Expressions of TRPV1 in Airway of Asthmatics (TRPV1)

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.

Study Overview

• Status: Withdrawn
• Conditions: Pulmonary Atelectasis; Severe Persistent Asthma; Moderate Persistent Asthma; Nodule Solitary Pulmonary
• Intervention / Treatment: Procedure: Bronchial biopsy

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
TRPV1 density in airway mucosa tissue	one year

Collaborators and Investigators

• Sponsor: Lu Yuan Lee
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Actual): November 20, 2018
• Study Completion (Actual): November 20, 2018

Study Registration Dates

• First Submitted: October 29, 2016
• First Submitted That Met QC Criteria: October 29, 2016
• First Posted (Estimate): November 2, 2016

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Pulmonary Atelectasis; Asthma
• Other Study ID Numbers: 15-0349-F6A; U01AI123832 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No