Assessment and Validation of a Device for Measuring Hydrogen Peroxide in Exhaled Breath Condensate in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Hydrogen Peroxide in Exhaled Breath Condensate
研究概览
简要总结
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.
详细描述
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 .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Hydrogen Peroxide in Exhaled Breath Condensate
时间窗: 6 months circa
Volunteer holds the device and breathes through the mouthpiece normally for a maximum of 5 minutes.
次要结局
未报告次要终点