Ignite Creation Date:
2025-12-24 @ 4:00 PM
Ignite Modification Date:
2025-12-24 @ 4:00 PM
Study NCT ID:
NCT02952066
Status:
WITHDRAWN
Last Update Posted:
2021-06-14
First Post:
2016-10-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expressions of TRPV1 in Airway of Asthmatics
Sponsor:
Lu Yuan Lee
Organization:
Study Overview
Official Title:
Expressions of TRPV1 in Airway of Asthmatics
Status:
WITHDRAWN
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Prior to any participant enrollment, the PI opted to not move forward with the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRPV1
Brief Summary:
The purpose of this study is to measure the density of a temperature-sensitive protein, named TRPV1, in the airway mucosa tissue of both non-asthmatic and moderate to severe persistent asthmatic patients. This study may generate information for developing new therapeutic strategy.
Detailed Description:
The research procedure will be conducted at University of Kentucky A.B. Chandler Hospital dedicated bronchoscopy suite located on third floor of Pavilion H module room #2, and will be performed only once as part of a standard of care bronchoscopy procedure scheduled by the participants pulmonary physician. This entire study (biopsy) will add 10 minutes or less. Following the biopsy, and after being discharged from the hospital, the participant's study participation will end.
Bronchial Biopsy: The investigator will collect five lung (bronchial) specimens (1-2 cubic millimeters each) from three zones of the participant's airway which will be individually coded, and stored for the computer image analysis of TRPV1 in the investigator's laboratory. Following analysis the samples will be destroyed. The results of the analysis cannot be used for determining a clinical diagnosis. Therefore, the investigator will not provide any findings to either the participant or their physician.
Participants will not get any personal benefit from taking part in this study. Their willingness to take part in this research study, may, in the future help doctors better understand and/or treat patients with asthma.
There will be no cost to the participant for having the bronchial biopsy performed.
Participants will not receive any rewards or payment for taking part in the study.
Bronchial Biopsy: The investigator will collect five lung (bronchial) specimens (1-2 cubic millimeters each) from three zones of the participant's airway which will be individually coded, and stored for the computer image analysis of TRPV1 in the investigator's laboratory. Following analysis the samples will be destroyed. The results of the analysis cannot be used for determining a clinical diagnosis. Therefore, the investigator will not provide any findings to either the participant or their physician.
Participants will not get any personal benefit from taking part in this study. Their willingness to take part in this research study, may, in the future help doctors better understand and/or treat patients with asthma.
There will be no cost to the participant for having the bronchial biopsy performed.
Participants will not receive any rewards or payment for taking part in the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|---|
| U01AI123832 | NIH | None | https://reporter.nih.gov/quic… | View |