Plain English Summary
Background and study aims
Most cells in your body can detect the presence of something that can cause a disease (a pathogen) like a virus or bacteria, or an environmental factor like pollution. If your cells detect a pollutant like cigarette smoke, they react by removing it from your body in the same way as viruses and bacteria. We believe that susceptibility to infection may be influenced by environmental pollutants like cigarette smoke. We would like to see if this is the case, and if so why this happens.
Who can participate?
Healthy volunteers (smokers and non-smokers).
What does the study involve?
We need blood samples from healthy smokers (within 20 minutes of smoking a cigarette) and non-smokers so that we can look at their response to bacteria and viruses and the effect that smoking has on these responses. These tests will be carried out a laboratory at Imperial College. We would like to take a small sample of your blood - about 10 tablespoons. This will be taken using a needle from a vein in your arm by a trained research nurse or qualified doctor in the Unit of Critical Care Medicine at the Royal Brompton Hospital, and should only take about 20 minutes. You will need to inform us of any medication that you are taking. At the end of the study we will reimburse all your travelling expenses.
What are the possible benefits and risks of participating?
There is a slight risk of a small bruise where the needle is put in, and occasionally people feel faint when blood is taken, but there are no other risks involved. We will only carry out those tests detailed above on your blood sample. We will not carry out any tests for serious infections such as HIV and there is no need to declare such tests on an insurance or mortgage application. In the very unlikely event of your coming to any harm, Imperial College has insurance in place so that you may receive compensation without having to prove negligence on our part. The blood samples you give will be coded before any tests are performed on them, so that you cannot be identified from the samples. All of your details will be kept strictly confidential. Some blood may be stored for future use in research in this area.
Where is the study run from?
Royal Brompton & Harefield NHS Foundation Trust (UK).
When is the study starting and how long is it expected to run for?
August 2008 to August 2013.
Who is funding the study?
Wellcome Trust (UK).
Who is the main contact?
Dr Mark Paul-Clark
m.paul-clark@imperial.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mark Paul-Clark
ORCID ID
Contact details
Royal Brompton & Harefield NHS Foundation Trust
Sydney Street
London
SW3 6NP
United Kingdom
-
m.paul-clark@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
5843
Study information
Scientific title
Role of TLR2 in the Sensing of oxidants and ensuing Inflammation: Implications for therapeutic Intervention - an observational study
Acronym
TSI
Study hypothesis
The aim of this project is to study how oxidants are sensed by Toll like receptors (TLRs)
1. Determine the effects that oxidants have on the ectodomain of TLR2
2. Assess the requirements for the TLR adaptor proteins MyD88 and TIRAP in oxidants dependant signalling
3. To assess the involvement of other PRRs in oxidant induced inflammation
4. Assess the differences in gene activation between classical TLR2 ligands and oxidants
5. Grow out blood-derived stem cells for assessment
More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=5843
Ethics approval
Royal Brompton & Harefield NHS Trust Ethics Committee, 08/H0708/69
Study design
Observational study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Immunology and inflammation
Intervention
Blood will be taken from volunteers who are either healthy smokers (within 20 mins of smoking a cigarette) or non-smokers. The blood will either be directly plated out into 96 well plates or cells isolated or grown out and characterised for their responses to various agonists and a number of mediators and cytokines will be measured. The total time a volunteer is need for is 20 mins although they may be asked back to participate again.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The blood or cellular responses will be compared between smokers and non-smokers. To assess the differences that oxidative exposure will have on smokers just 20 mins after having a cigarette.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
06/08/2008
Overall trial end date
08/08/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy volunteer (either a smoker or non-smoker)
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 100
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
06/08/2008
Recruitment end date
08/08/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Brompton & Harefield NHS Foundation Trust
London
SW3 6NP
United Kingdom
Funders
Funder type
Charity
Funder name
Wellcome Trust (UK) ref: WT083429MA
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list