Asthma AcuteABBANCT03084016
Asthma Breath Biomarker Assessment
An observational study of Asthma Acute, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
This study aims to assess the feasibility of capturing data on exhaled breath compounds during an acute asthma exacerbation. In addition to assessing the feasibility of such a study the investigators will collect data on exploratory outcomes including the ability of breath biomarkers to distinguish between controlled… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma Acute
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Mar 2017to 31 Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18+ with asthma diagnosis meeting British Thoracic Society guidelines.
Who may be able to join
- Male or female
- Aged 18 or above
- Able to provide informed consent
- A confirmed asthma diagnosis requiring treatment with inhaled bronchodilator therapy +/- inhaled corticosteroids.
- Non-smoker (or ex-smoker of 6 months or more with a less than 10 pack year history).
- Current exacerbation or exacerbation within the previous 12 months.
- Within 24 hours of having presented to acute secondary care (applicable to current exacerbation only)
Who cannot join
- Major chronic cardiorespiratory disease other than asthma
- Significant comorbid condition
- Receiving maintenance oral corticosteroid therapy or other immunosuppressant or immunomodulatory therapy (including biologics)
- Pregnant
- Participating in a clinical trial of an investigational medicinal product (CTIMP).
- Unable to speak English.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UY
About this study
Official title: Exhaled Breath Biomarkers in Acute Asthma: A Feasibility Study
This study aims to assess the feasibility of capturing data on exhaled breath compounds during an acute asthma exacerbation. In addition to assessing the feasibility of such a study the investigators will collect data on exploratory outcomes including the ability of breath biomarkers to distinguish between controlled and exacerbated states and their ability to differentiate between triggers of exacerbation.
Read the detailed description
This will be a longitudinal observational study in which the investigators assess the ability to capture information on volatile organic compounds in exhaled breath during an acute asthma exacerbation using two different approaches:
- Recruitment and assessment of patients in secondary care during an acute exacerbation of their asthma; patients to be re-assessed once their asthma is stable and controlled.
- Recruitment of clinically stable outpatients who are at increased risk of exacerbation by virtue of having had an acute exacerbation within the previous 12 months. Participants to be followed for a period of up to 12 months; assessed in the event of an exacerbation; and re-assessed once controlled.
- Conditions
- Asthma Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute asthma exacerbation | Recruited in secondary care when presenting with acute asthma exacerbation. | |
| At risk of acute asthma exacerbation | Recruited in outpatient clinics. Acute exacerbation within the previous 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study feasibility - recruitment
Recruitment rate
Measured: 18 months
Study feasibility - assessment
Percentage of participants who experience an exacerbation, contact the study team and complete an assessment
Measured: 18 months
Study feasibility - patient acceptability
Patient acceptability of breath capture devices (assessed by questionnaire)
Measured: 18 months
Secondary outcomes (1)
Breath profile of exhaled volatile organic compounds (VOCs).
A profile of VOCs in exhaled breath obtained through gas chromatography-mass spectrometry during asthma exacerbation and when stable.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start6 Mar 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma AcuteStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Wilson, Study director, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084016
- Sponsor's protocol ID
- 197935
- Acronym
- ABBA
- Status last verified
- Oct 2022
- First submitted
- 6 Mar 2017
- Last updated
- 20 Oct 2022
- 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 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Biomarkers in Acute Asthma: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03084016
- Acronym / sponsor ID
- ABBA / 197935
- Conditions
- Asthma Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 20 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.
This study aims to assess the feasibility of capturing data on exhaled breath compounds during an acute asthma exacerbation. In addition to assessing the feasibility of such a study the investigators will collect data on exploratory outcomes including the ability of breath biomarkers to distinguish between controlled and exacerbated states and their ability to differentiate between triggers of exacerbation.
Detailed description
This will be a longitudinal observational study in which the investigators assess the ability to capture information on volatile organic compounds in exhaled breath during an acute asthma exacerbation using two different approaches:
- Recruitment and assessment of patients in secondary care during an acute exacerbation of their asthma; patients to be re-assessed once their asthma is stable and controlled.
- Recruitment of clinically stable outpatients who are at increased risk of exacerbation by virtue of having had an acute exacerbation within the previous 12 months. Participants to be followed for a period of up to 12 months; assessed in the event of an exacerbation; and re-assessed once controlled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute asthma exacerbation | – | –Recruited in secondary care when presenting with acute asthma exacerbation. |
| At risk of acute asthma exacerbation | – | –Recruited in outpatient clinics. Acute exacerbation within the previous 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18+ with asthma diagnosis meeting British Thoracic Society guidelines.
Key inclusion criteria (7 listed)
- Male or female
- Aged 18 or above
- Able to provide informed consent
- A confirmed asthma diagnosis requiring treatment with inhaled bronchodilator therapy +/- inhaled corticosteroids.
- Non-smoker (or ex-smoker of 6 months or more with a less than 10 pack year history).
Key exclusion criteria (6 listed)
- Major chronic cardiorespiratory disease other than asthma
- Significant comorbid condition
- Receiving maintenance oral corticosteroid therapy or other immunosuppressant or immunomodulatory therapy (including biologics)
- Pregnant
- Participating in a clinical trial of an investigational medicinal product (CTIMP).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study feasibility - recruitment
Time frame: 18 months
Recruitment rate
Study feasibility - assessment
Time frame: 18 months
Percentage of participants who experience an exacerbation, contact the study team and complete an assessment
Study feasibility - patient acceptability
Time frame: 18 months
Patient acceptability of breath capture devices (assessed by questionnaire)
1 secondary outcome
Breath profile of exhaled volatile organic compounds (VOCs).
Time frame: 12 months
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 Oct 2022.
- PhD thesisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Andrew Wilson study director
University of East Anglia
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 Asthma Acute, run by University of East Anglia at 1 site in United Kingdom.
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 7 inclusion and 6 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 Oct 2022. 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 Kingdom. 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?
Study feasibility - recruitment (time frame: 18 months). The study lists 3 primary outcomes in all. 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 Oct 2022.