SLP Model Development in the Diagnosis of COPD Patients
NCT ID: NCT04584801
Last Updated: 2024-09-19
Study Results
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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COMPLETED
201 participants
OBSERVATIONAL
2021-05-05
2023-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Pneumacare Ltd
INDUSTRY
Responsible Party
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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
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Medway Community Healthcare
Gillingham, , United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
Liverpool University Hospitals NHS Foundation Trust
Liverpool, , United Kingdom
Barts Health NHS Trust - the Royal London Hospital
London, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Countries
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Other Identifiers
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PMC-SLPCOPD-2020
Identifier Type: -
Identifier Source: org_study_id
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