SLP Model Development in the Diagnosis of COPD Patients

COPD Clinical Trial

— SLPCOPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04584801
• Other study ID #: PMC-SLPCOPD-2020
• Status: Completed
• Start date: May 5, 2021
• Est. completion date: June 15, 2023

Study information

• Verified date: January 2024
• Source: Pneumacare Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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™).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Healthy Smoker

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Buckinghamshire Healthcare NHS Trust - Stoke Mandeville Hospital	Aylesbury
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Medway Community Healthcare	Gillingham
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool
United Kingdom	Liverpool University Hospitals NHS Foundation Trust	Liverpool
United Kingdom	Barts Health NHS Trust - the Royal London Hospital	London
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Pneumacare Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the safety of the Thora-3Di™	Incidence of adverse events while the SLP techniques are carried out.	2 years