Handling Inhalers - Technique Error Comparison (HI-TEC)

NCT01794390 | Completed

• 1 other identifier: PJ1201
• Study Type: observational
• Target: 431
• Locations: 1 country
• Sites: 1

Brief Summary

Randomised, cross sectional, observational study evaluating inhaler device critical errors (errors that could affect dose delivery to the lungs) for the Pulmojet inhaler compared to Diskus or Turbuhaler in asthma and COPD patients receiving regular maintenance inhaled steroid therapy.

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Keywords

COPD (Chronic Obstructive Pulmonary Disease); Asthma; Pulmojet; Inhalers; Respiratory; Inhaler Technique; Critical Errors

Outcome Measures

Primary Outcomes (1)

• Nurse-observed critical inhaler technique errors

  Proportion of patients making errors considering nurse-observed errors only with Pulmojet vs comparator. Comparator was Diskus for current Turbuhaler and MDI patients, and Turbuhaler for current Diskus patients. A maximum of 2 attempts is allowed (self taught using a patient information leaflet (PIL), patient video). A list of critical errors for each inhaler has been produced by an independent steering committee. Nurse observed critical errors are recorded using a device-specific error checklist.

  up to 1 year

Secondary Outcomes (1)

• All critical inhaler technique errors (including both nurse-observed and inhalation errors recorded via the Vitalograph Pneumotrac Spirometer)

  up to 1 year

Study Arms (2)

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

Diskus patients (Arm 2)

Patients (Turbuhaler naive) will be randomised to receive training on the PulmoJet© device followed by Turbohaler, or vice versa

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients from a representative UK primary care asthma and COPD population

You may qualify if:

• Patient is aged over 18
• Patient has an asthma and/ or COPD diagnosis
• Patient is receiving current therapy including either inhaled corticosteroids (ICS) or fixed dose combination ICS/ Long acting Beta-agonists(FDC ICS/LABA's)
• The patient's current therapy is being administered through a metered dose inhaler (MDI), Turbuhaler or Diskus device
• Patients must be able and willing to read and comprehend written and verbal instructions
• 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
• All Turbuhaler and MDI patients are required to have no use of the Diskus device in the past year
• All Diskus patients are required to have no use of the Turbuhaler device in the past year

You may not qualify if:

• Current therapy with ICS or ICS/LABA in any device other than a Diskus, Turbuhaler or metered dose inhaler (MDI)
• An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in this study
• 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)

Sponsors & Collaborators

• Research in Real-Life Ltd: lead
• Sanofi: collaborator

Study Sites (1)

UK GP sites

Cambridge, United Kingdom

Location

Related Publications (9)

• 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

• 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.

  PMID: 18350401 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

• 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.

  PMID: 17140424 BACKGROUND

• 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.

  PMID: 20477123 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

• 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.

  PMID: 14572322 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

• 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.

  PMID: 26769482 DERIVED

Related Links

• Organisation's webpage
• U.K. Webpage providing information on Asthma
• Organisation's webpage

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Prof. David Price, Investigator

  Research in Real Life

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Primary Care Respiratory Medicine (University of Aberdeen) and Managing Director of Research in Real-Life Ltd.

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 18, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 27, 2015

Record last verified: 2015-10

Locations

GB (1)