AsthmaNCT05496582
The Association of Transgelin-2, Metallothionein-2 and Ezrin With Asthma
An observational study of Asthma, run by Shanghai University of Traditional Chinese Medicine at 2 sites in China.
Trial summary
Asthma is one of the most common chronic respiratory diseases. Previous study found a series of differentially expressed genes and proteins (transgelin-2, metallothionein-2, ezrin) in asthmatic rat. The aim of the study is to investigate the changes and associations of these gene with asthma in human. Read more about this study
- Who is it for?
- Ages 14 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 14 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants with asthma or non-asthma
Who may be able to join
- Males or females, aged 14-75 years;
- Patients with a definite diagnosis of bronchial asthma;
- The diagnosis of asthma according to the Global Initiative for Asthma (GINA), with positive bronchodilator responsiveness (reversibility) test;
- Healthy volunteers without respiratory symptoms such as cough, wheezing, chest tightness or dyspnea;
- Agree with all procedures in this trial by signing a written informed consent form.
Who cannot join
- Patients with chronic obstructive pulmonary disease or other airway disease;
- Complicated with other severe primary diseases (including hypertension, cancer, hyperthyroidism, bronchiectasia, cardiac insufficiency) and conditions that would prevent participation in the trial or put the participant at risk;
- Women who are known to be pregnant or breastfeeding;
- Not willing to participate;
- Psychiatric history and neurological disorders can not work normally;
- Other conditions that the researcher considers inappropriate to participate in this study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Xiangya Hospital, Central South University
Changsha, Hunan, 410000
Jun-Tao Feng, MD, 13786145799, jtfeng1976@csu.edu.cn
- Not yet recruiting
Yueyang Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200030
Lei-Miao Yin, MD, 13774384237, collegeylm@shutcm.edu.cn
About this study
Official title: The Association of Transgelin-2, Metallothionein-2 and Ezrin With Asthma: A Case-control Study
Asthma is one of the most common chronic respiratory diseases. Previous study found a series of differentially expressed genes and proteins (transgelin-2, metallothionein-2, ezrin) in asthmatic rat. The aim of the study is to investigate the changes and associations of these gene with asthma in human.
Read the detailed description
This study will investigate the changes and associations in asthma. In this project, the investigators will explore the changes of gene expression of transgelin-2, metallothionein-2 and ezrin in asthma and investigate their correlation with current diagnosis markers of asthma, including pulmonary function, fractional exhaled nitric oxide,eosinophil counts,immunoglobulin E, interleukin-5, etc.
- Conditions
- Asthma
- Being tested
- No intervention
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDiagnostic test
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Previously disgnosed asthma patients Receives: Diagnostic Test: No intervention | |
| Control | Healthy participants Receives: Diagnostic Test: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in gene expression of transgelin-2, metallothionein-2 and ezrin between controls and asthmatic patients
PCR test of gene expression of transgelin-2, metallothionein-2 and ezrin between controls and asthmatic patients
Measured: Two year
Association of transgelin-2, metallothionein-2 and ezrin with asthma
Correlation analysis between gene expressions of transgelin-2, metallothionein-2, ezrin and current asthmatic tests (pulmonary function, fractional exhaled nitric oxide,immunoglobulin E, serum eosinophil counts, interleukin-5, etc)
Measured: Two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Nov 2022
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, National Natural Science Foundation of China
- Responsible party
- Sponsor
- Investigators
- Lei-Miao Yin, MD, Study chair, Yueyang Hospital, Shanghai University of Traditional Chinese medicineJun-Tao Feng, MD, Study director, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496582
- Sponsor's protocol ID
- SHUTCM-0806
- Status last verified
- Apr 2024
- First submitted
- 9 Aug 2022
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Transgelin-2, Metallothionein-2 and Ezrin With Asthma: A Case-control Study
- ClinicalTrials.gov ID
- NCT05496582
- Acronym / sponsor ID
- SHUTCM-0806
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, National Natural Science Foundation of China
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Aug 2022 (actual)
- 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.
Asthma is one of the most common chronic respiratory diseases. Previous study found a series of differentially expressed genes and proteins (transgelin-2, metallothionein-2, ezrin) in asthmatic rat. The aim of the study is to investigate the changes and associations of these gene with asthma in human.
Detailed description
This study will investigate the changes and associations in asthma. In this project, the investigators will explore the changes of gene expression of transgelin-2, metallothionein-2 and ezrin in asthma and investigate their correlation with current diagnosis markers of asthma, including pulmonary function, fractional exhaled nitric oxide,eosinophil counts,immunoglobulin E, interleukin-5, etc.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | Diagnostic Test: No interventionPreviously disgnosed asthma patients |
| Control | – | Diagnostic Test: No interventionHealthy participants |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with asthma or non-asthma
Key inclusion criteria (5 listed)
- Males or females, aged 14-75 years;
- Patients with a definite diagnosis of bronchial asthma;
- The diagnosis of asthma according to the Global Initiative for Asthma (GINA), with positive bronchodilator responsiveness (reversibility) test;
- Healthy volunteers without respiratory symptoms such as cough, wheezing, chest tightness or dyspnea;
- Agree with all procedures in this trial by signing a written informed consent form.
Key exclusion criteria (6 listed)
- Patients with chronic obstructive pulmonary disease or other airway disease;
- Complicated with other severe primary diseases (including hypertension, cancer, hyperthyroidism, bronchiectasia, cardiac insufficiency) and conditions that would prevent participation in the trial or put the participant at risk;
- Women who are known to be pregnant or breastfeeding;
- Not willing to participate;
- Psychiatric history and neurological disorders can not work normally;
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 |
|---|---|---|
| No interventionNo intervention | Diagnostic test | Asthma, Control |
Primary outcome
Difference in gene expression of transgelin-2, metallothionein-2 and ezrin between controls and asthmatic patients
Time frame: Two year
PCR test of gene expression of transgelin-2, metallothionein-2 and ezrin between controls and asthmatic patients
Association of transgelin-2, metallothionein-2 and ezrin with asthma
Time frame: Two year
Correlation analysis between gene expressions of transgelin-2, metallothionein-2, ezrin and current asthmatic tests (pulmonary function, fractional exhaled nitric oxide,immunoglobulin E, serum eosinophil counts, interleukin-5, etc)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Lei-Miao Yin, MD study chair
Yueyang Hospital, Shanghai University of Traditional Chinese medicine
Jun-Tao Feng, MD study director
Xiangya Hospital of Central South University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Shanghai University of Traditional Chinese Medicine at 2 sites in China.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei-Miao Yin, MD (13774384237, collegeylm@shutcm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in gene expression of transgelin-2, metallothionein-2 and ezrin between controls and asthmatic patients (time frame: Two year). The study lists 2 primary outcomes in all. 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 8 May 2024.