Measuring Hydrogen Peroxide in Exhaled Breath Condensate in HV
Condition: Proof Of Concept Study
Study type: Observational

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.
    

Intervention name(s): Measurement of inhaled measuring hydrogen peroxide in exhaled breath
Intervention type(s): Device
Intervention description(s): Participant exhales from device
Intervention MeSH terms: Hydrogen Peroxide
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
      
Biospecimen description: 
      Exhaled breath condensate (EBC)