Improving Asthma Treatment Using Inhaler Technology

NCT ID: NCT02977078

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-04-30

Brief Summary

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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

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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.

Conditions

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Asthma

Keywords

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Inhaler

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Inhaler use monitored by device but no feedback to participants (control); this group is unaware of the second arm receiving feedback on inhaler use.

Group Type SHAM_COMPARATOR

Inhaler casing

Intervention Type DEVICE

Monitors inhaler use

Active

Inhaler use monitored with feedback to participants (active); participants randomized to this group sign an additional consent to receive feedback on inhaler use

Group Type EXPERIMENTAL

Active feedback on monitored inhaler use

Intervention Type BEHAVIORAL

Feedback given on inhaler use by research nurse/ doctor based on mobile application feedback

Inhaler casing

Intervention Type DEVICE

Monitors inhaler use

Mobile application

Intervention Type DEVICE

Mobile application software linked to inhaler casing

Interventions

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Active feedback on monitored inhaler use

Feedback given on inhaler use by research nurse/ doctor based on mobile application feedback

Intervention Type BEHAVIORAL

Inhaler casing

Monitors inhaler use

Intervention Type DEVICE

Mobile application

Mobile application software linked to inhaler casing

Intervention Type DEVICE

Eligibility Criteria

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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')
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dominick Shaw

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

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Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus

Nottingham, Nottinghamshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Dominick Shaw

Role: CONTACT

Email: [email protected]

Maria Koufali

Role: CONTACT

Email: [email protected]

Facility Contacts

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Ireti Adejumo

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35257874 (View on PubMed)

Other Identifiers

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193750

Identifier Type: OTHER

Identifier Source: secondary_id

14RM008

Identifier Type: -

Identifier Source: org_study_id