SLP Model Development in the Diagnosis of COPD Patients

Completed

• Conditions: COPD; Healthy Smoker
• Interventions: Device: Structured Light Plethysmography

• Registration Number: NCT04584801
• Lead Sponsor: Pneumacare Ltd

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-12
• Study First Posted: 2020-10-14
• Study Start: 2021-05-05
• Primary Completion: 2023-06-15
• Study Completion: 2023-06-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD Patients	Structured Light Plethysmography	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
Healthy Smoker Subjects	Structured Light Plethysmography	• 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)

Primary Outcome Measures

Name	Time	Method
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.	2 years	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

Name	Time	Method
To evaluate the safety of the Thora-3Di™	2 years	Incidence of adverse events while the SLP techniques are carried out.

Trial Locations

Locations (7)

Buckinghamshire Healthcare NHS Trust - Stoke Mandeville Hospital; 🇬🇧 Aylesbury, United Kingdom

University Hospitals Birmingham NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom

Liverpool Heart and Chest Hospital; 🇬🇧 Liverpool, United Kingdom

Medway Community Healthcare; 🇬🇧 Gillingham, United Kingdom

Barts Health NHS Trust - the Royal London Hospital; 🇬🇧 London, United Kingdom

Oxford University Hospitals NHS Foundation Trust; 🇬🇧 Oxford, United Kingdom

Liverpool University Hospitals NHS Foundation Trust; 🇬🇧 Liverpool, United Kingdom