Handling Inhalers - Technique Error Comparison (HI-TEC)
Condition: Pulmonary Disease, Chronic Obstructive; Asthma
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Observational [Patient Registry]

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.
    

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)
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients from a representative UK primary care asthma and COPD population
      
Keywords: COPD (Chronic Obstructive Pulmonary Disease); Asthma; Pulmojet; Inhalers; Respiratory; Inhaler Technique; Critical Errors