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Improving Asthma Treatment Using Inhaler Technology

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NHS Trust

Status

Unknown

Conditions

Asthma

Treatments

Device: Mobile application
Device: Inhaler casing
Behavioral: Active feedback on monitored inhaler use

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02977078
14RM008
193750 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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')

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Control
Sham Comparator group
Description:
Inhaler use monitored by device but no feedback to participants (control); this group is unaware of the second arm receiving feedback on inhaler use.
Treatment:
Device: Inhaler casing
Active
Experimental group
Description:
Inhaler use monitored with feedback to participants (active); participants randomized to this group sign an additional consent to receive feedback on inhaler use
Treatment:
Behavioral: Active feedback on monitored inhaler use
Device: Mobile application
Device: Inhaler casing

Trial contacts and locations

1

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Central trial contact

Maria Koufali; Dominick Shaw

Data sourced from clinicaltrials.gov

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