We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nasal LPS Challenge in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284074
First Posted: November 5, 2014
Last Update Posted: November 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Imperial College London
  Purpose

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 Intervention
Healthy Other: Nasal LPS spray

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Participant)
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)

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 15
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA

  • Males and females aged 18 to 60 years
  • Current non-smokers for last 6 months (<5 cigs per week), with a smoking history of <5 pack years
  • BMI 20-30 kg/m2

EXCLUSION CRITERIA

  • History of allergy
  • Upper airway infection in 2 weeks before screening
  • Lower respiratory tract infection in past 3 months
  • Treatment with local or systemic corticosteroids during previous 2 months
  • Signs or symptoms of chronic rhinitis, hypertrophy of turbinates, major septum deviation, nasal polyposis or recurrent sinusitis
  • Previous nasal or sinus surgery
  • Clinically significant cardiovascular, hepatic, GIT, renal, endocrine, infective, haematological, neurological, dermatological, neoplastic conditions, gastro-oesophageal reflux, depression, TB
  • Participation in a therapeutic drug trial in the prior 30 days.
  • Medical therapy other than that permitted for contraception.
  • Positive pregnancy test
  • Inability or unwillingness to use contraception if the patient is a female of child-bearing age.
  • History of drug abuse or urine test showing evidence of recreational drug abuse
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United Kingdom
Imperial Clinical Respiratory Research Unit (ICRRU), St Mary's Hospital
Paddington, London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
GlaxoSmithKline
Investigators
Principal Investigator: Trevor T Hansel, FRCPath, PhD Imperial College London
  More Information

Publications:
American Thoracic Society Workshop. Immunobiology of asthma and rhinitis. Pathogenic factors and therapeutic options. Am J Respir Crit Care Med 1999; 160(5 Pt 1):1778-87. (8) Gelfand EW. Inflammatory mediators in allergic rhinitis. J Allergy Clin Immunol 2004; 114(5 Suppl):S135-S138.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02284074     History of Changes
Other Study ID Numbers: ICRRU/2010/001
10/H0803/110, ICRRU/2010/001 ( Other Grant/Funding Number: CRO1595 )
First Submitted: September 19, 2014
First Posted: November 5, 2014
Last Update Posted: November 5, 2014
Last Verified: October 2014

Keywords provided by Imperial College London:
Lipopolysaccharide (LPS)
Biomarkers
Chemokines
Cytokines
Gene Expression
Nasal Challenge
Inflammation
Nasal
Nasosorption
Respiratory