Using Breath Metabolites to Determine Specific Virus Infection in Asthmatic Patients

August 18, 2021 updated by: University of California, Davis
Respiratory virus infections cause a majority of asthma exacerbations in the fall to spring months. Current diagnostic platforms for respiratory viruses have limitations including cost, availability, and invasiveness. The use of noninvasive breath collection to analyze breath metabolites may be used to differentiate virus-infected asthmatics from other causes of acute asthma exacerbations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 96817
        • University of California Davis Medical Ceneter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with asthma with or without an acute exacerbation will be recruited

Description

Inclusion Criteria:

  • Asthma, Age ≥12, Symptoms/signs of an early asthma exacerbation, Ability to provide exhaled breath condensate (EBC) x15 min, Body mass index (BMI) ≥18

Exclusion Criteria:

  • Chronic lung diseases other than asthma (e.g., chronic obstructive pulmonary disease [COPD], lung cancer, fibrotic lung disease, etc.), Smoking in the past 7 days, Eating or non-clear liquids <4 hrs prior to EBC collection, Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy asthma
Asthmatic patients not with an exacerbation, i.e., stable asthmatics
Diagnostic test: Exhaled breath condensate collection
Breath from humans is cooled, condensed, and collected
Rhinovirus-infected asthmatics
Asthmatics with an exacerbation and associated rhinovirus infection
Diagnostic test: Exhaled breath condensate collection
Breath from humans is cooled, condensed, and collected
Influenza A-infected asthmatics
Asthmatics with an exacerbation and associated influenza A infection
Diagnostic test: Exhaled breath condensate collection
Breath from humans is cooled, condensed, and collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breath metabolite differences between groups
Time Frame: 36 months
Metabolites from breath will be identified and quantified using gas chromatography-mass spectrometry; these will be compared between groups. Specific breath metabolites include isoprostane, linear and branched alkanes (C6-C9), alcohols, and thiol-containing moieties. However, we will also measure metabolites in an un-targeted manner.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Michael Schivo, MD, MAS, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

March 10, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (Actual)

March 24, 2017

Study Record Updates

Last Update Posted (Actual)

August 20, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 637013
  • 1K23HL127185-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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