Proof of Concept StudyNCT06788457
Measuring Hydrogen Peroxide in Exhaled Breath Condensate in COPD
An observational study of Proof of Concept Study, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Following a successful pilot study and a clinical assessment in healthy volunteers (ClinicalTrials.gov ID: NCT05844553) this study aims to evaluate the accuracy and precision of an Exhaled Breath Condensate (EBC) device in patients with COPD. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Proof of Concept Study
- What is being tested?
- Exhaled Breath Condensate
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 May 2022to 12 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with COPD and Heathy participants
Who may be able to join
- COPD participants:
- A diagnosis of COPD.
- Not current smokers
- Stable COPD (no chest infection requiring antibiotics and/or oral steroids in the past 1 month).
- Able to give written informed consent prior to participation in the study including all of its procedures.
- Male or female subject aged 18 years and above at screening.
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- Able to complete the study and all measurements.
- Able to read, comprehend, and write at a sufficient level to complete study related materials
- Healthy subjects:
- non-smokers
- Healthy individuals, free of significant disease.
- Able to give written informed consent prior to participation in the study including all of its procedures.
- Able to comply with the requirements and restrictions listed in the consent form.
- Male or female subject aged 18 years and above at screening.
- Able to complete the study and all measurements.
- Able to read, comprehend, and write at a sufficient level to complete study related materials.
Who cannot join
- COPD Participants:
- We will not recruit subjects who lack the capacity to consent.
- Current or past diagnosis of asthma.
- History of any chronic respiratory diseases other than COPD.
- History of another medical condition, which in the opinion of the Unit Physician, contraindicates his/her participation in the study.
- Unstable respiratory disease in the last four weeks prior to the screening visit (indicated by any change in their maintenance inhaled therapy or who have had a lower respiratory tract infection in the previous four weeks).
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- Evidence of a respiratory exacerbation requiring emergency room treatment and/or hospitalisation within four weeks before screening.
- Use of systemic (oral or intravenous) steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 12 months.
- Patients who have evidence of alcohol or substance abuse.
- Participation in another clinical trial with an investigational drug in the four weeks preceding the screening visit.
- Those, in the opinion of the investigator, who may prove non-compliant with study procedures.
- History of an upper or lower respiratory infection (including coryza) within 3 weeks of baseline assessments (assessments and entry could be deferred.
- Healthy subjects:
- A history of recreational drug use or allergy which in the opinion of the investigators contra-indicates their participation.
- Participation within 3 months in any other study testing a new molecular entity or drug or involving invasive procedures.
- Those, in the opinion of the investigator, who may prove non-compliant with study procedures.
- History of an upper or lower respiratory infection (including coryza) within 3 weeks of baseline assessments.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research Facility, Royal Brompton Hospital
London, SW3 6LY
About this study
Official title: Assessment and Validation of a Device for Measuring Hydrogen Peroxide in Exhaled Breath Condensate in Healthy Volunteers
Following a successful pilot study and a clinical assessment in healthy volunteers (ClinicalTrials.gov ID: NCT05844553) this study aims to evaluate the accuracy and precision of an Exhaled Breath Condensate (EBC) device in patients with COPD. The study will evaluate the reproducibility of 3 measurements a month apart in real breath samples. This will take place at the Clinical Research Facility (CRF) at the Royal Brompton Hospital. Real biological specimens are complex and there is the potential for losses of precision and accuracy. This can only be evaluated by comparison with established methodology. Secondly, whilst many reports can correctly classify COPD patients, there are substantial variations in absolute levels between researchers. It has been shown with artificial samples that correcting for variations in heat and mass transport can substantially reduce these variations. Collecting replicate samples from patients with COPD will allow the evaluation within this patient group.
Read the detailed description
The study aim is to recruit 15 patients with COPD and 15 healthy volunteers in order tevaluate the analytical performance of the device and the data processing and consistency of measurements over a 3-month period.
Three successive measurements will be made at monthly intervals in each patient with COPD and with each healthy volunteer requiring them to visit the Hospital on three occasions. The first visit also includes screening which will take up to 1 hour.
Firstly, each potential participant will be sent a participant information sheet.
If they decide that they wish to take part in the research study, they will be asked to come to the Clinical Research Facility (CRF) at the Royal Brompton Hospital, for screening where the research team will further explain the study to the participant. A hard copy of the participant information sheet will be provided at the appointment and participants will be encouraged to ask questions. Participants will then be presented with a consent form which they will be asked to sign before any procedures are made.
