Clinical trial NCT05733299: Aflo™ Device Trial
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Asthma in Children
Keywords: asthma
asthma control
respiratory management platform
medical device
inhaler technique
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: Northern Ireland Clinical Research Service
First posted: 2023-02-17
Enrollment: 104
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Inhaler Proficiency checklist Score (IPS)
timeFrame: Change over 24 weeks
Secondary outcomes:
measure: Asthma control
timeFrame: Change over 24 weeks
measure: Medication usage
timeFrame: Change over 24 weeks
measure: Health impairment in asthma patients
timeFrame: Change over 24 weeks
measure: Lung function
timeFrame: Change over 24 weeks
measure: Lung function
timeFrame: Change over 24 weeks
measure: Lung function
timeFrame: Change over 24 weeks
measure: Inflammation
timeFrame: Change over 24 weeks
measure: Inflammation
timeFrame: Change over 24 weeks
measure: Exhaled breath nitric oxide (FeNO)
timeFrame: Change over 24 weeks
measure: Asthma health and symptoms questionnaire
timeFrame: Change over 24 weeks
Other outcomes:
measure: Patient satisfaction
timeFrame: At 24 weeks
measure: Device feedback
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Qualitative feedback
timeFrame: Baseline, 12 weeks and 24 weeks
Locations:
city: Coleraine
country: United Kingdom
facility: Human Intervention Studies Unit
state: N.Ireland
city: Derry / Londonderry
country: United Kingdom
facility: Health Hub Professionals
state: N.Ireland
Study officials:
References: