Respiratory DiseaseVICTORYNCT04467190
Investigation of Inflammacheck to Measure Exhaled Breath Condensate Hydrogen Peroxide in Respiratory Conditions
An observational study of Respiratory Disease, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
People with lung conditions can suffer significantly with their symptoms and often require multiple trips to their GP or secondary care before a diagnosis is made. It can be difficult to diagnose lung disease and to differentiate between different lung conditions, so many people may be misdiagnosed or incorrectly not… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Respiratory Disease
- How many people
- 425 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Sep 2019to 13 Oct 2022
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Participants with respiratory disease or healthy controls as defined in the inclusion and exclusion criteria
Who may be able to join
- Male or Female, aged ≥16 years
- A confirmed, clinician made diagnosis of the following (supported by standard accepted diagnostic criteria):
- Asthma with a ≤10 pack year smoking history (confirmed by spirometry and/or airway inflammation and function tests)
- COPD (confirmed by spirometry)
- Bronchiectasis (confirmed by CT scan)
- Interstitial Lung Disease (confirmed by CT scan and MDT/specialist consensus)
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- has or is eventually proven to have a histological OR radiological and MDT confirmed diagnosis of primary lung cancer, and not yet started treatment for this
- current pneumonia (confirmed by chest imaging)
- Breathing Pattern Disorder, with no other significant respiratory co-morbidity (specialist confirmed)
- Healthy controls (defined as no current clinical diagnosis of, or be receiving treatment for, a lung or other significant medical disorder).
- Willing and able to give informed consent for participation in the study.
- In a stable state (at least 4 weeks after treatment of an exacerbation of their respiratory disease)
Who cannot join
- Existing co-morbidities that may prevent them from performing spirometry, for those with asthma, COPD, or healthy controls, with no spirometry in the previous 12 months (at the discretion of the clinical investigator).
- Unable to comprehend the study, provide informed consent, and unable to perform any of the study procedures.
- Requirement of supplemental oxygen (pneumonia participants only)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS Trust
Portsmouth, PO6 3LY
About this study
Official title: A Single Visit, Cross-sectional, Observational Study of EBC H2O2 Levels and Other Exhaled Breath Condensate Parameters as Measured by Inflammacheck, in People With a Variety of Respiratory Conditions and Volunteers With no Known Lung Disease
People with lung conditions can suffer significantly with their symptoms and often require multiple trips to their GP or secondary care before a diagnosis is made. It can be difficult to diagnose lung disease and to differentiate between different lung conditions, so many people may be misdiagnosed or incorrectly not given a diagnosis. The tests currently used to diagnose lung diseases can be difficult or uncomfortable to do, especially if the person is experiencing lots of symptoms, and therefore can give poor or unreliable results.A new quick and easy to perform test is needed that can differentiate between various lung conditions and people with no lung disease, that can be performed in primary and secondary care with immediate results.
Read the detailed description
Lung disease is one of the largest contributors to morbidity and mortality in the UK, with 20% of the population diagnosed with, or receiving treatment for a respiratory condition.
Methods of diagnosis are still convoluted and can be difficult to perform, or very costly in patient and clinician time. Some diagnostic tests only look for a specific type of inflammation (e.g. Fractional exhaled Nitric Oxide) and so can overlook other causes. It can be hard to differentiate between different conditions, and as a result there are thousands of people in the UK who have undiagnosed or misdiagnosed respiratory disease.
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.
In studies using the previous version of the Inflammacheck™ device, significant differences have been demonstrated between levels of H2O2 in people with COPD, asthma, ILD and lung cancer compared to healthy controls. These studies have been instrumental in the continued improvement of the device, to ensure that the participant has the best experience, and simplify the procedure, so that the H2O2 result can be obtained with a single test in under 3 minutes.
Although the primary result of the Inflammacheck™ device is EBC H2O2, it is now also able to measure clinically important parameters including breath temperature, humidity, Carbon Dioxide waveforms, and intra-thoracic pressure changes. These parameters, in combination with the EBC H2O2 may be able to be used together to identify differences between people with various respiratory diseases and healthy volunteers. The device has also been improved based on the participant feedback, to ensure that it is user friendly and comfortable.
The investigators need to determine whether the parameters (H2O2, humidity, temperature, exhaled CO2 waveform and intra-thoracic pressure), as measured by 'Inflammacheck™' can either alone or in combination differentiate asthma, COPD, lung cancer, ILD, breathing pattern disorder, bronchiectasis and pneumonia from other each other and from healthy controls.
