Expressions of TRPV1 in Airway of Asthmatics
Status: | Active, not recruiting |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 2/17/2019 |
Start Date: | September 20, 2017 |
End Date: | June 2020 |
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.
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.
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.
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.
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
We found this trial at
1
site
740 South Limestone Street
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Phone: 859-323-6339
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