Nasal LPS Challenge in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT02284074|
Recruitment Status : Completed
First Posted : November 5, 2014
Last Update Posted : November 5, 2014
The purpose of this study is to develop a nasal challenge model that causes a mild degree of inflammation, without causing any pain or symptoms, but that allows us to measure a variety of proteins in nasal secretions which causes inflammation in the nose. The nasal challenge model involves spraying the nostrils in the form of a fine mist with 4 different doses (1, 10, 30 and 100µg per nostril) of lipopolysaccharide (LPS) including a placebo. LPS is a type of protein which has been carefully purified from the outer cell wall of certain bacteria, is sterile and does not contain live bacteria, and will not cause infection.
The investigators will measure any inflammation in the nose by looking at cells collected by washing the inside of the nose (nasal lavage) and placing small strips of paper in the nasal cavity. The paper absorbs the nasal fluid and the chemicals produced during inflammation and can be extracted from the paper and analysed in the laboratory. The investigators will also be collecting a small amount of nasal epithelium taken by way of a nasal scrape; this is done by using a Rhinoprobe, a small plastic curette which is used to scrape a small piece of lining of the nose. The investigators hope that information obtained from this study will be used in future studies that will test new study drugs designed to treat diseases of the airways and lungs ( like asthma and chronic obstructive pulmonary disease (COPD) and hay fever.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: Nasal LPS spray||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Nasal Lipopolysaccharide (LPS) Challenge in Healthy Volunteers (HVs): Investigation of Tolerability, Dose Response and the Expression Profile of Intercellular Adhesion Molecule-1 (ICAM-1)|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Experimental: Nasal LPS spray
This is a 5-way crossover, randomised, placebo-controlled study.
Arms consists of the following nasal challenges:
placebo, 1, 10, 30 and 100µg LPS.
Other: Nasal LPS spray
LPS solution (250µl) will be prepared at 10, 100, 300 and 1000µg/ml, 100µl is administered to each nostril, both nostrils will be sprayed. The dose per nostril corresponds to 1, 10, 30 and 100µg.
- Level of nasal mucosal inter-cellular adhesion molecule-1 (ICAM-1) by gene expression analysis [ Time Frame: 8 hours following nasal lipopolysaccharide (LPS) challenge ]Measurement of gene expression (mRNA) for inter-cellular adhesion molecule-1 (ICAM-1) in nasal mucosal curettage samples, 8h following nasal lipopolysaccharide (LPS) challenge.
- Nasal mucosal lining fluid IL-1beta levels after nasal lipopolysaccharide (LPS) challenge [ Time Frame: Up to 8h after nasal LPS challenge ]Nasal mucosal IL-1beta levels after LPS challenge (area under curve, 0 to 8h) will be compared to placebo responses (AUC, 0-8h) in nasal mucosal lining fluid
- Nasal mucosal lining fluid IL-6 levels after nasal lipopolysaccharide (LPS) challenge [ Time Frame: Up to 8h after nasal LPS challenge ]Nasal mucosal IL-6 levels after LPS challenge (area under curve, 0 to 8h) will be compared to placebo responses (AUC, 0-8h) in nasal mucosal lining fluid
- Nasal mucosal lining fluid CXCL8 levels after nasal lipopolysaccharide (LPS) [ Time Frame: Up to 8h after nasal LPS challenge ]Nasal mucosal CXCL8 levels after LPS challenge (area under curve, 0 to 8h) will be compared to placebo responses (AUC, 0-8h) in nasal mucosal lining fluid
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284074
|Imperial Clinical Respiratory Research Unit (ICRRU), St Mary's Hospital|
|Paddington, London, United Kingdom, W2 1NY|
|Principal Investigator:||Trevor T Hansel, FRCPath, PhD||Imperial College London|