Clinical trial NCT02977078: Improving Asthma Treatment Using Inhaler Technology
Official title: Improving Asthma Treatment Using Inhaler Technology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: Inhaler
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2016-11-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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')

Primary outcomes:
measure: Impact on adherence to preventative medication use based on the mean percentage of prescribed doses taken daily over the study period
timeFrame: Upto 24 weeks (study duration)
measure: 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
timeFrame: Upto 24 weeks (study duration)
Secondary outcomes:
measure: Patient acceptability via qualitative feedback with questionnaires
timeFrame: Upto 24 weeks (study duration)
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: Dominick Shaw
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adejumo I, Patel M, McKeever TM, Shaw DE. Does inhaler technology improve adherence and asthma control? A pilot randomized controlled trial. Ann Allergy Asthma Immunol. 2022 Jun;128(6):727-729. doi: 10.1016/j.anai.2022.02.023. Epub 2022 Mar 4. No abstract available.