Nasal LPS Challenge in Healthy Volunteers

Launched by IMPERIAL COLLEGE LONDON · Nov 3, 2014

Keywords

ClinConnect Summary

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 The study will recruit a total of 15 healthy participants.

STUDY VISITS The study will involve a total of 11 outpatients visits. The screening visit is the initial visit where the study is discussed with the participant and written informed consent is obtained by the PI or his designee. This is done prior to performing any study related procedures. The participant will have had the study info...

Gender

ALL

Eligibility 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