Improving Asthma Treatment Using Inhaler Technology
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nottinghamshire
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Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
- Recruiting
- Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus
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Contact:
- Ireti Adejumo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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')
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Control
Inhaler use monitored by device but no feedback to participants (control); this group is unaware of the second arm receiving feedback on inhaler use.
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Monitors inhaler use
|
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Experimental: Active
Inhaler use monitored with feedback to participants (active); participants randomized to this group sign an additional consent to receive feedback on inhaler use
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Monitors inhaler use
Feedback given on inhaler use by research nurse/ doctor based on mobile application feedback
Mobile application software linked to inhaler casing
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What is the study measuring?
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
Time Frame: Upto 24 weeks (study duration)
|
Co-primary endpoint
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Upto 24 weeks (study duration)
|
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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
Time Frame: Upto 24 weeks (study duration)
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Co-primary endpoint
|
Upto 24 weeks (study duration)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient acceptability via qualitative feedback with questionnaires
Time Frame: Upto 24 weeks (study duration)
|
Upto 24 weeks (study duration)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Dominick Shaw, University of Nottingham
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14RM008
- 193750 (Other Identifier: IRAS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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