Improving Asthma Treatment Using Inhaler Technology

Asthma Clinical Trial

Official title:

Improving Asthma Treatment Using Inhaler Technology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02977078
• Other study ID #: 14RM008
• Secondary ID: 193750
• Status: Recruiting
• Phase: N/A
• First received: November 18, 2016
• Last updated: December 6, 2016
• Start date: December 2016
• Est. completion date: April 2018

Study information

• Verified date: December 2016
• Source: Nottingham University Hospitals NHS Trust
• Contact: Dominick Shaw
• Email: Dominic.Shaw[@]nottingham.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Active feedback on monitored inhaler use
Feedback given on inhaler use by research nurse/ doctor based on mobile application feedback

Device:
• Inhaler casing
Monitors inhaler use
• Mobile application
Mobile application software linked to inhaler casing

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus	Nottingham	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust	GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact on adherence to preventative medication use based on the mean percentage of prescribed doses taken daily over the study period	Co-primary endpoint	Upto 24 weeks (study duration)	No
Primary	Impact on adherence to reliever medication use based on the number of days with >16 actuations/day of Salbutamol taken in a 24-hour period	Co-primary endpoint	Upto 24 weeks (study duration)	No
Secondary	Patient acceptability via qualitative feedback with questionnaires		Upto 24 weeks (study duration)	No