COPD ExacerbationEXHALE 1VNCT04024657
A Cross Sectional, Diagnostic Accuracy Study to Validate the Use of a New Device(Inflammacheck™) in Diagnosing COPD
An observational study of COPD Exacerbation, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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) Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD Exacerbation
- How many people
- 313 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Dec 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: COPD patients and healthy controls
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, PO6 3LY
About this study
Official title: 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)
Read the 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.
- Conditions
- COPD Exacerbation
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of exhaled breath condensate hydrogen peroxide (EBC H2O2)
Respiratory outcome EBC H202 as measured by the inflammacheck sensor
Measured: 1 day study visit
Safety outcome
incidence of adverse events reported during the study procedures
Measured: 1 day study visit
Experience outcome
Rating of ease of use test assessed by Self Completion Questionnaire
Measured: 1 day study visit
Experience outcome
Rating of whether test is acceptable to participant assessed by Self Completion Questionnaire
Measured: 1 day study visit
Experience outcome
Participants' perception of the device assessed by Self Completion Questionnaire
Measured: 1 day study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start17 Dec 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024657
- Sponsor's protocol ID
- PHT/2018/71
- Acronym
- EXHALE 1V
- Status last verified
- Apr 2023
- First submitted
- 3 May 2019
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04024657
- Acronym / sponsor ID
- EXHALE 1V / PHT/2018/71
- Conditions
- COPD Exacerbation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients and healthy controls
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of exhaled breath condensate hydrogen peroxide (EBC H2O2)
Time frame: 1 day study visit
Respiratory outcome EBC H202 as measured by the inflammacheck sensor
Safety outcome
Time frame: 1 day study visit
incidence of adverse events reported during the study procedures
Experience outcome
Time frame: 1 day study visit
Rating of ease of use test assessed by Self Completion Questionnaire
Experience outcome
Time frame: 1 day study visit
Rating of whether test is acceptable to participant assessed by Self Completion Questionnaire
Experience outcome
Time frame: 1 day study visit
Participants' perception of the device assessed by Self Completion Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of exhaled breath condensate hydrogen peroxide (EBC H2O2) (time frame: 1 day study visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.