SLP Model Development in the Diagnosis of COPD Patients

NCT04584801 | Completed DMC

• 1 other identifier: PMC-SLPCOPD-2020
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 7

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.

Conditions

COPD; Healthy Smoker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To evaluate the safety of the Thora-3Di™

  2 years

Study Arms (2)

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

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

Interventions

Structured Light Plethysmography DEVICE

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

Also known as: Thora-3Di™

COPD Patients; Healthy Smoker Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• Pneumacare Ltd: lead

Study Sites (7)

Buckinghamshire Healthcare NHS Trust - Stoke Mandeville Hospital

Aylesbury, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

Medway Community Healthcare

Gillingham, United Kingdom

Location

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

Location

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

Location

Barts Health NHS Trust - the Royal London Hospital

London, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mona Bafadhel, PhD

  King's College London

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

• Sanjay Ramakrishnan, MD

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

• Suraj Rajput, MSc

  Medway Community Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: May 5, 2021
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7)