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Trial record 2 of 126 for:    improving asthma

Improving Asthma Treatment Using Inhaler Technology

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ClinicalTrials.gov Identifier: NCT02977078
Recruitment Status : Recruiting
First Posted : November 30, 2016
Last Update Posted : December 7, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust

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.


Condition or disease Intervention/treatment Phase
Asthma Behavioral: Active feedback on monitored inhaler use Device: Inhaler casing Device: Mobile application Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Improving Asthma Treatment Using Inhaler Technology
Study Start Date : December 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: 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.
Device: Inhaler casing
Monitors inhaler use
Experimental: Active
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 use
Feedback given on inhaler use by research nurse/ doctor based on mobile application feedback
Device: Inhaler casing
Monitors inhaler use
Device: Mobile application
Mobile application software linked to inhaler casing



Primary Outcome Measures :
  1. Impact on adherence to preventative medication use based on the mean percentage of prescribed doses taken daily over the study period [ Time Frame: Upto 24 weeks (study duration) ]
    Co-primary endpoint

  2. 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 [ Time Frame: Upto 24 weeks (study duration) ]
    Co-primary endpoint


Secondary Outcome Measures :
  1. Patient acceptability via qualitative feedback with questionnaires [ Time Frame: Upto 24 weeks (study duration) ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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')

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977078


Contacts
Contact: Dominick Shaw Dominic.Shaw@nottingham.ac.uk
Contact: Maria Koufali researchsponsor@nuh.nhs.uk

Locations
United Kingdom
Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Contact: Ireti Adejumo         
Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
GlaxoSmithKline
Investigators
Principal Investigator: Dominick Shaw University of Nottingham

Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02977078     History of Changes
Other Study ID Numbers: 14RM008
193750 ( Other Identifier: IRAS )
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD

Keywords provided by Nottingham University Hospitals NHS Trust:
Inhaler

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases