Using Breath Metabolites to Determine Specific Virus Infection in Asthmatic Patients

Completed

• Conditions: Upper Respiratory Tract Infections, Asthma, Exhaled Breath
• Interventions: Diagnostic Test: Exhaled breath condensate collection

• Registration Number: NCT03089970
• Lead Sponsor: University of California, Davis

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-24
• Primary Completion: 2020-03-10
• Study Completion: 2020-09-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy asthma	Exhaled breath condensate collection	Asthmatic patients not with an exacerbation, i.e., stable asthmatics
Rhinovirus-infected asthmatics	Exhaled breath condensate collection	Asthmatics with an exacerbation and associated rhinovirus infection
Influenza A-infected asthmatics	Exhaled breath condensate collection	Asthmatics with an exacerbation and associated influenza A infection

Primary Outcome Measures

Name	Time	Method
Breath metabolite differences between groups	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.

Trial Locations

Locations (1)

University of California Davis Medical Ceneter; 🇺🇸 Sacramento, California, United States