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
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
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™).
Inclusion Criteria:

 -  Any adult (between 18 to 80 years old) who has been diagnosed with COPD guide GOLD
 criteria (FEV1/FVC ratio post bronchodilator <0.70)

 Exclusion Criteria:

 -  Have a history of myocardial infarct

 -  Be unable to sit in an upright position for required period

 -  Have significant co-morbidities (i.e. Chest work or spinal deformity, OSA, AHI >30
 secs

 -  Any other significant disease or disorder which, in the opinion of the investigator,
 may either put the participants at risk because of participation in the study, or may
 influence the result of the study, or the participants' ability to participate in the
 study

 -  Height > 194 cm

 -  BMI >40