Handling Inhalers - Technique Error Comparison (HI-TEC)
NCT ID: NCT01794390
Last Updated: 2015-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
431 participants
OBSERVATIONAL
2013-09-30
2014-03-31
Brief Summary
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Detailed Description
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376 patients recruited from 10 primary care practices will be invited to participate in this single visit study. Upon entry to the study, all patients will be assessed as to their current inhaler device technique before entering into a randomised cross-over to receive device training according to their current device:
Current Diskus users (i.e. Turbuhaler naive): will be randomised to receive inhaler device training for the Pulmojet device followed by the Turbuhaler, or vice versa.
Current Turbuhaler / pMDI users (i.e. Diskus naive): will be randomised to receive inhaler device training for the Pulmojet device followed by the Diskus, or vice versa.
For all devices, critical errors in the use of inhalers will be assessed through nurse observation and vitalograph pneumotrac spirometry ('technology recorded'). A two step device training protocol will be used to establish the ease to which patients can be taught to use the study devices (Pulmojet, Turbohaler (in current Diskus users) and Diskus (in current Turbohaler or pMDI users). In Step 1 patients will be given the product Patient Information Leaflet (PIL) to read, and in Step 2 patients will be asked to watch a device instructional video. After each step patients will be assessed on their device use. Patients will progress from Step 1 to Step 2 unless device mastery is achieved at Step 1, in which case the patient will progress onto the second device or the study will have been completed.
All inhalers provided to participants will be supplied completely empty, i.e. with no active drug or placebo present, and participants will not receive any medication or interventional procedure during the study conduct.
An independent virtual steering committee has been assembled to oversee the study protocol. The steering committee members are international inhalation technology experts.
The primary objective will be to evaluate the critical errors and number of steps to achieve device mastery (defined as absence of critical errors):
* Diskus vs. Pulmojet
* Turbuhaler vs. Pulmojet
The secondary objective will be to evaluate critical errors in device use between:
• Current device vs. Pulmojet (all patients)
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Turbuhaler and MDI patients (Arm 1)
Patients (Diskus naive) will be randomised to receive training on the PulmoJet© device followed by Diskus, or vice versa
No interventions assigned to this group
Diskus patients (Arm 2)
Patients (Turbuhaler naive) will be randomised to receive training on the PulmoJet© device followed by Turbohaler, or vice versa
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Patient has an asthma and/ or COPD diagnosis
3. Patient is receiving current therapy including either inhaled corticosteroids (ICS) or fixed dose combination ICS/ Long acting Beta-agonists(FDC ICS/LABA's)
4. The patient's current therapy is being administered through a metered dose inhaler (MDI), Turbuhaler or Diskus device
5. Patients must be able and willing to read and comprehend written and verbal instructions
6. After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study
7. All Turbuhaler and MDI patients are required to have no use of the Diskus device in the past year
8. All Diskus patients are required to have no use of the Turbuhaler device in the past year
Exclusion Criteria
2. An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in this study
3. Patient has received oral steroids and/or antibiotics for a lower respiratory condition (identified using lower respiratory diagnoses) in the 4 weeks preceding the study (used as a proxy measure for identifying an exacerbation and / or lower respiratory infection, which might suggest altered inspiratory capabilities)
18 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Research in Real-Life Ltd
NETWORK
Responsible Party
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David Price, Prof., MD
Professor of Primary Care Respiratory Medicine (University of Aberdeen) and Managing Director of Research in Real-Life Ltd.
Principal Investigators
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Prof. David Price, Investigator
Role: STUDY_DIRECTOR
Research in Real Life
Locations
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UK GP sites
Cambridge, , United Kingdom
Countries
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References
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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.
Molimard M, Le Gros V. Impact of patient-related factors on asthma control. J Asthma. 2008 Mar;45(2):109-13. doi: 10.1080/02770900701815727.
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.
Price D, Thomas M. Breaking new ground: challenging existing asthma guidelines. BMC Pulm Med. 2006 Nov 30;6 Suppl 1(Suppl 1):S6. doi: 10.1186/1471-2466-6-S1-S6.
Thomas M, Price D. Impact of comorbidities on asthma. Expert Rev Clin Immunol. 2008 Nov;4(6):731-42. doi: 10.1586/1744666X.4.6.731.
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.
Molimard M, Raherison C, Lignot S, Depont F, Abouelfath A, Moore N. Assessment of handling of inhaler devices in real life: an observational study in 3811 patients in primary care. J Aerosol Med. 2003 Fall;16(3):249-54. doi: 10.1089/089426803769017613.
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.
Chrystyn H, Price DB, Molimard M, Haughney J, Bosnic-Anticevich S, Lavorini F, Efthimiou J, Shan D, Sims E, Burden A, Hutton C, Roche N. Comparison of serious inhaler technique errors made by device-naive patients using three different dry powder inhalers: a randomised, crossover, open-label study. BMC Pulm Med. 2016 Jan 14;16:12. doi: 10.1186/s12890-016-0169-5.
Related Links
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Organisation's webpage
U.K. Webpage providing information on Asthma
Organisation's webpage
Other Identifiers
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PJ1201
Identifier Type: -
Identifier Source: org_study_id
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