterol (BF) Spiromax® | Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process as Assessed by Expert Assessor | 58 percent of participants |
Secondary
Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor
Examined at the end of level 2 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYMBICORT Turbohaler® | Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor | 77 percent of participants |
| Budesonide/Formoterol (BF) Spiromax® | Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor | 86 percent of participants |
Secondary
Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor
Examined for both at the end of level 2 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYMBICORT Turbohaler® | Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor | 93 percent of participants |
| Budesonide/Formoterol (BF) Spiromax® | Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor | 92 percent of participants |
Secondary
Preference of Device Questionnaire 4 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score
Device preference for either Spiromax or Turbohaler device 4 weeks after baseline visit assessed by PASAPQ Part II Q15 score
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYMBICORT Turbohaler® | Preference of Device Questionnaire 4 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score | 74.5 percent of participants |
| Budesonide/Formoterol (BF) Spiromax® | Preference of Device Questionnaire 4 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score | 15.5 percent of participants |
| No Preference | Preference of Device Questionnaire 4 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score | 10 percent of participants |
Secondary
Preference of Device Questionnaire 8 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score
Device preference for either Spiromax or Turbohaler device 8 weeks after baseline visit assessed by PASAPQ Part II Q15 score
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYMBICORT Turbohaler® | Preference of Device Questionnaire 8 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score | 79 percent of participants |
| Budesonide/Formoterol (BF) Spiromax® | Preference of Device Questionnaire 8 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score | 14 percent of participants |
| No Preference | Preference of Device Questionnaire 8 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score | 7 percent of participants |
Secondary
Preference of Participant Device Questionnaire Assessed by PASAPQ Part II Q15 Score
Device preference for either Spiromax or Turbohaler device at baseline assessed by PASAPQ Part II Q15 score
Time frame: 0 weeks (Visit 1)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SYMBICORT Turbohaler® | Preference of Participant Device Questionnaire Assessed by PASAPQ Part II Q15 Score | 74 percent of participants |
| Budesonide/Formoterol (BF) Spiromax® | Preference of Participant Device Questionnaire Assessed by PASAPQ Part II Q15 Score | 16 percent of participants |
| No Preference | Preference of Participant Device Questionnaire Assessed by PASAPQ Part II Q15 Score | 10 percent of participants |
Secondary
The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor
Number of levels required to achieve device mastery out of a 6 level training processrequired by each patient at each visit as assessed by expert assessor
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SYMBICORT Turbohaler® | The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor | Visit 1 | 2.48 levels | Standard Deviation 1.15 |
| SYMBICORT Turbohaler® | The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor | Visit 2 | 1.57 levels | Standard Deviation 0.91 |
| SYMBICORT Turbohaler® | The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor | Visit 3 | 1.33 levels | Standard Deviation 0.73 |
| Budesonide/Formoterol (BF) Spiromax® | The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor | Visit 1 | 3.03 levels | Standard Deviation 3 |
| Budesonide/Formoterol (BF) Spiromax® | The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor | Visit 2 | 1.94 levels | Standard Deviation 1.01 |
| Budesonide/Formoterol (BF) Spiromax® | The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor | Visit 3 | 1.45 levels | Standard Deviation 0.72 |
Secondary
Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SYMBICORT Turbohaler® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Device is not held upright (±45°) during dose prep | 0 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Does not remove cap | 0 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Vigorous shaking before or after dose preparation | 19 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Inhaler not held upright (± 45°) until inhalation | 0 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Device is not held upright (±90°) during dose prep | 106 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Fails to seal lips around mouthpi | 15 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Exhales into the device before taking a dose | 23 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Puts fingers or mouth/face around air inlets | 0 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Not twisting the base until it clicks | 0 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Does not open cap | 0 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Inhalation is not as fast as possible from start | 148 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | A click is not heard when the cap is opened | 2 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Not holding device with mouthpiece cover at bottom | 6 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | A click is not heard when the cap is opened | 0 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Not holding device with mouthpiece cover at bottom | 0 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Device is not held upright (±90°) during dose prep | 0 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Device is not held upright (±45°) during dose prep | 184 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Not twisting the base until it clicks | 204 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Vigorous shaking before or after dose preparation | 8 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Exhales into the device before taking a dose | 36 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Inhalation is not as fast as possible from start | 166 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Does not remove cap | 0 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Inhaler not held upright (± 45°) until inhalation | 119 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Fails to seal lips around mouthpi | 20 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Puts fingers or mouth/face around air inlets | 43 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants | Does not open cap | 0 errors |
Secondary
Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants
Time frame: 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Device is not held upright (±45°) during dose prep | 0 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Does not remove cap | 0 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Vigorous shaking before or after dose preparation | 6 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Inhaler not held upright (± 45°) until inhalation | 0 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Device is not held upright (±90°) during dose prep | 34 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Fails to seal lips around mouthpi | 5 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Exhales into the device before taking a dose | 12 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Puts fingers or mouth/face around air inlets | 41 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Not twisting the base until it clicks | 0 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Does not open cap | 0 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Inhalation is not as fast as possible from start | 71 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | A click is not heard when the cap is opened | 0 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Not holding device with mouthpiece cover at bottom | 3 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | A click is not heard when the cap is opened | 0 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Not holding device with mouthpiece cover at bottom | 0 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Device is not held upright (±90°) during dose prep | 0 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Device is not held upright (±45°) during dose prep | 70 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Not twisting the base until it clicks | 49 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Vigorous shaking before or after dose preparation | 2 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Exhales into the device before taking a dose | 19 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Inhalation is not as fast as possible from start | 82 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Does not remove cap | 0 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Inhaler not held upright (± 45°) until inhalation | 30 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Fails to seal lips around mouthpi | 5 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Puts fingers or mouth/face around air inlets | 39 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants | Does not open cap | 0 errors |
Secondary
Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants
Time frame: 0 weeks (Visit 1)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Device is not held upright (±45°) during dose prep | 0 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Does not remove cap | 0 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Vigorous shaking before or after dose preparation | 78 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Inhaler not held upright (± 45°) until inhalation | 0 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Device is not held upright (±90°) during dose prep | 318 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Fails to seal lips around mouthpi | 131 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Exhales into the device before taking a dose | 61 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Puts fingers or mouth/face around air inlets | 105 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Not twisting the base until it clicks | 0 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Does not open cap | 28 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Inhalation is not as fast as possible from start | 613 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | A click is not heard when the cap is opened | 51 errors |
| SYMBICORT Turbohaler® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Not holding device with mouthpiece cover at bottom | 62 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | A click is not heard when the cap is opened | 0 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Not holding device with mouthpiece cover at bottom | 0 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Device is not held upright (±90°) during dose prep | 0 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Device is not held upright (±45°) during dose prep | 614 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Not twisting the base until it clicks | 557 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Vigorous shaking before or after dose preparation | 29 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Exhales into the device before taking a dose | 101 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Inhalation is not as fast as possible from start | 581 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Does not remove cap | 6 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Inhaler not held upright (± 45°) until inhalation | 402 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Fails to seal lips around mouthpi | 157 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Puts fingers or mouth/face around air inlets | 93 errors |
| Budesonide/Formoterol (BF) Spiromax® | Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants | Does not open cap | 0 errors |