Aflo™ Device Trial (AFLO)

Ulster University

Status: Enrolling

Conditions: Asthma; Asthma in Children

Treatments: Device: aflo™ digital respiratory management platform; Other: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT05733299

22.WM.0278

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Standard Care

Active Comparator group

Treatment:

Other: Standard care

aflo™ digital respiratory management platform with standard care

Experimental group

Description:

The new aflo™ digital respiratory management platform will provide automated inhaler technique direction, with real time quantitative personalised feedback on inhaler technique and timing.

Treatment:

Other: Standard care

Device: aflo™ digital respiratory management platform