Handling Inhalers - Technique Error Comparison (HI-TEC) — HI-TEC  

Asthma Clinical Trial

Official title: Critical Errors in Pulmojet and Other Devices

Status Completed

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

• Asthma
• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT01794390
• Study type: Observational [Patient Registry]
• Source: Research in Real-Life Ltd
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Completion date: March 2014