An Observational, Comparative, Multi Centre Study, Validating the Structured Light Plethysmography Against Standard of Care (Spirometry) in the Diagnosis of Chronic Obstructive Pulmonary Disease for Patients Who Plan to Undergo Spirometry Testing

Summary

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Description

This is an observational, comparative, multicentre study to validate the Thora3Di™ against standard practice in patients who are undergoing investigation for COPD. The core methodology involves capturing of data during a short period of measurement of breathing using SLP against spirometric outcomes...

This is an observational, comparative, multicentre study to validate the Thora3Di™ against standard practice in patients who are undergoing investigation for COPD. The core methodology involves capturing of data during a short period of measurement of breathing using SLP against spirometric outcomes. This study is a comparative study with two study visits (Part A and Part B ) to generate data to characterise the tidal breathing patterns and parameters with Thora3Di™againt spirometry FEV1/FVC and %predicted. Subjects will have a Part A visit 1(Development Phase), and a Part B visit 2(Validation Phase) after developing algorithms for COPD diagnosis from Part A. At Part A visit 1, subjects will have two 5-minute SLP measurements (Pre and Post bronchodilator). At Part B visit 2, subjects will be seen in the clinics and have three 5-minute SLP measurements (pre-bronchodilator, post-bronchodilator and post spirometry testing) along with spirometry testing (pre-bronchodilator and post-bronchodilator). The SLP measurement should be performed prior to standard lung function tests with minimal impact on clinical time and no change to hospital attendance. Also, each visit subjects will be asked to report concomitant medications and adverse events, and fill in COPD assessment test (CAT™).

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