Proof Of Concept Study
Conditions
Brief 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. 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.
Interventions
DEVICEMeasurement of inhaled measuring hydrogen peroxide in exhaled breath
Participant exhales in to device
Sponsors
Imperial College London
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hydrogen Peroxide in Exhaled Breath Condensate | 6 months circa | Volunteer holds the device and breathes through the mouthpiece normally for a maximum of 5 minutes. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exhaled Breath Measurement Patient inhales from device
Measurement of inhaled measuring hydrogen peroxide in exhaled breath: Participant exhales from device | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Exhaled Breath Measurement | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 20 Participants | — |
| Age, Continuous | 34.5 years STANDARD_DEVIATION 12.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 20 participants | — |
| Sex: Female, Male Female | 12 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exhaled Breath Measurement | Hydrogen Peroxide in Exhaled Breath Condensate | 0.101 µM | Standard Deviation 0.11 |