N/A
Completed N=20
Measuring Hydrogen Peroxide in Exhaled Breath Condensate in HV
Proof Of Concept Study
Source: ClinicalTrials.gov NCT05844553 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcomePrimary: Hydrogen Peroxide in Exhaled Breath Condensate — 0.101 µM
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hydrogen Peroxide in Exhaled Breath Condensate |
0.101 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05844553). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.