Using Breath Metabolites to Determine Specific Virus Infection in Asthmatic Patients

NCT ID: NCT03089970

Last Updated: 2021-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2020-09-01

Brief Summary

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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

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Conditions

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Upper Respiratory Tract Infections, Asthma, Exhaled Breath

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy asthma

Asthmatic patients not with an exacerbation, i.e., stable asthmatics

Exhaled breath condensate collection

Intervention Type DIAGNOSTIC_TEST

Breath from humans is cooled, condensed, and collected

Rhinovirus-infected asthmatics

Asthmatics with an exacerbation and associated rhinovirus infection

Exhaled breath condensate collection

Intervention Type DIAGNOSTIC_TEST

Breath from humans is cooled, condensed, and collected

Influenza A-infected asthmatics

Asthmatics with an exacerbation and associated influenza A infection

Exhaled breath condensate collection

Intervention Type DIAGNOSTIC_TEST

Breath from humans is cooled, condensed, and collected

Interventions

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Exhaled breath condensate collection

Breath from humans is cooled, condensed, and collected

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Schivo, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California Davis Medical Ceneter

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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1K23HL127185-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

637013

Identifier Type: -

Identifier Source: org_study_id

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