Upper Respiratory Tract Infections, Asthma, Exhaled BreathNCT03089970
Using Breath Metabolites to Determine Specific Virus Infection in Asthmatic Patients
An observational study of Upper Respiratory Tract Infections, Asthma, Exhaled Breath, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Upper Respiratory Tract Infections, Asthma, Exhaled Breath
- What is being tested?
- Exhaled breath condensate collection
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with asthma with or without an acute exacerbation will be recruited
Who may be able to join
- Asthma, Age ≥12, Symptoms/signs of an early asthma exacerbation, Ability to provide exhaled breath condensate (EBC) x15 min, Body mass index (BMI) ≥18
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Medical Ceneter
Sacramento, California, 96817
About this study
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.
- Being tested
- Exhaled breath condensate collection
- Medical subject headings
- Respiratory Tract Infections, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exhaled breath condensate collectionDiagnostic test
Breath from humans is cooled, condensed, and collected
| Study group | Role | What they receive |
|---|---|---|
| Healthy asthma | Asthmatic patients not with an exacerbation, i.e., stable asthmatics Receives: Diagnostic Test: Exhaled breath condensate collection | |
| Rhinovirus-infected asthmatics | Asthmatics with an exacerbation and associated rhinovirus infection Receives: Diagnostic Test: Exhaled breath condensate collection | |
| Influenza A-infected asthmatics | Asthmatics with an exacerbation and associated influenza A infection Receives: Diagnostic Test: Exhaled breath condensate collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath metabolite differences between groups
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Feb 2017
- Primary completion10 Mar 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract Infections, Asthma, Exhaled BreathStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michael Schivo, MD, MAS, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089970
- Sponsor's protocol ID
- 637013
- Other IDs
- 1K23HL127185-01A1
- Status last verified
- Aug 2021
- First submitted
- 20 Mar 2017
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Breath Metabolites to Determine Specific Virus Infection in Asthmatic Patients
- ClinicalTrials.gov ID
- NCT03089970
- Acronym / sponsor ID
- 637013
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy asthma | – | Diagnostic Test: Exhaled breath condensate collectionAsthmatic patients not with an exacerbation, i.e., stable asthmatics |
| Rhinovirus-infected asthmatics | – | Diagnostic Test: Exhaled breath condensate collectionAsthmatics with an exacerbation and associated rhinovirus infection |
| Influenza A-infected asthmatics | – | Diagnostic Test: Exhaled breath condensate collectionAsthmatics with an exacerbation and associated influenza A infection |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with asthma with or without an acute exacerbation will be recruited
Key inclusion criteria (1 listed)
- Asthma, Age ≥12, Symptoms/signs of an early asthma exacerbation, Ability to provide exhaled breath condensate (EBC) x15 min, Body mass index (BMI) ≥18
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exhaled breath condensate collectionBreath from humans is cooled, condensed, and collected | Diagnostic test | Healthy asthma, Influenza A-infected asthmatics, Rhinovirus-infected asthmatics |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Schivo, MD, MAS principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Respiratory Tract Infections, Asthma, Exhaled Breath, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath metabolite differences between groups (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.