SLP Model Development in the Diagnosis of COPD Patients (SLPCOPD)

PneumaCare

Status: Completed

Conditions: Healthy Smoker; COPD

Treatments: Device: Structured Light Plethysmography

Study type: Observational

Funder types: Industry

Identifiers

NCT04584801

PMC-SLPCOPD-2020

Details and patient eligibility

About

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.

Full 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™).

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

201 participants in 2 patient groups

COPD Patients

Description:

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

Treatment:

Device: Structured Light Plethysmography

Healthy Smoker Subjects

Description:

• 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)

Treatment:

Device: Structured Light Plethysmography