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| ID | Type | Description | Link |
|---|---|---|---|
| 193750 | Other Identifier | IRAS |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
The SmartTouchâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | 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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| Active | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active feedback on monitored inhaler use | Behavioral | Feedback given on inhaler use by research nurse/ doctor based on mobile application feedback |
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| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient acceptability via qualitative feedback with questionnaires | Upto 24 weeks (study duration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominick Shaw | Contact | Dominic.Shaw@nottingham.ac.uk | ||
| Maria Koufali | Contact | researchsponsor@nuh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Dominick Shaw | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus | Recruiting | Nottingham | Nottinghamshire | NG7 2UH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35257874 | Derived | Adejumo I, Patel M, McKeever TM, Shaw DE. Does inhaler technology improve adherence and asthma control? A pilot randomized controlled trial. Ann Allergy Asthma Immunol. 2022 Jun;128(6):727-729. doi: 10.1016/j.anai.2022.02.023. Epub 2022 Mar 4. No abstract available. |
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No plan to share IPD
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Inhaler casing | Device | Monitors inhaler use |
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| Mobile application | Device | Mobile application software linked to inhaler casing |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |