Status:
TERMINATED
Response of Airway Cells to 20,000 EU of Endotoxin in Normal Adults
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
Healthy Controls
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the range of neutrophil response (influx of PMNs to the airways as determined in sputum) after inhalation of CCRE (20,000 EU).
Detailed Description
Twenty-four or forty-eight hours (study day 1) prior to the inhalation challenge, subjects will undergo a physical examination of the ears, nose, throat and chest and will have an assessment of vital ...
Eligibility Criteria
Inclusion
- Inclusion: Healthy, non-allergic, non-asthmatic 18-50 year old males and females with a \< 0.5 pack year history of tobacco use who have a negative allergy skin test, normal lung function, defined as (Knudsen 1976/1984 predicted set):
- FVC of \> 80 % of that predicted for gender, ethnicity, age and height
- FEV1 of \> 80 % of that predicted for gender, ethnicity, age and height
- FEV1/FVC ratio of \> 75% of that predicted for gender, ethnicity , age and height
- Oxygen saturation of \> 94 %,
- Normal blood pressure (Systolic between 150 - 90, Diastolic between 90-60 mm Hg),
- Symptom Score no greater than 6 (out of a possible 24) for total symptom score with a value no greater than 2 for any one score. No score may be greater than 2,
- Negative methacholine inhalation challenge.
- On the day of a challenge, body temperature must be no greater than 37.8 degrees, measured orally.
Exclusion
- A history of significant chronic illnesses (to include diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or asthma, hypertension).
- Allergy to any medications which may be used in the course of this study (albuterol, acetaminophen, aspirin or non-steroidal anti-inflammatory agents, corticosteroids, lactose).
- Positive pregnancy test within 48 hours of the time of challenge.
- Medications which may impact the results of the endotoxin challenge, interfere with any other medications potentially used in the study (to include steroids, beta antagonists, non-steroidal anti-inflammatory agents) or suggest an ongoing illness (such as antibiotics).
- Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 2 weeks.
- Unspecified illnesses, which in the judgment of the investigator increase the risk associated with endotoxin inhalation challenge, will be a basis for exclusion.
- Persons employed within the past 6 months in an occupation with high risk for endotoxin exposure (specifically persons working in a swine confinement facility, cotton storage or grain storage site)
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00838851
Start Date
August 1 2003
End Date
July 1 2012
Last Update
October 8 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UNC Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, United States, 27599-7310