跳至主要内容
临床试验/NCT05322785
NCT05322785
Enrolling By Invitation
不适用

Optimization of Exhaled Biomarker Collection and Analysis

Indiana University1 个研究点 分布在 1 个国家目标入组 1,000 人2020年2月2日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Respiratory Disease
发起方
Indiana University
入组人数
1000
试验地点
1
主要终点
Breath amount, pH, components
状态
Enrolling By Invitation
最后更新
去年

概览

简要总结

This is an exploratory study designed to optimize, standardize, and validate novel breath biomarkers; there are no objective endpoints. The goal of this study is to generate pilot data to be used to generate hypothesis-driven studies.

详细描述

Exhaled breath has three fractions - gaseous breath, volatile breath, and breath condensate. Biomarkers have been identified in each of these fractions and non-invasive collection methods have been developed. Exhaled breath can be safely and easily performed in all patient populations, including neonatal children and the elderly. We have shown that relative to normal controls, condensed exhalates obtained from asthmatic subjects reproducibly contain elevated concentrations of oxides of nitrogen and are more acidic (having hydrogen ion concentrations two to three log orders higher). We wish to extend these studies across all breath fractions and other lung diseases and respiratory processes including viral upper respiratory tract infections, cystic fibrosis, pneumonia, pulmonary hypertension, bronchiolitis obliterans, chronic obstructive pulmonary disease, tracheostomized patients and cigarette smokers. Through this study extension, we will obtain pilot data/preliminary information about the potential utility of this new technique to non-invasively evaluate disease status in various respiratory diseases. We also wish to obtain data regarding specificity by evaluating the exhaled breath obtained from patients with non-respiratory illnesses, such as, but not limited to diabetes, gastroenteritis, and various inflammatory disorders. We think it is likely that the exhaled biomarkers reflect underlying airway inflammation and infection. Following informed consent, exhaled breath will be passively collected from subjects during quiet oral breathing through a simple mouthpiece or mask. Exhaled breath will be diverted into a collection device, which may include a bag, tube, or other device with minimal resistance. The collection process, including completing forms, will not exceed 30 minutes. Subjects may be asked to provide several specimens during the course of their inpatient stay or clinic visit to obtain longitudinal data. At no time will the patients be breathing anything other than ambient air with or without oxygen enrichment as clinically indicated. Inhaled air will not be manipulated. Exhaled breath collection technique is completely comfortable, causing neither discomfort nor fatigue.

注册库
clinicaltrials.gov
开始日期
2020年2月2日
结束日期
2030年1月31日
最后更新
去年
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Principal Investigator
主要研究者

Michael D. Davis

Assistant Research Professor

Indiana University

入排标准

入选标准

  • Study sample will consist of individuals aged 4-110 with a diagnosis of acute or chronic respiratory disorders, or metabolic or systemic conditions involving diffuse inflammation, or normal subjects with no pulmonary disease.

排除标准

  • Subjects that are unable or unwilling to cooperate with specimen collection.

结局指标

主要结局

Breath amount, pH, components

时间窗: During the exhaled breath collection procedure, not to exceed 30 minutes

Breath collected will be measured for total volume of condensation collected, pH from the pH scale and other components of airway factors

研究点 (1)

Loading locations...

相似试验