Interstitial Lung DiseaseEXHALE 1BNCT04061356
Assessment of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) as Measured Using a New Device (Inflammacheck™) in Patients With Interstitial Lung Disease, Lung Cancer and Healthy Volunteers.
An observational study of Interstitial Lung Disease and Lung Cancer, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
A cross-sectional study of EBC H2O2 levels, as measured by a novel device, 'Inflammacheck™', and other markers of disease severity in patients with ILD and Lung Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Lung Cancer
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Oct 2018to 14 Sep 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 18 years and older
- All sexes
- Adult, Older adult
Study population: A total of 75 participants will be recruited, comprised of 50 participants with an established diagnosis that affects their breathing and 25 participants with no history of disease (healthy volunteers).
Who may be able to join
- Male or Female, aged ≥18 years.
- A confirmed, clinician made diagnosis of Interstitial Lung Disease (ILD) supported by evidence of ILD on a CT chest scan recorded at any time.
- OR a clinician suspected or confirmed Lung Cancer, with or without asthma and/or COPD
- OR a healthy volunteer with no known history of lung disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung disease).
- 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 or other study measurements (at the discretion of the clinical investigator).
- Known other lung, chest wall, neuromuscular, or cardiac disease or abnormality (including end-stage disease or cancer) that would confound symptom scores and spirometry.
- 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: Assessment of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) as Measured Using a New Device (Inflammacheck™) in Patients With Interstitial Lung Disease, Lung Cancer and Healthy Volunteers. The EXHALE 1B Study
A cross-sectional study of EBC H2O2 levels, as measured by a novel device, 'Inflammacheck™', and other markers of disease severity in patients with ILD and Lung Cancer.
Read the detailed description
Inflammation and oxidative stress are processes that occur early in the disease process within both ILD and lung cancer. Current tools for assessing inflammation and oxidative stress, such as fibre-optic bronchoscopy with bronchial wall biopsy and bronchial fluid lavage, are invasive procedures not suitable for regular repeat sampling. Sample analysis requires a series of laboratory measurements and results can take over 24 hours to become available.
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.
To date, the measurement of EBC H2O2 has been used as a research tool only, due to the complex multiple procedural steps required to deliver a result from the collected exhaled breath. Exhalation Technology Ltd. have now developed a novel, handheld device (Inflammacheck™) which can produce an immediate measurement of EBC H2O2 levels at the patient's side. By detecting EBC H2O2 levels immediately, Inflammacheck™ could tell clinicians and patients the current level of global airway inflammation in a simple, effort independent manner. This could be used by clinicians to diagnose ILD and even Lung Cancer.
The 'Inflammacheck™' device now requires a study in a clinical setting to determine whether it can detect ILD and Lung Cancer. The acceptability and ease of use of the device also needs to be assessed for both patients and clinicians.
- Conditions
- Interstitial Lung Disease, Lung Cancer
- Medical subject headings
- Lung Diseases, Interstitial, Lung Neoplasms
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 H2O2 levels as measured by 'Inflammacheck™'
Measured: 1 day study visit
Secondary outcomes (4)
Experience outcome
rating of ease of use of test and participants perception of device as assessed by self completion questionnaire
Measured: 1 day study visit
Disease Stage (lung cancer)
measured by Tumour, Node, Metastasis stage
Measured: 1 day study visit
Disease stage (interstitial lung disease)
measured by the GAP index
Measured: 1 day study visit
safety outcome
incidence of adverse events reported during the study procedures
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 posted19 Aug 2019
- Study start30 Oct 2018
- Primary completion14 Sep 2019
- Study completion14 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 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
- NCT04061356
- Sponsor's protocol ID
- PHT/2017/121
- Acronym
- EXHALE 1B
- 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
- Assessment of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) as Measured Using a New Device (Inflammacheck™) in Patients With Interstitial Lung Disease, Lung Cancer and Healthy Volunteers. The EXHALE 1B Study
- ClinicalTrials.gov ID
- NCT04061356
- Acronym / sponsor ID
- EXHALE 1B / PHT/2017/121
- Conditions
- Interstitial Lung Disease, Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 14 Sep 2019 (actual)
- Study completion
- 14 Sep 2019 (actual)
- First posted
- 19 Aug 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 study of EBC H2O2 levels, as measured by a novel device, 'Inflammacheck™', and other markers of disease severity in patients with ILD and Lung Cancer.
Detailed description
Inflammation and oxidative stress are processes that occur early in the disease process within both ILD and lung cancer. Current tools for assessing inflammation and oxidative stress, such as fibre-optic bronchoscopy with bronchial wall biopsy and bronchial fluid lavage, are invasive procedures not suitable for regular repeat sampling. Sample analysis requires a series of laboratory measurements and results can take over 24 hours to become available.
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.
To date, the measurement of EBC H2O2 has been used as a research tool only, due to the complex multiple procedural steps required to deliver a result from the collected exhaled breath. Exhalation Technology Ltd. have now developed a novel, handheld device (Inflammacheck™) which can produce an immediate measurement of EBC H2O2 levels at the patient's side. By detecting EBC H2O2 levels immediately, Inflammacheck™ could tell clinicians and patients the current level of global airway inflammation in a simple, effort independent manner. This could be used by clinicians to diagnose ILD and even Lung Cancer.
The 'Inflammacheck™' device now requires a study in a clinical setting to determine whether it can detect ILD and Lung Cancer. The acceptability and ease of use of the device also needs to be assessed for both patients and clinicians.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A total of 75 participants will be recruited, comprised of 50 participants with an established diagnosis that affects their breathing and 25 participants with no history of disease (healthy volunteers).
Key inclusion criteria (5 listed)
- Male or Female, aged ≥18 years.
- A confirmed, clinician made diagnosis of Interstitial Lung Disease (ILD) supported by evidence of ILD on a CT chest scan recorded at any time.
- OR a clinician suspected or confirmed Lung Cancer, with or without asthma and/or COPD
- OR a healthy volunteer with no known history of lung disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung disease).
- Willing and able to give informed consent for participation in the study.
Key exclusion criteria (4 listed)
- Existing co-morbidities that may prevent them from performing spirometry or other study measurements (at the discretion of the clinical investigator).
- Known other lung, chest wall, neuromuscular, or cardiac disease or abnormality (including end-stage disease or cancer) that would confound symptom scores and spirometry.
- 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 H2O2 levels as measured by 'Inflammacheck™'
4 secondary outcomes
Experience outcome
Time frame: 1 day study visit
Disease Stage (lung cancer)
Time frame: 1 day study visit
Disease stage (interstitial lung disease)
Time frame: 1 day study visit
safety outcome
Time frame: 1 day study visit
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 Interstitial Lung Disease and Lung Cancer, 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 5 inclusion and 4 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). 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.