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

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)

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).

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: Training on BF Spiromax followed by SYMBICORT Turbohaler; Device: Training on SYMBICORT Turbohaler followed by BF Spiromax

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).

• Study Type: Interventional
• Enrollment (Actual): 516
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Research in Real-Life Ltd
• Collaborators: Teva Branded Pharmaceutical Products R&D, Inc.; University of Sydney; The University of New South Wales; Woolcock Institute of Medical Research; University of Technology, Sydney
• Investigators: Principal Investigator: Sinthia Bosnic-Anticevich, PhD, University of Sydney

Publications and helpful links

General Publications

• Al-Jahdali H, Ahmed A, Al-Harbi A, Khan M, Baharoon S, Bin Salih S, Halwani R, Al-Muhsen S. Improper inhaler technique is associated with poor asthma control and frequent emergency department visits. Allergy Asthma Clin Immunol. 2013 Mar 6;9(1):8. doi: 10.1186/1710-1492-9-8.
• National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043. Erratum In: J Allergy Clin Immunol. 2008 Jun;121(6):1330.
• Gupta R, Sheikh A, Strachan DP, Anderson HR. Burden of allergic disease in the UK: secondary analyses of national databases. Clin Exp Allergy. 2004 Apr;34(4):520-6. doi: 10.1111/j.1365-2222.2004.1935.x.
• Ovchinikova L, Smith L, Bosnic-Anticevich S. Inhaler technique maintenance: gaining an understanding from the patient's perspective. J Asthma. 2011 Aug;48(6):616-24. doi: 10.3109/02770903.2011.580032. Epub 2011 May 31.
• Basheti IA, Armour CL, Bosnic-Anticevich SZ, Reddel HK. Evaluation of a novel educational strategy, including inhaler-based reminder labels, to improve asthma inhaler technique. Patient Educ Couns. 2008 Jul;72(1):26-33. doi: 10.1016/j.pec.2008.01.014. Epub 2008 Mar 7.
• Giraud V, Roche N. Misuse of corticosteroid metered-dose inhaler is associated with decreased asthma stability. Eur Respir J. 2002 Feb;19(2):246-51. doi: 10.1183/09031936.02.00218402.
• Basheti IA, Armour CL, Reddel HK, Bosnic-Anticevich SZ. Long-term maintenance of pharmacists' inhaler technique demonstration skills. Am J Pharm Educ. 2009 Apr 7;73(2):32. doi: 10.5688/aj730232.
• Beasley R, Crane J, Lai CK, Pearce N. Prevalence and etiology of asthma. J Allergy Clin Immunol. 2000 Feb;105(2 Pt 2):S466-72. doi: 10.1016/s0091-6749(00)90044-7.
• Cain WT, Cable G, Oppenheimer JJ. The ability of the community pharmacist to learn the proper actuation techniques of inhaler devices. J Allergy Clin Immunol. 2001 Dec;108(6):918-20. doi: 10.1067/mai.2001.119153.
• Hanania NA, Wittman R, Kesten S, Chapman KR. Medical personnel's knowledge of and ability to use inhaling devices. Metered-dose inhalers, spacing chambers, and breath-actuated dry powder inhalers. Chest. 1994 Jan;105(1):111-6. doi: 10.1378/chest.105.1.111.
• Haughney J, Price D, Barnes NC, Virchow JC, Roche N, Chrystyn H. Choosing inhaler devices for people with asthma: current knowledge and outstanding research needs. Respir Med. 2010 Sep;104(9):1237-45. doi: 10.1016/j.rmed.2010.04.012. Epub 2010 May 15.
• Haughney J, Price D, Kaplan A, Chrystyn H, Horne R, May N, Moffat M, Versnel J, Shanahan ER, Hillyer EV, Tunsater A, Bjermer L. Achieving asthma control in practice: understanding the reasons for poor control. Respir Med. 2008 Dec;102(12):1681-93. doi: 10.1016/j.rmed.2008.08.003. Epub 2008 Sep 23.
• Papi A, Haughney J, Virchow JC, Roche N, Palkonen S, Price D. Inhaler devices for asthma: a call for action in a neglected field. Eur Respir J. 2011 May;37(5):982-5. doi: 10.1183/09031936.00150910. No abstract available.
• Pinnock H, Thomas M, Tsiligianni I, Lisspers K, Ostrem A, Stallberg B, Yusuf O, Ryan D, Buffels J, Cals JW, Chavannes NH, Henrichsen SH, Langhammer A, Latysheva E, Lionis C, Litt J, van der Molen T, Zwar N, Williams S. The International Primary Care Respiratory Group (IPCRG) Research Needs Statement 2010. Prim Care Respir J. 2010 Jun;19 Suppl 1(Suppl 1):S1-20. doi: 10.4104/pcrj.2010.00021.
• Inhaler Error Steering Committee; Price D, Bosnic-Anticevich S, Briggs A, Chrystyn H, Rand C, Scheuch G, Bousquet J. Inhaler competence in asthma: common errors, barriers to use and recommended solutions. Respir Med. 2013 Jan;107(1):37-46. doi: 10.1016/j.rmed.2012.09.017. Epub 2012 Oct 23.
• Price DB, Thomas V, Richard Dekhuijzen PN, Bosnic-Anticevich S, Roche N, Lavorini F, Raju P, Freeman D, Nicholls C, Small IR, Sims E, Safioti G, Canvin J, Chrystyn H. Evaluation of inhaler technique and achievement and maintenance of mastery of budesonide/formoterol Spiromax(R) compared with budesonide/formoterol Turbuhaler(R) in adult patients with asthma: the Easy Low Instruction Over Time (ELIOT) study. BMC Pulm Med. 2018 Jun 28;18(1):107. doi: 10.1186/s12890-018-0665-x.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: August 7, 2015
• First Submitted That Met QC Criteria: October 5, 2015
• First Posted (Estimate): October 7, 2015

Study Record Updates

• Last Update Posted (Estimate): May 30, 2016
• Last Update Submitted That Met QC Criteria: April 27, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Asthmatic Agents; Respiratory System Agents; Budesonide, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: OR00114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Decision has not been made