Clinical trial NCT04584801: SLP Model Development in the Diagnosis of COPD Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Healthy Smoker
Lead sponsor: Pneumacare Ltd
Sponsor class: INDUSTRY
First posted: 2020-10-14
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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™).

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 2 years
Secondary outcomes:
measure: To evaluate the safety of the Thora-3Di™
timeFrame: 2 years
Other outcomes:
Locations:
city: Aylesbury
country: United Kingdom
facility: Buckinghamshire Healthcare NHS Trust - Stoke Mandeville Hospital
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Gillingham
country: United Kingdom
facility: Medway Community Healthcare
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Barts Health NHS Trust - the Royal London Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
Study officials:
affiliation: King's College London
name: Mona Bafadhel, PhD
role: STUDY_CHAIR
affiliation: Liverpool Heart and Chest Hospital NHS Trust
name: Dennis Wat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Birmingham NHS Foundation Trust
name: Brendan Cooper, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Liverpool University Hospital NHS Foundation Trust
name: Paul Walker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: London Barts Health NHS Foundation Trust
name: Richa Singh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Buckinghamshire Healthcare NHS Trust
name: Mitra Shahidi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oxford University Hospitals NHS Trust
name: Sanjay Ramakrishnan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medway Community Healthcare
name: Suraj Rajput, MSc
role: PRINCIPAL_INVESTIGATOR
References: