Aflo™ Device Trial

Study Overview
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Brief Summary
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This randomised, prospective, controlled parallel study aims to evaluate the role and potential of the aflo™ digital platform for improving asthma control, inhalation technique and adherence in patients who use metred dose inhalers (MDI). The study will recruit 104 patients with uncontrolled asthma in the North-West of Northern Ireland. Fifty two patients will remain on standard care over 24-weeks and 52 will combine standard care with the aflo™ platform. The data collected over a 24-week period will be used to determine 1. whether the aflo™platform improves inhalation technique and user adherence to prescribed medication and 2. Lead to better asthma control and reduced symptoms as measured by the Asthma Control Test (ACT). During the study clinicians will be able to remotely monitor and review user analytics via a clinical dashboard. ACT measurements will be recorded at start and end of study. The study aims to test the functionality and impact of automated inhaler technique with real-time feedback, adherence prompts and air quality data sharing for patients who use metered dose inhalers (MDI) using the newly developed aflo™ digital respiratory management platform.

Official Title
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Automating Patient Inhaler Technique When Using Pressurised Metered Dose Inhalers: Testing the Functionality and Impact of the Aflo™ Digital Respiratory Management Platform in a Randomised Controlled Trial.

Conditions
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Asthma, Asthma in Children

Intervention / Treatment
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* Device: aflo™ digital respiratory management platform
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed as suitable for inclusion by their General Practitioner or asthma nurse. Access to WiFi and a smart phone (Android or apple phone with latest version -2) and knowledge of / carer support with using a smartphone. For children (parent/ carer must register and provide smart phone access) Aged > 5 years (with carer/ parental consent if < 17 years old) Smart phone user/ willing to use (or parent/ carer) and have access to and knowledge of working a smart phone and WIFI / 4G Currently prescribed an inhaled reliever +/- preventer medication via pressurised Metered Dose Inhaler (MDI) short acting beta2 agonist (SABA), inhaled corticosteroid (ICS) ICS / long acting beta2 agonist (LABA) MDI +/- spacer Adherence/ symptom control issues with medication (as identified by excess use of SABA/ healthcare personnel visits/ calls/ emergency department visit/ hospital admission Those who understand written and spoken English Exclusion Criteria: < 5 years old Other major respiratory illness or significant concurrent disease that might prevent completion of the study

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care<br> | Other: Standard care<br>* Health service standard care will be continued<br>|
| Experimental: aflo™ digital respiratory management platform with standard care<br>The new aflo™ digital respiratory management platform will provide automated inhaler technique direction, with real time quantitative personalised feedback on inhaler technique and timing. | Device: aflo™ digital respiratory management platform<br>* medical device, user app, clinician portal, data analytics hub<br>Other: Standard care<br>* Health service standard care will be continued<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhaler Proficiency checklist Score (IPS) | Inhalation score 0-7 (higher the score the greater the proficiency) | Change over 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control | Asthma Control Test (ACT) (0-25 with a score <20: uncontrolled; 20-24: reasonably well controlled; 25: controlled) | Change over 24 weeks | 
| Medication usage | Usage of asthma medication: increased usage of 'preventer' inhaler and decreased use of salbutamol/' reliever' inhaler | Change over 24 weeks | 
| Health impairment in asthma patients | Measured by St George's Respiratory Questionnaire (SGRQ).(0: best health; 100: worse health) | Change over 24 weeks | 
| Lung function | Lung volume / capacity measured by a spirometer | Change over 24 weeks | 
| Lung function | Lung rates of flow measured by a spirometer | Change over 24 weeks | 
| Lung function | Lung gas exchange measured by a spirometer | Change over 24 weeks | 
| Inflammation | Blood immunoglobulin E (IgE) (microarray) | Change over 24 weeks | 
| Inflammation | Blood eosinophils (Sysmex full blood count) | Change over 24 weeks | 
| Exhaled breath nitric oxide (FeNO) | Measured by a FeNO monitoring system | Change over 24 weeks | 
| Asthma health and symptoms questionnaire | Number of hospital visits, number of attacks (the higher number the more negative the outcome). | Change over 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, asthma control, respiratory management platform, medical device, inhaler technique