Pulmonary Disease, Chronic ObstructiveHI-TECNCT01794390
Handling Inhalers - Technique Error Comparison (HI-TEC)
An observational study of Pulmonary Disease, Chronic Obstructive and Asthma, run by Research in Real-Life Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Asthma
- How many people
- 431 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Mar 2014
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from a representative UK primary care asthma and COPD population
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Critical Errors in Pulmojet and Other Devices
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.
Read the detailed description
Single-visit, randomised, crossover, open-label study comparing critical device handling errors for the Pulmojet compared to Diskus with Turbohaler in patients receiving maintenance inhaled corticosteroid (ICS) or ICS plus long acting beta2 agonist via Diskus, Turbuhaler or pMDI. Pulmojet is an inhaler developed by Zentiva (a subsidiary of Sanofi Aventis); other inhalers are the major prescribed inhalers in the treatment of asthma and COPD. This will allow critical errors in the use of the Pulmojet inhaler to be assessed and evaluated against commonly prescribed inhalers.
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
- Pulmonary Disease, Chronic Obstructive, Asthma
- Keywords
- COPD (Chronic Obstructive Pulmonary Disease), Asthma, Pulmojet, Inhalers, Respiratory, Inhaler Technique, Critical Errors
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
All critical inhaler technique errors (including both nurse-observed and inhalation errors recorded via the Vitalograph Pneumotrac Spirometer). Proportion of patients making errors considering all critical inhaler technique errors was compared between 1) Pulmojet vs comparator and 2) Pulmojet vs current device. Comparator was Diskus for current Turbuhaler and MDI patients, and Turbuhaler for current Diskus patients.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 431 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Research in Real-Life Ltd
- Sponsor type
- Research network
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, David Price, Prof., MD, Research in Real-Life Ltd
- Investigators
- Prof. David Price, Investigator, Study director, Research in Real Life
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794390
- Sponsor's protocol ID
- PJ1201
- Acronym
- HI-TEC
- Status last verified
- Oct 2015
- First submitted
- 14 Feb 2013
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15080802Molimard M, Le Gros V. Impact of patient-related factors on asthma control. J Asthma. 2008 Mar;45(2):109-13. doi: 10.1080/02770900701815727.
PubMed 18350401Haughney 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.
PubMed 20472415Price 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.
PubMed 17140424Thomas 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.
PubMed 20477123Giraud 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.
PubMed 11866004Molimard 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.
PubMed 14572322Haughney 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.
PubMed 18815019Chrystyn 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.
PubMed 26769482
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critical Errors in Pulmojet and Other Devices
- ClinicalTrials.gov ID
- NCT01794390
- Acronym / sponsor ID
- HI-TEC / PJ1201
- Conditions
- Pulmonary Disease, Chronic Obstructive, Asthma
- Keywords
- COPD (Chronic Obstructive Pulmonary Disease), Asthma, Pulmojet, Inhalers, Respiratory, Inhaler Technique, Critical Errors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Research in Real-Life LtdResearch network
- Collaborators
- Sanofi
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Single-visit, randomised, crossover, open-label study comparing critical device handling errors for the Pulmojet compared to Diskus with Turbohaler in patients receiving maintenance inhaled corticosteroid (ICS) or ICS plus long acting beta2 agonist via Diskus, Turbuhaler or pMDI. Pulmojet is an inhaler developed by Zentiva (a subsidiary of Sanofi Aventis); other inhalers are the major prescribed inhalers in the treatment of asthma and COPD. This will allow critical errors in the use of the Pulmojet inhaler to be assessed and evaluated against commonly prescribed inhalers.
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)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from a representative UK primary care asthma and COPD population
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nurse-observed critical inhaler technique errors
Time frame: up to 1 year
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.
1 secondary outcome
All critical inhaler technique errors (including both nurse-observed and inhalation errors recorded via the Vitalograph Pneumotrac Spirometer)
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
- Background: PubMed 15080802Gupta 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.
- Background: PubMed 18350401Molimard M, Le Gros V. Impact of patient-related factors on asthma control. J Asthma. 2008 Mar;45(2):109-13. doi: 10.1080/02770900701815727.
- Background: PubMed 20472415Haughney 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.
- Background: PubMed 17140424Price 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.
- Background: PubMed 20477123Thomas 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.
- Background: PubMed 11866004Giraud 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.
- Background: PubMed 14572322Molimard 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.
- Background: PubMed 18815019Haughney 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.
- Derived from this study: PubMed 26769482Chrystyn 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.
- Organisation's webpageLink provided by the sponsor.
- U.K. Webpage providing information on AsthmaLink provided by the sponsor.
- Organisation's webpageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. David Price, Investigator study director
Research in Real Life
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive and Asthma, run by Research in Real-Life Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nurse-observed critical inhaler technique errors (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01794390, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2015.