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Expressions of TRPV1 in Airway of Asthmatics (TRPV1)

Primary Purpose

Moderate Persistent Asthma, Severe Persistent Asthma, Nodule Solitary Pulmonary

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bronchial biopsy

About this trial

This is an interventional basic science trial for Moderate Persistent Asthma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Kentucky Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TRP1 Density

Arm Description

Bronchial Biopsy: During the biopsy procedure the investigator will collect five bronchial specimens (1-2 cubic millimeters) each the major, lobar and segmental bronchi.

Outcomes

Primary Outcome Measures

TRPV1 density in airway mucosa tissue

Secondary Outcome Measures

Full Information

NCT ID

NCT02952066

First Posted

October 29, 2016

Last Updated

June 9, 2021

Sponsor

Lu Yuan Lee

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT02952066

Brief Title

Expressions of TRPV1 in Airway of Asthmatics

Acronym

TRPV1

Official Title

Expressions of TRPV1 in Airway of Asthmatics

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Prior to any participant enrollment, the PI opted to not move forward with the study.

Study Start Date

September 20, 2017 (Actual)

Primary Completion Date

November 20, 2018 (Actual)

Study Completion Date

November 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lu Yuan Lee

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Moderate Persistent Asthma, Severe Persistent Asthma, Nodule Solitary Pulmonary, Pulmonary Atelectasis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TRP1 Density

Arm Type

Experimental

Arm Description

Bronchial Biopsy: During the biopsy procedure the investigator will collect five bronchial specimens (1-2 cubic millimeters) each the major, lobar and segmental bronchi.

Intervention Type

Procedure

Intervention Name(s)

Bronchial biopsy

Intervention Description

Bronchial tissue taken during biopsy

Primary Outcome Measure Information:

Title

TRPV1 density in airway mucosa tissue

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lu-Yan Lee, PhD

Organizational Affiliation

University of Kentucky

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mehdi Khosravi, MD

Organizational Affiliation

University of Kentucky

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kentucky Medical Center

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Expressions of TRPV1 in Airway of Asthmatics

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