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

Asthma Clinical Trial

— HCP-ELIOT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570425
• Other study ID #: OR00114
• Status: Completed
• Phase: N/A
• First received: August 7, 2015
• Last updated: October 5, 2015
• Start date: July 2014
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Research in Real-Life Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeAustralia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 462
• Est. completion date: June 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Training HCPs with a placebo Budesonide/Formoterol (BF) Spiromax® device
Training with a placebo 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.
• Training HCPs with a placebo SYMBICORT® Turbohaler device
Training with a placebo 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.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Research in Real-Life Ltd	Teva Branded Pharmaceutical Products, R&D Inc., The University of New South Wales, University of Sydney, University of Technology, Sydney, Woolcock Institute of Medical Research

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Haughney J, Price D, Kaplan A, Chrystyn H, Horne R, May N, Moffat M, Versnel J, Shanahan ER, Hillyer EV, Tunsäter 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. Review. — View Citation

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. Review. — View Citation

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. Erratum in: J Allergy Clin Immunol. 2008 Jun;121(6):1330. — View Citation

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. — View Citation

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. — View Citation

Pinnock H, Thomas M, Tsiligianni I, Lisspers K, Østrem A, Ställberg 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:S1-20. doi: 10.4104/pcrj.2010.00021. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	4 weeks	No
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.	1 week	No
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.	1 week	No
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.	4 weeks	No
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.	4 weeks	No
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.	8 weeks	No
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.	8 weeks	No
Secondary	Number of participants achieving device mastery at each level of training out of a 6 level training process as assessed by expert assessor	Number of levels required to achieve device mastery. The mean/median number of levels required to achieve device mastery between the two devices was compared by using the Mann-Whitney test	1 week	No
Secondary	Number of participants achieving device mastery at each level out of a 6 level training process after 4 weeks from baseline visit as assessed by expert assessor	Number of levels required to achieve device mastery. The mean/median number of levels required to achieve device mastery between the two devices was compared by using the Mann-Whitney test	4 weeks	No
Secondary	Number of participants achieving device mastery at each level out of a 6 level training process after 8 weeks from baseline visit as assessed by expert assessor	Number of levels required to achieve device mastery. The mean/median number of levels required to achieve device mastery between the two devices was compared by using the Mann-Whitney test; - Time taken to achieve device mastery.	8 weeks	No
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.	4 weeks	No
Secondary	Number of assessor-observed errors recalled during baseline visit by all participants	Quantity of errors made at each level	1 week	No
Secondary	Number of assessor-observed errors recalled at 4 weeks after baseline visit by all participants	Quantity of errors made at each level	4 weeks	No
Secondary	Number of assessor-observed errors recalled 8 weeks after baseline visit by all participants	Quantity of errors made at each level	8 weeks	No
Secondary	Type of participant handling errors recalled by expert assessors at baseline visit by all participants		1 week	No
Secondary	Type of participant handling errors by expert assessors 4 weeks after baseline visit by all participants		4 weeks	No
Secondary	Type of participant handling errors recalled by expert assessors 8 weeks after baseline visit by all participants		8 weeks	No
Secondary	Preference of participant device questionnaire assessed by PASAPQ Part II Q15 score	Device preference for either Spiromax or Turbohaler device	1 week	No
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	No
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	No