Expressions of TRPV1 in Airway of Asthmatics

Sponsor

Lu Yuan Lee (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02952066

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Moderate Persistent Asthma Severe Persistent Asthma Nodule Solitary Pulmonary Pulmonary Atelectasis	Procedure: Bronchial biopsy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

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 :

Sep 20, 2017

Actual Primary Completion Date :

Nov 20, 2018

Actual Study Completion Date :

Nov 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

TRPV1 density in airway mucosa tissue [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Competent to understand informed consent
Diagnosis of moderate to severe persistent allergic asthma.
Clinical need for diagnostic bronchoscopy for assessment of asthmatic symptoms (e.g., to assess presence of chronic infection with non-tuberculous mycobacteria or other infectious agents as a cause for lack of asthma control) or therapeutic bronchoscopy for management of asthmatic symptoms (e.g., thermoplasty).
Asthmatic subjects with history of positive skin test to confirm presence of allergy.
Asthmatic subjects with pre-albuterol forced expiratory volume in the first second (FEV1) of <70% of the predicted value.
Non-asthmatic patients will include those patients with solitary pulmonary nodules and healthy individuals with acute lung atelectasis (e.g. airway blocked by mucus plugs or foreign object).
Scheduled for a diagnostic or therapeutic bronchoscopy procedure.

Exclusion Criteria:

Inability to perform pulmonary function testing
Unstable asthma control for asthmatic subjects
An asthma exacerbation within the past month
History of intubation for asthma
History of smoking
History of prematurity
History of any lung disease or disorder except asthma
History of congenital or acquired heart disease
Pregnant/lactating females
Any serious concurrent systemic disease including but not limited to diabetes, coronary artery disease, vasculitis, etc.
History of heart arrhythmias including supraventricular tachycardia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky Medical Center	Lexington	Kentucky	United States	40536

Sponsors and Collaborators

Lu Yuan Lee
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair: Lu-Yan Lee, PhD, University of Kentucky
Principal Investigator: Mehdi Khosravi, MD, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lu Yuan Lee, Sponsor/PI, University of Kentucky

ClinicalTrials.gov Identifier:

NCT02952066

Other Study ID Numbers:

15-0349-F6A
U01AI123832

First Posted:

Nov 2, 2016

Last Update Posted:

Jun 14, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Asthma

Pulmonary Atelectasis

Study Results

No Results Posted as of Jun 14, 2021