Ignite Creation Date:
2024-05-05 @ 9:12 PM
Last Modification Date:
2024-10-26 @ 10:01 AM
Study NCT ID:
NCT00839124
Status:
COMPLETED
Last Update Posted:
2012-12-05
First Post:
2009-02-06
Brief Title:
A Study of Inhalation of 20000 EU CCRE in Normal Volunteers Compared to Allergic Asthmatic Individuals
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
A Study of Inhalation of 20000 EU Clinical Center Reference Endotoxin in Normal Volunteers Compared to Allergic Asthmatic Individuals
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Endomac
Brief Summary:
This will be a single center open label study comparing baseline characteristics of recovered sputum cells collected on screening day to those of cells recovered 6 hours after inhalational challenge with 20000 EU Clinical Center Reference Endotoxin CCRE a component of air pollution within each group as well as cross group comparisons between individuals with allergic asthma AAsand normal volunteers NVs The primary objective of this study is to test the hypothesis that persons with allergic asthma will have an increased neutrophil response to challenge with 20000 EU CCRE compared to normal volunteers Secondary objectives include post CCRE comparison between AAs and NVs with regard to changes in airway cells and blood as well as changes in mucociliary clearance MCC in response to inhalation of 20000 EU CCRE
Detailed Description:
This will be a single center open label study of allergic asthmatic and normal volunteers The protocol will compare baseline characteristics of recovered sputum cells collected on screening day to those of cells recovered 6 hours after inhalational challenge with CCRE within each group as well as cross group comparisons between AAs and NVs The following information indicates procedures to be performed at each visit as well as the anticipated duration of visits Subsequent to this description are details regarding specific study procedures
Visit 1 Baseline Visit 5 hours
1 Consent will be obtained review of subjects medical history current medications and inclusionexclusion criteria
2 Vital sign measurements temperature pulse respiratory rate blood pressure oxygen saturation and symptom scoring
3 Urine pregnancy test for women of child bearing potential
4 Spirometry
5 Venipuncture for CBC with differential and baseline blood analyses
6 Physical exam of the ears nose throat and chest
7 Collection of exhaled breath for measurement of nitric oxide level
8 Xenon equilibrium gas scan and MCC
9 MCC scan
10 Sputum induction
11 After completion of the sputum induction subjects will have brief MCC scan 10 minutes
Visit 2 24 hours post baseline subjects will return for the following 1 hour visit
1 Review any change in medical status over prior 24 hours vital signs O2 saturation and symptom score
2 Follow up MCC scan
Visit 3 24-48 hours prior to challenge visit at least 2 days after the baseline visit ½ hour
1 Review change in medical status since last visit vital signs oxygen saturation symptom score
2 Urine pregnancy test
3 Spirometry
Visit 4 Endotoxin CCRE challenge day 85 to 9 hours
1 Review any change in medical status since last visit
2 Vital signs oxygen saturation and symptom score
3 Spirometry
4 Physical exam of the ears nose throat and chest
5 If above measures are acceptable CCRE challenge will be performed
6 Post-challenge monitoring including spirometry vital signs oxygen saturation and symptom score at the following intervals post challenge 30 and 60 minutes and then hourly for 5 additional hours
7 Post challenge venipuncture blood draw for CBC with differential and post CCRE blood analyses
8 Collection of exhaled breath for measurement of nitric oxide level
9 Four hours post challenge subject will have MCC evaluated
10 After MCC is assessed sputum induction will be performed
11 After completion of the sputum induction subjects will have brief MCC scan 10 minutes
12 Discharge home or alternatively to GCRC for overnight observation per study MD
Visit 5 24 hours post challenge visit 1 hour
1 Subject returns to the CEMALB vital signs oxygen saturation and symptom score
2 Collection of exhaled breath for measurement of nitric oxide level
3 Spirometry
4 Follow-up MCC scan
5 Each volunteer will be given a symptom scoring sheet for each day up to 96 hours 4 days after challenge see accompanying symptom scoring sheet in Appendix 3
Post Challenge ObservationsReporting 5 minutes
1 Subjects will be contacted for phone call follow-up 48-96 hours after challenge see script Appendix 4 of accompanying protocol
Study discontinuation visit within 10 days of the challenge dose 15 minutes
1 Vital signs O2 saturation symptom score spirometry
2 If any findings are abnormal medical evaluation as directed by the study physician will be undertaken Appendix 1 of the accompanying protocol provides a summary table regarding procedures performed at each subject study visit
Visit 1 Baseline Visit 5 hours
1 Consent will be obtained review of subjects medical history current medications and inclusionexclusion criteria
2 Vital sign measurements temperature pulse respiratory rate blood pressure oxygen saturation and symptom scoring
3 Urine pregnancy test for women of child bearing potential
4 Spirometry
5 Venipuncture for CBC with differential and baseline blood analyses
6 Physical exam of the ears nose throat and chest
7 Collection of exhaled breath for measurement of nitric oxide level
8 Xenon equilibrium gas scan and MCC
9 MCC scan
10 Sputum induction
11 After completion of the sputum induction subjects will have brief MCC scan 10 minutes
Visit 2 24 hours post baseline subjects will return for the following 1 hour visit
1 Review any change in medical status over prior 24 hours vital signs O2 saturation and symptom score
2 Follow up MCC scan
Visit 3 24-48 hours prior to challenge visit at least 2 days after the baseline visit ½ hour
1 Review change in medical status since last visit vital signs oxygen saturation symptom score
2 Urine pregnancy test
3 Spirometry
Visit 4 Endotoxin CCRE challenge day 85 to 9 hours
1 Review any change in medical status since last visit
2 Vital signs oxygen saturation and symptom score
3 Spirometry
4 Physical exam of the ears nose throat and chest
5 If above measures are acceptable CCRE challenge will be performed
6 Post-challenge monitoring including spirometry vital signs oxygen saturation and symptom score at the following intervals post challenge 30 and 60 minutes and then hourly for 5 additional hours
7 Post challenge venipuncture blood draw for CBC with differential and post CCRE blood analyses
8 Collection of exhaled breath for measurement of nitric oxide level
9 Four hours post challenge subject will have MCC evaluated
10 After MCC is assessed sputum induction will be performed
11 After completion of the sputum induction subjects will have brief MCC scan 10 minutes
12 Discharge home or alternatively to GCRC for overnight observation per study MD
Visit 5 24 hours post challenge visit 1 hour
1 Subject returns to the CEMALB vital signs oxygen saturation and symptom score
2 Collection of exhaled breath for measurement of nitric oxide level
3 Spirometry
4 Follow-up MCC scan
5 Each volunteer will be given a symptom scoring sheet for each day up to 96 hours 4 days after challenge see accompanying symptom scoring sheet in Appendix 3
Post Challenge ObservationsReporting 5 minutes
1 Subjects will be contacted for phone call follow-up 48-96 hours after challenge see script Appendix 4 of accompanying protocol
Study discontinuation visit within 10 days of the challenge dose 15 minutes
1 Vital signs O2 saturation symptom score spirometry
2 If any findings are abnormal medical evaluation as directed by the study physician will be undertaken Appendix 1 of the accompanying protocol provides a summary table regarding procedures performed at each subject study visit
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U19AI077437-02 | NIH | None | httpsreporternihgovquickSearch5U19AI077437-02 |