AsthmaABCNCT03575663
The Asthma Bronchial Challenge Study
An observational study of Asthma, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
This is a randomised, controlled, cross-over study to determine the effect of indirect bronchial challenge testing upon volatile organic compounds (VOCs) in the exhaled breath of adults with well-controlled, mild-to-moderate asthma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Indirect bronchial challenge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Apr 2018to 28 Feb 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with well-controlled, mild asthma, managed in primary care and treated at level 1 to 2 of the British Thoracic Society treatment guidelines.
Who may be able to join
- Male or female
- Aged 18 or over
- Able to provide informed consent
- Self-report of asthma diagnosis from health professional
- Diagnostic confirmation meeting British Thoracic Society guidelines will be sought from primary care
- Non-smokers; or ex-smokers of at least two years duration with less than a ten pack year history
- Asthma Control Questionnaire score < 1.0
- Asthma treated according to level-1 to level-2 of British Thoracic Society treatment guidelines
Who cannot join
- Respiratory tract infection, asthma exacerbation or change in treatment step within the previous four weeks
- Major chronic cardiorespiratory disease other than asthma
- Significant comorbid condition
- Condition that may be compromised by repeated spirometry manoeuvres or induced bronchospasm
- Asthma Control Questionnaire score >1.0
- Asthma treated at level 3 of the treatment guidelines or higher
Show all 13Show fewer
- Pregnant or nursing mothers
- Current smokers or 'vapers'
- Ex-smokers of < 2 years duration or > 10 pack years.
- Participating in a clinical trial of an investigational medicinal product (CTIMP).
- Unable to speak English.
- Low baseline lung function (FEV1 <1.50 litres or < 70% predicted value)
- Known hypersensitivity to mannitol, gelatin or strong anaphylactic response in the past.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of East Anglia
Norwich, Norfolk, NR47TJ
About this study
Official title: Bronchial Challenge Testing in Asthma: The Effect of Mannitol Dry Powder Inhalation on Volatile Organic Compounds in Exhaled Breath
This is a randomised, controlled, cross-over study to determine the effect of indirect bronchial challenge testing upon volatile organic compounds (VOCs) in the exhaled breath of adults with well-controlled, mild-to-moderate asthma.
Participants will undergo baseline evaluation including clinical history, spirometry, exhaled nitric oxide measurement (FeNO), phlebotomy (blood eosinophil count), and sampling of exhaled breath VOCs. Participants will be randomised to receive either an indirect bronchial challenge test using mannitol dry powder (MDP) or a sham bronchial challenge, followed by further sampling of breath VOCs. The study will consist of a consent visit and two assessment visits with participants allocated to receive one of the two challenges (MDP or sham) at each assessment. Data will be analysed to determine the effect of bronchial challenge upon exhaled breath VOC profiles.
- Conditions
- Asthma
- Being tested
- Indirect bronchial challenge, Sham bronchial challenge
- Keywords
- Breathomics, Metabolomics, Exhaled breath test, Biomarker
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect bronchial challengeDiagnostic test
Also called Osmohale / Aridol
Mannitol dry powder inhalation
Sham bronchial challengeOther
Mock dry powder inhalation
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in exhaled breath profile
Exhaled volatile organic compounds (VOCs) will be captured on sorbent material and analysed by gas chromatography-mass spectrometry. Post-bronchial challenge samples will be compared with baseline, pre-challenge samples. Differences in exhaled VOC profile will be assessed for significance.
Measured: Immediately post-bronchial challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start25 Apr 2018
- Primary completion19 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester, Asthma UK Centre for Applied Research
- Responsible party
- Sponsor
- Investigators
- Adam M Peel, BSc, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575663
- Sponsor's protocol ID
- 2229225
- Acronym
- ABC
- Status last verified
- Apr 2018
- First submitted
- 11 Jun 2018
- Last updated
- 25 Apr 2019
- 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 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchial Challenge Testing in Asthma: The Effect of Mannitol Dry Powder Inhalation on Volatile Organic Compounds in Exhaled Breath
- ClinicalTrials.gov ID
- NCT03575663
- Acronym / sponsor ID
- ABC / 2229225
- Conditions
- Asthma
- Keywords
- Breathomics, Metabolomics, Exhaled breath test, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- University of Manchester, Asthma UK Centre for Applied Research
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 19 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 2 Jul 2018 (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 is a randomised, controlled, cross-over study to determine the effect of indirect bronchial challenge testing upon volatile organic compounds (VOCs) in the exhaled breath of adults with well-controlled, mild-to-moderate asthma.
Participants will undergo baseline evaluation including clinical history, spirometry, exhaled nitric oxide measurement (FeNO), phlebotomy (blood eosinophil count), and sampling of exhaled breath VOCs. Participants will be randomised to receive either an indirect bronchial challenge test using mannitol dry powder (MDP) or a sham bronchial challenge, followed by further sampling of breath VOCs. The study will consist of a consent visit and two assessment visits with participants allocated to receive one of the two challenges (MDP or sham) at each assessment. Data will be analysed to determine the effect of bronchial challenge upon exhaled breath VOC profiles.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with well-controlled, mild asthma, managed in primary care and treated at level 1 to 2 of the British Thoracic Society treatment guidelines.
Key inclusion criteria (8 listed)
- Male or female
- Aged 18 or over
- Able to provide informed consent
- Self-report of asthma diagnosis from health professional
- Diagnostic confirmation meeting British Thoracic Society guidelines will be sought from primary care
Key exclusion criteria (13 listed)
- Respiratory tract infection, asthma exacerbation or change in treatment step within the previous four weeks
- Major chronic cardiorespiratory disease other than asthma
- Significant comorbid condition
- Condition that may be compromised by repeated spirometry manoeuvres or induced bronchospasm
- Asthma Control Questionnaire score >1.0
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 |
|---|---|---|
| Indirect bronchial challengeAlso: Osmohale / AridolMannitol dry powder inhalation | Diagnostic test | – |
| Sham bronchial challengeMock dry powder inhalation | Other | – |
Primary outcome
Changes in exhaled breath profile
Time frame: Immediately post-bronchial challenge
Exhaled volatile organic compounds (VOCs) will be captured on sorbent material and analysed by gas chromatography-mass spectrometry. Post-bronchial challenge samples will be compared with baseline, pre-challenge samples. Differences in exhaled VOC profile will be assessed for significance.
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 25 Apr 2019.
- 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.
Adam M Peel, BSc principal investigator
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, 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 8 inclusion and 13 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 25 Apr 2019. 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?
Changes in exhaled breath profile (time frame: Immediately post-bronchial challenge). 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 25 Apr 2019.