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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma
• Intervention / Treatment: Diagnostic test: No intervention

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Lei-Miao Yin, MD; Phone Number: 13774384237; Email: collegeylm@shutcm.edu.cn
• Study Contact Backup: Name: Jun-Tao Feng, MD; Phone Number: 13786145799; Email: jtfeng1976@csu.edu.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410000
      • Xiangya Hospital, Central South University
      • Contact: Jun-Tao Feng, MD; Phone Number: 13786145799; Email: jtfeng1976@csu.edu.cn
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Yueyang Hospital, Shanghai University of Traditional Chinese Medicine
      • Contact: Lei-Miao Yin, MD; Phone Number: 13774384237; Email: collegeylm@shutcm.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants with asthma or non-asthma

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Healthy participants	Diagnostic test: No intervention; No intervention
Asthma; Previously disgnosed asthma patients	Diagnostic test: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: National Natural Science Foundation of China; Xiangya Hospital of Central South University
• Investigators: Study Chair: Lei-Miao Yin, MD, Yueyang Hospital, Shanghai University of Traditional Chinese Medicine; Study Director: Jun-Tao Feng, MD, Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: SHUTCM-0806

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No