Aflo™ Device Trial

NCT ID: NCT05733299

Last Updated: 2023-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-06

Study Completion Date

2024-02-05

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.

Detailed Description

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Conditions

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Asthma Asthma in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Independent allocation, no masking.

Study Groups

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Standard Care

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type OTHER

Health service standard care will be continued

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.

Group Type EXPERIMENTAL

aflo™ digital respiratory management platform

Intervention Type DEVICE

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

Standard care

Intervention Type OTHER

Health service standard care will be continued

Interventions

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aflo™ digital respiratory management platform

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

Intervention Type DEVICE

Standard care

Health service standard care will be continued

Intervention Type OTHER

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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northern Ireland Clinical Research Service

UNKNOWN

Sponsor Role collaborator

University of Ulster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Human Intervention Studies Unit

Coleraine, N.Ireland, United Kingdom

Site Status RECRUITING

Health Hub Professionals

Londonderry, N.Ireland, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Ruth Karen Price

Role: CONTACT

02870123878

Julie Sittlington

Role: CONTACT

+442870124101

Facility Contacts

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Ruth Karen Price

Role: primary

02870123878

Julie Sittlington

Role: backup

+442870124101

Geraldine Horigan

Role: primary

07753138782

Other Identifiers

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22.WM.0278

Identifier Type: -

Identifier Source: org_study_id

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