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Improving Asthma Treatment Using Inhaler Technology

Primary Purpose

Asthma

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Active feedback on monitored inhaler use

Inhaler casing

Mobile application

About this trial

This is an interventional basic science trial for Asthma focused on measuring Inhaler

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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')

Sites / Locations

Nottingham University Hospitals NHS Trust, Queens Medical Centre CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control

Active

Arm 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.

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

Outcomes

Primary Outcome Measures

Impact on adherence to preventative medication use based on the mean percentage of prescribed doses taken daily over the study period

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 period

Co-primary endpoint

Secondary Outcome Measures

Patient acceptability via qualitative feedback with questionnaires

Full Information

NCT ID

NCT02977078

First Posted

November 18, 2016

Last Updated

December 6, 2016

Sponsor

Nottingham University Hospitals NHS Trust

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02977078

Brief Title

Improving Asthma Treatment Using Inhaler Technology

Official Title

Improving Asthma Treatment Using Inhaler Technology

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

April 2018 (Anticipated)

Study Completion Date

April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nottingham University Hospitals NHS Trust

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Inhaler

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Sham Comparator

Arm 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.

Arm Title

Active

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Active feedback on monitored inhaler use

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Inhaler casing

Intervention Description

Monitors inhaler use

Intervention Type

Device

Intervention Name(s)

Mobile application

Intervention Description

Mobile application software linked to inhaler casing

Primary Outcome Measure Information:

Title

Impact on adherence to preventative medication use based on the mean percentage of prescribed doses taken daily over the study period

Description

Co-primary endpoint

Time Frame

Upto 24 weeks (study duration)

Title

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

Description

Co-primary endpoint

Time Frame

Upto 24 weeks (study duration)

Secondary Outcome Measure Information:

Title

Patient acceptability via qualitative feedback with questionnaires

Time Frame

Upto 24 weeks (study duration)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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')

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dominick Shaw

Dominic.Shaw@nottingham.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Maria Koufali

researchsponsor@nuh.nhs.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dominick Shaw

Organizational Affiliation

University of Nottingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus

City

Nottingham

State/Province

Nottinghamshire

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ireti Adejumo

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plan to share IPD

Citations:

PubMed Identifier

35257874

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.

Results Reference

derived

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Improving Asthma Treatment Using Inhaler Technology

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