Handling Inhalers - Technique Error Comparison
Research type
Research Study
Full title
Comparing critical errors with the use of metered dose inhaler (MDI), Turbohaler and Diskus vs Pulmojet (C) in treated patients (P) and with Diskus vs. Pulmojet and Turbohaler vs. Pulmojet in patients that have not used these devices in the last 12 months (O). A real-life observational study using a representative UK primary care asthma and COPD patient population.
IRAS ID
116238
Contact name
David Price
Contact email
Sponsor organisation
Zentiva Group a.s.
Clinicaltrials.gov Identifier
Research summary
Incorrect inhaler device use is associated with worse outcomes in both asthma and chronic obstructive pulmonary disease (COPD). Designing inhaler devices that are easier to use could improve outcomes in asthma and COPD.
This is a UK centred, single visit, pragmatic observational study evaluating how easily patients can be taught to use the Pulmojet inhaler, a new pre-filled dry-powder inhaler device, compared to the most frequently prescribed comparable inhaler devices in the UK: Turbohaler and Diskus, in patients with asthma and chronic obstructive pulmonary disease (COPD). For this study, all inhalers provided to participants will be empty (no active drug or placebo present).
The study visit (lasting up to 60 minutes) will comprise a review of current asthma or COPD disease, evaluation of current inhaler device use and randomised training on the Pulmojet inhaler followed by either Diskus (in patients who have not used a Diskus for at least 12 months) or Turbohaler (in patients who have not used a Turbohaler for at least 12 months), or vice versa. Training comprises: step 1) reading package information leaflet instructions, and step 2) watching a short video showing device use. After each training step, patients will demonstrate device use. Inhaler device use will be evaluated in terms of critical handling errors (handling errors that could affect dose delivery to the lungs) identified by a research nurse, and critical inspiratory flow errors (errors occurring while patients inhale through the device) measured by attaching the inhaler device to a spirometer.
Eligible patients will be aged 18 years or over and receiving regular inhaled corticosteroid (ICS) therapy via Diskus, Turbohaler or metered dose inhaler (MDI) devices. We aim to recruit 376 patients from 20 primary care sites. All visits will be completed during a three month period.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
13/EE/0164
Date of REC Opinion
1 Jul 2013
REC opinion
Further Information Favourable Opinion