A Cross Sectional, Diagnostic Accuracy Study to Validate the Use of a New Device(Inflammacheck™) in Diagnosing COPD

NCT04024657 | Completed

• 1 other identifier: PHT/2018/71
• Study Type: observational
• Target: 313
• Locations: 1 country
• Sites: 1

Brief Summary

A cross-sectional, diagnostic accuracy study to evaluate the use of the 'Inflammacheck™' device in the diagnosis of COPD. Participants will be asked to provide an exhaled breath sample for measurement of their EBC H2O2 using 'Inflammacheck™'. The result will be correlated with spirometry (FEV1/ FVC ratio)

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (5)

• Level of exhaled breath condensate hydrogen peroxide (EBC H2O2)

  Respiratory outcome EBC H202 as measured by the inflammacheck sensor

  1 day study visit

• Safety outcome

  incidence of adverse events reported during the study procedures

  1 day study visit

• Experience outcome

  Rating of ease of use test assessed by Self Completion Questionnaire

  1 day study visit

• Experience outcome

  Rating of whether test is acceptable to participant assessed by Self Completion Questionnaire

  1 day study visit

• Experience outcome

  Participants' perception of the device assessed by Self Completion Questionnaire

  1 day study visit

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients and healthy controls

You may qualify if:

• Male or Female, aged ≥40 years.
• A confirmed, clinician made diagnosis of COPD supported by spirometric evidence of fixed airflow limitation (post-bronchodilator ratio of FEV1/FVC \<0.7) recorded at any time.
• OR no known history of lung disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung disease) and be a current non-smoker. Ex-smokers with a less than 5 pack year history of smoking (cigarettes and cannabis) and who have stopped smoking ≥6 months ago can be included.
• Willing and able to give informed consent for participation in the study.

You may not qualify if:

• Existing co-morbidities that may prevent them from performing spirometry (at the discretion of the clinical investigator).
• Known other lung, chest wall, neuromuscular, or cardiac disease (including end-stage disease or cancer) that would confound Inflammacheck™ measurements and spirometry (at the discretion of the clinical investigator).
• Has received treatment for an exacerbation of their COPD within the last 2 weeks.
• In the opinion of the clinical investigator, participant could be put at risk of harm by having to perform any of the study procedures.
• Unable to comprehend the study and provide informed consent e.g. insufficient command of English in the absence of someone to adequately interpret.

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: July 18, 2019
• Study Start: December 17, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)