Breath Test Development for Respiratory Diseases

(EBC Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Uncooperative, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop and refine a new breath test to identify markers related to respiratory diseases. Researchers will collect participants' exhaled breath to explore potential indicators of lung conditions and inflammation. Individuals with acute or chronic breathing problems, as well as those with systemic inflammation issues, might be suitable candidates. Participants will breathe into a breath collection device during a brief, 30-minute session.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to early detection methods for respiratory diseases.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this breath collection method is safe?

Research has shown that collecting breath samples is safe and easy. This non-invasive method does not involve breaking the skin or entering the body. It resembles breathing normally into a simple device, such as a bag or a tube. Participants breathe regular air, sometimes with additional oxygen if needed.

Studies have not reported any serious side effects, and most people handle the process well, with no known risks. The procedure is quick, typically taking about 30 minutes. Overall, it provides a safe way to gain insights into bodily functions, particularly for breathing issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the breath test development for respiratory diseases because it promises a non-invasive and quick way to gather diagnostic information. Unlike traditional methods like sputum tests or imaging, which can be uncomfortable and time-consuming, this approach simply collects exhaled breath through a mouthpiece or mask in under 30 minutes. This makes it much easier for patients, as they only need to breathe normally while ambient air is collected. The potential for early and accurate detection without discomfort is what makes this method stand out.

What evidence suggests that this breath collection method is effective for respiratory diseases?

Research has shown that examining exhaled air can provide important insights into lung health. Studies using exhaled breath condensate (EBC) have identified unique patterns that aid in diagnosing lung diseases. In one study, researchers analyzed breath samples from 121 patients, creating a detailed collection of breath-related indicators. These indicators are tiny signs in the breath that can suggest the presence of a specific disease. Recent improvements in biosensors—devices that detect these indicators—have made it easier to diagnose lung diseases quickly without needles or blood tests. Overall, breath analysis is proving to be a promising, non-invasive method for understanding and potentially diagnosing lung conditions. Participants in this trial will undergo a single visit for breath collection to contribute to this growing field of research. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people aged 4-110 with acute or chronic respiratory disorders, metabolic or systemic conditions with widespread inflammation, and healthy individuals without lung disease. Participants must be willing and able to cooperate with breath collection procedures.

Inclusion Criteria

I am between 4-110 years old with a respiratory, metabolic, or systemic condition, or I am healthy with no lung disease.

Exclusion Criteria

I am willing and able to provide samples for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Single Visit breath collection

Exhaled breath is passively collected from subjects during quiet oral breathing through a simple mouthpiece or mask.

30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after breath collection

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Breath Collection

Trial Overview The study focuses on optimizing the way we collect and analyze exhaled biomarkers from participants. It's an exploratory study aiming to create pilot data that will help form more specific research questions in future studies.

How Is the Trial Designed?

Group I: Single Visit breath collection Experimental Treatment 1 Intervention

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. 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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

In a meta-analysis of 11,028 healthy participants across 394 non-oncology phase I studies, 63.7% experienced adverse events, but 85% of these were classified as mild, indicating a relatively safe profile for the study drugs.

Only 0.31% of participants experienced serious adverse events, with no deaths or life-threatening incidents reported, suggesting that while adverse events are common, they are mostly not severe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying the risks of non-oncology phase I research in healthy volunteers: meta-analysis of phase I studies. Emanuel, EJ., Bedarida, G., Macci, K., et al.[2018]

The proposed three-part framework for analyzing adverse events includes phases for documenting incidents, conducting in-depth reviews, and assessing the association between exposure and adverse events, which can enhance product safety.

By standardizing the evaluation of adverse events through this framework, companies can better manage risks and improve consumer products based on reliable data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-market surveillance of consumer products: Framework for adverse event management. Kingston, R., Sioris, K., Gualtieri, J., et al.[2022]

The definition of an adverse drug event (ADE) should be tailored to the specific purpose of the evaluation, with stricter definitions needed for scientific studies and more flexible ones for clinical use.

Postmarketing safety data for drugs is limited at launch, but can be supplemented through systems like the FDA's Spontaneous Reporting System and targeted research projects, emphasizing the importance of robust epidemiological evidence for regulatory actions like drug recalls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. Rogers, AS.[2022]

A review of 192 randomized clinical trials revealed that safety information is often underreported, with only 46% specifying reasons for withdrawals due to toxicity and only 39% adequately reporting clinical adverse effects.

To enhance safety reporting, the study emphasizes the need for standardized scales for adverse effects, systematic data collection, and detailed reporting of severe reactions, suggesting that improved practices could lead to better safety insights in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. Ioannidis, JP., Lau, J.[2018]

The study found that an electronic nose, which analyzes exhaled gas from mechanically ventilated patients, correlates well with a clinical pneumonia score, showing a strong correlation coefficient of r = 0.81.

This innovative biosensor technology could potentially serve as a reliable tool for assessing pneumonia in intensive care settings, as indicated by the close agreement between the electronic nose predictions and actual pneumonia scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nose prediction of a clinical pneumonia score: biosensors and microbes. Hanson, CW., Thaler, ER.[2019]

Citations

1. nature.com nature.com/articles/s41597-024-03052-2

A Clinical Breathomics Dataset | Scientific Data This study entailed a comprehensive GC‒MS analysis conducted on 121 patient samples to generate a clinical breathomics dataset.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05727852

Breath Analysis and Arterial Stiffness in Patients With ... The aim of our study is to determine the diagnostic significance of PTR-TOF analysis in patients with chronic respiratory diseases and to identify specific eVOC ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0956566324008273

Recent advances in biosensors detecting biomarkers from ... This comprehensive review explores advancements in biosensors for non-invasive, rapid respiratory disease diagnosis through exhaled breath and saliva.

4. atsjournals.org atsjournals.org/doi/full/10.1164/ajrccm.164.5.2101032

Collection and Analysis of Exhaled Breath Condensate in ... In this review, we present the current body of knowledge on exhaled breath condensate as published in peer-reviewed journals in the English language.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12302435/

Molecular profiling of exhaled breath condensate in ... This review presents the state-of-the-art in EBC-based omics approaches—particularly metabolomics and proteomics—to characterize molecular signatures associated ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1455483/

Exhaled Breath Analysis: from Occupational to Respiratory ... Measurement of exhaled breath is safe, rapid, simple to perform, and effort independent. Given that human breath contains upwards of 250 chemicals, the ...

7. publications.ersnet.org publications.ersnet.org/content/erj/28/3/479

Safety and feasibility of exhaled breath condensate collection ... The aim of this study was to develop a technique for the collection of exhaled breath condensate (EBC) from ventilated children and assess its safety and ...

8. mdpi.com mdpi.com/2304-6732/12/9/848

Exhaled Breath Analysis (EBA): A Comprehensive Review ... Exhaled breath analysis (EBA) is an advanced, non-invasive diagnostic technique that utilizes volatile organic compounds (VOCs) to detect and monitor ...