Handling Inhalers - Technique Error Comparison (HI-TEC)

Study Overview
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Brief Summary
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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
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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)

Official Title
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Critical Errors in Pulmojet and Other Devices

Conditions
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Asthma, Pulmonary Disease, Chronic Obstructive

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Turbuhaler and MDI patients (Arm 1)<br>Patients (Diskus naive) will be randomised to receive training on the PulmoJet© device followed by Diskus, or vice versa | |
| Diskus patients (Arm 2)<br>Patients (Turbuhaler naive) will be randomised to receive training on the PulmoJet© device followed by Turbohaler, or vice versa | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD (Chronic Obstructive Pulmonary Disease), Asthma, Pulmojet, Inhalers, Respiratory, Inhaler Technique, Critical Errors