Aflo™ Device Trial

Asthma Clinical Trial

— AFLO  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05733299
• Other study ID #: 22.WM.0278
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: February 5, 2024

Study information

• Verified date: February 2023
• Source: University of Ulster
• Contact: Ruth Karen Price
• Phone: 02870123878
• Email: rk.price[@]ulster.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: February 5, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Device:
• aflo™ digital respiratory management platform
medical device, user app, clinician portal, data analytics hub

Other:
• Standard care
Health service standard care will be continued

Locations

Country	Name	City	State
United Kingdom	Human Intervention Studies Unit	Coleraine	N.Ireland
United Kingdom	Health Hub Professionals	Derry / Londonderry	N.Ireland

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulster	Northern Ireland Clinical Research Service

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction	Evaluation of device (4-point scale; higher score the more satisfied)	At 24 weeks
Other	Device feedback	Functionality of device (4-point scale; higher score the more satisfied)	Baseline, 12 weeks and 24 weeks
Other	Qualitative feedback	Unstructured open-ended feedback	Baseline, 12 weeks and 24 weeks
Primary	Inhaler Proficiency checklist Score (IPS)	Inhalation score 0-7 (higher the score the greater the proficiency)	Change over 24 weeks
Secondary	Asthma control	Asthma Control Test (ACT) (0-25 with a score <20: uncontrolled; 20-24: reasonably well controlled; 25: controlled)	Change over 24 weeks
Secondary	Medication usage	Usage of asthma medication: increased usage of 'preventer' inhaler and decreased use of salbutamol/' reliever' inhaler	Change over 24 weeks
Secondary	Health impairment in asthma patients	Measured by St George's Respiratory Questionnaire (SGRQ).(0: best health; 100: worse health)	Change over 24 weeks
Secondary	Lung function	Lung volume / capacity measured by a spirometer	Change over 24 weeks
Secondary	Lung function	Lung rates of flow measured by a spirometer	Change over 24 weeks
Secondary	Lung function	Lung gas exchange measured by a spirometer	Change over 24 weeks
Secondary	Inflammation	Blood immunoglobulin E (IgE) (microarray)	Change over 24 weeks
Secondary	Inflammation	Blood eosinophils (Sysmex full blood count)	Change over 24 weeks
Secondary	Exhaled breath nitric oxide (FeNO)	Measured by a FeNO monitoring system	Change over 24 weeks
Secondary	Asthma health and symptoms questionnaire	Number of hospital visits, number of attacks (the higher number the more negative the outcome).	Change over 24 weeks