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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
Sponsor:
Information provided by (Responsible Party):
Lu Yuan Lee, University of Kentucky

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 Not Applicable

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma 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




Primary Outcome Measures :
  1. TRPV1 density in airway mucosa tissue [ Time Frame: one year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Lu Yuan Lee
Investigators
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Study Chair: Lu-Yan Lee, PhD University of Kentucky
Principal Investigator: Mehdi Khosravi, MD University of Kentucky

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Responsible Party: Lu Yuan Lee, Sponsor/PI, University of Kentucky
ClinicalTrials.gov Identifier: NCT02952066     History of Changes
Other Study ID Numbers: 15-0349-F6A
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Pulmonary Atelectasis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases