AsthmaAFLONCT05733299
Aflo™ Device Trial
A study testing aflo™ digital respiratory management platform in people with Asthma and Asthma in Children, run by University of Ulster at 2 sites in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma, Asthma in Children
- What is being tested?
- aflo™ digital respiratory management platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 6 Feb 2023to 5 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- < 5 years old
- Other major respiratory illness or significant concurrent disease that might prevent completion of the study
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Human Intervention Studies Unit
Coleraine, N.Ireland, BT52 1SA
Ruth Karen Price, 02870123878, rk.price@ulster.ac.uk
Julie Sittlington, +442870124101, jj.sittlington@ulster.ac.uk
- Recruiting
Health Hub Professionals
Londonderry, N.Ireland, BT48 0LU
Geraldine Horigan, 07753138782, geraldine@nicrs.co.uk
About this study
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.
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
- Being tested
- aflo™ digital respiratory management platform, Standard care
- Keywords
- asthma, asthma control, respiratory management platform, medical device, inhaler technique
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aflo™ digital respiratory management platformDevice
medical device, user app, clinician portal, data analytics hub
Standard careOther
Health service standard care will be continued
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Not described Receives: 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. Receives: Device: aflo™ digital respiratory management platform; Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhaler Proficiency checklist Score (IPS)
Inhalation score 0-7 (higher the score the greater the proficiency)
Measured: Change over 24 weeks
Secondary outcomes (10)
Asthma control
Asthma Control Test (ACT) (0-25 with a score <20: uncontrolled; 20-24: reasonably well controlled; 25: controlled)
Measured: Change over 24 weeks
Medication usage
Usage of asthma medication: increased usage of 'preventer' inhaler and decreased use of salbutamol/' reliever' inhaler
Measured: Change over 24 weeks
Health impairment in asthma patients
Measured by St George's Respiratory Questionnaire (SGRQ).(0: best health; 100: worse health)
Measured: Change over 24 weeks
Lung function
Lung volume / capacity measured by a spirometer
Measured: Change over 24 weeks
Lung function
Lung rates of flow measured by a spirometer
Measured: Change over 24 weeks
Lung function
Lung gas exchange measured by a spirometer
Measured: Change over 24 weeks
Inflammation
Blood immunoglobulin E (IgE) (microarray)
Measured: Change over 24 weeks
Inflammation
Blood eosinophils (Sysmex full blood count)
Measured: Change over 24 weeks
Exhaled breath nitric oxide (FeNO)
Measured by a FeNO monitoring system
Measured: Change over 24 weeks
Asthma health and symptoms questionnaire
Number of hospital visits, number of attacks (the higher number the more negative the outcome).
Measured: Change over 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start6 Feb 2023 (estimated)
- Primary completion5 Feb 2024 (estimated)
- Study completion5 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Ireland Clinical Research Service
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733299
- Sponsor's protocol ID
- 22.WM.0278
- Acronym
- AFLO
- Status last verified
- Feb 2023
- First submitted
- 20 Jan 2023
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Commercially sensitive
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05733299
- Acronym / sponsor ID
- AFLO / 22.WM.0278
- Conditions
- Asthma, Asthma in Children
- Keywords
- asthma, asthma control, respiratory management platform, medical device, inhaler technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Northern Ireland Clinical Research Service
- Study start
- 6 Feb 2023 (estimated)
- Primary completion
- 5 Feb 2024 (estimated)
- Study completion
- 5 Feb 2024 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Other: Standard care |
| aflo™ digital respiratory management platform with standard care | Experimental | Device: aflo™ digital respiratory management platform, Other: Standard careThe new aflo™ digital respiratory management platform will provide automated inhaler technique direction, with real time quantitative personalised feedback on inhaler technique and timing. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- < 5 years old
- Other major respiratory illness or significant concurrent disease that might prevent completion of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aflo™ digital respiratory management platformmedical device, user app, clinician portal, data analytics hub | Device | aflo™ digital respiratory management platform with standard care |
| Standard careHealth service standard care will be continued | Other | Standard Care, aflo™ digital respiratory management platform with standard care |
Primary outcome
Inhaler Proficiency checklist Score (IPS)
Time frame: Change over 24 weeks
Inhalation score 0-7 (higher the score the greater the proficiency)
10 secondary outcomes
Asthma control
Time frame: Change over 24 weeks
Medication usage
Time frame: Change over 24 weeks
Health impairment in asthma patients
Time frame: Change over 24 weeks
Lung function
Time frame: Change over 24 weeks
Lung function
Time frame: Change over 24 weeks
Lung function
Time frame: Change over 24 weeks
Inflammation
Time frame: Change over 24 weeks
Inflammation
Time frame: Change over 24 weeks
Exhaled breath nitric oxide (FeNO)
Time frame: Change over 24 weeks
Asthma health and symptoms questionnaire
Time frame: Change over 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Individual participant dataSharing planned: No. Commercially sensitive
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aflo™ digital respiratory management platform in people with Asthma and Asthma in Children, run by University of Ulster at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruth Karen Price (02870123878, rk.price@ulster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhaler Proficiency checklist Score (IPS) (time frame: Change over 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.