Electronic medical device- patient adherence study in COPD patients

• Research type

  Research Study

• Full title

  A 24-week randomised, multicentre, single blinded, international study to evaluate the effect of reminder notifications and motivational/adaptive messaging on treatment adherence of COPD subjects receiving Ultibro® Breezhaler® treatment using Concept2 inhaler for dose tracking

• IRAS ID

  238608

• Contact name

  Dan Mihailescu

• Contact email

  dan.mihailescu@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2017-001593-42

• Clinicaltrials.gov Identifier

  NCT01744028

• Duration of Study in the UK

  1 years, 2 months, 2 days

• Research summary

  The intervention in this study consists solely of the use of an investigational digital system consisting of the patient application and the Concept2 inhaler. The system will be used in half of the subjects while the other group will receive Usual Care delivered by the Concept2 inhaler, with no patient application. All subjects in this study will be receiving Ultibro® Breezhaler® capsules (110/50ug) daily as prescribed by their physician prior to their inclusion in the study.
  The Concept2 inhaler will monitor subjects' adherence with the approved once daily dosing regimen for Ultibro® Breezhaler® capsules. The digital adherence system enables in addition the real-time, wireless transfer of inhaler use data to the patient application. These inhaler data are then interpreted and specific appropriate feedback to the subject are provided. The study will look at whether the use of dose tracking by the inhaler in conjunction with reminder notifications and messages sent by the patient application can improve on-time adherence or total adherence over 24 weeks of intervention.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  18/EE/0070

• Date of REC Opinion

  30 Apr 2018

• REC opinion

  Further Information Favourable Opinion