AsthmaNCT04134351
Sphingosine-1-phosphate in Asthma
A study testing Bronchial challenge test in people with Asthma, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study is being undertaken in order to enhance our understanding how human airways are being constricted in healthy people and in individuals with asthma. There is an unmet need for identification of new pathways (mediators) related to enhanced constriction of the asthmatic airways that would reveal new targets… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Bronchial challenge test
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Feb 2020to 22 Feb 2022
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Cases (asthmatics) inclusion criteria
- Physician diagnosed asthma, defined as a clear history of typical symptoms and clear reversibility of the PEF/FEV1 (12% or more) within the past year and/or methacholine PC20 < 8mg/ml.
Cases Exclusion criteria
- Pregnancy or lactation
- Moderate / Severe asthma (FEV1/PEF < 80%of the predicted value at screening)
- Patients with any chronic illness other than asthma and other recognised atopic diseases (eczema, rhinitis) or any other abnormality which in the opinion of the principal investigator might compromise the study findings
- A history of recent (within the past 4 weeks) upper or lower respiratory tract infection
- Patients receiving oral, inhaled or parenteral glucocorticoid therapy (steroid) within the last 4 weeks, long acting relievers (salmeterol, formoterol) and antileukotrienes (montelukast) within last 72 hours.
- Inadequate contraception in women of childbearing age
- Inability to comprehend or comply with the protocol
Controls inclusion criteria
- Lifelong absence of asthma symptoms and lung function within the normal range.
Controls exclusion criteria
- Pregnancy or lactation
- Patients with any chronic illness or any other abnormality which in the opinion of the principal investigator might compromise the study findings
- A history of recent (within the past 4 weeks) upper or lower respiratory tract infection
- Oral, inhaled or parenteral glucocorticoid therapy (steroid) within the last 4 weeks, long acting relievers (salmeterol, formoterol) and antileukotrienes (montelukast) within last 72 hours
- Inadequate contraception in women of childbearing age
- Inability to comprehend or comply with the protocol
Trial locations and contacts
1 site in 1 country.
Leonard Siew, MRCP, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Allergy Day Care Unite, Guy's Hospital
London, SE1 9RT
Stephanie Yung, Dr, 020 7188 5846, Stephanie.yung@gstt.nhs.uk
About this study
Official title: Does Sphingosine-1-phosphate Constrict Human Airways? In-vivo Challenge Pilot Study.
This study is being undertaken in order to enhance our understanding how human airways are being constricted in healthy people and in individuals with asthma. There is an unmet need for identification of new pathways (mediators) related to enhanced constriction of the asthmatic airways that would reveal new targets for therapy. Sphingosine-1-phosphate (S1P) is a naturally occurring bioactive lipid molecule that has been suggested to play an important role in asthma. Physiologically, S1P can be detected in human blood but local tissue concentrations (for example in the lung) are very low. Upon activation many cells can secrete S1P. Increased concentrations of S1P have been detected in airways of asthmatic subjects after allergen inhalation. When studied in animal models, S1P did not cause contraction of airways in healthy animals but contracted airways in animal with pulmonary inflammation. In laboratory experiments S1P has been shown to be a potent constrictor of cells responsible for contraction of human airways. As yet, however, we lack evidence that S1P actually causes constriction of airways in real life. Establishing S1P as a molecule capable of causing airway constriction in humans and perhaps specifically in asthmatics will have important implications for our understanding of physiological and pathophysiological responses in human airways and could open new windows for therapeutic strategies in diseases like asthma.
- Conditions
- Asthma
- Being tested
- Bronchial challenge test
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchial challenge testOther
Bronchial challenge test with sphingosine-1-phosphate
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchoconstriction
Bronchoconstriction in response to challenge measured by spirometry (FEV1)(PC20)
Measured: 1 hour after challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start4 Feb 2020
- Primary completion22 Feb 2022 (estimated)
- Study completion22 Feb 2022 (estimated)
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.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Grzegorz Woszczek, MD, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134351
- Sponsor's protocol ID
- 223069
- Status last verified
- Jul 2021
- First submitted
- 18 Oct 2019
- Last updated
- 28 Jul 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 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Sphingosine-1-phosphate Constrict Human Airways? In-vivo Challenge Pilot Study.
- ClinicalTrials.gov ID
- NCT04134351
- Acronym / sponsor ID
- 223069
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 22 Feb 2022 (estimated)
- Study completion
- 22 Feb 2022 (estimated)
- First posted
- 22 Oct 2019 (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 is being undertaken in order to enhance our understanding how human airways are being constricted in healthy people and in individuals with asthma. There is an unmet need for identification of new pathways (mediators) related to enhanced constriction of the asthmatic airways that would reveal new targets for therapy. Sphingosine-1-phosphate (S1P) is a naturally occurring bioactive lipid molecule that has been suggested to play an important role in asthma. Physiologically, S1P can be detected in human blood but local tissue concentrations (for example in the lung) are very low. Upon activation many cells can secrete S1P. Increased concentrations of S1P have been detected in airways of asthmatic subjects after allergen inhalation. When studied in animal models, S1P did not cause contraction of airways in healthy animals but contracted airways in animal with pulmonary inflammation. In laboratory experiments S1P has been shown to be a potent constrictor of cells responsible for contraction of human airways. As yet, however, we lack evidence that S1P actually causes constriction of airways in real life. Establishing S1P as a molecule capable of causing airway constriction in humans and perhaps specifically in asthmatics will have important implications for our understanding of physiological and pathophysiological responses in human airways and could open new windows for therapeutic strategies in diseases like asthma.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Bronchial challenge testBronchial challenge test with sphingosine-1-phosphate | Other | – |
Primary outcome
Bronchoconstriction
Time frame: 1 hour after challenge
Bronchoconstriction in response to challenge measured by spirometry (FEV1)(PC20)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- 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.
Leonard Siew, MRCP, PhD contact
Grzegorz Woszczek, MD, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchial challenge test in people with Asthma, run by Guy's and St Thomas' NHS Foundation Trust 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?
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: status not confirmed, as of the sponsor's last update on 28 Jul 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grzegorz Woszczek, MD, PhD (+44 2071880597, grzegorz.woszczek@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchoconstriction (time frame: 1 hour after 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 28 Jul 2021.