Back to resultsSphingosine-1-phosphate in Asthma
Primary Purpose
Asthma
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Bronchial challenge test
Sponsored by
About this trial
This is an interventional basic science trial for Asthma
Eligibility Criteria
Cases (asthmatics) inclusion criteria
1. 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
1. 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
Sites / Locations
- Allergy Day Care Unite, Guy's HospitalRecruiting
Outcomes
Primary Outcome Measures
Bronchoconstriction
Bronchoconstriction in response to challenge measured by spirometry (FEV1)(PC20)
Secondary Outcome Measures
Full Information
NCT ID
NCT04134351
First Posted
October 18, 2019
Last Updated
July 27, 2021
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College London
1. Study Identification
Unique Protocol Identification Number
NCT04134351
Brief Title
Sphingosine-1-phosphate in Asthma
Official Title
Does Sphingosine-1-phosphate Constrict Human Airways? In-vivo Challenge Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
February 22, 2022 (Anticipated)
Study Completion Date
February 22, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Bronchial challenge test
Intervention Description
Bronchial challenge test with sphingosine-1-phosphate
Primary Outcome Measure Information:
Title
Bronchoconstriction
Description
Bronchoconstriction in response to challenge measured by spirometry (FEV1)(PC20)
Time Frame
1 hour after challenge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Cases (asthmatics) inclusion criteria
1. 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
1. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grzegorz Woszczek, MD, PhD
Phone
+44 2071880597
Email
grzegorz.woszczek@kcl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Leonard Siew, MRCP, PhD
Email
leonard.siew@gstt.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grzegorz Woszczek, MD, PhD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergy Day Care Unite, Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Yung, Dr
Phone
020 7188 5846
Email
Stephanie.yung@gstt.nhs.uk
12. IPD Sharing Statement
Plan to Share IPD
No
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Sphingosine-1-phosphate in Asthma
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