The Association of Transgelin-2, Metallothionein-2 and Ezrin With Asthma

Asthma Clinical Trial

Official title:

The Association of Transgelin-2, Metallothionein-2 and Ezrin With Asthma: A Case-control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05496582
• Other study ID #: SHUTCM-0806
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Lei-Miao Yin, MD
• Phone: 13774384237
• Email: collegeylm[@]shutcm.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Males or females, aged 14-75 years;

2. Patients with a definite diagnosis of bronchial asthma;

3. The diagnosis of asthma according to the Global Initiative for Asthma (GINA), with positive bronchodilator responsiveness (reversibility) test;

4. Healthy volunteers without respiratory symptoms such as cough, wheezing, chest tightness or dyspnea;

5. Agree with all procedures in this trial by signing a written informed consent form.

Exclusion Criteria:

1. Patients with chronic obstructive pulmonary disease or other airway disease;

2. 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;

3. Women who are known to be pregnant or breastfeeding;

4. Not willing to participate;

5. Psychiatric history and neurological disorders can not work normally;

6. Other conditions that the researcher considers inappropriate to participate in this study.

Related Conditions & MeSH terms

• Asthma

Intervention

Diagnostic Test:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Xiangya Hospital, Central South University	Changsha	Hunan
China	Yueyang Hospital, Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	National Natural Science Foundation of China, Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Two year
Primary	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)	Two year