SLPCOPD: 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 Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed 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 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™).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Part A 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
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).
Other Names:
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| Part B 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
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).
Other Names:
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Outcome Measures
Primary Outcome Measures
- Develop and Validate SLP parameters [1 year]
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.
Secondary Outcome Measures
- Agreement between SLP and Spirometry testing [1 year]
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.
Eligibility Criteria
Criteria
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:
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Be unable to sit in an upright position for required period
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Have significant co-morbidities (i.e. Chest work or spinal deformity, OSA, AHI >30 secs
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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
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Height > 194 cm
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BMI >40
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Buckinghamshire Healthcare NHS Trust - Stoke Mandeville Hospital | Aylesbury | United Kingdom | ||
| 2 | University Hospitals Birmingham NHS Foundation Trust | Birmingham | United Kingdom | ||
| 3 | Liverpool Heart and Chest Hospital | Liverpool | United Kingdom | ||
| 4 | Liverpool University Hospitals NHS Foundation Trust | Liverpool | United Kingdom | ||
| 5 | Barts Health NHS Trust - the Royal London Hospital | London | United Kingdom | ||
| 6 | Oxford University Hospitals NHS Foundation Trust | Oxford | United Kingdom |
Sponsors and Collaborators
- Pneumacare Ltd
Investigators
- Study Chair: Mona Bafadhel, PhD, Oxford University Hospitals NHS Trust
- Principal Investigator: Dennis Wat, MD, Liverpool Heart and Chest Hospital NHS Trust
- Principal Investigator: Brendan Cooper, PhD, University Hospital Birmingham NHS Foundation Trust
- Principal Investigator: Paul Walker, MD, Liverpool University Hospital NHS Foundation Trust
- Principal Investigator: Richa Singh, MD, London Barts Health NHS Foundation Trust
- Principal Investigator: Mitra Shahidi, MD, Buckinghamshire Healthcare NHS Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PMC-SLPCOPD-2020