NCT04584801

SLP Model Development in the Diagnosis of COPD Patients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 201 (actual)
• Sponsor: Pneumacare Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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™).

Conditions

• COPD
• Healthy Smoker

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2021-05-05
• Primary completion: 2023-06-15
• Completion: 2023-06-15
• First posted: 2020-10-14
• Last updated: 2024-09-19

Locations

7 sites across 1 country: United Kingdom