SLP Model Development in the Diagnosis of COPD Patients

NCT ID: NCT04584801

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-05

Study Completion Date

2023-06-15

Brief Summary

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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

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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™).

Conditions

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COPD Healthy Smoker

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Structured Light Plethysmography

Intervention Type 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

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)

Structured Light Plethysmography

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Thora-3Di™

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pneumacare Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mona Bafadhel, PhD

Role: STUDY_CHAIR

King's College London

Dennis Wat, MD

Role: PRINCIPAL_INVESTIGATOR

Liverpool Heart and Chest Hospital NHS Trust

Brendan Cooper, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Birmingham NHS Foundation Trust

Paul Walker, MD

Role: PRINCIPAL_INVESTIGATOR

Liverpool University Hospital NHS Foundation Trust

Richa Singh, MD

Role: PRINCIPAL_INVESTIGATOR

London Barts Health NHS Foundation Trust

Mitra Shahidi, MD

Role: PRINCIPAL_INVESTIGATOR

Buckinghamshire Healthcare NHS Trust

Sanjay Ramakrishnan, MD

Role: PRINCIPAL_INVESTIGATOR

Oxford University Hospitals NHS Trust

Suraj Rajput, MSc

Role: PRINCIPAL_INVESTIGATOR

Medway Community Healthcare

Locations

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Buckinghamshire Healthcare NHS Trust - Stoke Mandeville Hospital

Aylesbury, , United Kingdom

Site Status

University Hospitals Birmingham NHS Foundation Trust

Birmingham, , United Kingdom

Site Status

Medway Community Healthcare

Gillingham, , United Kingdom

Site Status

Liverpool Heart and Chest Hospital

Liverpool, , United Kingdom

Site Status

Liverpool University Hospitals NHS Foundation Trust

Liverpool, , United Kingdom

Site Status

Barts Health NHS Trust - the Royal London Hospital

London, , United Kingdom

Site Status

Oxford University Hospitals NHS Foundation Trust

Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PMC-SLPCOPD-2020

Identifier Type: -

Identifier Source: org_study_id

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