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Clinical Trial Summary

This is a pilot study to demonstrate early validation of objective home-monitoring of Chronic obstructive pulmonary disease (COPD) patients by combining accurate and relevant patient data of medication and lung function (lung impedance) through patient-facing devices.


Clinical Trial Description

The study goals are to demonstrate early validation of objective home-monitoring of COPD patients using CareCOPD mature devices, paving way for follow-up work of care integration and larger studies. The data will consist of time-series airway obstruction parameters, medication quality, and symptoms data to detect correlations with exacerbation events. 50 COPD patients (diagnosed GOLD 2- 3, C- D for moderate-severe, poorly controlled) will be monitored for 6 months. A successful outcome will be improved acute exacerbation of COPD or AECOPD detection of at least one day earlier than patient-reported assessment (COPD Assessment Test or CAT, modified Medical Research Council or mMRC questionnaires) and false positives of <20%. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04918095
Study type Observational
Source Cognita Labs LLC
Contact Rajoshi Biswas, Ph.D.
Phone 8325383042
Email rajoshi@cognitalabs.com
Status Recruiting
Phase
Start date November 9, 2020
Completion date July 31, 2023

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