SLP Model Development in the Diagnosis of COPD Patients (SLPCOPD)

A Comparative, Multi Centre Study, to Develop a Model for Structured Light Plethysmography Against Standard of Care in the Diagnosis of Chronic Obstructive Pulmonary Disease for Patients Who Plan to Undergo Spirometry Testing

This is an observational, comparative, multicentre study to develop a model for 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.

Study Overview

• Status: Completed
• Conditions: COPD; Healthy Smoker
• Intervention / Treatment: Device: Structured Light Plethysmography

Detailed Description

This study will generate data to characterise the tidal breathing patterns and parameters with Thora-3Di™ against spirometry FEV1/FVC and %predicted. Subjects will have a Part A visit (Development Phase) to develop algorithms for COPD diagnosis. At Part A visit, subjects will have two 5-minute SLP measurements (Pre 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, subjects will be asked to report concomitant medications and adverse events and fill in COPD assessment test (CAT™).

• Study Type: Observational
• Enrollment (Actual): 201

Contacts and Locations

Study Locations

• United Kingdom
  • Aylesbury, United Kingdom
    • Buckinghamshire Healthcare NHS Trust - Stoke Mandeville Hospital
  • Birmingham, United Kingdom
    • University Hospitals Birmingham NHS Foundation Trust
  • Gillingham, United Kingdom
    • Medway Community Healthcare
  • Liverpool, United Kingdom
    • Liverpool Heart and Chest Hospital
  • Liverpool, United Kingdom
    • Liverpool University Hospitals NHS Foundation Trust
  • London, United Kingdom
    • Barts Health NHS Trust - The Royal London Hospital
  • Oxford, United Kingdom
    • Oxford University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Development Phase (Original Part A)

• 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)

Description

Inclusion Criteria:

• Any adult (≥18 years old) who has been diagnosed with COPD guide GOLD criteria (FEV1/FVC ratio post bronchodilator <0.70)
• Healthy Smokers (≥35 years old, current or ex-smoker with a history of ≥10 pack years (20 cigarettes smoked per day for 10 year))

Exclusion Criteria:

• Be unable to sit in an upright position for required period
• Have had deteriorated COPD symptoms since the last spirometry unless willing to undergo spirometry testing
• 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
• Female participant who is pregnant, lactating or planning pregnancy during the course of the study
• Be unable to consent or comply with the study protocol

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD Patients; 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	Device: Structured Light Plethysmography; Development Phase (Original Part A): Participants will have two 5-minute SLP measurements (Pre and Post bronchodilator). Participants will also undergo standard of care spirometry assessment; Other Names: Thora-3Di™
Healthy Smoker Subjects; • 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)	Device: Structured Light Plethysmography; Development Phase (Original Part A): Participants will have two 5-minute SLP measurements (Pre and Post bronchodilator). Participants will also undergo standard of care spirometry assessment; Other Names: Thora-3Di™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To develop a machine learning model to use SLP data in patients diagnosed with COPD or healthy smokers to predict historical spirometry results (within 6 months) or prospective spirometry results, and classify subjects according to COPD/non-COPD.	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety of the Thora-3Di™	Incidence of adverse events while the SLP techniques are carried out.	2 years

Collaborators and Investigators

• Sponsor: Pneumacare Ltd
• Investigators: 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 Chair: Mona Bafadhel, PhD, King's College London; Principal Investigator: Sanjay Ramakrishnan, MD, Oxford University Hospitals NHS Trust; Principal Investigator: Suraj Rajput, MSc, Medway Community Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PMC-SLPCOPD-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Via UK NIHR website

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No