Comparing Maintenance of Device Mastery With Turbohaler© vs. Spiromax© in Healthcare Professionals naïve to Both Devices

Study Overview
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Brief Summary
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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
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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).

Official Title
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THE HCP ELIOT STUDY: Comparing Maintenance of Device Mastery With TURBOHALER© vs. SPIROMAX© in Healthcare Professionals naïve to Both Devices (The Easy Low Instruction Over Time [ELIOT] Study)

Conditions
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Asthma

Intervention / Treatment
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* Device: Training on BF Spiromax followed by SYMBICORT Turbohaler
* Device: Training on SYMBICORT Turbohaler followed by BF Spiromax


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Spiromax followed by Turbohaler<br>Training on BF Spiromax followed by SYMBICORT Turbohaler | Device: Training on BF Spiromax followed by SYMBICORT Turbohaler<br>* 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.<br>Device: Training on SYMBICORT Turbohaler followed by BF Spiromax<br>* 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.<br>|
| Placebo Comparator: Turbohaler followed by Spiromax<br>Training on SYMBICORT Turbohaler followed by BF Spiromax | Device: Training on BF Spiromax followed by SYMBICORT Turbohaler<br>* 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.<br>Device: Training on SYMBICORT Turbohaler followed by BF Spiromax<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0 weeks (Visit 1) | 
| 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. | 0 weeks (Visit 1) | 
| 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. | 4 weeks | 
| 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. | 4 weeks | 
| 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. | 8 weeks | 
| 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. | 8 weeks | 
| 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 | 0 weeks (Visit 1) | 
| 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 | 0 weeks (Visit 1) | 
| 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 | 8 weeks | 
| 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 | 4 weeks | 
| 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 | 0 weeks (Visit 1) | 
| 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 | 4 weeks | 
| 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 | 8 weeks | 
| 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 | Device preference for either Spiromax or Turbohaler device at baseline assessed by PASAPQ Part II Q15 score | 0 weeks (Visit 1) | 
| 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 | 4 weeks | 
| 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 | 8 weeks |