NCT02977078

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

1.3 years

First QC Date

November 18, 2016

Last Update Submit

December 6, 2016

Conditions

Asthma

Keywords

Inhaler

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Secondary Outcomes (1)

  • Patient acceptability via qualitative feedback with questionnaires

    Upto 24 weeks (study duration)

Study Arms (2)

Control

SHAM COMPARATOR

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

Device: Inhaler casing

Active

EXPERIMENTAL

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

Behavioral: Active feedback on monitored inhaler useDevice: Inhaler casingDevice: Mobile application

Interventions

Active feedback on monitored inhaler useBEHAVIORAL

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

Active
Inhaler casingDEVICE

Monitors inhaler use

ActiveControl
Mobile applicationDEVICE

Mobile application software linked to inhaler casing

Active

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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')

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35257874DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Dominick Shaw

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominick Shaw

CONTACT

Dominic.Shaw@nottingham.ac.uk

Maria Koufali

CONTACT

researchsponsor@nuh.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2016

First Posted

November 30, 2016

Study Start

December 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

December 7, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

No plan to share IPD

Locations

GB(1)