AsthmaEXHALE PilotNCT03055923
EXhaled Hydrogen Peroxide As a Marker of Lung diseasE (EXHALE) Pilot Study.
An observational study of Asthma and Chronic Obstructive Pulmonary Disease, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This Pilot study evaluates the use of a new device called Inflammacheck and whether it can consistently measure hydrogen peroxide levels in exhaled breath condensate. It will also assess whether exhaled breath condensate hydrogen peroxide levels as measured by Inflammacheck can differentiate people with asthma and… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease
- What is being tested?
- The Inflammacheck Device
- Type of treatment
- Medical device
- How many people
- 149 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Nov 2016to 10 Apr 2018
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Three populations of older adolescent and adult patients (all aged ≥16yrs) will be invited to participate: 1. Asthma patients (n=30) 2. COPD patients (n=30) 3. Comparator group (n=30) - Volunteers with no previous history of lung disease.
Who may be able to join
- Subject has a clinician made diagnosis of asthma with symptoms for ≥ 3 months supported by objective evidence of airflow variability, reversibility or airway hyper-responsiveness
- Subject has a confirmed, clinician made diagnosis of COPD for ≥ 3 months supported by spirometric evidence of fixed airflow limitation (post-bronchodilator ratio of FEV1/FVC <0.7) recorded at any time
- Subject has no known history of lung disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung disease).
- Subject is willing and able to give informed consent for participation in the study.
Who cannot join
- Subject has existing co-morbidities that may prevent them from performing spirometry, FeNO or other study measurements (at the discretion of the clinical investigator).
- Subject has known other lung, chest wall, neuromuscular, or cardiac disease or abnormality (including end-stage disease or cancer) that would confound symptom scores and spirometry.
- Subject has received treatment for an exacerbation of their respiratory disease 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.
- Subject is 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, PO6 3LY
About this study
Official title: A Cross-sectional, Feasibility Study to Explore the Use of a New Device (Inflammacheck™) in Measuring the Level of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) in Patients With Asthma, COPD, and Healthy Volunteers. The EXHALE Pilot
This Pilot study evaluates the use of a new device called Inflammacheck and whether it can consistently measure hydrogen peroxide levels in exhaled breath condensate. It will also assess whether exhaled breath condensate hydrogen peroxide levels as measured by Inflammacheck can differentiate people with asthma and COPD from healthy individuals.
Read the detailed description
Hydrogen Peroxide levels in Exhaled Breath Condensate (EBC) is a direct biomarker of oxidative stress from the airway epithelium. Levels have been shown to be raised in asthma and Chronic Obstructive Pulmonary Disease (COPD) both in stable and exacerbating states.
Previously it has been difficult to measure this volatile compound away from a laboratory based setting. However a new device has been developed to measure Hydrogen peroxide levels in exhaled breath by the patients side.
This Pilot study will test this new device in a clinical setting. It will assess whether the device can monitor levels consistently and reliably and whether it can distinguish disease from healthy individuals.
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Being tested
- The Inflammacheck Device
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Inflammacheck DeviceDevice
A new hand-held, Non-invasive breathing test, that only requires tidal breathing.
| Study group | Role | What they receive |
|---|---|---|
| Asthma Patients | 30 people who suffer from a confirmed diagnosis of asthma Receives: Device: The Inflammacheck Device | |
| Chronic Obstructive Pulmonary Disease Patients | 30 people who suffer from a confirmed diagnosis of COPD Receives: Device: The Inflammacheck Device | |
| Healthy Controls | 30 healthy volunteers who have no known diagnosis of Lung disease Receives: Device: The Inflammacheck Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled Breath Condensate hydrogen peroxide levels as measured by the inflammacheck device.
Measured: 12 months
Secondary outcomes (9)
Disease severity as measured by Global Initiative for Asthma (GINA) Stage for asthma.
Measured: 12 months
Disease severity as measured by Global Obstructive Lung Disease (GOLD) Stage for COPD.
Measured: 12 months
Disease control as measured by the Asthma Control Questionnaire (ACQ) score for asthma patients.
Measured: 12 months
Disease control as measured by the COPD Assessment Test (CAT) score for COPD patients.
Measured: 12 months
Quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ) score in asthma patients
Measured: 12 months
Lung function as recorded by the forced expiratory volume in 1 second (FEV1)
Measured: 12 months
Eosinophilic Lung Inflammation as recorded by the exhaled Nitric Oxide level (FeNO).
Measured: 12 months
Usability of inflammacheck device as measured by how frequently patients are unable to perform EBC collection by using the 'Inflammacheck' device.
