A Cross Sectional, Diagnostic Accuracy Study to Validate the Use of a New Device(Inflammacheck™) in Diagnosing COPD (EXHALE 1V)

A Cross Sectional, Diagnostic Accuracy Study to Validate the Use of a New Device(Inflammacheck™) in Diagnosing COPD by Measuring the Level of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2)

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)

Study Overview

• Status: Completed
• Conditions: COPD Exacerbation

Detailed Description

A key component of COPD is airway inflammation. Current tools for assessing airway inflammation and oxidative stress, such as fibre-optic bronchoscopy with bronchial wall biopsy and bronchial fluid lavage, are invasive procedures not suitable for routine clinical practice or regular repeat sampling. Sample analysis requires a series of laboratory measurements and results can take over 24 hours to become available.

Non-invasive methods of measuring airway inflammation assess exhaled gases. Fractional exhaled Nitric Oxide (FeNO) measures eosinophilic airway inflammation. However, FeNO does not provide information about neutrophilic airway inflammation, a recognised component of Chronic Obstructive Pulmonary Disease (COPD).

In contrast, measurement of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) is performed during normal tidal breathing, and is well tolerated even in patients with severe airways obstruction and those unable to perform a consistent controlled exhalation. It is also not limited to inflammatory cell specific inflammation. It has the potential to diagnose COPD and to give information about the degree of airway inflammation.

Exhalation Technology Ltd. Have developed a novel, handheld device (Inflammacheck™) which can produce a measurement of EBC H2O2 levels at the patient's side. By detecting EBC H2O2 levels immediately, Inflammacheck™ could tell potentially clinicians and patients the current level of global airway inflammation in a simple, effort independent manner. This could be used by clinicians to diagnose COPD both in hospital and in the community. Previous studies using the 'Inflammacheck™' device have shown that there is a difference in the EBC H2O2 between participants with COPD and those with no underlying lung disease. It has the potential to further measure increased levels of airway inflammation that may indicate an exacerbation of a persons' respiratory disease.

The 'Inflammacheck™' device now requires a study in a clinical setting to validate its use in accurately diagnosing COPD.

The investigators hypothesise that the The 'Inflammacheck™' device will be able to accurately diagnose patients with COPD using EBC H2O2 as compared to the gold standard of Spirometry.

• Study Type: Observational
• Enrollment (Actual): 313

Contacts and Locations

• Study Contact: Name: Anoop Chauhan; Phone Number: 6263 02392286000; Email: anoop.chauhan@porthosp.nhs.uk
• Study Contact Backup: Name: Elaine Baddeley; Phone Number: 6263 02392286000; Email: research.office@porthosp.nhs.uk

Study Locations

• United Kingdom
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO6 3LY
      • Portsmouth Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COPD patients and healthy controls

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcome	incidence of adverse events reported during the study procedures	1 day study visit
Level of exhaled breath condensate hydrogen peroxide (EBC H2O2)	Respiratory outcome EBC H202 as measured by the inflammacheck sensor	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

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PHT/2018/71

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No