Aflo™ Device Trial (AFLO)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma; Asthma in Children
• Intervention / Treatment: Other: Standard care; Device: aflo™ digital respiratory management platform

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruth Karen Price; Phone Number: 02870123878; Email: rk.price@ulster.ac.uk

Study Locations

• United Kingdom
  • N.Ireland
    • Coleraine, N.Ireland, United Kingdom, BT52 1SA
      • Recruiting
      • Human Intervention Studies Unit
      • Contact: Ruth Karen Price; Phone Number: 02870123878; Email: rk.price@ulster.ac.uk
    • Derry / Londonderry, N.Ireland, United Kingdom, BT48 0LU
      • Recruiting
      • Health Hub Professionals
      • Contact: Geraldine Horigan; Phone Number: 07753138782; Email: geraldine@nicrs.co.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Evaluation of device (4-point scale; higher score the more satisfied)	At 24 weeks
Device feedback	Functionality of device (4-point scale; higher score the more satisfied)	Baseline, 12 weeks and 24 weeks
Qualitative feedback	Unstructured open-ended feedback	Baseline, 12 weeks and 24 weeks

Collaborators and Investigators

• Sponsor: University of Ulster
• Collaborators: Northern Ireland Clinical Research Service

Study record dates

Study Major Dates

• Study Start (Anticipated): February 6, 2023
• Primary Completion (Anticipated): February 5, 2024
• Study Completion (Anticipated): February 5, 2024

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: asthma; medical device; asthma control; respiratory management platform; inhaler technique
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 22.WM.0278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Commercially sensitive

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No