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

NCT02570425 | Completed Results DMC

• 1 other identifier: OR00114
• Study Type: interventional
• Target: 516
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• 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)

• 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)

• 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

• 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

• 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

Study Arms (2)

Spiromax followed by Turbohaler

PLACEBO COMPARATOR

Training on BF Spiromax followed by SYMBICORT Turbohaler

Device: Training on BF Spiromax followed by SYMBICORT Turbohaler; Device: Training on SYMBICORT Turbohaler followed by BF Spiromax

Turbohaler followed by Spiromax

PLACEBO COMPARATOR

Training on SYMBICORT Turbohaler followed by BF Spiromax

Device: Training on BF Spiromax followed by SYMBICORT Turbohaler; Device: Training on SYMBICORT Turbohaler followed by BF Spiromax

Interventions

Training on BF Spiromax followed by SYMBICORT Turbohaler DEVICE

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.

Spiromax followed by Turbohaler; Turbohaler followed by Spiromax

Training on SYMBICORT Turbohaler followed by BF Spiromax DEVICE

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.

Spiromax followed by Turbohaler; Turbohaler followed by Spiromax

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participants will be excluded from participating in this study if they have asthma.

Sponsors & Collaborators

• Research in Real-Life Ltd: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator
• University of Sydney: collaborator
• Woolcock Institute of Medical Research: collaborator
• University of Technology, Sydney: collaborator
• The University of New South Wales: collaborator

Related Publications (16)

• 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.

  PMID: 23510684 BACKGROUND

• 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.

  PMID: 19513170 BACKGROUND

• 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.

  PMID: 18314294 BACKGROUND

• 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.

  PMID: 10669525 BACKGROUND

• 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.

  PMID: 11742268 BACKGROUND

• 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.

  PMID: 17983880 BACKGROUND

• 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.

  PMID: 11866004 BACKGROUND

• 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.

  PMID: 15080802 BACKGROUND

• 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.

  PMID: 8275720 BACKGROUND

• 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.

  PMID: 20472415 BACKGROUND

• 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.

  PMID: 18815019 BACKGROUND

• 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.

  PMID: 21623690 BACKGROUND

• 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.

  PMID: 21532013 BACKGROUND

• 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.

  PMID: 20514388 BACKGROUND

• 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.

  PMID: 23098685 BACKGROUND

• 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.

  PMID: 29954359 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Assoc Prof Sinthia Bosnic-Anticevich
• Organization: Sydney Medical School, University of Sydney & Woolcock Institute of Medical Research

sinthia.bosnic-anticevich@sydney.edu.au

+61 2 9114 0040

Study Officials

• Sinthia Bosnic-Anticevich, PhD

  University of Sydney

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: October 7, 2015
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: June 1, 2015
• Last Updated: May 30, 2016
• Results First Posted: May 30, 2016

Record last verified: 2016-04