ADHERENCE WITH APP-CONNECTED INHALERS VIA SENSORS FITTED ON PMDIs
Research type
Research Study
Full title
12-week randomised controlled clinical trial to explore the effect of a smartphone application connected to an Add-on DeVICE system (Propeller Health) fitted on pMDI inhaler on adherence to take medications as prescribed and clinical outcomes in difficult-to-treat asthmatic patients
IRAS ID
262015
Contact name
Simon Rogers
Contact email
Sponsor organisation
Chiesi Farmaceutici S.p.A.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 14 days
Research summary
The purpose of this clinical investigation is to check if the use of an electronic add-on device named “sensor” fitted onto patient's asthma treatment and connected with their smartphone via a smartphone application (app) will have an effect on their adherence to treatment and on their clinical outcomes. The investigational medical device is composed by a sensor device and a smartphone application (app) that collect data about patients use of medication and sometimes about their health status. The sensor is compatible with the Fostair 200/6 pMDI. The sensor and the app together is a way to collect data and help to manage patients disease recording how they take their medication every day. The sensor captures treatment action and securely sends the information to the Propeller App.
This clinical investigation will last 14 weeks at the most. During this period, patients will need to visit the clinic 3 times and their clinical investigation doctor will call them twice. It is expected that approximately 150 patients will participate in the clinical investigation.
There will be 2 experience arms which patients will be randomised to.
The full experience arm: The patient has access to all functions of the smartphone app (eg: location, adherence data in real time, some tips related to asthma management, regular analysis ofrescue medication use, monthly asthma control tests available) including reminders to take Fostair 200/6 pMDI twice daily. Moreover, patients physician will be able to see patient data (treatment doses taken and rescue medication use).
the control experience arm: The patient carries on the same access type as after screening which means that reminders to take Fostair 200/6 pMDI twice daily are disabled and patients will only have access to rescue use data collected from the app. Patients physician also will not be able to see any of the patient data (treatment doses taken and rescue medication use).REC name
South East Scotland REC 02
REC reference
19/SS/0059
Date of REC Opinion
24 May 2019
REC opinion
Further Information Favourable Opinion