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Expressions of TRPV1 in Airway of Asthmatics (TRPV1)

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ClinicalTrials.gov Identifier: NCT02952066
Recruitment Status : Withdrawn (Prior to any participant enrollment, the PI opted to not move forward with the study.)
First Posted : November 2, 2016
Last Update Posted : June 14, 2021
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Lu Yuan Lee, University of Kentucky

Tracking Information
First Submitted Date  ICMJE October 29, 2016
First Posted Date  ICMJE November 2, 2016
Last Update Posted Date June 14, 2021
Actual Study Start Date  ICMJE September 20, 2017
Actual Primary Completion Date November 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2016)
TRPV1 density in airway mucosa tissue [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Expressions of TRPV1 in Airway of Asthmatics
Official Title  ICMJE Expressions of TRPV1 in Airway of Asthmatics
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Moderate Persistent Asthma
  • Severe Persistent Asthma
  • Nodule Solitary Pulmonary
  • Pulmonary Atelectasis
Intervention  ICMJE Procedure: Bronchial biopsy
Bronchial tissue taken during biopsy
Study Arms  ICMJE 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.
Intervention: Procedure: Bronchial biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 9, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2016)
12
Actual Study Completion Date  ICMJE November 20, 2018
Actual Primary Completion Date November 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02952066
Other Study ID Numbers  ICMJE 15-0349-F6A
U01AI123832 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lu Yuan Lee, University of Kentucky
Study Sponsor  ICMJE Lu Yuan Lee
Collaborators  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
Study Chair: Lu-Yan Lee, PhD University of Kentucky
Principal Investigator: Mehdi Khosravi, MD University of Kentucky
PRS Account University of Kentucky
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP