Proof Of Concept StudyNCT05844553
Measuring Hydrogen Peroxide in Exhaled Breath Condensate in HV
An observational study of Proof Of Concept Study, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the performance of an Exhaled Breath Condensate (EBC) device. EBC measurements can be used for the assessments of lung inflammation in asthma and chronic obstructive pulmonary disease (COPD). Current assessments are based on patient symptoms and simple spirometry tests. 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?
- Measurement of inhaled measuring hydrogen peroxide in exhaled breath
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jun 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Healthy volunteers
Who may be able to join
- non-smokers Healthy individuals, free of significant disease.
- Given written informed consent prior to participation in the study including all of its procedures.
- Comply with the requirements and restrictions listed in the consent form.
- Male or female subject aged 18-65 years 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
- Subjects will not be eligible if any of the following apply: -
- 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 (assessments and entry could be deferred.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial Clinical Respiratory Research Unit (ICRRU), St Mary's Hospital
London, SW36LY
About this study
Official title: Assessment and Validation of a Device for Measuring Hydrogen Peroxide in Exhaled Breath Condensate in Healthy Volunteers
The purpose of this study is to evaluate the performance of an Exhaled Breath Condensate (EBC) device. EBC measurements can be used for the assessments of lung inflammation in asthma and chronic obstructive pulmonary disease (COPD). Current assessments are based on patient symptoms and simple spirometry tests. Unfortunately, these tests are not directly correlated to lung inflammation in these diseases. Exhaled Breath Condensate (EBC) serves as a simple and non-invasive measurement which can potentially inform clinical decision-making. EBC measures hydrogen peroxide (H2O2) concentrations in exhaled breath and significantly higher concentrations are found in COPD patients. Following a successful pilot study we now want to evaluate the device with real breath samples from healthy volunteers. We want to evaluate the consistency of 3 measurements a month apart.
Read the detailed description
We aim to recruit 20 healthy volunteers . Our purpose with this study is to evaluate the analytical performance of the device and the data processing and consistency of measurement over 3 measurements a month apart.
Participants will be screened to see if they are suitable for the study. The Screening procedure will take approximately one hour and involve the researcher going through a list of questions related to their health and any medications they are currently taking.
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..
After the consent form has been signed, the breath collection protocol can then begin.
The handheld breath collection apparatus will be switched on by the researcher and allowed to achieve the correct temperature (1-2 minutes). A sterilised disposable plastic mouthpiece will be fitted. The participant will be asked to hold the breath collection device and breath normally into the plastic mouthpiece for up to 5 minutes .
The researcher will take the instrument and remove the condensed breath sample, place it in a numbered vial and remove it for analysis in the laboratory. Ideally, three samples per participant will be collected, but the participant may withdraw consent at any point.
All samples will be pseudonymised to protect participant confidentiality. The individual results of the analysis will be made available to the participants. If requested. Three successive measurements will be made at monthly intervals in each individual healthy volunteer requiring them to visit the Hospital on three occasions.
- Conditions
- Proof Of Concept Study
- Being tested
- Measurement of inhaled measuring hydrogen peroxide in exhaled breath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of inhaled measuring hydrogen peroxide in exhaled breathDevice
Participant exhales in to device
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy Volunteers Receives: Device: Measurement of inhaled measuring hydrogen peroxide in exhaled breath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydrogen Peroxide in Exhaled Breath Condensate
Volunteer holds the device and breathes through the mouthpiece normally for a maximum of 5 minutes.
Measured: 6 months circa
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start17 Jun 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844553
- Sponsor's protocol ID
- 20IC6380
- Status last verified
- Jun 2024
- First submitted
- 25 Apr 2023
- Last updated
- 6 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 6 Jun 2024. 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
- NCT05844553
- Acronym / sponsor ID
- 20IC6380
- Conditions
- Proof Of Concept Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the performance of an Exhaled Breath Condensate (EBC) device. EBC measurements can be used for the assessments of lung inflammation in asthma and chronic obstructive pulmonary disease (COPD). Current assessments are based on patient symptoms and simple spirometry tests. Unfortunately, these tests are not directly correlated to lung inflammation in these diseases. Exhaled Breath Condensate (EBC) serves as a simple and non-invasive measurement which can potentially inform clinical decision-making. EBC measures hydrogen peroxide (H2O2) concentrations in exhaled breath and significantly higher concentrations are found in COPD patients. Following a successful pilot study we now want to evaluate the device with real breath samples from healthy volunteers. We want to evaluate the consistency of 3 measurements a month apart.
Detailed description
We aim to recruit 20 healthy volunteers . Our purpose with this study is to evaluate the analytical performance of the device and the data processing and consistency of measurement over 3 measurements a month apart.
Participants will be screened to see if they are suitable for the study. The Screening procedure will take approximately one hour and involve the researcher going through a list of questions related to their health and any medications they are currently taking.
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..
After the consent form has been signed, the breath collection protocol can then begin.
The handheld breath collection apparatus will be switched on by the researcher and allowed to achieve the correct temperature (1-2 minutes). A sterilised disposable plastic mouthpiece will be fitted. The participant will be asked to hold the breath collection device and breath normally into the plastic mouthpiece for up to 5 minutes .
The researcher will take the instrument and remove the condensed breath sample, place it in a numbered vial and remove it for analysis in the laboratory. Ideally, three samples per participant will be collected, but the participant may withdraw consent at any point.
All samples will be pseudonymised to protect participant confidentiality. The individual results of the analysis will be made available to the participants. If requested. Three successive measurements will be made at monthly intervals in each individual healthy volunteer requiring them to visit the Hospital on three occasions.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Device: Measurement of inhaled measuring hydrogen peroxide in exhaled breathHealthy Volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (6 listed)
- non-smokers Healthy individuals, free of significant disease.
- Given written informed consent prior to participation in the study including all of its procedures.
- Comply with the requirements and restrictions listed in the consent form.
- Male or female subject aged 18-65 years at screening.
- Able to complete the study and all measurements.
Key exclusion criteria (5 listed)
- Subjects will not be eligible if any of the following apply: -
- 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 (assessments and entry could be deferred.
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 |
|---|---|---|
| Measurement of inhaled measuring hydrogen peroxide in exhaled breathParticipant exhales in to device | Device | Healthy Volunteers |
Primary outcome
Hydrogen Peroxide in Exhaled Breath Condensate
Time frame: 6 months circa
Volunteer holds the device and breathes through the mouthpiece normally for a maximum of 5 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 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 6 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 6 Jun 2024. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hydrogen Peroxide in Exhaled Breath Condensate (time frame: 6 months circa). 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 6 Jun 2024.