MedPath

Improving Asthma Treatment Using Inhaler Technology

Not Applicable
Conditions
Asthma
Interventions
Behavioral: Active feedback on monitored inhaler use
Device: Inhaler casing
Device: Mobile application
Registration Number
NCT02977078
Lead Sponsor
Nottingham University Hospitals NHS Trust
Brief Summary

This study will use inhaler technology to observe and feedback overall patterns of medication use. We will look at whether this improves preventer inhaler use and reduces reliever inhaler overuse.

We will also assess whether inhaler technology is patient-friendly and cost effective, whether it helps with treatment decisions in asthma and whether it can help us to predict and prevent asthma attacks.

Detailed Description

The SmartTouch™ range of electronic casings will record the use of metered dose inhalers (MDI) by participants in the study. The actuation data can be remotely viewed and analyzed by the investigators.

The hypothesis is that employing such technology to measure medication patterns and to help provide patient feedback improves inhaler adherence and potentially clinical outcomes (asthma control and exacerbations) in asthma patients with recent asthma attacks in a practical, real-world setting.

We will assess whether electronic inhaler data capture can identify patients requiring more frequent reviews or treatment change and enable proactive self- management.

Using qualitative methods, we will explore participants' attitudes to their asthma management, whether the use of inhaler technology has had an impact on this and whether they found its use acceptable.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
50
Inclusion Criteria
  • Use of systemic corticosteroids for worsening asthma (or an increase from baseline dose in patients on long-term oral corticosteroids) in the prior 12 months [i.e. at least one asthma exacerbation requiring additional systemic corticosteroid in the prior 12 months] patient reported.
  • Doctor's diagnosis of asthma for at least 12 months
  • On BTS step 2-5 treatment via MDI [monitoring devices to be utilised in the study are compatible with MDI inhalers]
  • Use of own internet-enabled and compatible mobile phone
Exclusion Criteria
  • Diagnosis of COPD or onset of symptoms after the age of 40 in patients with ≥10 Pack Year History of smoking
  • Other clinically significant coexisting respiratory disease e.g. fibrosis, bronchiectasis
  • Patients on maintenance and reliever therapy ('SMART' or 'Fostair® MART')

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ActiveInhaler casingInhaler use monitored with feedback to participants (active); participants randomized to this group sign an additional consent to receive feedback on inhaler use
ActiveActive feedback on monitored inhaler useInhaler use monitored with feedback to participants (active); participants randomized to this group sign an additional consent to receive feedback on inhaler use
ControlInhaler casingInhaler use monitored by device but no feedback to participants (control); this group is unaware of the second arm receiving feedback on inhaler use.
ActiveMobile applicationInhaler use monitored with feedback to participants (active); participants randomized to this group sign an additional consent to receive feedback on inhaler use
Primary Outcome Measures
NameTimeMethod
Impact on adherence to preventative medication use based on the mean percentage of prescribed doses taken daily over the study periodUpto 24 weeks (study duration)

Co-primary endpoint

Impact on adherence to reliever medication use based on the number of days with >16 actuations/day of Salbutamol taken in a 24-hour periodUpto 24 weeks (study duration)

Co-primary endpoint

Secondary Outcome Measures
NameTimeMethod
Patient acceptability via qualitative feedback with questionnairesUpto 24 weeks (study duration)

Trial Locations

Locations (1)

Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus

🇬🇧

Nottingham, Nottinghamshire, United Kingdom

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