Measuring Hydrogen Peroxide in Exhaled Breath Condensate in HV

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.

Study Overview

• Status: Completed
• Conditions: Proof Of Concept Study
• Intervention / Treatment: Device: Measurement of inhaled measuring hydrogen peroxide in exhaled breath

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW36LY
    • Imperial Clinical Respiratory Research Unit (ICRRU), St Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exhaled breath measurement; Patient inhales from device	Device: Measurement of inhaled measuring hydrogen peroxide in exhaled breath; Participant exhales from device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Precision and accuracy of the EBC device in healthy subjects	Assess consistency in three successive measurements at monthly intervals in individual healthy volunteers	12 months

Collaborators and Investigators

• Sponsor: Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Estimate): May 4, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Hydrogen Peroxide
• Other Study ID Numbers: 201C6380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No