An observational study in Proof Of Concept Study, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-06.
Sponsored by Imperial College London · Observational
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.
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.
Imperial College London is the lead sponsor of 842 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Healthy volunteers
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
non-smokers Healthy individuals, free of significant disease.
Exclusion Criteria:
Subjects will not be eligible if any of the following apply: -
Healthy Volunteers
Device: Measurement of inhaled measuring hydrogen peroxide in exhaled breath
Participant exhales in to device
Hydrogen Peroxide in Exhaled Breath Condensate
Volunteer holds the device and breathes through the mouthpiece normally for a maximum of 5 minutes.
Time frame: 6 months circa
| Milestone | Exhaled Breath Measurement |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Volunteer holds the device and breathes through the mouthpiece normally for a maximum of 5 minutes.
| µM | Exhaled Breath Measurement |
|---|---|
| Hydrogen Peroxide in Exhaled Breath Condensate | 0.101 ± 0.110 |
Collected over 6 months circa. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Volunteers | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
Healthy subjects
| Age, Categorical(Participants) | Exhaled Breath Measurement |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 20 |
| >=65 years | 0 |
| Age, Continuous(years) | Exhaled Breath Measurement |
|---|---|
| Mean | 34.5 ± 12.2 |
| Sex: Female, Male(Participants) | Exhaled Breath Measurement |
|---|---|
| Female | 12 |
| Male | 8 |
| Race and Ethnicity Not Collected(Participants) | Exhaled Breath Measurement |
|---|
| Region of Enrollment(participants) | Exhaled Breath Measurement |
|---|---|
| United Kingdom | 20 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jun 2021 to primary completion in Dec 2021, 6 months.
Results were first posted in Jun 2024, 2 years 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.