Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT00838851
Status:
TERMINATED
Last Update Posted:
2012-10-08
First Post:
2009-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Response of Airway Cells to 20,000 EU of Endotoxin in Normal Adults
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Range of Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Normal Adult
Status:
TERMINATED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no further funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 signs (temperature, pulse, respiratory rate, blood pressure), oxygen saturation, symptom score assessment and undergo spirometry to rule out acute illness prior to challenge. All female volunteers will undergo a urine pregnancy test. A similar examination will take place immediately prior to inhalation challenge with 20,000 EU of CCRE, as well as 30, 60, 120, 180, 240, 300 and 360 minutes and 24 hours after challenge (with the exception of a pregnancy test which will only be administered prior to sputum induction on study day 1). Induced sputum will be 24 to 48 hours prior to challenge, and again six hours after challenge on Study day 2. Sputum will be analyzed for PMN content, CD14 expression on airway macrophages and monocytes, soluble CD14 levels, cytokine levels in sputum and products of inflammatory cells (eosinophil, cationic protein, myeloperoxidase). Blood will be collected for a CBC and differential when the pre- challenge induced sputum is obtained and again 6 hours after challenge and 24 hours after challenge. Blood lymphocytes from a 10 ml aliquot will be assessed for lymphocyte subset and activation markers, as well as proliferative and cytokine responses. Blood will also be collected and will be assessed by whole blood assays for markers of inflammatory and immune activation (CD11b, CD14, CD64, CD16, HLA-DR, CD45, CD3, CD80, CD86, CD83, CD40) and function (phagocytosis and oxidative burst) by three color flow cytometry. Plasma will be separated from 4 ml and frozen at 70° C for future analysis of mediators of interest, such as cytokines, as well as other systemic effects of endotoxin.
Subjects will then be discharged to home with contact information for study staff. If a volunteer has an unexpected complication such as shortness of breath, decrease in pulmonary function, unstable vital signs or other he or she will be admitted to the GCRC for overnight observation. The next morning (study day 3) subjects will return to the CEMALB for a final set of vital signs, spirometry, symptom scoring, a venipuncture and an examination by a study physician.
Each volunteer will be given a symptom scoring sheet for each day up to 96 hours (4 days) after challenge.
Each sheet will include the name and phone number of the study coordinator and study MD. Sample home symptom scoring sheets and instructions are included with this protocol.
Between 48 and 96 hours after challenge, each volunteer will be called to determine their status, inquiring about symptoms, symptom scoring, and need for medication and/or physician visits.
Between 7 and 10 days of the challenge dose, each subject will be asked to return for a study discontinuation visit. At that time temperature, pulse, systolic and diastolic BP, respiratory rate, FVC and FEV1 and SpO2 (oxygen saturation), and symptoms scores will be assessed and, if abnormal, medical evaluation as directed by the study physician will be undertaken.
Subjects will then be discharged to home with contact information for study staff. If a volunteer has an unexpected complication such as shortness of breath, decrease in pulmonary function, unstable vital signs or other he or she will be admitted to the GCRC for overnight observation. The next morning (study day 3) subjects will return to the CEMALB for a final set of vital signs, spirometry, symptom scoring, a venipuncture and an examination by a study physician.
Each volunteer will be given a symptom scoring sheet for each day up to 96 hours (4 days) after challenge.
Each sheet will include the name and phone number of the study coordinator and study MD. Sample home symptom scoring sheets and instructions are included with this protocol.
Between 48 and 96 hours after challenge, each volunteer will be called to determine their status, inquiring about symptoms, symptom scoring, and need for medication and/or physician visits.
Between 7 and 10 days of the challenge dose, each subject will be asked to return for a study discontinuation visit. At that time temperature, pulse, systolic and diastolic BP, respiratory rate, FVC and FEV1 and SpO2 (oxygen saturation), and symptoms scores will be assessed and, if abnormal, medical evaluation as directed by the study physician will be undertaken.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1RC1ES018417 | NIH | None | https://reporter.nih.gov/quic… | View |