Expressions of TRPV1 in Airway of Asthmatics

NCT02952066 | Withdrawn

• 2 other identifiers: 15-0349-F6AU01AI123832
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• TRPV1 density in airway mucosa tissue

  one year

Study Arms (1)

TRP1 Density

EXPERIMENTAL

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

Interventions

Bronchial biopsy PROCEDURE

Bronchial tissue taken during biopsy

TRP1 Density

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lu Yuan Lee: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lu-Yan Lee, PhD

  University of Kentucky

  STUDY CHAIR

• Mehdi Khosravi, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor/PI

Study Record Dates

• First Submitted: October 29, 2016
• First Posted: November 2, 2016
• Study Start: September 20, 2017
• Primary Completion: November 20, 2018
• Study Completion: November 20, 2018
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)