COPDSLPCOPDNCT04584801

SLP Model Development in the Diagnosis of COPD Patients

An observational study of COPD and Healthy Smoker, run by Pneumacare Ltd at 7 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COPD, Healthy Smoker
What is being tested?: Structured Light Plethysmography
Type of treatment: Medical device
How many people: 201 participants
Where: 7 sitesUnited Kingdom
Study dates: 5 May 2021to 15 Jun 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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)

Who may be able to join

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))

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United Kingdom7 sites

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

Other trials in United Kingdom

About this study

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

Read the 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™).

Conditions: COPD, Healthy Smoker
Being tested: Structured Light Plethysmography
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Structured Light PlethysmographyDevice
Also called Thora-3Di™
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

Study groups in NCT04584801
Study group	Role	What they receive
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 Receives: 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) Receives: Device: Structured Light Plethysmography

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 years

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 202115 Jun 2023

First posted14 Oct 2020
Study start5 May 2021
Primary completion15 Jun 2023
Study completion15 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COPDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04584801
Sponsor's protocol ID: PMC-SLPCOPD-2020
Acronym: SLPCOPD
Status last verified: Jan 2024
First submitted: 6 Oct 2020
Last updated: 19 Sep 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Via UK NIHR website

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04584801
Acronym / sponsor ID: SLPCOPD / PMC-SLPCOPD-2020
Conditions: COPD, Healthy Smoker
Study type: Observational
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: Pneumacare LtdIndustry (pharma, biotech, devices)
Study start: 5 May 2021 (actual)
Primary completion: 15 Jun 2023 (actual)
Study completion: 15 Jun 2023 (actual)
First posted: 14 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
COPD Patients	–	Device: Structured Light PlethysmographyDevelopment 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	–	Device: 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)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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)

Key inclusion criteria (2 listed)

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))

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Structured Light PlethysmographyAlso: Thora-3Di™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	Device	COPD Patients, Healthy Smoker Subjects

Primary outcome

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.
Time frame: 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.

1 secondary outcome

To evaluate the safety of the Thora-3Di™
Time frame: 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Individual participant dataSharing planned: No. Via UK NIHR website

Related trials for COPD

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mona Bafadhel, PhD study chair

King's College London

Dennis Wat, MD principal investigator

Liverpool Heart and Chest Hospital NHS Trust

Brendan Cooper, PhD principal investigator

University Hospital Birmingham NHS Foundation Trust

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COPD and Healthy Smoker, run by Pneumacare Ltd at 7 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04584801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.