Moderate Persistent AsthmaTRPV1NCT02952066
Expressions of TRPV1 in Airway of Asthmatics
A study testing Bronchial biopsy in people with Moderate Persistent Asthma and Severe Persistent Asthma, run by Lu Yuan Lee at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate Persistent Asthma, Severe Persistent Asthma, Nodule Solitary Pulmonary
- What is being tested?
- Bronchial biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2017to 20 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Medical Center
Lexington, Kentucky, 40536
About this study
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.
Read the 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.
- Conditions
- Moderate Persistent Asthma, Severe Persistent Asthma, Nodule Solitary Pulmonary, Pulmonary Atelectasis
- Being tested
- Bronchial biopsy
- Medical subject headings
- Solitary Pulmonary Nodule, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchial biopsyProcedure or surgery
Bronchial tissue taken during biopsy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bronchial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRPV1 density in airway mucosa tissue
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start20 Sep 2017
- Primary completion20 Nov 2018
- Study completion20 Nov 2018
Why it stopped: Prior to any participant enrollment, the PI opted to not move forward with the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Persistent AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lu Yuan Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lu Yuan Lee, University of Kentucky
- Investigators
- Lu-Yan Lee, PhD, Study chair, University of KentuckyMehdi Khosravi, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952066
- Sponsor's protocol ID
- 15-0349-F6A
- Other IDs
- U01AI123832
- Acronym
- TRPV1
- Status last verified
- Jun 2021
- First submitted
- 29 Oct 2016
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expressions of TRPV1 in Airway of Asthmatics
- ClinicalTrials.gov ID
- NCT02952066
- Acronym / sponsor ID
- TRPV1 / 15-0349-F6A
- Conditions
- Moderate Persistent Asthma, Severe Persistent Asthma, Nodule Solitary Pulmonary, Pulmonary Atelectasis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Prior to any participant enrollment, the PI opted to not move forward with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lu Yuan LeeUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRP1 Density | Experimental | Procedure: Bronchial biopsyBronchial Biopsy: During the biopsy procedure the investigator will collect five bronchial specimens (1-2 cubic millimeters) each the major, lobar and segmental bronchi. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchial biopsyBronchial tissue taken during biopsy | Procedure or surgery | TRP1 Density |
Primary outcome
TRPV1 density in airway mucosa tissue
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu-Yan Lee, PhD study chair
University of Kentucky
Mehdi Khosravi, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchial biopsy in people with Moderate Persistent Asthma and Severe Persistent Asthma, run by Lu Yuan Lee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TRPV1 density in airway mucosa tissue (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.