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Clinical Trials/NCT02203266
NCT02203266
Completed
Not Applicable

A Randomised, Parallel-group, Multi-centre Trial Using a Novel INCA Tracker Device to Measure and Monitor Compliance and Technique of Seretide Diskus Inhaler in a Community Pharmacy Setting

Beaumont Hospital1 site in 1 country152 target enrollmentFebruary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Beaumont Hospital
Enrollment
152
Locations
1
Primary Endpoint
Rate of adherence
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this trial is to discover whether providing feedback to patients from a device that records when and how well a patient uses a Seretide Diskus inhaler will lead to:

  • Improved compliance with prescribed inhaler use
  • Improved technique of inhaler use
  • A reduction in respiratory health related outcomes caused by poor inhaler compliance and usage.
  • An improvement in patient quality of life scores
Registry
clinicaltrials.gov
Start Date
February 2014
End Date
January 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Beaumont Hospital
Responsible Party
Principal Investigator
Principal Investigator

Professor Richard Costello

Professor Richard Costello

Beaumont Hospital

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years old or above
  • Capable of understanding and willing to provide voluntary informed consent before any protocol specific procedures are performed
  • Capable of understanding and complying with the requirements of the protocol, and demonstrating a willingness to attend for all required visits.
  • Able and willing to take inhaled medication.
  • Have a valid prescription for use of a Seretide diskus inhaler or already using a Seretide diskus inhaler.
  • Have a history of regular attendance in the pharmacy in which they are recruited which will be demonstrated by the subject having collected three prescriptions for any medication in that pharmacy in the six months preceeding their recruitment to the study.

Exclusion Criteria

  • Patient expressly reports that their physician has indicated that they will not be continuing to receive Seretide over the next 6 months

Outcomes

Primary Outcomes

Rate of adherence

Time Frame: 2 months and 6 months

The rate of adherence is the proportion of correctly taken drugs at the correct time relative to the prescribed interval.

Secondary Outcomes

  • Rescue antibiotic and/or steroid medication use(6 months)
  • Adherence in the time domain(Two months and six months)
  • Rescue inhaled medication use(Six months)
  • Quality of life(2 months and 6 months)
  • Technique adherence(Two months and six months)

Study Sites (1)

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