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Trial record 26 of 90 for:    asthma | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Using Breath Metabolites to Determine Specific Virus Infection in Asthmatic Patients

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ClinicalTrials.gov Identifier: NCT03089970
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Upper Respiratory Tract Infections, Asthma, Exhaled Breath Diagnostic Test: Exhaled breath condensate collection

Study Type : Observational
Estimated Enrollment : 78 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Using Breath Metabolites to Determine Specific Virus Infection in Asthmatic Patients
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Exhaled breath condensate


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with asthma with or without an acute exacerbation will be recruited
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089970


Contacts
Contact: Michael Schivo, MD, MAS (916) 734-3564 mschivo@ucdavis.edu

Locations
United States, California
University of California Davis Medical Ceneter Recruiting
Sacramento, California, United States, 96817
Contact: Michael Schivo, MS, MAD         
Sponsors and Collaborators
University of California, Davis
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Michael Schivo, MD, MAS University of California, Davis

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03089970     History of Changes
Other Study ID Numbers: 637013
1K23HL127185-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases