Asthma
Conditions
Keywords
Inhaler
Brief summary
This study will use inhaler technology to observe and feedback overall patterns of medication use. We will look at whether this improves preventer inhaler use and reduces reliever inhaler overuse. We will also assess whether inhaler technology is patient-friendly and cost effective, whether it helps with treatment decisions in asthma and whether it can help us to predict and prevent asthma attacks.
Detailed description
The SmartTouch™ range of electronic casings will record the use of metered dose inhalers (MDI) by participants in the study. The actuation data can be remotely viewed and analyzed by the investigators. The hypothesis is that employing such technology to measure medication patterns and to help provide patient feedback improves inhaler adherence and potentially clinical outcomes (asthma control and exacerbations) in asthma patients with recent asthma attacks in a practical, real-world setting. We will assess whether electronic inhaler data capture can identify patients requiring more frequent reviews or treatment change and enable proactive self- management. Using qualitative methods, we will explore participants' attitudes to their asthma management, whether the use of inhaler technology has had an impact on this and whether they found its use acceptable.
Interventions
BEHAVIORALActive feedback on monitored inhaler use
Feedback given on inhaler use by research nurse/ doctor based on mobile application feedback
DEVICEInhaler casing
Monitors inhaler use
DEVICEMobile application
Mobile application software linked to inhaler casing
Sponsors
GlaxoSmithKline
Nottingham University Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Use of systemic corticosteroids for worsening asthma (or an increase from baseline dose in patients on long-term oral corticosteroids) in the prior 12 months \[i.e. at least one asthma exacerbation requiring additional systemic corticosteroid in the prior 12 months\] patient reported. * Doctor's diagnosis of asthma for at least 12 months * On BTS step 2-5 treatment via MDI \[monitoring devices to be utilised in the study are compatible with MDI inhalers\] * Use of own internet-enabled and compatible mobile phone
Exclusion criteria
* Diagnosis of COPD or onset of symptoms after the age of 40 in patients with ≥10 Pack Year History of smoking * Other clinically significant coexisting respiratory disease e.g. fibrosis, bronchiectasis * Patients on maintenance and reliever therapy ('SMART' or 'Fostair® MART')
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact on adherence to preventative medication use based on the mean percentage of prescribed doses taken daily over the study period | Upto 24 weeks (study duration) | Co-primary endpoint |
| Impact on adherence to reliever medication use based on the number of days with >16 actuations/day of Salbutamol taken in a 24-hour period | Upto 24 weeks (study duration) | Co-primary endpoint |
Secondary
| Measure | Time frame |
|---|---|
| Patient acceptability via qualitative feedback with questionnaires | Upto 24 weeks (study duration) |
Countries
United Kingdom
Contacts
Primary ContactDominick Shaw
Backup ContactMaria Koufali
Outcome results
None listed