Measuring Hydrogen Peroxide in Exhaled Breath Condensate in HV

NCT05844553 | Completed Results

• 1 other identifier: 20IC6380
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Proof Of Concept Study

Outcome Measures

Primary Outcomes (1)

• Hydrogen Peroxide in Exhaled Breath Condensate

  Volunteer holds the device and breathes through the mouthpiece normally for a maximum of 5 minutes.

  6 months circa

Study Arms (1)

Healthy Volunteers

Healthy Volunteers

Device: Measurement of inhaled measuring hydrogen peroxide in exhaled breath

Interventions

Measurement of inhaled measuring hydrogen peroxide in exhaled breath DEVICE

Participant exhales in to device

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial Clinical Respiratory Research Unit (ICRRU), St Mary's Hospital

London, SW36LY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Exhaled breath condensate (EBC)

Results Point of Contact

• Title: Prof. Omar Usmani
• Organization: Imperial College London, National Heart & Lung Institute and RBH

o.usmani@imperial.ac.uk

02073518053

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: June 17, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 6, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)