Response of Airway Cells to 20,000 EU of Endotoxin in Normal Adults

NCT00838851 | Terminated Phase 1

• 2 other identifiers: 03-1523 (GCRC 2040)1RC1ES018417
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Controls

Keywords

endotoxin; CCRE; LPS

Outcome Measures

Primary Outcomes (1)

• Neutrophil response (influx of PMNs to the airways as determined in sputum) after inhalation of CCRE (20,000 EU),

  0-24 hours post challenge

Secondary Outcomes (1)

• changes in PFT's and vital signs

  0-21 days post challenge

Study Arms (1)

CCRE

EXPERIMENTAL

Biological: Clinical Center Reference Endotoxin (CCRE)

Interventions

Clinical Center Reference Endotoxin (CCRE) BIOLOGICAL

Inhalation of 20,000 EU Clinical Center Reference Endotoxin (CCRE)

Also known as: LPS

CCRE

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599-7310, United States

Location

Study Officials

• David B Peden, MD, MS

  University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Director of CEMALB

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 9, 2009
• Study Start: August 1, 2003
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 8, 2012

Record last verified: 2012-10

Locations

US (1)