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

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Breath Collection for respiratory diseases?

Breath analysis, which involves collecting and analyzing exhaled breath, is a promising non-invasive method for diagnosing respiratory diseases. Studies have shown that it can distinguish between people with respiratory diseases and healthy individuals by analyzing volatile organic compounds (VOCs) in the breath. However, more research is needed to standardize the methods and validate the results across different settings. ^{1 2 3 4 5}

Is the breath test for respiratory diseases safe for humans?

There is no specific safety data available for the breath test for respiratory diseases in the provided research articles. ^{6 7 8 9 10}

How does the breath collection treatment for respiratory diseases differ from other treatments?

The breath collection treatment is unique because it is a non-invasive method that analyzes the 'breathprint'—a collection of thousands of molecules in exhaled breath—to diagnose and monitor respiratory diseases. Unlike traditional treatments, it uses advanced technologies like mass spectrometry and chemical sensors to provide rapid and specific health assessments without the need for blood tests or other invasive procedures. ^{1 11 12 13 14}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Breath analysis: translation into clinical practice. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Clinical applications of breath testing. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Human exhaled breath analysis. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Electronic nose prediction of a clinical pneumonia score: biosensors and microbes. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Breath analysis in respiratory diseases: state-of-the-art and future perspectives. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Quantifying the risks of non-oncology phase I research in healthy volunteers: meta-analysis of phase I studies. [2018]

8. England pubmed.ncbi.nlm.nih.gov

The role of nurses in preventing adverse events related to respiratory dysfunction: literature review. [2016]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Post-market surveillance of consumer products: Framework for adverse event management. [2022]

11. England pubmed.ncbi.nlm.nih.gov

News from the Breath Analysis Summit 2011. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Analysis of breath by proton transfer reaction time of flight mass spectrometry in rats with steatohepatitis induced by high-fat diet. [2015]

13. England pubmed.ncbi.nlm.nih.gov

Chemical sensors for breath gas analysis: the latest developments at the Breath Analysis Summit 2013. [2018]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Evolution of clinical and environmental health applications of exhaled breath research: Review of methods and instrumentation for gas-phase, condensate, and aerosols. [2023]