- Conditions
- Respiratory Disease
- Medical subject headings
- Respiration Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the levels of H2O2 in EBC in patients with a range of commonly occurring respiratory conditions
levels of H2O2 in Exhaled Breath Condensate
Measured: immediately after the procedure (breathing into device)
To measure humidity levels in EBC in patients with a range of commonly occurring respiratory conditions
level of humidity in breath in Exhaled Breath Condensate
Measured: immediately after the procedure (breathing into device)
To measure the breath temperature in EBC in patients with a range of commonly occurring respiratory conditions
temperature of breath in Exhaled Breath Condensate
Measured: immediately after the procedure (breathing into device)
To measure CO2 waveform in patients with a range of commonly occurring respiratory conditions
exhaled CO2 waveform
Measured: immediately after the procedure (breathing into device)
To measure intrathoracic pressure in patients with a range of commonly occurring respiratory conditions
intrathoracic pressure
Measured: immediately after the procedure (breathing into device)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start13 Sep 2019
- Primary completion13 Oct 2022
- Study completion13 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 425 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
- NCT04467190
- Sponsor's protocol ID
- PHT/2019/77
- Acronym
- VICTORY
- Status last verified
- Apr 2023
- First submitted
- 7 Feb 2020
- 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 Single Visit, Cross-sectional, Observational Study of EBC H2O2 Levels and Other Exhaled Breath Condensate Parameters as Measured by Inflammacheck, in People With a Variety of Respiratory Conditions and Volunteers With no Known Lung Disease
- ClinicalTrials.gov ID
- NCT04467190
- Acronym / sponsor ID
- VICTORY / PHT/2019/77
- Conditions
- Respiratory Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 13 Oct 2022 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 10 Jul 2020 (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.
People with lung conditions can suffer significantly with their symptoms and often require multiple trips to their GP or secondary care before a diagnosis is made. It can be difficult to diagnose lung disease and to differentiate between different lung conditions, so many people may be misdiagnosed or incorrectly not given a diagnosis. The tests currently used to diagnose lung diseases can be difficult or uncomfortable to do, especially if the person is experiencing lots of symptoms, and therefore can give poor or unreliable results.A new quick and easy to perform test is needed that can differentiate between various lung conditions and people with no lung disease, that can be performed in primary and secondary care with immediate results.
Detailed description
Lung disease is one of the largest contributors to morbidity and mortality in the UK, with 20% of the population diagnosed with, or receiving treatment for a respiratory condition.
Methods of diagnosis are still convoluted and can be difficult to perform, or very costly in patient and clinician time. Some diagnostic tests only look for a specific type of inflammation (e.g. Fractional exhaled Nitric Oxide) and so can overlook other causes. It can be hard to differentiate between different conditions, and as a result there are thousands of people in the UK who have undiagnosed or misdiagnosed respiratory disease.
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.
In studies using the previous version of the Inflammacheck™ device, significant differences have been demonstrated between levels of H2O2 in people with COPD, asthma, ILD and lung cancer compared to healthy controls. These studies have been instrumental in the continued improvement of the device, to ensure that the participant has the best experience, and simplify the procedure, so that the H2O2 result can be obtained with a single test in under 3 minutes.
Although the primary result of the Inflammacheck™ device is EBC H2O2, it is now also able to measure clinically important parameters including breath temperature, humidity, Carbon Dioxide waveforms, and intra-thoracic pressure changes. These parameters, in combination with the EBC H2O2 may be able to be used together to identify differences between people with various respiratory diseases and healthy volunteers. The device has also been improved based on the participant feedback, to ensure that it is user friendly and comfortable.
The investigators need to determine whether the parameters (H2O2, humidity, temperature, exhaled CO2 waveform and intra-thoracic pressure), as measured by 'Inflammacheck™' can either alone or in combination differentiate asthma, COPD, lung cancer, ILD, breathing pattern disorder, bronchiectasis and pneumonia from other each other and from healthy controls.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with respiratory disease or healthy controls as defined in the inclusion and exclusion criteria
Key inclusion criteria (12 listed)
- Male or Female, aged ≥16 years
- A confirmed, clinician made diagnosis of the following (supported by standard accepted diagnostic criteria):
- Asthma with a ≤10 pack year smoking history (confirmed by spirometry and/or airway inflammation and function tests)
- COPD (confirmed by spirometry)
- Bronchiectasis (confirmed by CT scan)
Key exclusion criteria (3 listed)
- Existing co-morbidities that may prevent them from performing spirometry, for those with asthma, COPD, or healthy controls, with no spirometry in the previous 12 months (at the discretion of the clinical investigator).
- Unable to comprehend the study, provide informed consent, and unable to perform any of the study procedures.
- Requirement of supplemental oxygen (pneumonia participants only)
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
To measure the levels of H2O2 in EBC in patients with a range of commonly occurring respiratory conditions
Time frame: immediately after the procedure (breathing into device)
levels of H2O2 in Exhaled Breath Condensate
To measure humidity levels in EBC in patients with a range of commonly occurring respiratory conditions
Time frame: immediately after the procedure (breathing into device)
level of humidity in breath in Exhaled Breath Condensate
To measure the breath temperature in EBC in patients with a range of commonly occurring respiratory conditions
Time frame: immediately after the procedure (breathing into device)
temperature of breath in Exhaled Breath Condensate
To measure CO2 waveform in patients with a range of commonly occurring respiratory conditions
Time frame: immediately after the procedure (breathing into device)
exhaled CO2 waveform
To measure intrathoracic pressure in patients with a range of commonly occurring respiratory conditions
Time frame: immediately after the procedure (breathing into device)
intrathoracic pressure
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 Respiratory Disease, 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 12 inclusion and 3 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?
To measure the levels of H2O2 in EBC in patients with a range of commonly occurring respiratory conditions (time frame: immediately after the procedure (breathing into device)). 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.