Improving Asthma Treatment Using Inhaler Technology

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Asthma Treatment Using Inhaler Technology

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Active feedback on monitored inhaler use
* Device: Inhaler casing
* Device: Mobile application


Participation Criteria
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Eligibility Criteria
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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')

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Inhaler use monitored by device but no feedback to participants (control); this group is unaware of the second arm receiving feedback on inhaler use. | Device: Inhaler casing<br>* Monitors inhaler use<br>|
| Experimental: Active<br>Inhaler use monitored with feedback to participants (active); participants randomized to this group sign an additional consent to receive feedback on inhaler use | Behavioral: Active feedback on monitored inhaler use<br>* Feedback given on inhaler use by research nurse/ doctor based on mobile application feedback<br>Device: Inhaler casing<br>* Monitors inhaler use<br>Device: Mobile application<br>* Mobile application software linked to inhaler casing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on adherence to preventative medication use based on the mean percentage of prescribed doses taken daily over the study period | Co-primary endpoint | Upto 24 weeks (study duration) | 
| 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 | Co-primary endpoint | Upto 24 weeks (study duration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient acceptability via qualitative feedback with questionnaires |  | Upto 24 weeks (study duration) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inhaler