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

Study Overview
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Brief Summary
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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.

Detailed Description
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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™).

Official Title
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A Comparative, Non-randomised Study to Validate the Structured Light Plethysmography (SLP) Against Standard Diagnostic Method (Spirometry) for COPD for Patients Who Plan to Undergo Spirometry Testing

Conditions
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COPD, Healthy Smoker

Intervention / Treatment
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* Diagnostic Test: Structured Light Plethysmography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any adult (≥18 years old) who has been diagnosed with COPD guide GOLD criteria (FEV1/FVC ratio post bronchodilator <0.70) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Part A<br>Development Phase Any adult (≥18 years old) who has been diagnosed with COPD guide GOLD criteria (FEV1/FVC ratio post bronchodilator <0.70) Cohort A (N=50): COPD stage 1 Cohort B (N=50): COPD stage 2 Cohort C (N=50): COPD stage 3 Cohort D (N=50): COPD stage 4 Cohort E (N=50): Healthy Smokers (≥35 years old, current or ex-smoker with a history of ≥10 pack-years (20 cigarettes smoked per day for 1 year) | Diagnostic Test: Structured Light Plethysmography<br>* Part A: Subjects will have two 5-minute SLP measurements (Pre and Post bronchodilator). Part B: Subjects will be seen in the clinics and have three 5-minute SLP measurements (pre-bronchodilator, post-bronchodilator and post spirometry testing).<br>* Other names: Spirometry;|
| Part B<br>Validation Phase Cohort A (N=50): COPD stage 1 Cohort B (N=50): COPD stage 2 Cohort C (N=50): COPD stage 3 Cohort D (N=50): COPD stage 4 Cohort E (N=50): Suspected COPD | Diagnostic Test: Structured Light Plethysmography<br>* Part A: Subjects will have two 5-minute SLP measurements (Pre and Post bronchodilator). Part B: Subjects will be seen in the clinics and have three 5-minute SLP measurements (pre-bronchodilator, post-bronchodilator and post spirometry testing).<br>* Other names: Spirometry;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop and Validate SLP parameters | The proportion of points falling between the upper and lower 95% CIs of the Bland-Altman plot of the average of FEV1/FVC spirometer values and the output from the model using the SLP parameters against the difference between the spirometer values and their SLP parameter model counterparts. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement between SLP and Spirometry testing | The agreement between COPD diagnosis classifications made by FEV1/FVC and from the model using SLP parameters will be assessed using the quadratic weighted Kappa statistic and F1 score. | 1 year |