CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 138 enrolled
Drug / intervention
Arm 1: BreatheMate device with application +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02864342
NCT02864342Phase 4Completed

A Randomized Clinical Study to Assess the Impact of Symbicort® pMDI Medication Reminders on Adherence in COPD Patients

AstraZeneca·interventional·Posted Aug 12, 2016·Updated Nov 20, 2018

In Brief

A Phase 4 clinical trial evaluating Arm 1: BreatheMate device with application and Arm 2: BreatheMate device without application for Chronic Obstructive Pulmonary Disease (COPD. Completed, enrolled 138 participants across 8 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsQuintiles, Inc.

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 12, 2016
Enrollment StartAug 12, 2016
Primary CompletionOct 31, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.9 years ago

Interventions

Arm 1: BreatheMate device with applicationdevice

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.

Arm 2: BreatheMate device without applicationdevice

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.