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Comparing Maintenance of Device Mastery With Turbohaler© vs. Spiromax© in Healthcare Professionals naïve to Both Devices (HCP-ELIOT)

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ClinicalTrials.gov Identifier: NCT02570425
Recruitment Status : Completed
First Posted : October 7, 2015
Results First Posted : May 30, 2016
Last Update Posted : May 30, 2016
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Research in Real-Life Ltd

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).

Condition or disease Intervention/treatment Phase
Asthma Device: Training on BF Spiromax followed by SYMBICORT Turbohaler Device: Training on SYMBICORT Turbohaler followed by BF Spiromax Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 516 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : July 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Placebo Comparator: Spiromax followed by Turbohaler
Training on BF Spiromax followed by SYMBICORT Turbohaler
Device: Training 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.

Device: Training 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.

Placebo Comparator: Turbohaler followed by Spiromax
Training on SYMBICORT Turbohaler followed by BF Spiromax
Device: Training 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.

Device: Training 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.




Primary Outcome Measures :
  1. Percentage of Participants Maintaining Correct Inhaler Technique for Spiromax Compared With Turbohaler 4 Weeks After Training as Assessed by Expert Assessor [ Time Frame: 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 Outcome Measures :
  1. Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process as Assessed by Expert Assessor [ Time Frame: 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.

  2. Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process as Assessed by Expert Assessor [ Time Frame: 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.

  3. 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 [ Time Frame: 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.

  4. 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 [ Time Frame: 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.

  5. 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 [ Time Frame: 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.

  6. 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 [ Time Frame: 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.

  7. Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor [ Time Frame: 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

  8. Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor [ Time Frame: 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

  9. Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor [ Time Frame: 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

  10. The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor [ Time Frame: 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

  11. Number of Assessor-observed Errors Recalled During Baseline Visit by All Participants [ Time Frame: 0 weeks (Visit 1) ]
    Quantity of errors made at each level recalled during baseline visit by all participants using an expert assessor

  12. Number of Assessor-observed Errors Recalled at 4 Weeks After Baseline Visit by All Participants [ Time Frame: 4 weeks ]
    Quantity of errors made at each level recalled by expert assessors at 4 weeks after baseline visit by all participants

  13. Number of Assessor-observed Errors Recalled 8 Weeks After Baseline Visit by All Participants [ Time Frame: 8 weeks ]
    Quantity of errors made at each level recalled by expert assessors at 8 weeks after baseline visit by all participants

  14. Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants [ Time Frame: 0 weeks (Visit 1) ]
  15. Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants [ Time Frame: 4 weeks ]
  16. Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants [ Time Frame: 8 weeks ]
  17. Preference of Participant Device Questionnaire Assessed by PASAPQ Part II Q15 Score [ Time Frame: 0 weeks (Visit 1) ]
    Device preference for either Spiromax or Turbohaler device at baseline assessed by PASAPQ Part II Q15 score

  18. Preference of Device Questionnaire 4 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score [ Time Frame: 4 weeks ]
    Device preference for either Spiromax or Turbohaler device 4 weeks after baseline visit assessed by PASAPQ Part II Q15 score

  19. Preference of Device Questionnaire 8 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score [ Time Frame: 8 weeks ]
    Device preference for either Spiromax or Turbohaler device 8 weeks after baseline visit assessed by PASAPQ Part II Q15 score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570425


Sponsors and Collaborators
Research in Real-Life Ltd
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
Investigators
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Principal Investigator: Sinthia Bosnic-Anticevich, PhD University of Sydney

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Research in Real-Life Ltd
ClinicalTrials.gov Identifier: NCT02570425     History of Changes
Other Study ID Numbers: OR00114
First Posted: October 7, 2015    Key Record Dates
Results First Posted: May 30, 2016
Last Update Posted: May 30, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Decision has not been made
Additional relevant MeSH terms:
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Budesonide, Formoterol Fumarate Drug Combination
Anti-Asthmatic Agents
Respiratory System Agents