Expressions of TRPV1 in Airway of Asthmatics (TRPV1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02952066|
Recruitment Status : Active, not recruiting
First Posted : November 2, 2016
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Moderate Persistent Asthma Severe Persistent Asthma Nodule Solitary Pulmonary Pulmonary Atelectasis||Procedure: Bronchial biopsy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Expressions of TRPV1 in Airway of Asthmatics|
|Actual Study Start Date :||September 20, 2017|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: TRP1 Density
Bronchial Biopsy: During the biopsy procedure the investigator will collect five bronchial specimens (1-2 cubic millimeters) each the major, lobar and segmental bronchi.
Procedure: Bronchial biopsy
Bronchial tissue taken during biopsy
- TRPV1 density in airway mucosa tissue [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952066
|United States, Kentucky|
|University of Kentucky Medical Center|
|Lexington, Kentucky, United States, 40536|
|Study Chair:||Lu-Yan Lee, PhD||University of Kentucky|
|Principal Investigator:||Mehdi Khosravi, MD||University of Kentucky|