Status:
COMPLETED
Nasal LPS Challenge in Healthy Volunteers
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
STUDY DESIGN AND METHODOLOGY This is a single-centre study which will be carried out at the Imperial Clinical Respiratory Research Unit (ICRRU) at St Mary's Hospital in London Paddington. RECRUITMENT...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02284074
Start Date
October 1 2010
End Date
April 1 2011
Last Update
September 15 2023
Active Locations (1)
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1
Imperial Clinical Respiratory Research Unit (ICRRU), St Mary's Hospital
Paddington, London, United Kingdom, W2 1NY