The Growth of Breath Research in Clinical Trials since 1994

Published on: 7 Dec 2018, under Breath Biopsy

 

This blog was initially published in December 2018. We aim to update it with new data on a regular basis. The last update was on 15th May 2023.


Cumulative number of clinical trials involving breath analysis

Analysis of clinical trial data uploaded to clinicaltrials.gov indicates that a total of 967 studies have used or are using a form of breath analysis as part of their workflow (1). The number of studies incorporating breath analysis has increased every year, indicating a growing understanding of the power that breath analysis can bring to clinical trials. Exhaled breath contains thousands of compounds that have the potential to serve as biomarkers for a range of clinical use, and in a range of disease focuses.

ClinicalTrials-2023_Cumulativegraph
Figure 1. The cumulative number of clinical trials conducted that involve breath analysis as part of their workflow, clinicaltrials.gov was used to compile the data.

 

Study area categorization in 967 clinical trials using breath analysis

The conducted clinical trials involving breath span a broad range of research areas, and the 967 identified trials were categorized into their relative fields. The criteria used to categorize the studies are outlined in the figure legend.

ClinicalTrials_ResearchArea_Graphic
Figure 2. The categories of clinical trials using breath analysis. The criteria for categorization were as follows: If evaluating the performance of a diagnostic test for a condition or the feasibility of a breath test – it was labelled test development. If evaluating the performance of a pharmaceutical (a drug treatment), it was labelled drug development. If the trial was evaluating a supplement or other treatment that is available over the counter (OTC), it was labelled as its area of research instead. All other trials were labelled based on the disease area the clinical trial was focused within. All data were retrieved from clinicaltrials.gov/.

From this data, breath analysis is increasingly becoming utilised in the trials of drug treatments or the development of new diagnostic tests. The most common disease area breath research is utilised within is gastrointestinal, followed by respiratory conditions. The gut microbiome is responsible for producing many of the gases and volatile compounds that can be detected in exhaled breath that are relevant for health and disease, including gastrointestinal conditions, cardiometabolic disease and cancer.

We can bring breath analysis to your clinical research.

As interdisciplinary specialists in breath, we have created Breath Biopsy® OMNI® to be the most advanced solution for reliable global breath biomarker analysis. We can support your investigation with our extensive study design, management, and data interpretation expertise.

When you work with us you also get access to our Breath Biopsy VOC Atlas. The VOC Atlas is a comprehensive catalogue of VOCs identified on exhaled human breath that will facilitate future biomarker discovery. These breath biomarkers can be used to study many disease contexts, as demonstrated by the wide variety of clinical trial areas that have been and are currently being conducted all over the world. Currently, more than 150 VOCs that have been rigorously identified and validated are registered within the ATLAS.

If you have any questions or would like more information, please do not hesitate to contact us to discuss investigating breath biomarkers for your disease of interest.

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If you want to learn more about how Owlstone Medical®‘s Breath Sampling and Analysis technology and Services are being utilized in early detection and precision medicine, why not download our free ebook: Breath Biopsy: The Complete Guide?

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References

1. Data from https://clinicaltrials.gov/.

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