- Conditions
- Proof of Concept Study
- Being tested
- Exhaled Breath Condensate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exhaled Breath CondensateDevice
Measurement of hydrogen peroxide in exhaled breath
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Healthy individuals, free of significant disease. Receives: Device: Exhaled Breath Condensate | |
| Participants with COPD | A diagnosis of COPD. Receives: Device: Exhaled Breath Condensate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precision and accuracy of the EBC device in COPD & healthy participants.
This will be assessed by comparison with the gold standard fluorometry and mass spectrometry methods.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start10 May 2022
- Primary completion12 Oct 2022
- Study completion12 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proof of Concept StudyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omar Usmani, MBBS, MRCP, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788457
- Sponsor's protocol ID
- 21IC7212
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- 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 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Validation of a Device for Measuring Hydrogen Peroxide in Exhaled Breath Condensate in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06788457
- Acronym / sponsor ID
- 21IC7212
- Conditions
- Proof of Concept Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 23 Jan 2025 (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.
Following a successful pilot study and a clinical assessment in healthy volunteers (ClinicalTrials.gov ID: NCT05844553) this study aims to evaluate the accuracy and precision of an Exhaled Breath Condensate (EBC) device in patients with COPD. The study will evaluate the reproducibility of 3 measurements a month apart in real breath samples. This will take place at the Clinical Research Facility (CRF) at the Royal Brompton Hospital. Real biological specimens are complex and there is the potential for losses of precision and accuracy. This can only be evaluated by comparison with established methodology. Secondly, whilst many reports can correctly classify COPD patients, there are substantial variations in absolute levels between researchers. It has been shown with artificial samples that correcting for variations in heat and mass transport can substantially reduce these variations. Collecting replicate samples from patients with COPD will allow the evaluation within this patient group.
Detailed description
The study aim is to recruit 15 patients with COPD and 15 healthy volunteers in order tevaluate the analytical performance of the device and the data processing and consistency of measurements over a 3-month period.
Three successive measurements will be made at monthly intervals in each patient with COPD and with each healthy volunteer requiring them to visit the Hospital on three occasions. The first visit also includes screening which will take up to 1 hour.
Firstly, each potential participant will be sent a participant information sheet.
If they decide that they wish to take part in the research study, they will be asked to come to the Clinical Research Facility (CRF) at the Royal Brompton Hospital, for screening where the research team will further explain the study to the participant. A hard copy of the participant information sheet will be provided at the appointment and participants will be encouraged to ask questions. Participants will then be presented with a consent form which they will be asked to sign before any procedures are made.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Device: Exhaled Breath CondensateHealthy individuals, free of significant disease. |
| Participants with COPD | – | Device: Exhaled Breath CondensateA diagnosis of COPD. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with COPD and Heathy participants
Key inclusion criteria (16 listed)
- A diagnosis of COPD.
- Not current smokers
- Stable COPD (no chest infection requiring antibiotics and/or oral steroids in the past 1 month).
- Able to give written informed consent prior to participation in the study including all of its procedures.
- Male or female subject aged 18 years and above at screening.
Key exclusion criteria (17 listed)
- We will not recruit subjects who lack the capacity to consent.
- Current or past diagnosis of asthma.
- History of any chronic respiratory diseases other than COPD.
- History of another medical condition, which in the opinion of the Unit Physician, contraindicates his/her participation in the study.
- Unstable respiratory disease in the last four weeks prior to the screening visit (indicated by any change in their maintenance inhaled therapy or who have had a lower respiratory tract infection in the previous four weeks).
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 |
|---|---|---|
| Exhaled Breath CondensateMeasurement of hydrogen peroxide in exhaled breath | Device | Healthy participants, Participants with COPD |
Primary outcome
Precision and accuracy of the EBC device in COPD & healthy participants.
Time frame: 12 months
This will be assessed by comparison with the gold standard fluorometry and mass spectrometry methods.
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 23 Jan 2025.
- Individual participant dataSharing planned: No
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.
Omar Usmani, MBBS, MRCP, PhD principal investigator
Imperial College London
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 Proof of Concept Study, run by Imperial College London 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 16 inclusion and 17 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 23 Jan 2025. 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?
Precision and accuracy of the EBC device in COPD & healthy participants. (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 23 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.