Aflo™ Device Trial

NCT05733299 | Unknown

• 1 other identifier: 22.WM.0278
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Asthma; Asthma in Children

Keywords

asthma; asthma control; respiratory management platform; medical device; inhaler technique

Outcome Measures

Primary Outcomes (1)

• Inhaler Proficiency checklist Score (IPS)

  Inhalation score 0-7 (higher the score the greater the proficiency)

  Change over 24 weeks

Secondary Outcomes (10)

• Asthma control

  Change over 24 weeks

• Medication usage

  Change over 24 weeks

• Health impairment in asthma patients

  Change over 24 weeks

• Lung function

  Change over 24 weeks

• Lung function

  Change over 24 weeks

Other Outcomes (3)

• Patient satisfaction

  At 24 weeks

• Device feedback

  Baseline, 12 weeks and 24 weeks

• Qualitative feedback

  Baseline, 12 weeks and 24 weeks

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Other: Standard care

aflo™ digital respiratory management platform with standard care

EXPERIMENTAL

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; Other: Standard care

Interventions

aflo™ digital respiratory management platform DEVICE

medical device, user app, clinician portal, data analytics hub

aflo™ digital respiratory management platform with standard care

Standard care OTHER

Health service standard care will be continued

Standard Care; aflo™ digital respiratory management platform with standard care

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 5 years old
• Other major respiratory illness or significant concurrent disease that might prevent completion of the study

Sponsors & Collaborators

• University of Ulster: lead
• Northern Ireland Clinical Research Service: collaborator

Study Sites (2)

Human Intervention Studies Unit

Coleraine, N.Ireland, BT52 1SA, United Kingdom

RECRUITING

Health Hub Professionals

Londonderry, N.Ireland, BT48 0LU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Ruth Karen Price

CONTACT

02870123878; rk.price@ulster.ac.uk

Julie Sittlington

CONTACT

+442870124101; jj.sittlington@ulster.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Independent allocation, no masking.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 17, 2023
• Study Start: February 6, 2023
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)