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Adherence Study in COPD Patients

NCT02864342 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2018-11-20

Study results available
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Summary

A randomized clinical study to assess the impact of Symbicort® pMDI medication reminders on adherence in COPD patients

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD

Interventions

DEVICE

Arm 1: BreatheMate device with application

The service known as 'BreatheMate' is a patient support tool that monitors daily Symbicort inhaler use. The BreatheMate service includes a bluetooth monitoring device that is attached to subjects' Symbicort pMDI inhaler which automatically detects and logs their maintenance medication use. Subjects will receive audio-visual daily reminders (beeps and flashes) on the BreatheMate Bluetooth device. The bluetooth device transmits this data to a cellular phone that is provided to all subjects in the study. Subjects in the intervention group will also receive audio-visual alerts (beeps, flashes) from the bluetooth device to take their medication.

DEVICE

Arm 2: BreatheMate device without application

The service known as 'BreatheMate' is a patient support tool that monitors daily Symbicort inhaler use. The BreatheMate service includes a bluetooth monitoring device that is attached to subjects' Symbicort pMDI inhaler which automatically detects and logs their maintenance medication use. The functionality of audio-visual daily reminders (beeps and flashes) is deactivated for this control group. The BreatheMate service also includes a cellular phone that will display whether the Bluetooth monitoring device is paired and communicating with the cellular phone. The Bluetooth device will transmit data regarding medication usage to the cellular phone.

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-12
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02864342 on ClinicalTrials.gov