Measured: 6 months
Acceptability of the inflammacheck device as measured by a questionnaire of the participants and healthcare professionals experience of 'Inflammacheck'.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start14 Nov 2016
- Primary completion10 Apr 2018
- Study completion10 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- Asthma UK
- Responsible party
- Sponsor
- Investigators
- Prof Anoop J Chauhan, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055923
- Sponsor's protocol ID
- PHT/2016/93
- Acronym
- EXHALE Pilot
- Status last verified
- Apr 2023
- First submitted
- 5 Dec 2016
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- 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, Feasibility Study to Explore the Use of a New Device (Inflammacheck™) in Measuring the Level of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) in Patients With Asthma, COPD, and Healthy Volunteers. The EXHALE Pilot
- ClinicalTrials.gov ID
- NCT03055923
- Acronym / sponsor ID
- EXHALE Pilot / PHT/2016/93
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- Asthma UK
- Study start
- 14 Nov 2016 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 16 Feb 2017 (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.
This Pilot study evaluates the use of a new device called Inflammacheck and whether it can consistently measure hydrogen peroxide levels in exhaled breath condensate. It will also assess whether exhaled breath condensate hydrogen peroxide levels as measured by Inflammacheck can differentiate people with asthma and COPD from healthy individuals.
Detailed description
Hydrogen Peroxide levels in Exhaled Breath Condensate (EBC) is a direct biomarker of oxidative stress from the airway epithelium. Levels have been shown to be raised in asthma and Chronic Obstructive Pulmonary Disease (COPD) both in stable and exacerbating states.
Previously it has been difficult to measure this volatile compound away from a laboratory based setting. However a new device has been developed to measure Hydrogen peroxide levels in exhaled breath by the patients side.
This Pilot study will test this new device in a clinical setting. It will assess whether the device can monitor levels consistently and reliably and whether it can distinguish disease from healthy individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asthma Patients | – | Device: The Inflammacheck Device30 people who suffer from a confirmed diagnosis of asthma |
| Chronic Obstructive Pulmonary Disease Patients | – | Device: The Inflammacheck Device30 people who suffer from a confirmed diagnosis of COPD |
| Healthy Controls | – | Device: The Inflammacheck Device30 healthy volunteers who have no known diagnosis of Lung disease |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Three populations of older adolescent and adult patients (all aged ≥16yrs) will be invited to participate: 1. Asthma patients (n=30) 2. COPD patients (n=30) 3. Comparator group (n=30) - Volunteers with no previous history of lung disease.
Key inclusion criteria (4 listed)
- Subject has a clinician made diagnosis of asthma with symptoms for ≥ 3 months supported by objective evidence of airflow variability, reversibility or airway hyper-responsiveness
- Subject has a confirmed, clinician made diagnosis of COPD for ≥ 3 months supported by spirometric evidence of fixed airflow limitation (post-bronchodilator ratio of FEV1/FVC <0.7) recorded at any time
- Subject has no known history of lung disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung disease).
- Subject is willing and able to give informed consent for participation in the study.
Key exclusion criteria (5 listed)
- Subject has existing co-morbidities that may prevent them from performing spirometry, FeNO or other study measurements (at the discretion of the clinical investigator).
- Subject has known other lung, chest wall, neuromuscular, or cardiac disease or abnormality (including end-stage disease or cancer) that would confound symptom scores and spirometry.
- Subject has received treatment for an exacerbation of their respiratory disease 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.
- Subject is 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Inflammacheck DeviceA new hand-held, Non-invasive breathing test, that only requires tidal breathing. | Device | Asthma Patients, Chronic Obstructive Pulmonary Disease Patients, Healthy Controls |
Primary outcome
Exhaled Breath Condensate hydrogen peroxide levels as measured by the inflammacheck device.
Time frame: 12 months
9 secondary outcomes
Disease severity as measured by Global Initiative for Asthma (GINA) Stage for asthma.
Time frame: 12 months
Disease severity as measured by Global Obstructive Lung Disease (GOLD) Stage for COPD.
Time frame: 12 months
Disease control as measured by the Asthma Control Questionnaire (ACQ) score for asthma patients.
Time frame: 12 months
Disease control as measured by the COPD Assessment Test (CAT) score for COPD patients.
Time frame: 12 months
Quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ) score in asthma patients
Time frame: 12 months
Lung function as recorded by the forced expiratory volume in 1 second (FEV1)
Time frame: 12 months
Eosinophilic Lung Inflammation as recorded by the exhaled Nitric Oxide level (FeNO).
Time frame: 12 months
Usability of inflammacheck device as measured by how frequently patients are unable to perform EBC collection by using the 'Inflammacheck' device.
Time frame: 6 months
Acceptability of the inflammacheck device as measured by a questionnaire of the participants and healthcare professionals experience of 'Inflammacheck'.
Time frame: 6 months
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.
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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.
Prof Anoop J Chauhan principal investigator
Portsmouth Hospitals NHS Trust
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 Asthma and Chronic Obstructive Pulmonary 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 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?
Exhaled Breath Condensate hydrogen peroxide levels as measured by the inflammacheck device. (time frame: 12 months). 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.