Condition category
Not Applicable
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

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

Trial website

Contact information



Primary contact

Dr Mark Paul-Clark


Contact details

Royal Brompton & Harefield NHS Foundation Trust
Sydney Street
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Role of TLR2 in the Sensing of oxidants and ensuing Inflammation: Implications for therapeutic Intervention - an observational study



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:

Ethics approval

Royal Brompton & Harefield NHS Trust Ethics Committee, 08/H0708/69

Study design

Observational study

Primary study design


Secondary study design

Case-control study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Immunology and inflammation


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



Not Applicable

Drug names

Primary outcome measures

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


Overall trial end date


Reason abandoned


Participant inclusion criteria

Healthy volunteer (either a smoker or non-smoker)

Participant type

Healthy volunteer

Age group




Target number of participants

Planned Sample Size: 100

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Royal Brompton & Harefield NHS Foundation Trust
United Kingdom

Sponsor information


Wellcome Trust (UK)

Sponsor details

Queen Square
United Kingdom

Sponsor type




Funder type


Funder name

Wellcome Trust (UK) ref: WT083429MA

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype



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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes